Modern Pharmaceuticals - March 2012 by Infomedia18

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Editorial

Budget 2012: Reforms on fast track?

ith this year’s Union Budget around the corner, and more importantly, its potential upshots for the near future, it will be pertinent to do a dipstick on some of the recent developments – both global and national – that can significantly impact the pharmaceutical sector. Also, it will be prudent to take strategic steps for the road ahead.

First, let’s touch upon the global scenario. The macroeconomic deceleration of recent times is primarily owing to sovereign debt issue in certain geographies rather than industry/company-specific financial meltdown as was experienced in 2008-09. This means there are good as well as bad news. The good part is that the extent of the meltdown pulling down businesses may not be as globally widespread as it was the last time; hence, there will still be some emerging growth markets, albeit with a slow pace of progress. However, the bad news is that no one is yet clear about how long this business dampener will draw out, and what if this malignancy spreads to other geographies. As far as India is concerned, the government’s policy paralysis seems to drag on with some of the crucial misses being the deferral in implementation of Goods and Services Tax (GST) and Direct Tax Code (DTC). However, recently things have picked up some pace as the government has reportedly been able to obtain in-principle approval from all state governments on implementation of GST.

Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair

From a sectoral perspective, it is expected on the part of the government to undo preferably all the benefits that were withdrawn in the last year’s Budget, in order to ensure a level playing field in the market atleast for a certain period. Besides, the Finance Ministry will do well in keeping overall policies stable and by making growth-centric tax amendments. All these should be in line with the Pharma Vision 2020 for India wherein it is envisioned to become one of the most attractive destinations for end-to-end drug discovery and innovation. That said, the forthcoming Union Budget will be an opportune moment for the policy-makers to make a decisive beginning, perhaps the second phase of economic liberalisation, and leave a long-lasting impression on the economy as well as the industry. Read on and stay tuned for more on this in the next edition.

IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Manas R Bastia manas@infomedia18.in

March 2012 I Modern Pharmaceuticals

Contents

REGULAR SECTIONS

In Conversation With Manish Doshi President, Indian Drugs Manufacturers Association and MD, Amoli Organics Pvt Ltd

Special Focus

Budget Wishlist .............................. 31

5 10 22 26 69 71 75 76 86 87

Editorial News, Views & Analysis Technology & Innovation Technology Transfer Projects Event List Book Review Products List of Products List of Advertisers

Automation Trends Tax incentives ............................................................... 32

Process Analytical Technology The less explored opportunities...................................58

R&D incentives ............................................................ 34 Interface - Dr Rajesh Jain ............................................... 36

Energy Management

Roundtable .................................................................... 38

Carbon neutrality Inching closer to the green dream ..............................60

Policies & Regulations

Facility Visit

Policies governing drug counterfeiting Rigorous implementation: The way forward ...............64

IKA India Pvt Ltd Capitalising on the India advantage

Strategy

Insight & Outlook

Pharma SMEs ...................... 43

What’s new in pharma marketing? Selective pampering ...................................................66 Dr Rajan T D, Pharma Consultant & Practising Dermatologist

Tips & Tricks Patent prosecution tips Factors to be considered before ﬁling a patent............68 Kamakhya Srivastava, Head-Group on Research Publication and Programme, LEX ORBIS IP Practice

SMEs growth story ........................................................ 44 Role of bankers and government ..................................... 46 SMEs in South India ..................................................... 48

Event Report BioAsia 2012 Targetting the vaccine and drug discovery market......73

SMEs in spotlight .......................................................... 50 Interface - Jagdeep Singh................................................ 52

Highlights of Next Edition

Roundtable .................................................................... 54

Special Focus: IT in pharma Insight & Outlook : Cleanrooms

Thyroid cancer therapeutics market ................................. 55 Case Study - Fighting counterfeits .................................. 56

March 2012 I Modern Pharmaceuticals

Details on page no. 30

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

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March 2012 I Modern Pharmaceuticals

News,Views & Analysis Suresh Kare steps down as the MD, Indoco Indoco Remedies has recently announced a change of leadership with the appointment of Aditi Kare Panandikar as the Managing Director (MD) and Sundeep Bambolkar as joint MD of the company. Aditi took over the coveted position from Suresh Kare who has stepped down from the post. However he informed that he would be retaining the position as the Chairman of the company. Suresh Kare has been handling the responsibilities of the company for the last ﬁve decades and has been instrumental in positioning the company as one of the top pharma companies in the country today. He informed that seeing Indoco’s growth over the years and the swift changes that is taking place in the industry it was high time to hand over the responsibilities to

L-R: Bambolkar, Kare and Panandikar

a younger and competitive generation. Commenting on the changing roles, Aditi Kare Panandikar said, “I am very happy with this decision as it had been my dream to take up this position, wherein I can contribute my share in the company’s

IIHMR and OPPI organise conclave on human resource strategy in pharma sector To emphasise the need for selecting the right people to man the innovationled pharma industry, the Indian Institute of Health Management Research (IIHMR) conducted a National Conclave on ‘Human Resource Management in Pharmaceutical Industry: Challenges and Future Directions’. The Organization of Pharmaceutical Producers of India (OPPI) lent active support for this step taken to analyse the importance of Human Resources in a

start-up, budding or a wellestablished pharma company. S D Gupta, Director, IIHMR, said, “By introducing courses such as hospital and pharma management, IIHMR strives to resolve the issue of talent crunch by producing wellqualified students capable of making a real difference in the field of pharma, by preparing them for the corporate roles,” added Gupta. The goals for human resources are talent development, employee retention and conflict management.

growth and development.” She added, “The company has plans to expand its business and explore new business ventures focussed on propelling and pushing the company towards its growth trajectory. Bambolkar, Joint MD, Indoco Remedies, informed that the company aims to grow the domestic formulations business accounting for about 65 per cent of the revenues and aggressively to expand its presence. “Our vision is to grow the international business by more than 50 per cent year on year in the next four to ﬁve years. For this the peripheral support systems such as trained technical manpower and manufacturing facilities approved by the most advanced regulatory agencies are already in place,” informed Bambolkar.

Aanjaneya Lifecare acquires Apex Drugs and Intermediates Mumbai-based Aanjaneya Lifecare Ltd, a leading manufacturer of bulk drugs, recently announced that the company has acquired Apex Drugs and Intermediates Ltd (ADIL), an integrated API and pharma intermediates manufacturing company based in Hyderabad. The acquisition was valued at ` 250 crore; with debt of ` 185 crore and equity dilution of ` 65 crore. Aanjaneya Lifecare Ltd has acquired ADIL’s assets, businesses, clients, licensees, employees and has merged both the companies’ operations, becoming a fully integrated formulation company. The company will also leverage the strong relations of ADIL developed in Asia, Europe, UAE & Latin America for exports. The acquisition also gives Aanjaneya an entry in Hyderabad market. Post acquisition, Aanjaneya Lifecare will have approximate sales of ` 700 crore with EBITDA of ` 130 crore and total long term debt in books of about ` 220 crore against net worth of ` 365 crore.

Ranbaxy opens manufacturing facility in Morocco Ranbaxy Morocco has announced the opening of its new manufacturing facility at Casablanca, Morocco, paving the way for a direct business presence in North Africa. With the successful audit of the facility by the Moroccan Health Authorities, Ranbaxy Morocco is now authorised to commence manufacturing of its products at its Casablanca facility. The achievement of this milestone positions Ranbaxy to access a $1 billion pharmaceutical market in Morocco.

Mahendra Bhardwaj, Head, Africa, Ranbaxy, said, “Ranbaxy has a signiﬁcant presence in Africa with its own ground operations in key markets. Morocco is one of the important markets and this manufacturing facility further reinforces our commitment to the people of Morocco and the African continent.” In addition to servicing the Morocco market, Ranbaxy also plans to extend the supply from this manufacturing unit to other African

countries, in the coming years. Ranbaxy has a strong presence in Africa. With the addition of Morocco, the Company now has three manufacturing facilities in Africa; the other two located in Nigeria and South Africa respectively. With five subsidiaries, five representative offices and a strong workforce of nearly a 1,000 people, Ranbaxy’s distribution network caters to 44 of the 54 countries in this continent.

Modern Pharmaceuticals I March 2012

News,Views & Analysis Dr K Anji Reddy honoured with Lifetime Achievement award Dr K Anji Reddy, Founder and Chairman, Dr Reddy’s Laboratories Ltd, has been honoured with the Lifetime Achievement in Health Award in the Asian Voice Political & Public Life Awards for 2012 at London for his lifetime commitment to medical research and improving the lives of others. Voted by a committee of Members of Parliament in Britain, this award is an annual event hosted by The Asian Voice, a weekly. The award ceremony was hosted at the Members’ Dining Room in the House of Commons, London.

Dr Reddy

Sun Pharma honoured at CNBC-TV18 CFO Awards 2012 Sudhir Valia, Director, Sun Pharma, was awarded the Best Performing CFO in the pharma/healthcare sector in an award ceremony hosted by CNBC-TV18. The event witnessed many prominent names from the industry such as Y M DeosthaleeChairman & Managing Director-L&T Finance

Holdings; Keki Mistry, Vice Chairman & Chief Executive Oﬃcer, HDFC Ltd among others. Speaking on the occasion, Udayan Mukherjee, Managing Editor, CNBC-TV18 said, “It takes intuition, leadership and vision to guide India’s corporates through the current turbulent phase.”

Dr Reddy’s launches of ziprasidone hydrochloride capsules Dr Reddy’s Laboratories has launched ziprasidone hydrochloride capsules, a bioequivalent generic version of Geodon® in the US market following the approval by the US FDA of Dr Reddy’s ANDA for ziprasidone hydrochloride capsules. The Geodon® brand had US sales of approximately $ 1.34 billion for the most recent twelve months ending December 2011 according to IMS Health.

Satish Reddy, MD & COO, Dr Reddy’s Laboratories Ltd, who collected the award on behalf of his father, also shared a note of thanks by Dr Reddy on the occasion. On receiving the award, Dr Reddy said, “I thank Keith Vaz, Member of Parliament, Britain and host and the organisers of this event for the recognition. I consider myself to be fortunate that my country had given me the opportunity to participate in the advent of aﬀordable medicine in India.”

Sourabh Mishra joins Sorento Healthcare as Business Strategy Consultant Sorento Healthcare Communications Pvt Ltd has brought Sourabh Mishra on board as Business Strategy Consultant.Mishra meanwhile also continues as Chief Strategy Oﬃcer at Saatchi & Saatchi, India. Talking about his new association, Mishra said, “The opportunity to Mishra enhance the value of Sorento’s communication solutions in healthcare by better integrating the strategic planning process is exciting. Sorento has already moved much beyond conventional mass media-based communications. In that context, the task is also to see how we can better integrate the various oﬀerings it has, in order to provide more holistic solutions to clients.”

IPC holds symposium for global quality standards for biologics and SCM India’s role as a leading ﬁgure in global pharma manufacturing brought together regulators, manufacturers and other stakeholders in global public health at the 11t IPC-USP Science & Standards Symposium on February 22–23 in Mumbai. Hosted by the Indian Pharmacopoeia Commission (IPC) and the US Pharmacopoeial Convention (USP), the nearly 400 attendees explored ways in which science and quality standards can help ensure good quality medicines in India and throughout the world. Symposium co-sponsors were the Association of Biotechnology Led Enterprises, the Bulk Drug Manufacturers Association, the Indian Drug

Manufacturers Association, the Indian Pharmaceutical Association, and the Organization of Pharmaceutical Producers of India. “When it comes to medicines, good quality begins with good science,” said Dr Praveen Tyle, Executive Vice President and Chief Science Oﬃcer, USP. Topics of discussion included therapeutic proteins, another important class of drugs for India’s growing biologics manufacturing sector; strategic perspectives on biotechnology products in developing countries; the role of bioassays in biosimilars; and the replacement of animal studies for potency testing of human vaccines. Dr V Srini Srinivasan, Executive Vice President, International Sites and

Standards, USP and moderator for the symposium’s opening session, said, “Increasingly sophisticated discoveries in science are leading to dramatic insights into health and disease, and the pharma community plays a key role in translating those advances into medical solutions that will help patients worldwide. At the same time, those in pharma and regulatory circles in India— and throughout the world—must look to increasingly robust measures to protect the quality of pharma products sourced and developed through a complex network of global partnerships and supply chains.” -Chandreyee Bhaumik

Modern Pharmaceuticals I March 2012

News,Views & Analysis Brenntag opens new head office in India Brenntag, the global leader in chemical distribution, inaugurated its new head office in Mumbai. This new office represents Brenntag’s continued commitment to invest in India and to ensure the company has ample room for its planned growth over the next few years. At the inauguration of the new office, Steve Holland, CEO, Brenntag Group, said, “India is a key market in Brenntag’s global strategy. By expanding our local presence in major cities such as Mumbai, we are supporting

Brenntag Indian team welcomes Holland

our strategy of being the leading chemical distributor in both specialty and industrial

chemicals. We already have a strong foothold in India and we expect to take advantage of the high growth potential in the growth market.” The new head office has a space area covering 15,000 sq ft and will have room for more than 100 employees. At present, there are 44 employees based at the new office, In addition,Brenntag has offices and distribution facilities in Baddi, Bengaluru, Chennai, Gurgaon, Haridwar and Hyderabad. -Chandreyee Bhaumik

Espicom launches Espicom Interactive

TAKE Solutions announces global release of PharmaReady 5.0

Espicom Business Intelligence, has recently announced the launch of Espicom Interactive. For many companies the cost of business information represents a significant investment. Its practical use in defining commercial strategy and in understanding market environment is critical to success. However, the value of such investments is really beneficial if the service empowers staff to greater efficiency in its use. Espicom Interactive is a new service that combines Espicom’s class-leading information services with an online delivery that is feature rich in user benefits saving time and money. Eric Wigart, Chairman, Espicom, stated, “We understand that customers need critical information for their practical day-to-day planning and development work. Such information is to be used, not just read. For 30 years Espicom has been at the forefront of meeting the informational needs of clients, and with the launch of Espicom Interactive we can save them a whole lot of time and effort in using it.”

TAKE Solutions Ltd has announced the availability of PharmaReadyTM 5.0, a web-based regulatory compliance solution suite for Life Science organisations to ensure faster approvals for their new products. The latest version introduces new document management features, and delivers technology framework upgrades to enhance scalability, response time, and ease-of-use. PharmaReady 5.0 supports submissions to Swissmedic (in addition to US FDA, Heath Canada and EMEA). It comes with an improved dashboard for easier navigation and management of documents from a centralised location, provides more visibility and control of e-document/e-submission processes, and introduces new

functionalities including drag and drop for quicker document uploads. In addition, PharmaReady 5.0 includes an enhanced, highly scalable technology framework allowing the suite to run seamlessly on any Microsoft platform. Ram Yeleswarapu, President and CEO, TAKE Solutions, said, “TAKE Solutions has understood the pulse of the life sciences market and has worked persistently towards achieving the goal of better value to our customers. Having used both our IT expertise, as well as our domain knowledge, we are proud to release the upgraded version PharmaReady 5.0.” He added, “PharmaReady is a stable and growing product line that has been consistently delivering value to our customers across the globe.”

Prayas launches disease awareness programmes Prayas, the social welfare initiative of Sanofi, launched its first disease awareness programme that focusses at empowering doctors in rural India with the latest developments and updates in medicine. It engages medical experts from tier I cities to help develop a course curriculum that is aligned to the needs of rural doctors. Further, these experts train a select pool of ‘mentors’ who are expert doctors from tier II towns who in turn then coach rural doctors or the ‘mentees’. Dr Viraj Rajadhyaksha, Associate Director, Medical Affairs and Prayas initiatives, Sanofi,

Dr Rajadhyaksha

said, “We aim at bridging the diagnosistreatment gap through a structured continuing education programme for rural doctors across India.

The ‘Prayas’ workshops are diﬀerent from other Continuing Medical Education (CME) programmes as the focus is not on a molecule or brand.” He added, till now, over 6,300 Prayas workshops have been conducted in 14 states of India. A total of 564 mentors guide 11,500 mentees who are registered on the programme. The programme aims to cover 1,00,000 mentees by 2015. Prayas would continue in its mission of facilitating healthcare to rural interiors through expansion of mentees covered in next ﬁve years. -Chandreyee Bhaumik

Modern Pharmaceuticals I March 2012

News,Views & Analysis Sanofi Pasteur partners with Emcure Pharmaceuticals for anti-rabies vaccine ‘Verorab’ Sanofi Pasteur, a vaccines division of Sanofi, has announced the formalisation of a marketing and distribution pact with Pune’s Emcure Pharmaceuticals for the anti-rabies vaccine - Verorab. The product will be imported and supplied by Sanofi Pasteur India Pvt Ltd and then it marketed and distributed by Emcure via its subsidiary, Zuventus Healthcare, according to Sanofi. Both the firms will be jointly working to increase the awareness on rabies vaccination

at the general practitioner and physician level, which is the first point of contact for patients and caregivers in regard to rabies exposure risk. Zuventus Healthcare will be promoting Verorab across India to more than 60,000 physicians and general practitioners. Verorab is a purified vero cell rabies vaccine and it has been unveiled by Sanofi Pasteur in 1987 in India. Since then, over 25-million doses of Verorab have been disbursed in India.

Panacea Biotec launches polio virus vaccine in Nigeria Panacea Biotec, India’s leading vaccine manufacturer launched POLPROTEC (an enhanced potency, inactivated poliovirus vaccine) in Nigeria in collaboration with Emzor Pharma, Nigeria. On this occasion, Panacea Biotec and Emzor announced a joint Planet Polio-Free Mission statement ‘To contribute towards achieving the goal of global polio eradication and to ensure that no child will ever again be paralysed by WPV or Vaccine-Derived Polio Virus (VDPV) by providing complete portfolio of Oral Polio Vaccines (OPV) & Inactivated Polio Vaccine (IPV) & IPV-based combination vaccine at an aﬀordable price’. Dr Rajesh Jain, Joint MD, Panacea Biotec, said, “Panacea Biotec foresaw the need of IPV during the end game of polio eradication programme long back and launched the vaccine in India in 2008. We are now taking this vaccine to other polio endemic countries and are pleased to launch POLPROTEC® in Nigeria. In 2011 till week 39, 30 cases of Acute Flaccid Paralysis (AFP) has been reported in Nigeria.

Ranbaxy crosses $2 billion in global sales Ranbaxy recently took on record the audited results for the quarter and year ended December 31, 2011. Commenting on the business results, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “I am delighted to share with you that Ranbaxy is the first pharma company of Indian origin to have surpassed sales of $ 2 billion. We successfully launched atorvastatin, generic Lipitor® in the US. I am satisfied with the progress we are making in resolving the long standing issues with the US regulators. The settlement with the US FDA and provision for eventual penalties that the DOJ may levy, brings greater predictability to our business in the US, one of our largest markets.” “During the year, we laid emphasis on strengthening our processes, focussing R&D efforts on our chosen therapies, working towards improving manufacturing efficiencies and costs, re-evaluating our brand marketing strategy and directing our energies at markets of greater importance.” Indian pharma business recorded sales of ` 19,513 million ($ 412 Mn), a growth of 7 per cent for the year. Of this, Consumer Healthcare or the OTC business recorded sales of ` 3,110 million ($ 67 million), a growth of over 20 per cent for the year.

Pfizer recalls Prevnar 13 pneumococcal vaccine Drugmaker Pﬁzer Inc is recalling one lot of its blockbuster vaccine against pneumococcal disease, Prevnar 13. The lot is being recalled from a drug wholesaler as the active ingredient was past its expiration date. The company says none was distributed to health care providers. Prevnar 13 protects against 13 strains of pneumococcal bacteria, which can cause meningitis, pneumonia and ear infections.

Life Technologies introduces machine capable of genome sequencing within 2 hour and at less than ` 50,000 Life Technologies Corporation, a California-based company announced the launch of its new benchtop Ion ProtonTM sequencer powered by Ion TorrentTM semiconductor in India that is enabled to whole genome sequencing of both human and plants in a day at the fraction of its current equipment and running costs. This device will be able to read an entire human gene at ` 50,000 in about two hours, as opposed to the earlier devices that required days to process an entire gene and at a cost

of $5,000 to 10,000. In India, this is the only technology present that is capable of providing this service at such a low price and fast speed. “The Indian market is a fast growing market and much of the worldwide pharmaceutical industry is positioning itself here in India,” says Gregory T Lucier, Chairman & CEO, Life Technologies. The company has spent almost $1 billion in the development of this semiconductor sequencer. Lucier

pointed out, “Cancer is the disease of the DNA but mostly up until now when somebody contracts that disease we are not reading the DNA to ﬁgure out what the right therapy is. With this technology we will be able to read somebody’s DNA who is suﬀering from cancer and develop a holistic approach for his/her treatment. This technology will also be useful to stop spread of infectious disease outbreaks.” -Titash Roy Choudhury

Modern Pharmaceuticals I March 2012

News,Views & Analysis Elder launches three female personal hygiene products Drug firm Elder Pharmaceuticals has launched three female personal hygiene products in India as part of its in-licensing pact with a US based firm, Combe Inc. The company has introduced the ‘Vagisil’ range of feminine personal hygiene products in India, in association with New York-based Combe Inc, a global brand leader in feminine care, Elder Pharma said in a statement. The Mumbai-based firm, which has in-licensed the range from Combe Inc, is introducing three key solutions, Vagisil anti-itch creme, Vagisil intimate

feminine wash and Vagisil intimate feminine lubricant, it added. Commenting on the development, Alok Saxena, Joint Managing Director, Elder Pharma said, “The Vagisil range of feminine Saxena hygiene products has been launched in India keeping in mind growing day-to-day problems of women, including vaginal itching, dryness, odour, irritation, burning and discharge. It is a new segment, something which

Strides Arcolab announces US FDA approval for its Brazilian facility Strides Arcolab Ltd (Strides) had announced that it has received US FDA approval for its ‘Brazilian Sterile Penems’ facility, which manufactures sterile dry powder injectables of Penems. The plant has already been approved by other international regulatory agencies such as MHRA and ANVISA and with this approval the company is in a position to commercialise products worldwide in the second half of 2012. The approval is also the ﬁrst US FDA approval for an international facility of Strides. The approval and commercialisation of the

products, which are already licensed to partners worldwide are expected in the second half of 2012. Commenting on the occasion, Venkat Iyer, CEO, Agila Specialties, said, “This approval for our Brazilian Sterile Penems manufacturing facility in the niche domain is another milestone in positioning Agila as a leading global injectable player”. Carbapenems are a class of βlactam antibiotics with a broad spectrum of antibacterial activity and one of the last resorts for many bacterial infections. The global market size for Penems is approximately $ 2 billion.

is new to the Indian market. So, it presents a huge opportunity for us.” According to the company, Vagisil anti-itch creme acts as an external itch reliever and soothes irritated skin and helps reduce further irritation. “It contains benzocaine, a fastacting itch reliever that works directly on the nerves to stop external feminine itching, burning and irritation,” said Roberta Bloom, Director of Product Safety and Scientiﬁc Support, Combe Inc.

Glenmark recalls select lot of oral contraceptive in US Glenmark Pharmaceuticals had issued a voluntary nationwide recall in the US for seven lots of its oral contraceptive norgestimate and ethinyl estradiol tablets due to a packaging error.The recall is issued by the company’s US arm Glenmark Generics Inc for tablets in strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, Glenmark Pharma said in a statement. “The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch,” it added. As a result of the error the daily regimen for these oral contraceptives could leave women consumers in US at risk for unintended pregnancy, the company said. It, however, did not mention the financial implications of the recall exercise.”At this time, there remains sufficient supply of unaffected lots of material in the marketplace to support demand, Glenmark said.

Novozymes Biopharma wins Technology Innovation Award for ground-breaking half-life extension platform Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, received the 2012 Drug Delivery Partnerships™ (DDP) Technology Innovation Award for the company’s half-life extension platform. The albumin-based technology platform offers the potential to enhance patient quality of life through tailoring drug circulatory half-life to meet specific medical needs. “The albumin-based technology is adaptable and can be used for both genetic fusion (Albufuse® Flex) or conjugation (Recombumin® Flex), providing a unique ability to decrease or increase a drug’s half-life. Clearly, this will help manufacturers to develop pharmaceuticals with enhanced pharmacokinetic properties, offering more favorable dosing regimes and improving patient compliance, while reducing healthcare costs,” said Dave Mead,

Business Development Director, Novozymes Biopharma. Lack of patient adherence to prescribed medications poses a tremendous challenge to the global healthcare community. The main reasons cited for poor compliance include patients’ forgetfulness and factors such as the route of administration. To overcome these issues, the technology exploits the natural interaction between albumin and the neonatal Fc receptor (FcRn). This exciting half-life extension technology enables drug manufacturers to design new eﬃcacious products, or life-cycle manage existing drugs, with longer serum half-life, reduced toxicity and improved pharmacokinetic proﬁles. As a result, the frequency of injections a patient receives or even the amount of drug delivered can be reduced. Modern Pharmaceuticals I March 2012

News,Views & Analysis Clinical reference laboratory strengthens its position in Asia Clinical Reference Laboratory (CRL), a global leader in the provision of central laboratory services for the clinical trials industry, has announced the full integration of its long-standing laboratory partner Phoenix Pharma Central Services in Singapore. The integration of Phoenix’s testing platforms into CRL’s proprietary Global LIMSystem enhances CRL’s support of clinical trials in Asia through improved eﬃciencies, increased quality, reduced costs and full global project oversight. Tim Sotos, Chief Executive Oﬃcer, CRL, said, “We have a trusted relationship

with Phoenix, having worked together for over a decade supporting a large number of clinical trials globally. “By incorporating Phoenix’s data into our centralised Global LIMSystem it allows for both sites and clinical teams to access their data throughout the world using CRL’s proprietary web-based ‘OASIS’ systems. This provides drug development companies with direct oversight on the status of their trial and allows them to evaluate drug safety on a real-time basis.” Through CRL’s globally implemented IT system, every clinical trial sample drawn anywhere in the world will immediately

be entered into its LIMSystem to assure real time global tracking of any specimen. Dr Yan Lee, Chief Executive Oﬃcer, Phoenix Pharma Central Services, said, “Together we are well positioned to provide support to pharmaceutical and biotechnological industries in the development of drugs and medical devices. ”Tim Sotos added, “The partnership also means our clients will receive the utmost local experience working with laboratories in every continent. Importantly the innovative execution of a sound business model allows us to fully streamline our global operations.”

AstraZeneca weighs options for Indian unit

Sartorius Stedim Biotech in pact with Trace Analytics

AstraZeneca Plc is considering options for its Indian unit, including buying the remaining 10 percent of AstraZeneca Pharma India Ltd in order to secure full ownership in a key emerging market. International companies have until mid-2013 under Indian regulatory rules to either reduce their stake below 75 percent or delist their Indian operations, after buying out minority shareholders. “We continue to consider two options, reducing our shareholding to the new statutory maximum of 75 percent and delisting,” said a company spokeswoman in London. An earlier report in a leading newspaper citing two people familiar with the matter, said that AstraZeneca was planning to delist and was in talks with top investment banks lifted shares in the Indian unit more than 5 percent. With a market value of around $ 1.1 billion, buying out the rest of AstraZeneca Pharma India would be well within AstraZeneca’s reach. The company had cash reserves of $ 7.6 billion at the end of December.

Sartorius Stedim Biotech (SSB) has entered into a private label agreement with Trace Analytics. This contract grants SSB exclusive global rights to market, distribute and BioPAT Trace service BioPAT Trace, the new online analysing system. BioPAT Trace is a glucose-lactate analyser used for monitoring and controlling both pilot-scale and process-scale fermentation and cell cultivation processes. The system measures the concentrations of the two analytes glucose and lactate simultaneously, in real time and online. BioPAT Trace can be integrated into either

single-use or reusable stainless-steel bioreactors. Thanks to its single-use sensors and microﬂuidic elements, it is immediately ready to use. The system enables reliably sterile, automated sampling, by either ﬁltration or dialysis, from the bioreactor. Mario Becker, Director, Marketing, PAT and Automation, Sartorius, said, “With BioPAT Trace, we are expanding our PAT portfolio by an important component. The new glucose-lactate analyser provides our customers with real-time information about their critical process parameters, helping them to further optimise and automate their processes.”

Sanofi and the Institut Pasteur create four prestigious awards to support innovative biomedical research Sanofi and the Institut Pasteur recently announced the creation of the SanofiInstitut Pasteur awards to encourage scientific excellence in the service of health. €480000 will support four innovative research projects demonstrating real progress in the life sciences and providing answers to major healthcare problems, more specifically in four fields: neglected tropical diseases, vaccine innovation, drug

resistance, and therapeutic approaches to ageing and regenerative medicine. The jury comprises seven prestigious members: Prof Peter C Agre, John Hopkins University, Baltimore, United States, Nobel Prize in Chemistry - 2003; Prof Elizabeth H Blackburn, University of California, San Francisco, Nobel Prize in Medicine - 2009; and many others. “With these awards, the Institut Pasteur

conﬁrms its commitment to the greater interest by encouraging research, notably in conditions aﬀecting the most vulnerable populations and diseases sharply on the rise in the world,” said Alice Dautry, President, Institut Pasteur. Candidates can submit their applications by April 20, 2012. The prizes will be awarded in November 2012 at the Institute Pasteur in Paris.

Modern Pharmaceuticals I March 2012

Technology & Innovation

3M’s filtration system offers a robust convenient solution for biomanufacturing customers

Pharmspective launches knowledge management apps

The Zeta Plus Encapsulated System (EZP) from 3M features a unique, easy-to-use pivot action. Addressing the demand for reliable, high-quality disposable depth filtration, EZP raises the bar in terms of ergonomics; capsule design and dual zone filter media, which is optimal for cell culture clarification and the removal of host cell derived impurities. “EZP is the latest addition to our industry-leading Zeta Plus product line that has been used by customers in the biotechnology and pharmaceutical industries for more than 35 years,” commented Lynne Deakin, Field Applications Specialist, 3M’s CUNO Filtration business. Adding to this he said, “It has been developed in response to requirements for a disposable depth filtration solution that allows loading and unloading at waist height so operators don’t have to lift capsules above their heads and risk exposure to fluid spills when handling used capsules.”

Pharmspective, a specialty therapeutics firm has recently launched a syndicated research offering and knowledge management application. The organisiation is going to launch a number of knowledge management applications that will allow subscribers to view and interact with real-time market intelligence through stateof-the-art user interfaces on PC and tablets. The company’s syndicated research studies will examine clinical decision-making, drug acquisition, access and reimbursement, and patient administration for specialty therapeutics in autoimmune diseases and oncology. “We are excited to launch the knowledge management applications in response to dramatic changes in new product development within the pharmaceutical industry,” announced Stephen Reid, Managing Partner and Co-Founder, Pharmspective. Adding to this Katie Derdeyn, MD, Managing Partner and Co-Founder, Pharmspective, said, “In designing our knowledge management apps, we have examined every factor that might play a role in the decision to develop or utilise a specialty therapeutic. Our product offerings follow specialty therapeutics from drug development through patient administration, and this focus will allow us to help our clients build a broad understanding of the markets in which they wish to enter and compete.”

Realise cost savings with the new DisiTest 50 DisiTest 50 disintegration tester from Dr Schleuniger® Pharmatron incorporates innovative induction heating technology and combines it with the benefits of automation to realise cost savings by significantly streamlining the disintegration testing process. The DisiTest 50 automatically detects the disintegration time of tablets and capsules in full compliance with current Pharmacopoeia. Visual monitoring of the disintegration process by the operator is not required. Induction heating technology reduces heating times to only 3-5 minutes and DisiTest 50 completely eliminates unproductive cleaning times typically associated with conventional water bath-based systems. DisiTest 50 ensures precise and homogeneous temperature control. Test medium temperature is monitored continuously by a contact-free infrared sensor and recorded for reporting purposes. The DisiTest 50 can be extended to a fully automatic disintegration testing system with up to four independent testing stations and one MediaPrep station - all controlled via the touch screen of the master station. Because individual testing stations are connected using state-of-the-art TCP/IP technology, system layout is flexible and retrofitting additional stations is possible anytime.

New technology to monitor crystal formation Researchers at the University of Leeds have come up with a technology that could help the pharmaceutical industry in controlling crystal formation during the process of drug development. The pharmaceuticals are often received in the crystalline form and the crystal structure can get altered due to the undetected ﬂuctuation in the system. This could cause changes in the

structure and pose a threat to the safety and eﬃcacy of the desired product. Also, there are chances that the drug might get delayed in reaching the market. As the composition of drug molecules are growing more complex by each passing day the real challenge is involved in processing the components to obtain the desired results. According to Dr Robert Hammond, Researcher,

“Here comes into play the potential of their technology. It makes possible monitoring of the crystals during their formation inside reactor, a phenomenon that was not thought of before. The technology uses powder X-ray diﬀ raction, which monitors the crystal structure while the crystalline form passes through a temperature controlled ﬂow cell.”

Modern Pharmaceuticals I March 2012

Technology & Innovation Lens produces hours of scientific work in seconds A new form of microscope which can produce results in seconds is being developed by researchers at the University of Strathclyde in Glasgow. Scientists are creating a lens which will be capable of showing three-dimensional images within cells and tissues at the same time as showing the whole organism. The innovative Mesolens – the only device of its kind in the world - will be able to capture detail in organisms which are too big to be examined satisfactorily by existing microscopes

Human ﬂea

and will oﬀer a deeper insight into areas such as cancerous tissues and the cortex

Next-generation HTS microplate reader BMG Labtech, a leading developer and manufacturer of microplate reader instrumentation for academic and pharmaceutical research, as well as highthroughput screening applications has come up with a technology called PHERAstar FS. This is the ultimate multi-detection microplate reader for HTS and assay development, especially where speed and sensitivity are imperative. The PHERAstar FS is based on the highly successful PHERAstar Plus with all of the outstanding features that one would expect from the ultimate HTS microplate reader. The technology also incorporates unique tandem technology, using an ultra-fast UV/Vis spectrometer (220 nm – 1,000 nm) for absorbance measurements and highly sensitive, filter-based detection in all modes including fluorescence intensity, FRET, fluorescence polarisation, time-resolved fluorescence, UV/Vis absorbance and luminescence.

Cryo Store and Transposafe present the KelvinBox T900 series for UN3373 dry ice shipments Cryo Store and Transposafe have announced the launch of the KelvinBox T900 series the packaging solution for all your UN3373 dry ice shipments. The KelvinBox T900 packaging systems series has been developed specifically for dry ice shipments of UN3373 biological substance, category B specimens, compliant with ADR/ICAO/IATA P650 packaging instructions. Standard UN3373 P650 sealbags are well suited for road transport (ADR), but do not meet the tight regulations of IATA for airtransportation. For this reason, Transposafe®, a specialist in the security sealing of valuable consignments, has developed the Transposafe AirSealbag®, the first-of-its-kind that guarantees leak-proof shipments at temperatures of -79°C (dry ice conditions). The KelvinBox T900 temperature-controlled packaging line is the result of combined know-how and years of experience within both companies. Available in different sizes, for sending a few tubes of sample material up to several vial boxes, with clear packaging instructions and test reports, the KelvinBox T900 series is a complete packaging solution with a well maintained balance between regulatory compliance and costs. The KelvinBox T900 series is available in different sizes, for shipping different quantities of sample material.

of the brain. Dr Gail McConnell, a Reader at the Strathclyde Institute of Pharmacy and Biomedical Sciences, a partner in research said, “Our research ﬁts with Strathclyde’s ethos of technical innovation with universal impact. We already have the two-dimensional technology for the lens in place, but a third dimension will allow us to take the revolutionary step of presenting images with a range and versatility which no single imaging platform can currently oﬀer.”

Bio-Rad launches multiplex immunoassays for hum T-helper Bio-Rad Laboratories has launched new magnetic bead– based multiplex immunoassays for human T-helper type 17 (Th17) cytokines and cancer biomarkers. The Bio-Plex Pro™ immunoassays take advantage of the magnetic bead workﬂow to simplify assay preparation and reduce variability. The Bio-Plex Pro human Th 17 cytokine panel is designed to detect 16 soluble proteins involved in the Th17 immune response pathway. The Bio-Plex Pro human cancer biomarker panel 1 detects 16 biomarkers commonly associated with cancer. These assays are designed to help preclinical and clinical researchers investigate mechanisms of disease and therapeutic drug action. The technology features nine new targets, including IL17F, IL-21, and IL-22, which are commonly requested by researchers, as well as IL-17 A/F, which is unique to Bio-Rad. The Th17 cytokines are believed to play a key role in inﬂammatory conditions such as autoimmune diseases, antimicrobial immunity, transplant rejection, and cancer.

Modern Pharmaceuticals I March 2012

Technology Transfer As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,lâ&#x20AC;&#x2122;-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring

device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint Venture, technology licensing, research partnerships

Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine

Forms of transfer Joint venture, technical services, technology licensing Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side-effects are reported to be the advantages of this product. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Process of preparation of nanoparticles for drug delivery system The present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application Medical and pharma industry Forms of transfer Technology licensing Pharmaceutical composition for the treatment of ophthalmic disease A company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Lithium chloride alone helped in proliferation of retinal cells but is associated with other effects. Areas of application Pharma and medical industry Transfer terms Consultancy, technical services, technology licensing

Modern Pharmaceuticals I March 2012

Technology Transfer

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater. Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others

Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others Manufacture of intravenous fluids A company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials. Areas of application

Pharma/medical Forms of transfer Others

Extract of medicinal and aromatic plants A company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others

Manufacturing technology of hepatits B, tetanus, diphtheria and pertussis vaccines An Indian company is interested in a complete technology for start up of manufacturing of combination vaccines from bulk to formulations including supply of protocols for manufacturing and production strains. Areas of application Human vaccines Transfer terms Others

IV fluid manufacturing as SME An Indian company needs new and good technology to start manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others

Manufacturing of liquid bio fertilisers An agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered (ie the product, efficacy, length of field trial) and a procedure of buying the technology along with the cost incurred.

Areas of application Biotechnology Transfer terms Others Manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid, D-biotin A company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotin Areas of application API/bulk drug Forms of transfer Others Pharma grade mannitol know-how A company is on the look out for a commercially proven latest technology & know how (turnkey) for manufacturing pharma grade mannitol in India. The estimated production capacity is 600 tonnes per annum. Areas of application Pharmaceuticals Forms of transfer Others Pharmaceutical Lyophilisation plant A Peru based company is looking for a Lyophilisation plant for pharmaceutical use. Capacity shall be around 175 to 200 square feet, for the lyophilisation of 20,000 vials of 10 mL per day. Areas of application Pharma and food processing industry Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016, Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org, For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

Share and Solicit Technology The mission of Modern Pharmaceuticals is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharmaceuticals, Infomedia 18 Ltd, â&#x20AC;&#x2DC;Aâ&#x20AC;&#x2122; Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: spedit@infomedia18.in

March 2012 I Modern Pharmaceuticals

In Conversation With: Manish Doshi

“One should focus on growth, and on all the input factors that lead to resultant growth,” …says Manish Doshi, President, Indian Drugs Manufacturers Association & Managing Director, Amoli Organics Pvt Ltd. Here, he reminscences his journey. Chandreyee Bhaumik

Photo: Joshua Navalkar

Modern Pharmaceuticals I March 2012

Manish Doshi Elaborate on your journey to become the President of IDMA

What are your views on today’s investment in R&D?

The journey has been an interesting one. I had an exciting student life. Since my family was already into the pharma business, I was keen to join this industry. I graduated in pharmacy and did my post graduation in Financial Management from Jamnanalal Bajaj Institute of Management, Mumbai. Frankly, I was a good scorer always. I am managing my family business since the last 28 years. The Amoli Group of Companies manufacture API and formulations. The group exports to more than 80 countries. My father has been my constant source of inspiration. He was very active socially. Professionally, he was in a signiﬁcant position. He was the President of the Chemists and Druggists Association and had started various businesses that I have subsequently grown. I always believe that starting is more challenging than taking it further. Further, through this journey I was privileged to interact with some of the leaders of the pharma industry such as Dilip Shanghvi of Sun Pharma and many other dignitaries.

Investment in the R&D of pharma industry is much better than most other industries in India. So by that benchmark, one cannot say that it is less. Again, the kind of profitability that Indian companies can enjoy in branded generics also put a little constraint or limitation that a company can do. Of course, the situation is different with the global giants or innovator companies such as Pfizer and Glaxo. Their profitabilities are huge because of the innovation models that they follow.

With a Presidential position comes a lot of responsibilities. How does it feel? While on one side, it certainly is exciting, on the other it is a huge responsibility. Today, the industry is growing reasonably well by 15 per cent and by and large the industry has been successful in catering to the diverse needs of the vast population. I have been associated with IDMA for the last 15 years. I was appointed as the Vice-President in 2007. Thus, it has been my constant focus to create the right environment so that the healthy growth continues or maybe further accelerates. This involves interaction with the government to ensure a healthy environment. In this context policies are formulated. Sometimes even at the operational levels there are issues that need to be brought to the attention or need to be sorted out. Apart from the interaction with the government there can be other things such as seminars, workshops that give the right exposure to the appropriate segments of the industry. It must be remembered that the industry comprises diﬀerent enterprises ranging from small to medium and large, and thereby the needs also diﬀer. So, it is our responsibility as an association to ensure that all needs are attended to.

March 2012 I Modern Pharmaceuticals

How does one live up to the legacy? There are no radical new strategies as such. One should focus on growth, and on all the input factors that lead to the resultant growth. There should be constant seminars, workshops, gatherings. These are the aspects that empower the members and ultimately result in the development of industries. Constant eﬀorts should be made to ensure that the government policies are in place and the medicines are accessible to the interiors. When Indira Gandhi, the then Prime Minister decided to go for Patent Act, it only resulted in process patent protection. Product patents were not under this purview. This has resulted in so many companies introducing products in India; developing the products, reverse engineering the products. Therefore, it is always a combination of the environmental and the inherent internal factors. Even today, if we consider ourselves to be the emerging powers it is important to delve deeper into the reasons. We are fortunate to have so many eﬃcient educational boards such as Delhi University, Mumbai University and many others. The leaders at that time gave importance to education. This forms the strength of the nation otherwise we would also be like any other African country. There are few aspects that must be remembered as far as the pharma industry in India is concerned. In India, medicines are most economical. Second, the industry has been growing in 15 per cent value terms and more in volume terms. Third, we are not only catering to the vast population of this country but India is also the exporter to more than 150 countries across the globe. So, if one looks at these yardsticks then one can give almost 9 out of 10 to pharma industry. Further, if one is

Quick Takes Success mantra: Hard work and smart work Favourite book: Atlas Shrugged by Ayn Rand Qualities important in a professional: Caliber, sincerity and reliability Interests and passions: Travelling. I am fortunate to have travelled to more than 60 countries talking about segments such as formulations, Active Pharmaceutical Ingredient (API) then it is not possible to segregate the segments on a priority basis. Therefore, formulation of appropriate government policies is what deserves immediate action.

What are your views on today’s student group? Any message for them? Our industry has either pharma students or the students from other related ﬁelds such as medicinal chemistry. They are the backbone of our industry. We are a knowledge-based industry and human resources is the most important component. There is a large amount of talented pharma students. They enter the industry and become major contributors. Thus, today, even if substantial number of pharma graduates is going abroad we are not having any shortage of pharma professionals. Additionally, it is true that most of the professional courses have disconnected with the actual job scenario. So, it would be useful if there is six months of paid internship during the B Pharm or M Pharm. There are enough opportunities both on the technical as well as marketing side post graduation. On the former side, there are scopes on production, Quality Control, quality assurance, regulatory aﬀairs and R&D is also a huge area. Patents will gain prominence over the years. Again, over a period of 10 years IPR will also become important.

Next 5 years? Personally our company that is in formulation is doing quite well. We do have plans for aggressive growth. From the overall association (IDMA) point of view,even though my term for President will be near completion (two years), whatever I am supposed to contribute to I will continue to do so. (chandreyee.bhaumik@infomedia18.in)

Special Focus

Budget Wishlist Tax incentives Never too late for too much ...................................................32 R&D incentives Will innovation and R&D get a boost?..................................34 Interface Dr Rajesh Jain, Chairman CII National Committee on Biotechnology & Joint MD, Panacea Biotec Ltd ...................................................36 Roundtable Will the Union Budget 2012 be SME friendly? ......................38

March 2012 I Modern Pharmaceuticals

Special Focus: Tax incentives

Never

too late for too much The pharma industry hopes that Budget 2012 will match its expectations and inject the much needed dose of tax incentives. While the wish list varies, the common dream remains getting good tax incentives.

Chandreyee Bhaumik

s we are gradually nearing the Budget season, individuals associated with the pharma industry, directly or indirectly, are tormented with the regular questions. Will the 2012-2013 Union Budget ultimately oﬀer solutions to the frequently faced questions or concerns of the industry? Will the Budget this year help the pharma industry in occupying the front seat globally? Since the Assembly polls in ﬁve states will be completed on March 6, the Government of India recently declared that the Budget session of Parliament will be convened on March 12, and the 2012-13 Union Budget will be presented on March 16. With the approaching

date, the fears and wishes of the pharma fraternity reaches a high crescendo.

Budget expectations There are several demands and expectations as far the tax incentives for the pharma industry are concerned. The Central Government may incentivise the pharma industry by lowering the taxes and duties on life-saving products such as drugs and Active Pharmaceutical Ingredient (API) to provide an impetus to the growth and development of the industry. Discussing his expectations and demands from the Union Budget, Kayvanna Shah, Chief Executive Oﬃcer, J B SEZ Pvt Ltd, explains, “From Special Economic Zones’ (SEZs) point of view, we hope that the upcoming Budget provides grandfathering provisions to all existing and upcoming SEZs and

unit-holders for a prolonged period. Let us not forget that SEZs have been one of the growth drivers for exports generated and various players have made immense investments keeping in mind the fiscal incentives and concessions offered earlier. Though certain benefits were withdrawn in the previous Budget, it would augur well for all if the Finance Ministry at least provides a level playing field to current players till a specific period.” Continuing in the same vein, he elaborates, “We also expect that certain extra SOPs and incentives would be offered for industrial zones coming up in rural hinterland for industrialisation of various states. This will have a magnifying effect on various industries since it would boost investments from all corners and concerned entities would consider developing in such areas.”

Modern Pharmaceuticals I March 2012

Tax incentives

Tax benefits should be provided for units engaged in the business of R&D and contract manufacturing by way of deduction from profits linked to investments.

We also expect that certain extra SOPs and incentives would be offered for industrial zones coming up in rural hinterland for industrialisation of various states. Kayvanna Shah Chief Executive Oﬃcer, J B SEZ Pvt Ltd

Talking about the expectations from the Union Budget, Tapan J Ray, Director General, Organisation of Pharmaceutical Producers of India (OPPI), says, “Setting up infrastructure involves substantial financial investment and a long gestation period. Hence, tax benefits should be provided for units engaged in the business of R&D and contract manufacturing by way of deduction from profits linked to investments.” He continues, “If India has to emerge as a low-cost healthcare medical tourism destination then there is a greater need to setup state-of-the-art healthcare facilities in the metros, tier-I and tier- II cities for which adequate direct tax incentives are to be provided.”

Tapan J Ray Director General, Organisation of Pharmaceutical Producers of India (OPPI)

Countervailing Duty (CVD)/ central excise duty to 1 per cent or 5 per cent to make it at par with drugs. This would help in making the said beneficial products affordable to the common man.” He adds that all life-saving drugs (including medical devices) should be exempted from customs duty. All equipment meant for diagnostic purposes and consumables thereof should be completely exempted from the levy of customs/central excise duty. CVD should be charged at a lower rate of 1 per cent on import of vaccines, specified medicaments and health supplements imported into India. BCD rate on import of formulations should be reduced to 5 per cent.

to 5 per cent. Further, he adds that an abatement of 45-50 per cent is necessary to enable pharma industry to cover its costs while calculating the central excise duty payable. Continuing in this vein, he says, “This abatement should be increased to 45-50 per cent as the current 35 per cent abatement does not even cover the trade margins, the value of R&D costs and other costs associated with the pharma industry such as distribution of many medicines (eg, vaccines) through ‘cold chain’.” Further, commenting on the ValueAdded Tax (VAT), Ray adds that the tax rate of 4-5 per cent on medicines and the list of tax-exempt goods and declared goods should be uniform across all states.

Central Excise Duty and VAT Customs duty There are also expectations as far as indirect taxes are concerned. Elaborating on customs duty, Ray says, “Basic Customs Duty (BCD) for health supplements should be reduced to 10 per cent and

According to Ray, the central excise duty rate of API (primary raw material for pharma formulation manufacturers) should be rationalised and made at par with pharma goods, ie, excise duty on the inputs should be reduced from 10 per cent

Pre-Budget expecta ons Segment

Previous Budget

Expectations

Tax incentives in pharma

Government proposed to levy Minimum Alternate Tax (MAT) of 18.5 per cent on the book proﬁts of Special Economic Zone (SEZ) developers and units

Provisions to all existing and upcoming SEZs and unit-holders for a prolonged period

Rectifying the lapse There were several diverse reactions to the previous Budget (2011-2012). Hopefully this Budget will rectify the situation. Signing off Shah says, “We were clearly taken aback by the Union Budget last year that imposed Minimum Alternative Tax (MAT) and Dividend Distribution Tax (DDT) on SEZ developers and unit-holders. This meant that few of our prospective clients had to rethink on their expansion plans with regards to setting up new units in SEZs. However, if the Finance Ministry can spur the investment climate by acting on reforms and offering incentives linked to investments, the situation shall certainly improve from here. We hope in respect of Direct Tax Code, full applicability of the existing SEZ scheme is enabled to all SEZs notified till a determined cut-off date.” (chandreyee.bhaumik@infomedia18.in)

March 2012 I Modern Pharmaceuticals

Special Focus: R&D incentives

Will innovation and R&D get a boost? With the Union Budget around the corner, it is time for pharma companies to chalk out their list of expectations. R&D incentives, in different forms, top the wish list of most of the pharma companies.

tax liability on a ` 400 crore income. This was 150 per cent till FY 2009 and in the last Budget it was increased to 200 per cent. Additionally, weighted deductions for payments inter-alia made to National Laboratory or a University or a speciﬁed person for the purpose of approved scientiﬁc research programme has increased from 175 per cent to 200 per cent. The Budget can provide a new drug delivery system for such dosage by extending weighted deduction for R&D activity beyond 2012 and provide incentives for the core R&D activity players. More importantly, there are enough claims that India spends less on R&D than it ought to. According to various expert reports, in India the spending on R&D is approximately 2 per cent of Gross Domestic Product (GDP) compared unfavourably with 3-4 per cent in advanced countries.

Expectations for this year

Chandreyee Bhaumik

ith time India has emerged as a hub for various collaborative and outsourced R&D activities. Along with this, there is a fundamental shift in the strategies of Indian pharma companies from ‘business-driven research’to ‘research-driven business.’ With the Budget coming soon there is constant focus whether the government will support the pharma industry and catalyse its growth to become global numero uno. Needless to say, the growth chart of the industry is dependent on extensive research capabilities and new product development, and major companies are looking forward for incentives in the same.

The present scenario Last year the Union Budget (2011-12) did not satisfy several industry insiders, especially pertaining to its R&D allowances. There was no extension provided on the weighted deduction on the in-house R&D that stands at 200 per cent and available till FY 2012. This was indeed a case of disappointment for the pharma companies that are actively involved in R&D activities. Weighed deduction on the in-house R&D means an Indian pharma company performing in-house R&D will get tax exemption on the amount spent. The exemption would be the double of what they spend on R&D. For example, when a company spends ` 200 crore on R&D it will have no

Indian pharma industry aspires to occupy the front seat with special emphasis on innovation and R&D. Undoubtedly, India has the potential required to be one of the countries with the highest levels of intelligence in its products. Thus, there should be eﬀorts to double the percentage that is spent on R&D over the next few years. Discussing the wish list from the Budget, Nidhi Saxena, Founder, President & CEO, Karmic Lifesciences, shares, “I expect a huge thrust to be given to R&D activities, including clinical research and stronger promotion for scientiﬁc and research infrastructure development in this year’s Union Budget. Next, the healthcare sector should be given an infrastructure status with zero duty on R&D equipment and a longer tax-free allowance on pharma and biotech SEZs. Additionally, R&D and clinical research activities should be incentivised by providing a 5-year tax holiday on all products developed in-house, extension of weighted deduction on R&D on all research-related services.” Over the past few years the pharma industry of the country has witnessed

Modern Pharmaceuticals I March 2012

R&D incentives

There are a lot of things that are required for R&D such as chemicals, raw materials and many others. So, there should be tax exemption on all the goods that are used for R&D.

R&D and clinical research activities should be incentivised by providing a 5-year tax holiday on all products developed in-house, extension of weighted deduction on R&D on all research-related services. Nidhi Saxena Founder, President & CEO, Karmic Lifesciences

steady growth. Today, it is considered as one of the sectors that is continuously driving the Indian growth story. Identifying this success story, the Department of Pharmaceuticals has come up with ‘Pharma Vision 2020’ in order to make India one of the attractive destinations for end-to-end drug discovery and innovation. Talking about the benefits that the R&D incentives provide the pharma industry, Saxena avers, “Currently, life sciences companies engaged in R&D activities do not get any tax deductions; if the R&D lab is not approved by Department of Scientific and Industrial Research (DSIR) even though the company spends considerable money on such R&D activities. Thus, there is a need to bring in a provision of giving tax exemptions to companies doing R&D outside the purview of DSIR.” Continuing in the same vein, she adds that a flat 10 per cent income tax on gross

Vikram Gupta Founder & Managing Partner, IvyCap Ventures Advisors Pvt Ltd

profit for the first five years will be a welcome step for Clinical Research Organisations (CROs) to start-up. She highlights, “The incentives normally given to service sector that brings in foreign exchange need to be introduced/re-introduced for CROs.” Further, discussing the need of a proper R&D culture, Vikram Gupta, Founder & Managing Partner, IvyCap Ventures Advisors Pvt Ltd, says, “Efforts should be made in order to facilitate a R&D culture and innovation. Further, there are a lot of things that are required for R&D such as chemicals, raw materials and many others. So, there should be tax exemption on all the goods that are used for R&D. In this way, there can be rationalisation of the entire R&D segment.” Further, according to him, there are several activities that are not falling in DSIR and lot of rationalisation is also required in that context. This is very

Pre-Budget expecta ons Segment

Previous Budget

Expectations

R&D in pharma

There was no extension provided on the weighted deduction on the in-house R&D that stands at 200 per cent and available till FY2012 only

Eﬀorts should be made in order to facilitate a R&D culture and innovation

important for building an entrepreneurial innovation culture in India.

Bringing a change With passing time, the performance of in-house R&D centres of major Indian institutes show that there is a definite requirement for strong merges between the in-house R&D centres and various national laboratories and several technical institutes in order to attain competence in the industry. It is true that India does not lack the scientific talent or the talent pool that is required. Therefore, it is essential that the centre concentrates on the R&D segment. This will help the country to assume a strong position in the global research field. With expectations comes an obvious comparison with the last year. The Union Budget 2012-2013 will hopefully fill the gaps left or created in the previous Budget. Elaborating in this vein, Saxena explains that in Budget 2011-12, the government made no proposals on reducing excise duty, tax on healthcare infrastructure and weighted deduction for expenses incurred outside R&D facility such as overseas trials, dossier preparation, consulting & legal fees on healthcare and pharma sector. The positives were that by considering the need of the industry for innovation, it enhanced the weighted deduction on payments made to National Laboratories, universities and institutes of technology, for scientific research, from 175- 200 per cent. She highlights, “This year does not look very positive on the R&D front until the government takes some concrete steps to address industry requirements.” (chandreyee.bhaumik@infomedia18.in)

March 2012 I Modern Pharmaceuticals

Special Focus: Interface - Dr Rajesh Jain

“Government must uniformly exempt all life-saving medicines from GST” …says Dr Rajesh Jain, Chairman, CII National Committee on Biotechnology & Joint MD, Panacea Biotec Ltd. He talks about his expectations from the Union Budget 2012-13 for R&D segment, pharma SMEs, among others. Chandreyee Bhaumik

Expectations from the Union Budget as far as the R&D incentives are concerned... The weighted tax exemption of 200 per cent on R&D expenses should be continued for at least the next 10 years. This will help R&D-oriented companies to take long-term strategic decisions on R&D projects. It will also act as a booster for further investment on R&D. Shortterm ﬁscal incentives do not encourage the industry to invest on long-term R&D projects. How will the Union Budget help in the tax benefits section? At present, 200 per cent tax exemption is allowed on revenue and capital expenses incurred by approved R&D centres on inhouse projects. Clinical trials conducted through Clinical Research Organisations (CROs) are not eligible for 200 per cent weighted tax deduction, not even 100 per cent. Since clinical trials conducted through CROs are important and integral part of overall R&D programmes and account for 2/3rd of R&D cost, therefore, weighted tax exemption of 200 per cent should be allowed on all clinical trials irrespective of whether conducted in-house or through CROs. This

will ensure the goal of Government of India to make drugs affordable. How do you think the Budget can favour SMEs? There should be Budget allocation for capacity development in pharma and biotechnology for concerned Ministries to work with industry and develop the following: Sector Skill Council in Pharma (SSC): CII has taken the initiative to form the pharma/biopharma sector skill council and currently working with all prominent industry bodies on devising the framework to bridge the gap between the demand and supply of skilled human resources in specialty area such as quality assurance, sales & marketing, regulatory affairs, licensing, business development of specialty products, etc. Good Laboratory Practice (GLP): CII is working with National GLP Compliance Monitoring Authority (NGCMA) to provide GLP training to interested organisations. Finishing school: CII Biotech finishing school proposal has received encouraging response from its members, organisations

and are willing to train 5-10 graduates in various biotech streams depending on organisations area of interest. This initiative would further be strengthened with active participation of Department of Biotechnology (DBT) and interested member organisations. Expense reimbursement: SME exporters incur expenses such as USFDA audit and National Science Foundation (NSF). As in many Asian countries, these SMEs must be allowed to take reimbursement from the Government for USFDA and NSF expenses so as to become globally competitive in quality and assurance. What kind of Budget will benefit the pharma/biotech SEZs? Government must create a budget through which 50 per cent of the total income tax paid by a company in the last 10 years can be paid back as a soft loan to an R&D organisation for 20 years re-payment terms at 1 per cent annual interest. This will encourage investment in R&D in an objective manner and at the same time ensure availability of economical, innovative new safe and eﬃcacious medicines for all

Modern Pharmaceuticals I March 2012

Dr Rajesh Jain Government should consider exempting all products from sales tax and excise duty that are specifically used for paediatric purposes (for all children up to the age of 12 years) Investment in upgrading quality of infrastructure and training and development of people should also be given 200 per cent weighted tax deduction for pharma and biotech sector Should there be a separate Budget for the pharma/biotech industry? If done, it will be very helpful to ensure cost-effective availability of international quality medicines with skilled and well-trained work force in our sector. On top my expectations from the proposed Finance Budget are as follows: Goods and Services Tax (GST) The likely implementation of GST will be watched closely by the pharma industry as the total tax rate might go up thereby make medicines costlier. To ensure continued availability of medicines, government must uniformly exempt all life-saving medicines from GST. Tax-free Zone The benefits granted to units set up in tax-free zones should be continued under GST. Excise Considering the long-term benefits of R&D to the economy at large, all excisable goods used for R&D purposes, should be exempted from Central Excise Duty as also import of all capital goods, raw materials, consumables, and reference standards for R&D purposes must be fully exempted from customs duty and other related duties. Grants & loans Government should encourage research and product development activities by offering grants and soft loans at zero interest in much bigger scale and liberal manner than today. Registration expenses A weighted deduction of twice the expenditure on scientific research incurred by a company is allowed. With increasing volume of exports all over the world, our companies need to invest substantial amounts in registration of products overseas. Hence, expenditure eligible for weighted deduction should also include expenditure on product registration in foreign countries and consultants’ fees for patent/product registration overseas. Land & Building At present, weighted deduction is not available towards land and building. However, several leading companies carry out the research at the locations exclusively designated for the purpose. This requires infusion of huge funds on purchase of land and on construction of buildings especially designed for research. Therefore, it is imperative that such companies are also granted the weighted deduction on the expenditure incurred on land and building. (chandreyee.bhaumik@infomedia18.in)

March 2012 I Modern Pharmaceuticals

Special Focus: Roundtable

Will the Union Budget 2012 be SME friendly? Apart from contributing to exports and manufacturing output, pharma Small and Medium Enterprises (SMEs) provide employment opportunities in rural areas. Will this Union Budget offer positive incentives for SMEs? Chandreyee Bhaumik

Dr Ajit Dangi President & CEO, Danssen Consulting

Hitesh Gajaria Managing Partner, KPMG

T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry (CIPI)

Since pharma SMEs contribute to over 35 per cent of the industry’s total turnover, they play an important role not only in nation’s economy but in making medicines available at affordable prices as well as employment generation. While Union Budget has limitations in resolving some of these issues, the least Government can do is to provide a consistent policy environment so as to plan the business for longer term rather than tinkering with taxes and duties and offer SOPs to balance the budget. It now appears almost certain that both Goods and Services Tax (GST) and Direct Tax Code (DTC), which were announced, are unlikely to be made operational in April this year, as promised earlier. Rationalisation of the excise duty for raw materials and finished product with abatement increased to 45 per cent will benefit the industry. Also, the SMEs in the bulk drug industry need special attention as cheaper Chinese imports have virtually brought this industry on the brink of closure.

There are many expectations from the forthcoming Union Budget towards incentivising this sector. The existing provisions do not provide any beneﬁt for units engaged in contract R&D. The Government could provide certain speciﬁc tax holidays to SMEs engaged in contract R&D and other manufacturing activities. The current low ceiling for tax audit of ` 60 lakh for business undertakings could be increased to at least ` 1 crore. Currently, CENVAT Credit is available where manufacturing is undertaken by the brand owner itself. Many SMEs are engaged in job work arrangements with large pharmaceuticals companies. The government could extend rules relating to CENVAT credit to such arrangements, which will in turn reduce the cost of the product. It is expected that the government should promote an encouraging environment for growth for this sector by keeping stable policies and by making favourable tax amendments.

With every Budget the taxes are on constant rise. Thus, it should be noted that if the government is not able to reduce the tax it should not increase it either. The tax should be allowed to be stable. One must not forget that SMEs are important as they form the backbone of the pharma industry. They should be given long term incentives, investment allowance, and many such related benefits. It might not have an immediate effect but they will help in the long term. This will help in developing manufacturing competitiveness. It is already a buzz that this Budget will witness reduction in the tax of the diesel vehicles. But the government should not forget that this is also an important industry. With inflation catching up most of the hospitals do not have the stock of the life-saving drugs. Therefore, there should be special incentives provided so that there is flexibility in the pricing of the drugs. This will increase the supply of drugs.

Editorial take

SMEs form a crucial part of the pharma industry. However, even today the primary challenges that they face point towards lack of funds. In this scenario, tax incentives in any form will be a blessing for the enterprises.

Modern Pharmaceuticals I March 2012

Facility Visit: IKA India Pvt Ltd

Capitalising on the India advantage IKA India Pvt Ltd, a part of 100-year-old German company, set up its first assembling unit in the country in 2009. Since then it has been bringing unique technologies to the country and leveraging on the Indian advantage. Jasleen Kaur Batra

KA, a German company by origin, has been present in the Indian market since 1999. Looking at the rate at which the pharmaceutical sector was growing in India, IKA decided to explore the opportunities that the Indian market has to oﬀer. It set up its manufacturing plant in Bengaluru, India in 2009. “As a company we felt that the Indian market was doing very well. We also noticed the gradual growth of business in India and so we decided to set up a manufacturing plant here. We chose to enter the Indian market also because we wanted to provide our support as well as services to the Indian market that was welcoming us and our products and also provide support to our distributors in India,” explains Suren Dixit, Managing Director, IKA India Pvt Ltd.

The growth story

Five years prior to setting up the facility in India, IKA set up a facility in China. Today, there are approximately 250 people working in the unit in China, where IKA has set up a huge laboratory production facility. Once the China facility was constructed, IKA set up a facility in Malaysia to manufacture process machinery, which today takes care of most of the requirement of IKA. The facility in India has been set up over 35, 000 sq ft of land and has an application lab, sales team and regional managers in each region. “We are also in the process of setting up a calibration laboratory and are setting our roots ﬁrmly in India. Out of our complete product portfolio, few of them are manufactured in India and few in other countries. Overall, we are present in eight countries - for us the manufacturing of the machines that we assemble and sell to our Indian clients are manufactured by our facility in Malaysia. We have facilities in Germany, the mother country, and a facility in the US, Belgium, China - where we have three units, Malaysia, India and Japan,” says Dixit. High quality is maintained not just in the products that are manufactured in India but also in all the other units of IKA. To ensure safe and high quality products IKA is ISO 9001 and ISO 17 027 certiﬁed.

Challenges faced There

are

cultural

and

commercial

Photo: Shrikanth

The Indian market has been one of the biggest markets along with China over the last 10 years. Though IKA did not have a facility in India its products were being sold in the Indian market for over

a decade. “We felt that the Indian market is growing. The cost factor is high in the Asian region and so to save on capital spent in transporting goods from one country to another we thought that having a manufacturing unit in India would be a good idea. We make sure all the quality standards are met as per the policies of our German manufacturing facility,” explains Dixit. The facility of IKA is an assembly line unit; all parts of the machines are imported from their other centres and are assembled in India, and are then sent back to various parts of the world according to the requirements. “We have not done much in the machines aspect as we do not have people and land in India. We are hiring people and training them as well but it would take time to bring them to our facility in India as the training takes place in Germany. What we do in India is import parts from all over the world and assemble them. About 50 per cent of the assembled products are sent to Germany, US and Europe and the rest is used in India to meet the requirements of the industry here,” informs Dixit.

Other geographical locations

The assembly line

Orbital shaker

Modern Pharmaceuticals I March 2012

IKA India Pvt Ltd challenges that one needs to face with every new set up. As IKA has entered the Indian pharma industry there is one major challenge it is facing. “Our main challenge was brand equity. Every international player has been in the country for the past 20 years. The Indian population today is very well educated and has in depth knowledge of the market. So having a German product holds no value today. The diﬀerences are reducing and one needs to give value for money. We are enhancing our service capabilities, our calibration support, sales support and are investing in marketing. We are participating in seminars, symposiums etc as we need to create a brand. We are also redoing our website for IKA, as web is a growing space today,” explains Dixit. Adding to this he says, “The Indian market is price sensitive. As of now, costumers expect a lot and try to push as much as possible to get the maximum in the most economical price. So, we did have to mend our ways to meet the demands and expectations of the competitive Indian market. What we do is try to sell our products in bulk as it helps us gain our revenues as well.” As a company, IKA tries to provide price reduction to its costumers and dealers. “We want to set our foot in India; hence, we are

Our USP lies in going from laboratory to process and having total inhouse international validated solutions right from R&D to the production floor. Suren Dixit Managing Director, IKA India Pvt Ltd

looking at selling more products and want to create a population of IKA products in India. Today, we are above the local prices and are trying to be a little below the international prices,” informs Dixit.

The facility in India has been set up over 35, 000 sq ft of land and has an application lab, sales team and regional managers in each region.

USP of the company

Testing of electronic contact thermometer ETS-D5

March 2012 I Modern Pharmaceuticals

IKA is one of the leading companies in pharma in the world today as it is present in the spaces of R&D, laboratory and producing products in pilot as well as production scale. “We are an instrumentation company and are known for homogenisers. We make a wide range of homogenisers that cater to all requirements. What we do is create software and machines that are capable of mixing elements such as liquid to liquid as well as liquid to solid in all sizes. We provide scaling up options to companies, as we have the technology to mix quantity as small as 50 litre to 2,000 litre or more. There can be companies who would mix such elements in 50 litre and few in 5,000 but the numbers of companies providing mixing technologies for scale up projects are very rare, and that is where our expertise in the industry comes into place,” says Dixit.

“Our USP lies in going from laboratory to process and having total inhouse international validated solutions right from R&D to the production ﬂoor. We are heading towards further reﬁning this with a lot of technical support, sales and marketing support along with a strong service support,” says Dixit.

What’s in store? IKA has plans of expansion as well as launching new products to explore the various options that India has to offer. “The future is almost endless. In India, we have a strong R&D team, a calibration laboratory, various assembly units and QA and QC labs. We plan to explore these verticals and make the most of it. We are also in the process of setting up offices and showrooms in all the cities in India. In the future, we would be definitely focussing on brand equity,” informs Dixit. Elaborating on the future plans of IKA he says, “In future, setting up a process factory is also on the cards and so is developing new products. But there is time for all that to happen. What we are doing in the near future is launching a whole new range of products, which will give IKA a leap in terms of the products it has. The products will be launched in June. A few products with an upgradation of the products available currently and a few would be new according to the trends in the pharma.” Over the years, IKA has invested a huge amount of capital and would not shy away from doing the same in future as its main motive is to provide its products and services to as many companies as possible. (jasleen.batra@infomedia18.in)

An invite that rewards as well...

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Insight & Outlook

Pharma SMEs SMEs growth story Withering tales! .................................................................44 Role of bankers and government About time to have a synergistic relation .............................46 SMEs in South India Need for government reforms .............................................48 SMEs in spotlight Waiting for the right push...................................................50 Interface Jagdeep Singh Secretary-General, SME Pharma Industries Confederation, India (SPIC) ...........................................................................52 Roundtable Are the current government schemes for SMEs satisfactory? ..................................................................54 Thyroid cancer therapeutics market Victim of weak competition ................................................55 Case Study - Fighting counterfeits Just an SMS away! ..............................................................56

March 2012 I Modern Pharmaceuticals

Insight & Outlook: SMEs growth story

Withering tales!

The SMEs in general, and pharma SMEs in particular, are considered the ‘growth engine’ of Indian economy. But since the past few years we have not seen many SMEs coming up in the pharma sector, which makes one wonder how something once considered the backbone of the industry is degenerating. We look at the initial stages of growth and how the scenario changed so drastically. Titash Roy Choudhury

uring the 1960s, the Indian pharma market was heavily dominated by multinationals, which aﬀected the price of medicines. However, during the 1970s and 80s we saw a slow entry of Indian companies in the market. “With encouragement from the government Indian companies started penetrating the market and during 70s and 80s we saw several small scale companies and SMEs coming into the picture,” reﬂects G D Chhibber, Chairman, Mcneil and Argus Pharmaceuticals Ltd. Over a period of time, many SMEs of yester years have become national companies and by hard work and their entrepreneurial abilities, many have grown to be large

pharma companies with manufacturing units in India and abroad. At present, there are around 8,000 pharma companies in the SME sector in India. These SMEs laid stress on quality and provided medicine at aﬀordable prices. Many of the MNCs slowly used the services of SMEs in India to manufacture their product. “With its low cost and high quality, pharma products of the SMEs have made its presence felt both in domestic and overseas market, thus enabling them to conquer the market,” says Daara Patel, Secretary General, IDMA. There were various factors that had propelled the inﬂux of SMEs in the pharma market. First, the initiative was taken by the government to give Indian companies at that time the opportunity to enter the market. “In the beginning government was the biggest buyer of medicines produced

by the SMEs,” informs Chhibber. Second, the advent of revised Schedule M around the turn of the 21st century triggered the modernisation of SME pharmaceutical plants. Although the SMEs had to undergo ﬁnancial hurdles, many of them have overcome the same and have created pharmaceutical plants of good standards. “Also, with the maturing of SMEs into Schedule M-compliant companies, more and more SMEs are becoming WHOGMP compliant units. It is estimated that there are over 1,000 SMEs, which will be WHO-GMP certiﬁed by the end of 2012,” believes Patel.

The present scenario It has been over a decade that the pharma market has been witnessing declining numbers of SMEs entering the market. “There are hardly any SMEs that have entered the market since the past ﬁve years. Instead, we are seeing the closure of existing SSI and SME units in pharma,” says Chhibber. Patel adds, “Compared to the scenario witnessed in the 80s and 90s, there is hardly any growth of SMEs in the pharma industry. Although the

Modern Pharmaceuticals I March 2012

SMEs growth story

The profitability of many of the surviving units is not that attractive and the credit availability to them is restricted as the banks and other funding agencies do not lend them easily.

There are hardly any SMEs that have entered the market since the past five years. Instead, we are seeing the closure of existing SSI and SME units in pharma. G D Chhibber Chairman, Mcneil and Argus Pharmaceuticals Ltd pharma SME market is very large and has tremendous potential, it is yet to be tapped to its full potential.” There are various reasons that have worked towards creating an environment that was not conducive for new SMEs to enter. For instance, the revised GMP norms that led to the closure of many SSIs as they refused to modify their manufacturing practices. One of the main reasons why the SMEs were not able to comply with Schedule M norms was their perennial financial problems. “The profitability of many of the surviving units is not that attractive and the credit availability to them is restricted as the banks and other funding agencies do not lend them easily. Most of the SMEs are also not getting due share of tender business of various government agencies and establishments, as many governmental organisations have stringent clauses that keep SMEs from participating in the tendering processes and bulk supplies,” informs Patel. The Indian pharma market has also become extremely competitive. However, many SMEs have started looking beyond regions to supply nationally and even to international markets. SMEs are now participating in contract research, clinical trials and biologicals, which are said to have a good scope in the future. Also, few decisions of the government made their survival difficult. “Initially any company that got the licence for manufacturing could supply products to the government. But since last 10 years from when government had put a turnover clause, we have seen a decline in the growth of SMEs in pharma. The government decided that a company with a particular turnover, which varied in different states, can supply medicine to the

March 2012 I Modern Pharmaceuticals

Daara Patel Secretary General, IDMA

government. And this decision according to me is an unjustiﬁed action taken by the government,” believes Chhibber.

Challenges faced and measures required The contribution of SMEs to the economy of any country is indispensable and for a developing country such as ours, SME plays an even greater role. “With the coming up of any new SME it helps in increasing the employment of a country, not only directly but also indirectly and employment generation directly affects the economy of the country,” remarks Chhibber. However, this sector is facing several challenges that needs to be addressed immediately to mend the present situation. The major challenges include organisational costs with limited resources and their ability to retain capable and trained employees, and at the same time hiring professionals. “An SME’s continued ability to market products while facing financial and technological challenges will determine its survival. The limitations and problems in raising funds as most banks tend to be biased with cumbersome procedures/ collaterals, lack of venture capitalists, etc,” says Patel. While Chhibber believes that government should provide more incentives to the SMEs and such clauses as the turnover of any company deciding the supplying factor for medicines should also be mended. “There is an increasing access to finances for SMEs, thanks to government policies. Of course, more needs to be done by the government to ensure availability of finance to the SME sector without much hassle,” believes Patel. Various steps have been proposed, which if followed can change the slow

growth rate. SMEs should tap the small towns and rural market. In today’s environment, synergy approaches are very important and beneficial to all partners. Also, partnering with bigger companies can benefit the SMEs and make their survival easier. “SMEs can engage in contract manufacturing and provide quality products to these large enterprises. They can also do regional marketing for large enterprises. And in turn, these large enterprises can encourage SMEs to grow with their expertise so that they can get continued quality support from them,” suggests Patel. Another avenue for SMEs would be co-marketing. Pharmaceutical marketing in India is a highly resource intensive activity and many SMEs are regionally well established in marketing activities. “Many large pharma companies and even foreign companies are eager to tieup with SMEs to utilise their local field force for marketing activities. The benefit of obtaining high quality and wellresearched marketing aids for product promotion from the big companies and foreign partners will definitely go in favour of the SMEs and help them in improving the market support of their local products,” informs Patel. Patel further adds continuous efforts are also made by organisations, such as IDMA, who have approached the Planning Commission to seriously consider a separate scheme for all SME units in the Indian pharmaceutical industry, to enable their rapid growth and development into world-class manufacturing units. (titash.choudhury@infomedia18.in)

Insight & Outlook: Role of bankers and government

About time to have a

synergistic relation

Titash Roy Choudhury

he pharma industry is growing exponentially. “Enormous opportunities are provided to the SMEs through not only globalisation, but also by the domestic market, which is growing at a rate of over 15 per cent,” says T S Jaishankar, Chairman, Confederation of Indian Pharmaceutical Industry (CIPI). There have been few schemes by the Indian government, but almost two decades after we are seeing how this sector is struggling to survive. “Competition from international generic players is increasing. MNCs are also trying to capitalise on India’s status as one of the fastest growing emerging markets by formulating country-speciﬁc pricing and marketing strategies. Big pharma companies are launching drugs and vaccines in India at substantially low prices than their home countries. This trend is going

to change the scenario of SME segment. Hence, it is time for the government to ensure that such activities are restricted to encourage SME. Otherwise it is going to be a game of bigger companies and small companies will be compelled to wind out their workshop,” believes Bodh Raj Sikri, Co-Chairman, Federation of Pharma Entrepreneurs (FOPE).

The Small and Medium Enterprises (SME) sector requires government and financial support for having an impactful existence in the competitive market for any industry. The government of India has launched various schemes along with financial institutions, but the lack of implementation is hindering the growth. government for support for upgrading manufacturing technology, brand promotion and marketing to enhance domestic sales and exports. Given the huge business opportunity available for contract manufacturing, SMEs need to have capabilities that comply with manufacturing standards such as GMP, WHO to be able to capture this. This requires liberal funding from government along with financial incentives. Lack of support from select banks authorised by the government to issue the incentives has also affected the free flow of funds allotted under this scheme to SMEs,” informs Sikri. Thus, there are certain schemes in favour of SME but implementation of such schemes at a later time when actually needed has become a futile exercise. “Moratorium should also be for a longer period and the rate of interest should be at par with Chinese pattern, which is around 6 per cent. China has converted their weakness into strength, ie population, by giving them ample opportunities to become small industrialists, whereas in India common man is deprived of such an opportunity,” avers Sikri.

Analysing the government schemes

Bank’s role

It would be unfair to say that the government has not introduced schemes for the SMEs. Several schemes are developed to support SMEs. Small companies are increasingly facing tough business environment due to marketing and regulatory constraints, pressure from buyers in regards to high eligibility barriers, and also from suppliers as SMEs cannot negotiate prices through bulk purchase resulting in high procurement costs. “SMEs are increasingly looking atthe

All banks in India have a mandate by RBI to help the SMEs with adequate funds. “Banks are looking positively towards funding the SME sector in India. And for the pharma sector we have been funding various companies in locations such as Dehradun, Hyderabad or Ahmedabad and helping them in setting up a new unit or expanding their present services,” informs Ramesh Dharmaji, Chief General Manager, Small Industries Development Bank of

Modern Pharmaceuticals I March 2012

Role of bankers and government

To be considered for eligibility, a long procedure needs to be followed that includes considerable time and money, and several SMEs cannot afford to spend either. T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) India, (SIDBI). The pharma sector has been undergoing modernisation and changes such as gaining WHO-GMP certification and upgradation under Schedule M, and for most of these changes non-asset creating funding is required. He adds, “Under this scenario, SIDBI has come out with a scheme few years back titled ‘Growth Capital Equity Assistance’ scheme under which intangibles such as marketing, branding, quality improvement and R&D initiatives, improving technical know-how and others, are covered. This scheme has received good response from the companies and will help the pharma companies in the coming years to meet the global requirement without financial hassles.” “Too many guidelines are at times creating bottlenecks in establishing new SMEs, particularly when young entrepreneur wants to start a unit,” believes Sikri. At present, there are various financing options for pharma industry such as Venture Capital, Private Equity, Initial Public Offering, debt funding from financial institutions and banks public funding. Some of the other schemes available at present are Credit Linked Capital Subsidy

Too many guidelines are at times creating bottlenecks in establishing new SMEs, particularly when a young entrepreneur wants to start a unit. Bodh Raj Sikri Co-Chairman, Federation of Pharma Entrepreneurs (FOPE)

Scheme, which was launched in 2001 by the Government of India and has been revised in 2005. Under this financing scheme, SMEs can avail a loan of up to ` 1 crore. It involves a subsidy rate of 15 per cent, which is calculated on the purchase price of plant or machinery. The other scheme is the Credit Guarantee Scheme launched by the Government of India to make bank credit available to SMEs without any collaterals or third party guarantees involved. The basic idea of this scheme is to make the lender give loan primarily on the basis of asset security. These are some of the government financial schemes but in India individual banks also have their own SME schemes, but what is required at the moment is first a pharma priority and proper implementation of the schemes. “Private sector banks also provide loans for SMEs but against 100 per cent collateral security. Banks consider pharma as potential investment sector and are liberal in financing projects,” says Jaishankar.

Calling for a change SME is facing lack of support from the government. “There is a strong need for these companies to be brought together on

Banks are looking positively towards funding the SME sector in India. And for the pharma sector SIDBI is funding various companies and helping them in setting up a new unit or expanding their present services. Ramesh Dharmaji Chief General Manager, Small Industries Development Bank of India, (SIDBI)

March 2012 I Modern Pharmaceuticals

a common platform and to facilitate coordination among them,” says Sikri. The tender clause of government needs to be readdressed since the situation has changed drastically over the years. Tender business of government institutions should be preferably routed through SME pharma companies only. They will be able to offer more competitive rates than organised companies or MNCs. “Drugs used for common ailments should be preferably sourced only through SME pharma industries. Banks and financial institutions normally go for strong credit rating companies to finance them, which falls in the segment of AAA credit rating. These ratings are normally done by RBI approved agencies such as ICRA, Crisil, etc but there is hardly 1 per cent such companies who qualify for the AAA rating. Therefore, while financing the SME segment, emphasis should be on the credit worthiness and not only AAA category,” says Sikri. At present, the pharma industry is not considered as a priority sector lending, whereas education, agriculture and infrastructure, among others are in the priority category. “Funding should be available to the pharma sector at a special or concession rate after all health is equally important for the citizens of our country. Time has come for the government to include pharma industry under this policy. Adequate amount of finance through interest subvention on term loan for technical up gradation of the plant, including GMP compliance and getting approvals from overseas regulatory authorities is required,” believes Sikri. (titash.choudhury@infomedia18.in)

Insight & Outlook: SMEs in South India

In the early 70s, Small and Medium Enterprises (SME) were on the rise in India. But off late those falling under the biotech and the pharma industries have withered away due to lack of government support and infrastructure. Jasleen Kaur Batra

he Indian pharmaceutical industry has expanded enormously over the decade. Today, there are about 250 large units that control 70 per cent of the pharma market with market leader holding nearly 7 per cent of the market share and about 8,000 small scale units. These together form the core of the pharmaceutical industry in India. Previously, the Indian pharma market was known for producing generic market but today it has entered all possible areas. The pharma and biotech companies in India today produce a complete range of products and have entered every stage of manufacturing.

Challenges SMEs today have challenges in various forms - land being one of them. “Getting a piece of land at a good location and at an aﬀordable cost is the biggest challenge today. There are a number of pharma and biotech companies that

have come up lately. Hence, space has become a problem. Only an MNC or a big pharma company can aﬀord to acquire land in the city. The rest need to go to the outskirts of the city,” avers Mohideen Kamil, Managing Director, Concern Pharma. Another challenge that is connected with land is the regular supply of water and electricity. “As we are a few kilometers away from the city there is considerabe problem that we face in terms of light and water. There are no street lights on the road and no water supply. The biggest challenge is lack of infrastructure and adding to this there are regular power cuts, which slow down the process of manufacturing of products,” informs Thankachan Thomas, Director, Navagen Products Pvt Ltd. Getting the required capital to set up a unit with high quality instruments and a team of experts takes a huge amount of investment, which is a challenge. “There are various MNCs entering India today and so the market has grown drastically over a short span of time. This has also increased the level of competition within the industry.

One of the problems that SMEs face and MNCs do not is that of capital. For an MNC it is very easy to get a ﬁnancial partner but for a SME it gets extremely diﬃcult to convince companies to invest,” explains Thomas. Acquiring labour at the right cost is another problem that is faced by the SME sector in India. “The shortage of labour is an issue we face in Karnataka today. Increasing construction work is one of the reasons for this shortage. The frequency of turnover of labour puts the SME units into a standstill. Being in the pharma sector, we have the disadvantage of location as most of the pharma industry to whom we cater to are either in Western or Northern part of India. This adds up to increasing logistic cost and many times we lose to local competitors. SME faces lot of challenges within and outside the industry. To set up an SME unit and surviving thereafter, lot of support from the big players is essential,” remarks Thomas. Further, gaining trust and building a brand takes ample of time and work; SMEs have to be patient and hang in there amidst not too favourable conditions. “A small set up company does not just have to undergo all the above-mentioned challenges but also has to struggle to make a name for itself and assure people that the

Modern Pharmaceuticals I March 2012

SMEs in South India

The biggest challenge is the lack of infrastructure and regular power cuts, which slow down the process of manufacturing of products. Thankachan Thomas Director, Navagen Products Pvt Ltd

It is the responsibility of the government to provide a few exemptions in terms of tax and land to ensure that SMEs grow. Alok Chaudhri Partner, Techno Remedies

this large small scale industry and to ensure that it is functioning in a good manner it is important for the government to step forward and come up with a few policies that would ease out the burden of the SME sector to ensure a speedy growth and it does not saturate and die away. To Government support ensure this, the government needs to come The Indian pharma sector is growing at up with a few reforms as well as policies a rate of 8-9 per cent and it is expected for the SME sector in totality. that in the coming years this rate will Expressing his views on the various continue to increase. To accommodate areas in which the Government of Case studies India needs to create Concern Pharma reforms for the SME Concern Pharma is an integrated research-based sector Alok Chaudhri, pharmaceutical company and produces a wide range of Partner, Techno quality medicines. Remedies, says, “The The major problem faced by Concern Pharma during its seems inception was getting license, experienced manpower, capital, government to be extremely getting all the formalities in place for setting up the unit. indecisive when it Investment: ` 75 lakh comes to taking policy Location: Chennai and reform decisions Years in the industry: 4 for SMEs. There have been a number Manan Healthcare Manan healthcare manufactures oral liquids and external of policies that the semi solids/liquid preparations. The major problem faced by government was in the Manan Healthcare was in ﬁnding authentic machine suppliers process of introducing and infrastructural problems such as water and electricity. such as Credit Linked Investment- ` 50 lakh Capital Subsidy Location: Bengaluru Scheme (CLCSS), Years in the industry: 2 but even before it could be formed it Navagen Products Pvt Ltd was withdrawn saying Navagen Products Pvt Ltd provides machines and services to that the policy was pharma companies. The problems faced by Navagen Products not apt for the SME were getting electricity supply to the plant and ﬁnding sector of biotech and appropriate labour as well as land. pharma industries. Investment- ` 20 lakh Th e government Location: Bengaluru needs to stop being so Years in the industry: 9 indecisive and needs to project would meet the desired quality. Because of a small set up, convincing companies about the strengths that we have as an organisation becomes a task,” says Thomas.

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pay attention on the various challenges that an SME faces today and needs to provide reforms accordingly.”

Stability provision The government has recently come up with a clause called the turnover clause. According to this a company needs to generate revenues of minimum ` 20 crore for one product to be eligible to enter the tender. This clause has worked against the SME sector instead of working for it. Adding to this Chaudhri says, “The government needs to understand that SMEs do not have a lot of capital to begin with and so are not in the position of producing such turnover. It is hence the responsibility of the government to provide a few exemptions in terms of tax and land to ensure that SMEs grow. They need to increase the excise duty from ` 1.5 crore to ` 3 crore. Once the government makes the necessary changes only then will the SMEs ﬂourish.” Meanwhile, The Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers of the Government of India has been taking initiatives to support the SMEs through various incentives/facilities such as CLCSS to SME units - this will help them in upgrading the facility and identifying approximately 18 SEZs that would oﬀer infrastructure, market access and exports. In the future, the government will set up a fund to promote R&D. Today, considering the rapid rate at which the industry is growing, the government too needs to be updated and provide facilities, opportunities and policies for the industry to grow. (jasleen.batra@infomedia18.in)

Insight & Outlook: SMEs in spotlight

Waiting for the

right push

The pharmaceutical sector in India has witnessed a lot of changes, upheavals, trends, and progressed to put the country on a global platform. One such trend that has fuelled the growth further is the emergence of SMEs. Titash Roy Choudhury

here are around 7,000 pharma companies in the SME sector in India. Out of these, the ones that have been focussed in this article include, Fourrts (India) Laboratories Pvt Ltd, a Chennaibased company started in 1977 by S V Veerramani, Chairman & Managing Director, Fourrts (India) Laboratories Pvt Ltd with an initial investment of only ` 2.5 lakh. Avik Pharmaceutical Pvt Ltd, a Mumbai-based SME started in 1981 with an investment of ` 88 lakh. “During that time SMEs growth was high and many new entrepreneurs were entering the market,” reminds Anant Thakore, Managing Director,

Avik Pharmaceuticals. Adding to this Ramesh Arora, Managing Director, Kwality Pharmaceuticals Pvt Ltd says, “We started our operations in 1980 with a meager sum of ` 2 lakh.”

The current scenario Veerramani points out various factors that are likely to bring up a number of winners from this sector in the future. “The advent of revised Schedule M has triggered the modernisation of SME pharmaceutical plants. Although the SMEs had to undergo ﬁnancial hurdles, many of them have overcome the same and have created pharmaceutical plant of good standards. These plants are likely to cater to outsourcing in a big way under contract manufacturing.” He continues,

“The SMEs are likely to play an increasing role in contract manufacturing to major Indian companies and MNCs. Compared to metro cities and major towns in the past, in future the will come from small towns and rural markets. This is precisely where the SMEs are operating and they are likely to be in an advantageous position. There is also an increasing access to finances for SMEs, thanks to Government policies.” Veerrammani also adds that more needs to be done by the Government to ensure availability of finance to the SME sector without much hassle. Both Thakore and Arora stresses on the lack of support by the government. “The government has not been liberal in funding, especially when it announced the mandatory upgradation under Schedule M but could not get the financial support for the same at that time. The financial support of ` 1 crore was extended but at a later stage, so proper planning and implementation could not be done. At present, the SMEs

Modern Pharmaceuticals I March 2012

SMEs in spotlight which are already in the market will grow though it will be a tough time for them with increasing prices and stiﬀ competition from MNCs. One has to be innovative and it will be the survival of the ﬁttest,” says Thakore.

Business model and growth trajectory Mostly SMEs are family business and may not have any well-established business model. “Our company is a close linked family held company and it has encountered steady growth over the past few years. There was some setback faced due to the entrance of Chinese products in the market but we have survived that and today we are growing at a rate of 15 to 20 per cent year-on-year,” informs Thakore. While when it came to the growth of the company Thakore points out, “At the time of establishment Government was pro-active towards SME growth and loans were available on easy terms. Every state had financial institutions and these state government institutions supported the industry by giving loan on capital investment, for equipment etc.” He elaborates, “For buying any equipment 25 per cent of the price was paid initially and the remaining 75 per cent could be paid over the next few years. Land was also made available by the state government, while working capital was given by nationalised banks on acceptable terms of the entrepreneur and, unlike today, without any collateral security. All these factors propelled the establishment and initial growth of the company.” He continues, “Getting schemes sanctioned and financial help was not difficult.

It was a smooth process, but yes every bureaucratic process has some predeﬁned procedures and once I had gone through them and applied. Asfter my interview I got the necessary help.” Fourrts has the vision to become an international pharmaceutical organisation of repute. “Fourrts’ initial activities were towards marketing its products in Tamil Nadu and neighbouring states from its plant at Perungudi, Chennai. From the initial plant at Perungudi in 1977, we built a GMP compliant plant at Kelambakkam near Chennai in 1985. From a regional

A major challenge for SMEs will be from MNCs due to the signing of WTO agreement by India.

marketer, we became an all India company in 1995. Now we are exporting formulations to more than 30 countries. Fourrts has grabbed many awards in its journey of excellence. To name a few, IDMA Quality Excellence Awards 7 times, outstanding Export Performance Awards 2 times from Pharmexcil, Government of India among few,” informs Veerramani. Arora talks about how government has been a major obstacle in the company’s growth path. “I had taken loan from the public sector

Although the SMEs had to undergo ﬁnancial hurdles, many of them have overcome the same and have created pharmaceutical plant of good standards. These plants are likely to cater to outsourcing in a big way under contract manufacturing. S V Veerramani Chairman & Managing Director, Fourrts (India) Laboratories Pvt Ltd

bank. But when it came to help from government schemes they never got fulﬁlled. There is a subsidy scheme and we had applied for it which came to us almost 10 years later. Hence, there are a lot of bureaucratic hazards in the way that lengthens the process and makes it troublesome.” The model that they use is that of marketing their products in the generics market, mainly outside India. “At the time when I started my company there was not much competition since there was not much of a demand. But today there is cut-throat demand and competition making the situation very challenging. Government has been implementing new laws and policies but not supporting them at the same time,” beleives Arora.

Competition and challenges The pharmaceutical industry is under acute competition from more than 20,000 pharma companies. There are various challenges towards their growth. As Arora points out, “Today, cost is the increasing for everything; land has become so expensive. Rather than continuing any unit selling the land becomes more proﬁtable. Also, SMEs are always blaming the government, but to make some deﬁnitive changes all SMEs should come together and collectively try to improve the situation.” While Veerramani informs how his company is facing growing competition, “A major challenge for SMEs will be from MNCs due to the signing of WTO agreement by India. We are planning to overcome the same by entering in niche segments where multinationals will not be operating. We have planned to work for tie-ups and collaborations with MNCs in our core segments.” When asked about their plans of growing into an MNC themselves Veerramani replies, “Fourrts has laid the foundation of a good manufacturing plant, has a strong national marketing team, besides exporting to 30 countries. It is only a question of time for Fourrts to become an MNC.” (titash.choudhury@infomedia18.in)

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Insight & Outlook: Interface - Jagdeep Singh

“Pharma SMEs are on the decline, which is a dangerous trend in a country like ours” …says Jagdeep Singh, Secretary General, SME Pharma Industries Confederation India (SPIC). Starting his career in 1979 by setting up a small scale industry unit for injectibles and eyedrops, he has been instrumental in driving the SMEs in pharma sector. He highlights the current state of pharma SMEs in India. Titash Roy Choudhury

You have been part of SPIC for more than 6 years now. How has been the journey? I have been the Secretary General of SME Pharma Industries Confederation (SPIC) since inception and the journey has been full of struggle for survival of industry. SPIC had come up because of the consequences of changes in law for pharma SMEs and it has been struggling over the years for the growth of pharma SMEs in India. Elaborate on the evolution of the pharma SME segment in India. In 2005, two important events took place that shaped the pharma SMEs sector. Amended Schedule M of Drug Act was implemented to upgrade pharma SSI to international levels. Around 300 SSI Units in Maharashtra and 90 in Haryana had to close down. Others faced major problems since government provided no technical support With the objective of higher revenue and to discourage printing of higher MRP on labels by companies, government changed excise modality whereby excise was levied on MRP (less 40 per cent) abatement instead of the ex-factory clearance value, which was the basis

earlier. Owing to anomalies in change of modality, the burden of excise on SSI increased manifold rendering it unviable at a time when they were mandated up gradation under Schedule M costing crore of rupees for each unit. Over 70 per cent of production of medicines migrated to Excise Free Zones (EFZ) of Himachal and Uttarakhand in existence since 2003. Not only they evaded the high burden of excise but became free to print higher and higher MRP on labels causing an unprecedented price rise in medicines. NIPER recorded a price rise of 326 per cent from EFZ in 2006. With shifting, 70 per cent production revenue was lost instead of a gain as envisaged while changing the policy. These issues were taken to the government. The Prime Minister then intervened and sought recommendations of Economic Advisory Council, which were approved but never implemented by the Ministry of Finance. What are the challenges faced by the Indian pharma SMEs? Till this day, India is saddled with unnecessary price rise and loss

of revenue, which is contrary to stated objectives of the change in policy. Further, the excise duty on medicines that was reduced in 2008 has not brought production back to non-EFZ, which means revenue is lost and price rise continues, while 5,000 pharma SMEs outside EFZ continue to struggle. Millions of shopkeepers across the country are sourcing their brands from EFZ at MRP of choice and pushing them through doctors after bribing them. 5,000 SSI elsewhere in the country are out of contention as excise on MRP prevents them to print higher MRPs as compared to EFZ and cannot bribe doctors. The fact that the consumer has become a hapless victim is of no consequence to government because price rise of medicines was never an election issue. With 70 per cent population earning less than ` 90 per day it is a hopeless situation. There are reports of people dying or slipping into poverty owing to high cost of medicines. Goverment has been unable to provide any relief even when the problem is essentially caused by change of policy.

Modern Pharmaceuticals I March 2012

Jagdeep Singh A plan to cut down prices of medicines to less than half was submitted to the government around two years ago. It has been unable to criticise the plan in several meetings but large industries/MNCs do not allow its implementation as it is averse to any price control. All these facts are mentioned in the plan and we have been following up with the same for years now.

to an unhealthy competition. Pharma SMEs whether in EFZ or outside have suﬀered over the years. And when it comes to government support to pharma SMEs it is only on paper despite the fact that it is the only regulated industry under price control. Ask any pharma SME whether it has ever got any support from the government?

How have the Indian pharma SMEs grown over the years? Around 5,000 pharma SMEs in non-EFZ have not grown over the last 5 years; their sales have declined instead. Most of those who migrated to EFZ in 2005 and created huge units have become unviable because they face stiff competition from each other. Central Drugs Standard Control Organization (CDSCO) officials have also confirmed that the highest number of spurious drugs is produced from EFZ. This happens not only because they provide 70 per cent production but because they cut corners on quality owing

Future of pharma SMEs in India... Pharma SMEs are on the decline, which is a dangerous trend in a country like ours. If you go through the Aﬀordable Medicines Plan you can see that only pharma SMEs are ready to bring down prices. If they are removed from the scene, which is likely if the present trend continues, not only prices of medicines will skyrocket but the capacity of the country to produce aﬀordable drugs will be lost forever. Around 25 per cent market has already been taken over by six MNCs alone. Government is showing worry but is unwilling to help SMEs or even

March 2012 I Modern Pharmaceuticals

SME classic growth

story:

One the classic gr owth stories is that of Torque Pharmaceuticals Pvt Ltd, a pharmac eutical company started in 1956. Thro ugh its product developments and advertisements the company has grow n signiﬁcantly over the years. Toda y, it has a varied product portfolio and almost everyone knows ab out Torex cough syrup. This compa ny has seen a phenomenal grow th story, which has been possible due to good product developmen t strategies and eﬃcient advertisem ent campaigns to reach the mass es and make its product well-know n.

implement consumer-friendly Aﬀordable Priced Quality Medicines Plan submitted by us, which could be a solution for both SMEs and consumer in times to come. (titash.choudhury@infomedia18.in)

Insight & Outlook: Roundtable

Are the current government schemes for SMEs satisfactory? Government initiatives have propelled the growth of the SMEs in the pharma sector. The question is, are these schemes, though available in large numbers, satisfactory to meet the need of the SMEs in the country? Titash Roy Choudhury

V S Chakravarthi Managing Director, Hi-Tech Pharmaceuticals Pvt Ltd

Vinod Kalani Chairman, MSME, Sub-Committee, IDMA

Rohan Hede Chairman, SME Pharma Industries Confederation India

The government schemes are mostly pro MNCs and the government is making eﬀorts to make large and medium companies and MNCs grow while the SMEs have taken a backseat. The SMEs in the pharma sector can easily be termed as the neglected lot and we are afraid that we will soon become extinct. At one point the government in public forum proclaims its continued support for the SMEs, while on the other had all the purchases by government organisations are from medium-large and MNCs. During the initial growth of SMEs in 70s and 80s government did extend support towards their growth but the scenario has changed in the past few years. There is an urgent need for government attention that needs to be paid towards the Indian pharma SMEs, to help them become MNCs of tomorrow.

The government is not doing what is required for the sector. Pharmaceutical sector in India is highly regulated and SMEs should be given individual attention. At present, the schemes and policies of government are inclined towards large companies and MNCs. Government should make a separate task force to look into pharma SMEs alone and bring out changes that are more supportive of this sector. Many causes are taken up by the government that are restricting the growth of the SMEs, like the ` 20 crore turnover clause or no concession in pricing for the SMEs or no separate platform for the SMEs to apply for any new drug. Subsidies are also diﬃcult to get since there are many requirements to be fulﬁlled. There is no co-ordination between a scheme passed and its requirement at that particular time.

I had applied for CLSS scheme from the government, but I was not given the same since the scheme would only be given to companies having profits during the last 3 years. There was an overriding clause on the scheme and even after doing the upgradation under Schedule M and investing money I did not get the subsidy. The establishment of EFZs has also affected the growth of the SMEs and especially the ones who were involved in contract manufacturing, who hve all shifted to EFZs. Before 2005 my annual business was about ` 10 crore, which today has gone down to ` 2 to 3 crore since most of my clients for contract manufacturing turned to EFZ. In reality, the changes in government schemes are all done in behest of the MNCs. The government has been indifferent to the growth of the SMEs and if there are no SMEs the country will loose the capability to provide affordable drugs and that is a situation we should try to avoid.

Editorial take

The SME scenario has changed drastically from the time when government pushed the growth to today where it is not the same. Present government schemes are insuﬃcient to meet the demands of SMEs and more eﬀorts should be taken to fuel the further growth of this sector.

Modern Pharmaceuticals I March 2012

Insight & Outlook: Thyroid cancer therapeutics market

Victim of weak competition The following analysis is an essential source of information and study on the global thyroid cancer therapeutics market. The report identifies the key trends shaping and driving the global thyroid cancer therapeutics market. Thyroid cancer therapeutics market, global, revenue and forecast ($ million), 2005-2017 350 CAGR (2010-2017): 27.3%

Revenues ($ million)

300 250

CAGR (2005-2010): 6.4%

200 150 100 50 0

2005

2010

2017

Source: GlobalData, GLOBOCAN 2008,The Lancet Oncology, New England Journal of Medicine, Annals of Oncology, GlobalData Epidemiology-based Market Forecasting Model, Primary Research Interviews, Key Opinion Leader (KOL) Interviews, Product Prescribing Information, Company Reports

he report by GlobalData provides valuable insights on the pipeline products within the global thyroid cancer therapeutics sector. It is formed using data and information sourced from proprietary databases, primary and secondary research and inhouse analysis by GlobalData’s team of industry experts. The report also provides insights on the prevalent competitive landscape and the emerging players expected to alter the thyroid cancer market signiﬁcantly and change the positioning of the current market leaders.

Forecast: A steep growth for thyroid cancer therapeutics market GlobalData estimates that the thyroid cancer market was worth $ 54.8 million in 2010. The major reason for the limited market revenues in 2010 was the lack

March 2012 I Modern Pharmaceuticals

of approved drugs for the treatment of thyroid cancer. However, Zactima (vandetanib) was approved by the US Food and Drug Administration (USFDA) on April 6, 2011 for the treatment of metastatic Medullary Thyroid Cancer (MTC). It is the first approved drug for thyroid cancer. It is registered in Europe as well. Also, doxorubicin is used as an off-label drug for treating patients with anaplastic thyroid cancer. The high growth forecast for the thyroid cancer therapeutics market is primarily attributed to the influence of recently approved drug Zactima, and the strong pipeline. The upcoming three pipeline molecules in Phase III stage of development, and Zactima, are expected to take a steep rise in the market in the next seven years. Overall, between 2010 and 2017, the thyroid cancer market is expected to grow at a Compounded Annual Growth

Rate (CAGR) of 27.3 per cent, to reach $ 297.5 million by 2017.

Strong pipeline candidates: Intense future competition GlobalData found that the pipeline of the thyroid cancer market is strong, as there are 26 molecules in diﬀerent stages of development. There are three promising molecules in Phase III stage. These drugs are expected to get approved in the next seven years. Zybrestat (combretastatin A4 phosphate) and XL184 have been granted an orphan drug status by the FDA. These new molecules (Zybrestat and XL-184) with novel mechanisms of action are expected to meet the current unmet needs and give physicians a better choice for the treatment of thyroid cancer. Once these molecules get approved they are expected to intensify competition in the market. Hence, the global thyroid cancer therapeutics market is heading towards a strong competitive landscape.

Weak competition GlobalData found that the current competition in the thyroid cancer market is weak, as the market has just one drug (Zactima), which was recently approved for the treatment of metastatic MTC, and the rest are oﬀ-label drugs used for other types of thyroid cancer. These oﬀ-label drugs are aimed at managing the conditions that contribute to thyroid cancer. There is an open space for companies to enter into this market and take substantial market share.

High unmet needs The thyroid cancer market poses high unmet needs due to the moderate efficacy and safety of the available treatment for thyroid cancer, however, the recently approved drug Zactima satisfies some unmet needs. To fulfill the remaning unmet needs, pipeline drugs will need to overcome the efficacy and safety concerns of the current products. Courtesy: GlobalData

Insight & Outlook: Case Study - Fighting counterfeits

Just an

SMS away! Counterfeiting of drugs has become one of the major concerns of the pharmaceutical industry. To help reduce the production and sale of such drugs, Activecubes has come forward with a unique SMS technique to help determine the genuineness of the drug. Oﬃcer, Activecubes. Adding to this, he says, “To try and lessen the occurrence of counterfeit drugs we have made a product that might not completely remove spurious drugs from the market but the numbers will deﬁnitely reduce.”

The technology

Jasleen Kaur Batra

he incidences of duplication of drugs have increased and one might never know when they are being cheated with a spurious drug. According to a report by The Associated Chambers of Commerce and Industry of India (ASSOCHAM), a staggering 20-30 per cent of drugs available in the market are spurious. The impact of selling these in the market is huge; it aﬀects not only the costumer but also the pharma industry. “Bringing out a drug to the market involves a lot of revenue right from R&D, manufacturing, marketing, branding and more. When a company faces competition from a spurious drug, the entire image of the company as well as the brand suﬀers. There is a huge loss in terms of revenue and brand,” explains Rajesh Varrier, Founder & Chief Executive

Over the years the government as well as the pharmaceutical industry has proactively done considerable work to check the duplication of drugs. The government has appointed a Drug Development Officer to check the drugs that are being made and exported. Pharma industry too has adopted measures such as sophisticated packaging that would reduce the chance of duplication of drugs as the people who perform such acts lack finance to have a large manufacturing and packaging unit to themselves. In the initiative to reduce counterfeit drugs in the market Activecubes, an analytical company, has formed an SMS software, which will educate the costumers and provide them the knowledge on whether they have purchased a fake or a genuine drug. Explaining the technology Varrier says, “Counterfeit drugs are a serious problem in India and other developing nations. This not only presents a significant health hazard but also revenue loss; not to mention the hit the brand takes. In order to reduce the menace of spurious drugs, it is important to be able to track the drug at the level of a strip or a vial. Bar coding them at the box level is really of little impact. Hence, we have come

up with a unique identiﬁcation number for every strip or vial that is manufactured.” Adding to this technique, he informs, “The unique identiﬁcation number would be printed on each strip of the drug that a company manufactures.The code is generated with an algorithm, which is proprietary to us. So, there is an algorithm that can read the code and decode it when required. When the drug goes out to the market, the number goes with the medicine. The customer can then send a SMS with the code printed on the strip to us and within three seconds the customer will receive a message from our end stating that the drug is genuine. How this will help stop spurious drugs? A person can duplicate one strip, but without his knowledge the number will also get duplicated. A counterfeiter can try to replicate it, but when we get a message of an alteration of the code we can check it and most importantly inform the costumer that the drug is fake.”

Dual solution There are two parts to the solution: Unique Identification Number (UIN) on strip/vial level: A unique identification number on every strip of medication is generated and linked to their database. The numbers are not simulated, hence, when a customer buys the medication all he/she does is SMS the code to the number on the strip. The code is received by the system and it is cross checked in the database. If it finds a match it issues a reply about the validity of the drug, if a SMS

Modern Pharmaceuticals I March 2012

Case Study - Fighting counterfeits

In India, the question is not about finding ways to understand the costumer better; it is but to find ways of reaching the market in the least possible time. Rajesh Varrier Founder & Chief Executive Officer, Activecubes with the same code is already received then the consumer is informed that the drug is not genuine. QRCode/2D code: A QRCode/2D code is also printed on every vial as an added mechanism for validation of the authenticity of the strip. The customer needs to download the mobile app once for free and key in the QR code post, which the application will communicate with the database at the backend and revert with the authenticity of the strip or vial. QR codes will be an additional level of security since they are not easy to replicate.

March 2012 I Modern Pharmaceuticals

Growth opportunities Although there are not many analytical companies present in India, the industry deﬁnitely has a lot of potential. “There is signiﬁcant space to grow and excel in the market abroad. If you consider the US market - it is mature in multiple ways. From an industry growth perspective, US does not have growth rates like that of India. For instance, if you consider the top companies is India one would notice that their growth rate is anything between 10-30 per cent, whereas in the US it might be 4-5 per cent year on year,” says Varrier. Explaining

the analytical market further he said, “When an industry grows at slow rate the competition definitely gets stiff. The companies want to understand every bit about the costumers, the buying pattern, what is selling and what is not. But the Indian market does not function in the same manner as the growth rate of companies is tremendous high. In India, the question is not about finding ways to understand the costumer better; it is but to find ways of reaching the market in the least possible time. Hence, India is still a few years away from reaching a state where pharma companies want to analyse all their data to find ways of doing better than their competitors.” However, there a few leaders in the Indian pharma industry who feel the need to analyse data to stay a step ahead. The India pharma sector needs the help of analytics for tackling spurious drugs, and hence, this technology has a lot of potential to turn the industry of counterfeit drugs upside down. (jasleen.batra@infomedia18.in)

Automation Trends: Process Analytical Technology

The

less explored opportunities A technology that has proved its importance in other industries is still at a nascent stage in the pharmaceutical sector. Though implemented by regulatory bodies, PAT is yet to enter the pharma market full-fledged and prove its potential.

Titash Roy Choudhury

he US Food and Drug Administration (USFDA) defines Process Analytical Technology (PAT) as a mechanism to create, analyse and calibrate the drug manufacturing process through the measurement of certain parameters called as ‘Critical Process Parameters’ (CPP). “The USFDA had approved and implemented this technology a few years ago for production of medicines in batches. PAT technology analyses and measures the CPP, which affects the quality of the product. Thus, in turn this process helps to analyse the quality of the end product,” says Sumeet Kad, Analyst, Synovate Healthcare. This process holds more prominence while manufacturing a generic version of any Active Pharmaceutical Ingredient (API), since that requires modifications and certain changes in the composition, and here in PAT helps to analyse how certain modifications are going to affect the quality of the final drug. “The basic methodology for the process is to test

the critical parameters of the drug being manufactured while in line without disrupting the production ﬂow. The analyses and the calibration happen on the line as well. Also the testing is done subsequently on the production line as well,” informs Dr Vikram Venkateswaran, Healthcare and Lifesciences Professional. “This technology analyses each and every process and helps in determining the properties of the end product,” says Arunabha Bhaduri, General Manager - Process Control Solutions, Rockwell. According to ARC Research, some of the leading suppliers of PAT are ABB, Aegis Analytical, GE, Perkin Elmer, Rockwell Automation, Siemens and Solvias.

Use of PAT in the pharma industry The pharmaceutical drug development process is a highly regulated mechanism starting from drug discovery to commercialistaion. In the traditional manufacturing line, the drug has to be taken oﬀ the line to be tested. This

is a long process and delays the final manufacturing time. Under PAT, the drug need not be taken off the line, instead using the PAT equipment the drug is monitored and tested for critical process parameters. This is to ensure that the manufactured drug meets the critical quality attributes. “Implementing PAT consists of two broad categories. The first step is to design the PAT roll out framework. This would depend on the nature of the drug being manufactured and the process that is currently running. There are two critical steps in designing the framework, deciding what information needs to be collected to qualify the critical quality attributes and deciding which stage in the manufacturing process does one need to collect that information. Th e second step involves selecting the right tool for the analytical process. The three main sets of tools that are an integral part of any PAT system include: Multivariate Data Analysis tool - some common tools are SPSS, SAS, Spotfire and Excel; Process Analytical Chemistry tools such as Bio Sensors, Near Infra Red Spectroscopy and Raman Spectroscopy; and Knowledge Management tools - this can be done through standard MES tools and Electronic Content management tools,” informs Dr Venkateswaran.

Advantages of PAT This technology has been used in other industries such as petrochemicals, food processing but in pharmaceuticals it has received a mixed response. This

Modern Pharmaceuticals I March 2012

Process Analytical Technology

PAT reduces the production cycle, which in-turn reduces the marketing time and gives the company a chance of getting a drug faster to the market. Sumeet Kad Analyst, Synovate Healthcare technology has several advantages, which if implemented in this sector, will give better results. One of the main advantages of this technology is that in manufacturing of the drugs, “The cycle times and the production time will be lowered substantially. Also, the inline testing will result in lesser changes in the line, which will fasten turnaround times,” informs Dr Venkateswaran. With reduction in production time, the drugs can also be marketed sooner. “It reduces the production cycle which inturn reduces the marketing time and gives the company a chance of getting a drug faster to the market,” says Kad. The second biggest impact area is supply chain. “With the shortening cycles of manufacturing, supply chains will become a closed loop and inventory planning would be faster and more accurate. According to research done in 2009, the implementation of PAT would create a one-time release of $ 79 billion, which otherwise is locked up in inventory due to production delays,” says Dr Venkateswaran. This technology will also assure the quality of the ﬁnal drug. “Through PAT, quality assurance on manufacturing would be met almost always - 100 per cent - once the quality parameters are set,” says Dr Venkateswaran and this will prevent rejection of batches of drugs due to quality issues. “There are various advantages of PAT like, higher through put, faster time to market, reduction in manufacturing cost, higher recall and better output,” sums up Bhaduri.

Challenges in implementation The implementation of this technology

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According to research done in 2009, the implementation of PAT would create a one-time release of $ 79 billion. Dr Vikram Venkateswaran Healthcare and Lifesciences Professional

has been slow in Indian pharma market since there are various challenges that need to be overcome before the market can fully integrate this technology. “This technology is gradually coming to India. The entry was so late because Indian pharma market is not technology driven but controlled more manually. This technology requires an initial high cost of investment so many companies have not yet invested in PAT, but it is going to prove immensely important for a generic market like India,” feels Bhaduri. Thus, the biggest

With the shortening cycles of manufacturing, supply chains will become a closed loop and inventory planning would be faster and more accurate.

challenge to PAT implementation is cost. “Not only is it expensive to implement PAT, it would also require a lot of modernisation to do the same. The current manufacturing process would not allow for PAT to be implemented so business process re-organisation would have to be done and the manufacturing line reassembled. Also, some of our processes are still manual and paper based, and PAT requires a relatively high degree of automation for the best results,” informs

Dr Venkateswaran. To implement this technology Indian market will also require trained professionals. “The knowhow and technical expertise for the same is also required and so investment has to be done in training. Also, the return on investment is diﬃcult to measure,” says Kad.

Attraction for many Many global pharmaceutical companies such as GSK have implemented PAT at their manufacturing sites including Ireland, US, UK and Singapore. PAT has also been implemented by Merck and Pﬁzer. But the absence of a compulsory mandate has resulted in many pharma companies ignoring this process. The Indian pharmaceutical industry is no diﬀerent. All these factors have resulted in companies in India putting this issue on the back burner. “For a country such as India, selective implementation is a better way of incorporating this technology, where instead of utilising PAT through the entire manufacturing process it is installed for few processes. In that way, they will understand the nuances of the technology while the initial investment will also not be very high,” suggests Kad. It is undoubted that this technology will be helpful for generics market like India. “It is slated that in the next 5-6 years PAT would become a regulatory mandate. Till then, PAT for the Indian pharmaceuticals looks like a distant reality,” believes Dr Venkateswaran. (titash.choudhury@infomedia18.in)

Energy Management: Carbon neutrality

Inching closer to the

green dream

Over a period of time it has become the need of the industry to maintain a net zero carbon footprint by balancing the measured amount of carbon released. We take a closer look to determine the importance of carbon neutrality. in the equivalent amount of CO₂. Further, it can be clarified that the term ‘climate neutral’ is used to reflect the fact that it is not just carbon dioxide (CO2) that is driving climate change. Even though carbon dioxide is present in huge dimension, there are also other greenhouse gases regulated by the Kyoto Protocol, namely: methane (CH4), nitrous oxide (N2O), hydrofluorocarbons (HFC), perfluorocarbons (PFC) and sulphur hexafluoride (SF6).

Chandreyee Bhaumik

he term carbon neutrality is gaining widespread recognition. It has become more recognisable as companies attempt to demonstrate their environmental and carbon management credentials. Carbon neutrality, or having a net zero carbon footprint, indicates achieving the net zero carbon emissions by balancing the measured amount of carbon released with an equivalent amount sequestered or oﬀset, or buying enough carbon credits in order to make up the diﬀerence. Therefore, it is used in the context of carbon dioxidereleasing processes, associated with transportation, energy production, and industrial processes. Thus, the carbon neutral concept may be extended to include other Greenhouse Gases (GHG) measured in terms of their carbon dioxide equivalence — the impact a GHG has on the atmosphere expressed

What is carbon neutral? According to several documents and reports, carbon neutrality refers to the completion of the following phases: Measuring emissions: Measuring carbon emissions is the essential first step in effecting behaviour change and managing emissions. According to Shruti Pande, Clinical Team Lead, Wockhardt Ltd, “Agencies gathered accurate information on the greenhouse gas emissions linked to their energy and electricity use, transport (including domestic and international air travel), and waste was sent to landfill. The credibility, transparency and reporting methods used aligned with international public and private sector carbon neutrality efforts.” Reducing emissions: Reduction planning is an essential part of the carbon neutrality process. It involves identifying opportunities to reduce emissions. Pande says, “The six lead agencies aimed to reduce the amount of greenhouse gases

they released by putting in place: energyefficiency measures, which included conducting energy use audits, educating staff on using less electricity, installing low-energy lighting systems and more efficient heating and cooling systems, and buying equipment that used less electricity travel measures, which included creating workplace travel plans to eliminate unnecessary journeys, buying more fuelefficient vehicles, and using transport alternatives such as videoconferencing facilities waste reduction and recycling systems.” She continues, “Agencies were expected to lower their carbon emissions, not reduce them to zero which would have been impractical with the available technology. Agencies did not undertake emission reductions that lessened their effectiveness. More emphasis was put on making procurement decisions that had the lowest overall cost in the long term, rather than a low initial purchase cost but high running costs.” Offsetting residual emissions: The third stage necessitates the acquisition of carbon credits to offset any residual emissions and achieving internal reductions. When offsetting, considerations should be given to the type of offsets bought to ensure that they are of sound quality and thereby represent real emissions reduction.

Essential elements Discussing the important attributes of carbon neutrality, H G Koshia, Commissioner, Food & Drugs Control Administration, Government of Gujarat, says, “Controlling the existing processes

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Carbon neutrality Controlling the existing processes with appropriate technology, efﬁcient maintenance and providing for renewable energy sources to reduce the carbon footprint is extremely important.

Agencies were expected to lower their carbon emissions, not reduce them to zero which would have been impractical with the available technology. Shruti Pande Clinical Team Lead, Wockhardt Ltd

with appropriate technology, efficient maintenance and providing for renewable energy sources to reduce the carbon footprint is extremely important. This includes re-designing the existing processes for identifying the steps that can be eliminated.” Further, according to him developing newer processes that are targeted to achieving zero carbon emission is also significant. He highlights, “Identifying the areas of indirect emissions which on an individual level or at the organisational level can be reviewed for reduction of carbon emission, application of renewable energy resources such as solar energy for domestic as well as industrial usages, use of biogases for mass canteens, etc is important. The basic approach is to work on both direct and indirect emissions, which in a planned or co-operative manner can be attended.” Koshia avers, “One needs to account for the sources of emission generation, quantify each source for its potential for emission and draw a balance sheet against the steps and quantities of emissions reduced or eliminated.” Continuing this strain of thought, he highlights, “The net balance must be targeted towards offsetting the debits-emissions, completely by the credits –elimination of emissions.”

Pharma context The pharma sector broadly consists of two segments - Active Pharmaceutical Ingredient (API) and formulations. According to Koshia, the direct carbon emission control is a bigger challenge for API facilities and this is achieved by migration from synthetic processes to biotechnology-based processes.

March 2012 I Modern Pharmaceuticals

H G Koshia Commissioner, Food & Drugs Control Administration, Government of Gujarat Koshia avers that carbon neutrality has huge importance in the pharma sector for following reasons: The significant investment in the pharma facilities is towards the creation of controlled environment for manufacturing areas. This is achieved by installation of HVAC systems. Carbon neutrality would contribute significantly towards reduction of DELTA factor, ie, the factor of control of ambient parameters to desired parameters such as dust/particle control, temperature control, etc The safety and health hazards reduction is feasible with adoption of technology and concepts of carbon neutrality Pande says, “Temperature excursions are serious because non-compliance with the manufacturer’s storage recommendations and the MHRA’s guidelines on general storage can lead to expensive product recalls, may prompt the destruction of affected products and, ultimately, could cause a health risk to patients. Issues relating to temperature control will cost the distributor in a number of ways, especially since they can lead to a loss of confidence in the distributor by manufacturers, the MHRA and pharmacists.” She continues that glossing over temperature control issues is not an option since the MHRA’s Orange Guide makes it clear that distributors must comply with the regulations or face sanctions if their facilities are found to be wanting. Adverse inspections will trigger recommendations for corrective action and if it is not taken the MHRA can take regulatory action. This may include suspension of a manufacturer’s or wholesale distribution

licence, compulsory variation of licences to exclude certain activities and sanctions against the responsible person. She highlights, “It is not the general conditions that aﬀect product quality, but extremes of temperature within the operational space. As global warming is widely accepted as a reality, temperature control issues are likely to become even more of a problem in warehouses that are not equipped with appropriate cooling.”

Maintaining carbon neutrality Pande says that unlike traditional systems, which pump more greenhouse gases into the environment,exacerbating the problem over the long term, to engineer systems to maximise ‘free’ cooling so that the chiller plant is only operational when daytime external temperatures are exceptionally high.” Signing off she adds, “HVAC solutions utilise technologically advanced ‘Balanced Jet’ air induction systems. Air flow and temperature throughout the operational space is maintained at ± 1°C of the desired level, as the systems are purpose-designed to entrain and recycle heat outputs from MHE; cope with tall, densely racked aisles, mezzanine areas and loading bays and integrate aesthetically with ancillary systems such as lighting, fire curtains and sprinklers. Importantly, engineer systems to deliver free cooling via a night time purge, when external air temperatures are lower, reduces the reliance on mechanical cooling and helps to reduce operating costs over the system’s life cycle.” These are the steps that a pharma company should follow in order to maintain carbon neutrality. (chandreyee.bhaumik@infomedia18.in)

Policies & Regulations: Policies governing drug counterfeiting

Rigorous implementation:

The

way forward

Globally, the counterfeit drug industry is estimated to be around $ 75 billion; although no exact figures are available for the Indian market the number of fake drugs is about 46 per 1,000. And this number will be increasing if proper measures are not taken. Although there are various policies and amendments to stop this menace their effective implementation is an issue. Titash Roy Choudhury

purious drugs have been affecting the Indian pharma market for many years now and today the country has become a major source of these drugs globally. Further, this problem gains serious momentum when it comes to healthcare as it directly affects the health of the patient and at times may lead to death. Also, the issue of economic loss to the manufacturing companies holding the rights for particular products pertains. The Drugs and Cosmetics Act has been in force since 56 years but the enforcement in many states has not yet reached the desired level. Penetration of such laws in the interior parts of several states is lacking. It is therefore imperative that efforts should come from all the stakeholders to ensure that safe and genuine drugs reach the public. The law for

curtailing this menace exists and so is the regulatory authority; the only thing missing is the strong will from the government to implement the same. “The law has been amended and many committees have been formed to look into the matter, but when it comes to implementation and taking concrete steps we see little action,” avers Bejon Misra, Founder, Partnership for Safe Medicines (PSM) India. Along with an overview of the current market scenario we need to look at the policies and what measures need to be taken to make the government more pro-active.

Market scenario The pharmaceutical industry in India is approximately $ 24 billion (` 120,000 crore) while the World Health Organization (WHO) estimates that counterfeit drugs make up to 20-30 per

cent of the market. According to the WHO, counterfeit drugs include medicine with wrong ingredients, insufficient active ingredients or illegitimate packaging. This has a range of negative effects - drug resistance, poisoning, allergic reactions, prolongation of treatment and even death. “India is the world’s third largest drug producer by volume and 14th by value, and is increasingly being identified as drug manufacturing hub for rest of the world. The size and value of the industry attracts counterfeiters to the space and low barriers to entry make it an easy market to access. Low barriers include weak supply chains, multilevel distribution channels and unregulated systems,” says Kishore Kar, Vice PresidentSales & Marketing, PharmaSecure. Other major factors that are fuelling the spurious drug market are lack of enforcement in existing laws, lack of co-ordination between various agencies among others. “Weak penal action is also another factor that has been reported by the Mashelkar Committee Report. They had proposed death penalty for the culprit that has been changed to life-imprisonment. The prosecution methods for crime of drug counterfeiting also has various technical faults,” informs Misra.

Modern Pharmaceuticals I March 2012

Policies governing drug counterfeiting The law has been amended and many committees have been formed to look into the matter, but when it comes to implementation and taking concrete steps we see little action. Bejon Misra Founder, Partnership for Safe Medicines (PSM) India

At the helm of affairs Health is ultimately a state affair and the state government is responsible for licensing of drug manufacturing establishments and sales premises, carrying out inspections of licenced premises for ensuring compliance to conditions of licences, drawing samples for test and monitoring the quality of drugs & cosmetics moving in the state, taking appropriate action such as suspension/cancellation of licences and instituting legal action wherever needed as provided under the Act and Rules. The Drugs and Cosmetics Act 1940 is dealing with unlicensed medicine and this law has been amended over the years. Various committees have been for looking into the issue of spurious drugs such as the Mashelkar Committee, which looked into the spurious drugs market in India. “Then, there was the P N Tandon Committee that looked into the incorporation of technology for detecting spurious drugs, but all that report is doing today is catching dust! A sub-committee was also setup under Dr VK Katoch but even that was not focussed. More efforts need to be taken; the policy exists but due to lack of implementation it is falling short” says Misra. As a strategic drug manufacturer and exporter in the Asia Pacific region, India plays a crucial role in fighting counterfeiting. The growing counterfeit drug mafia poses a huge threat to India’s image as a reliable exporter. “Hence, the Director General of Foreign Trade (DGFT) in India has mandated a step-by-step implementation process of serialisation as the first move against counterfeit drugs. Thus, providing the foundation for a track and trace system

March 2012 I Modern Pharmaceuticals

By July 2012 all tertiary packages must be serialised followed by secondary (boxes typically at chemist shops) and primary packages (blister packs and vials) by 2013. Kishore Kar Vice President - Sales & Marketing, PharmaSecure

that can monitor the supply chain at all points of distribution. Serialisation is a widely prevalent measure being used across the globe and the DGFT notiﬁcations help Indian manufacturers comply with global standards. This helps pharmaceutical companies standardise operations and logistics for eﬀective international trade. By July 2012 all tertiary packages must be serialised followed by secondary (boxes typically at chemist shops) and primary packages (blister packs and vials) by 2013,” informs Kar.

The Drugs and Cosmetics Act has been in force since 56 years but the enforcement in many states has not yet reached the desired level.

Measures to be taken The reason behind widespread counterfeit drug prevalence in India is due in part to weak regulations, loopholes in the distribution chain and lack of enforcement at the ground level. “The entire system requires an eﬀective overhaul at the policy and implementation level. Hence, a collective eﬀort from manufacturers, distributors, retailers, industry bodies and the government is needed to restrict the growth of counterfeit drugs in India,” Kar believes. While according to Misra the government needs to be more pro-active

and demonstrate the seriousness of the situation in a time-bound manner. There is a huge dearth of trained professional to detect the crime and government should help in building the capacity of the state authorities. “They should look into capacity within state government adequately supplemented, which means manpower up gradation, and people should be given adequate incentive among others,” says Misra. Technology integration is also a major hurdle to the proper implementation of the law and nothing concrete has been taken in that direction. India still has a long way to go in adopting such security measures within the system and hence the need for authentication measures is even higher. “Mobile authentication has high relevance in a country such as India, because it has leapfrogged the landline culture and mobile usage has become a way of life. The ease of use is another advantage in popularising the concept and its beneﬁts. Appropriate measures have been taken at the manufacturing and packaging stage to ensure only authentic medicines reaches the market place. The logistics management at the manufacturers end and policy regulations from the governing bodies together construct an adverse environment for counterfeit drug makers,” says Kar. Thus, what India needs right now are more concerted eﬀorts towards implementation of the suggestions made by various committees, and strengthening the state regulatory authorities. More than changes or amendments in the existing policy, the need of the hour is to look into proper execution of the same. (titash.choudhury@infomedia18.in)

Strategy: What’s new in pharma marketing?

Selective pampering Pharmaceutical companies resort to several tactics to meet their initial sales target in the shortest possible time. This is attempted through several time-tested techniques. Here’s providing a unique method to effectively use the industry for successful marketing.

harmaceutical companies are always looking out for innovations to rev up their sales. Traditionally, like all other businesses, the pharma industry too, built up its trade brick by brick. It was well accepted that for any product that is launched there would be an initial sluggish phase in its sales figures before it hits pay dirt. Today, the scenario is completely different. Due to skyrocketing cost of land, rentals and capital, investments have gone up. Raw materials are costlier, prices of transportation have multiplied and therefore overheads are higher. Besides, in a growing economy clubbed with high inflation, personal aspirations are much higher than that in the past. Therefore, the qualified executive as well as skilled workers demand better pay. Industries are mostly set up with funds borrowed at high interest rates. All these factors shoot up the cost of research, manufacturing and trading of pharmaceutical products.

High stakes When drugs are researched, manufactured and sold at a high price; when funds are available at a premium, the obvious thing that the manufacturer needs is quick and huge returns. Unless the bottomline zooms northwards immediately, the industry’s survival itself appears to be under threat. Just like a $ 100-million movie must fetch huge box-oﬃce returns

in the first week of its opening itself so that the substantial amount paid to artists, technicians, theatres, etc is recovered immediately to fetch profits for the producer; the pharmaceutical industry also desires a quick buck. Any delay in building up sales and amassing profits becomes a drain on the organisation because it continues to pay high interest rates on funds borrowed from financial institutions. Therefore, a drug launch must immediately be followed by a spike in sales. Moreover, the growth in profits should remain sustained for a reasonably long period so as to prevent a close competitor from overtaking it.

Traditional strategies Intensive training as well as greater incentives to the sales force, oﬀering higher margins to chemists, trimming avoidable expenses, diluting the non-sales workforce, etc are the standard operating procedures for pharma companies to achieve their sales target. Appointing senior physicians and consultants as Key Opinion Leaders (KOL) to speak to august medical audiences is among the modern methods

of pharmaceutical marketing. The senior practitioner discusses his views and experiences with the molecule in question and the audience gradually gets influenced by the underlying message. While this technique was considered to be fairly ‘scientific,’ it has its share of detractors who feel that the contents of most of the talks by these KOL are ‘doctored!’ The latter approach was a tough proposition, since zeroing upon a KOL is by no means an easy task. The KOL had to be an expert with over a decade and a half in practice or who worked as a professor at a high-profile medical college hospital /research institute. Some of these KOL tend to be too demanding by insisting on elaborate scientific information, greater compensation as appearance fee or for conducting clinical trials etc.

Modern trends Identification of genuine KOL is a complicated task as it not just involves approaching people with impeccable integrity and scientific knowledge. Besides, these leaders must be those who are popular, respectable and have an inherent ability to influence the rest of their

Modern Pharmaceuticals I March 2012

What’s new in pharma marketing? fraternity. Moreover, these senior experts are naturally available at a premium that only large corporations can aﬀord. Moving away from the KOL ‘game plan’ is the latest modus operandi, particularly of the smaller players in the pharmaceutical market. Instead of focussing on a few, major, pricey KOL, these companies ‘enlist’ a large number of Supporters Or Loyalists (SOL). These cohorts are usually physicians across age and personality barriers but who either have already built up a thriving practice or show promise in the growth of their patient load. The peer-holding capacity of the physician or his ability to address a gathering is not a criterion for being enlisted so long as the company can ‘deal’ with him comfortably and their mutual needs are met! These prescribers are wooed with clinic inputs such as textbooks, clinical equipment, hospital supplies, stationery or may extend up to personal utilities / gadgets, tours, sponsorships, etc.

Comparisons Both methods have its pros and cons for the company as well as the persons benefitted. The KOL system was originally intended to be a scientific system wherein astute, senior consultants were invited by drug-research majors to provide an insight into therapeutic approaches, both for the benefit of the company as well as his subordinates in the specialty. However, this system favoured few physicians and most of them tended to be academicians or retired professors from major medical colleges. With the gradual lowering of moral standards of society in general and the added suspicion about collusion of the KOL with the company’s financial needs, the fraternity has begun to lose faith in the system. Consequently, KOL have lost their authority on prescribing patterns of the rest of the members of the speciality. Moreover, since the general members do not gain anything other than knowledge from KOL-led meetings, they have lost their charm. KOL have to be handled at all times by senior members of the marketing team only. On the other hand, the SOL

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system works well for smaller companies with shoe-string budgets as it does not have to handle big guns! The National Marketing Manager finds it easier to divest responsibilities among the junior cadre to identify reclusive, budding doctors. Instead of providing intense training to the Professional Sales Representative (PSR) and the Area Manager on technical product information, they are taught to handle specific personal needs of the physician, similar to the hospitality industry. In these cases, demands from SOL are of minor nature and the senior marketing staff need not be involved in processing the request so long as the prescriptions keep flowing thick and fast. The quarterly review of the PSR will speak more about the way the SOL is performing rather than the PSR. Since the prescribing pattern of the doctor can be directly monitored by the PSR, the loss incurred in the case of ‘noncooperation’, if any, is minor.

When drugs are researched, manufactured and sold at a high price; when funds are available at a premium, the obvious thing that the manufacturer needs is quick and huge returns.

Since KOL are visible across the industry as well as the medical fraternity, they are identiﬁed as being part of a particular company.Therefore, should things not work out the way a company desires, dumping a KOL is not an easy task, In comparison, SOL being imperceptible outside the known group, not everyone is aware of the nexus. If one group of SOL does not work, the company simply switches to another band of supporters in the next quarter.

Boomerang! Until the past decade, only a small number of people were chosen as KOL and the rest

of the fraternity found the system working well. This was because not everyone with a busy practice could boast of the scientific thinking that a senior medical teacher or an aged consultant possessed. Except for a few disgruntled voices, everyone listened to the speaker with rapt attention and went back to their clinics with the take-home message. Under the present system of pampering, SOL with personal tours, excursions and the like, many companies are alienating a significant section of sincere, conscientious prescribers. Doctors, who are not part of the SOL-circle and yet, have been regularly prescribing good products of companies may gradually begin to go for alternative brands. This is a new development that SOL-based companies have yet to understand! Companies who have started mollycoddling SOL are progressively distancing away sensitive, genuine physician who keep their patient’s interest supreme. These quiet-prescribers are not showered with any goodies since they have an image of maintaining their individuality, “It is unfair to provide incentives to others to prescribe the same brands that we have already been doing without any expectations,” said a senior consultant on the condition of anonymity. Such physicians, who feel that they have been ignored, will form another cartel to switch loyalties to another brand. Over a period of time these hostile physicians influence their like-minded colleagues and they deviate from all brands introduced by such pharmaceutical companies. Eventually, while the SOL brings in revenue, the original, genuine loyalists’ reluctance to prescribe could erode into the drug company’s bottom line. (rajan.td@gmail.com)

Dr Rajan T D Pharma Consultant & Practising Dermatologist

Tips & Tricks: Patent prosecution tips

Factors to be considered before ﬁling a patent

atent prosecution is the exchange of information, between the patent examiner and the applicant, in determining as to whether the invention is eligible and satisfies the requirements for grant of a patent. It involves writing and filing a patent application with the Patent Office

Claim drafting: Claims should be drafted towards the invention. Knowing what you want to protect before filing the application is the primary requirement of drafting claims. A poorly drafted claim set may not capture the protection needed or desired. Misdirected claims may create difficulties and difficult to anticipate what might be claimed in the future.

Tips& Tricks

2 T

Claim set from broad to ips narrow: Draft your claim ricks beginning with the broadest scope to which you feel you are entitled and concluding with the narrowest scope that merits protection. A claim set that is graduated in scope assists in performing a complete and focussed search.

Number of claims: It is always better to avoid ﬁling excessive numbers of claims and keep the number of claims manageable. An optimal number of claims enable the patent examiner to enhance the quality of prosecution by focussing the search and examination eﬀorts at the core of the applicant’s invention.

Tips& Tricks

and pursuing protection for the invention as disclosed in the patent application. The global pharmaceutical market has been encountering significant growth over the years and filing patent for drugs is a crucial component for fuelling that growth. But there are various factors that should be considered before filing a patent.

Highlight limitations: During the course of prosecution, when limitations are added to the claim to narrow down its scope, it is always better to include a brief note to that eﬀect citing the location in the speciﬁcation or drawings from where the support is derived for that limitation.

Tips& Tricks

Comprehensive reply: An applicant must ensure that thorough responses are filed addressing the specific objections set forth in the patent examiner’s office action. This on one hand may reduce the chances of a second examination report and on the other also provide time to respond to the second examination report, if issued.

Tips& Tricks

Early amendments/ arguments: File arguments and amendments at the earliest stage of prosecution, and prior to a final rejection if at all possible. Amendments submitted after final are more difficult to deal with procedurally and extend prosecution.

Tips& Tricks

Kamakhya Srivastava Head-Group on Research Publication and Programme, LEX ORBIS IP Practice

Ask for hearing: The applicant may request for a hearing when possible. It can help applicants and patent examiners quickly identify points of disagreements and correcting them and hopefully ﬁle for an early patent.

Tips& Tricks

Co-ordinate foreign applications: The applicant may amend the application in view of the prosecution in a corresponding US or EPO application. An applicant must ﬁle it in Form 3 either along with the application or within six months from the date of ﬁling application.

Tips& Tricks

Respect deadlines: The Patent Oﬃce’s position is that when the Act itself prescribes timelines, it must be treated as a fundamental aspect of the process for granting patents.

Tips& Tricks

Checklist: An exhaustive checklist covering legal and technical points must remain at hand to ﬁnalise the application and make any corrections before submitting with the Patent Oﬃce.

Tips& Tricks

Modern Pharmaceuticals I March 2012

Projects New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.

Alembic Pharmaceuticals Ltd Project type New facility Project news Alembic Pharmaceuticals Ltd is planning to set up a new pharmaceutical facility that would involve manufacturing of diene. Project location Panchamahal, Gujarat Project cost Unknown Implementation stage Construction Contact details: Alembic Pharmaceuticals Ltd Alembic Road Vadodara, Gujarat- 390003 Tel: 265-2280550 Fax: 265-2281508 E-mail: infoal@alembic.co.in

Aries Laboratories Project type New facility Projet news Aries Laboratories is in the process of setting up a new facility for bulk drug manufacturing. The project is scheduled for completion in April 2012. Project location Ahmedabad, Gujarat Project cost Unknown Implementation stage Construction Contact details: Aries Laboratories 18, Natraj Industrial Estate Sanand Dist Sanand- 382170, Ahmedabad Tel: 079-26926689 E-mail: parth_patel2001@yahoo.com

Celestial Biologicals Ltd Project type New Facility March 2012 I Modern Pharmaceuticals

Project News Celestial Biologicals Ltd is planning to set up a new pharmaceuticals project which would involve manufacturing of Albumin Factor Viii Immunoglobulin. Project Location Ahmedaad in Gujarat Project Cost Unknown Implementation Stage Construction Contact details: Celestial Biologicals Ltd Saekethej Bayla Highway Village Matoda, Sanand Ahmedabad, Gujarat- 382210 Tel: 2717-662103 Fax: 2717-662126 E-mail: info@celestailbiologicals.in

Eisai Pharmatechnology and Manufacturing Pvt Ltd Project type New facility Project news Eisai has announced expansion of the existing facility to increase manufacturing and research capabilities. Expansion of the facility will increase annual production capacity to 60 tonnes of formulations and two billion tablets by 2013. Project location Vishakhapatnam, Andhra Pradesh Project cost $20 million Implementation stage Construction Contact details: Eisai Pharmatechnology and Manufacturing Pvt Ltd Eisai Knowledge Centre Ramky Pharma City (SEZ) Andhra Pradesh Tel: 891-3047100 Fax: 8924-282500 E-mail: s_somnath@epm.eisai.co.in

Epsilon Pharmaceuticals Project type New facility Project news Epsilon Pharmaceuticals is implementing a sterile injectables manufacturing unit, which would be spread over a land of 5 acres. Project location Mahabubnagar, Andhra Pradesh Project cost Unknown Implementation stage Construction Contact details: Epsilon Pharmaceuticals Ltd 6th Floor, Midtown Complex Road No. 1 Banjara Hills Hyderabad - 500 035, Andhra Pradesh Tel: 040-44609000 / 44609020 Fax: 040 44609007 E-mail: info@epsilonpharma.net

Hyacinths Pharma Pvt Ltd Project type New facility Project news Hyacinths Pharma Pvt Ltd is planning to set up a new pharma project that would involve manufacturing of ethambutal. Project location Srikakulam, Andhra Pradesh Project cost Unknown Implementation stage Construction Contact details: Hyacinths Pharma Pvt Ltd H. No 8-3-678/60 Park View apartments Yousufguda Hyderabad- 500045, Andhra Pradesh Fax: 040-23756566 E-mail: hyacinthspharma@gmail.com

Projects

Igen Labs Pvt Ltd

Symbiotec Pharma Lab

Ushma Technologies Pvt Ltd

Project type New facility Project news Igen Labs Pvt Ltd plans to set up an active pharmaceutical ingredients unit. The completion is targeted in 1.5 years.

Project type New facility Project news Symbiotec Pharmalab is in the process of setting up a new fermentation facility to produce corticosterioids. The facility is expected to be ready in 2014.

Project type New facility Project news Ushma Technologies is in the process of implementing an API and formulation project in Madhya Pradesh to develop anti-cancer drugs.

Project location Dhar, Madhya Pradesh Project cost ` 450 million Implementation stage Construction

Project location Dhar, Madhya Pradesh Project cost Unknown Implementation stage Construction

Contact details: Igen Labs Pvt Ltd Venkateshwarlu CTO, Plot 106A Road 7 Jubliee hills Hyderabad- 500033 Tel: 040-40114001/02 Fax: 040-40114004 E-mail: info@igenlabs.in

Contact details: Symbiotec Pharmalab Ltd Off A B Road 385, Pigdamber Rau Indore- 453331 Tel: 731-4200052 Fax: 731 4201222 E-mail: sumbiotec@symbiotec.in

Contact details: Ushma Technologies Pvt Ltd 301, Evershine Mall Off Malad Link Road Malad (W) Mumbai 400064 Tel: 022- 42172222 Fax: 022 4003 8925 E-mail: info@resonances.com

Lupin Healthcare Ltd

Torrent Pharmaceutical Ltd

Project type New facility Project news Lupin Healthcare in planning to set up a new pharmaceutical project that would involve manufacturing of pharmaceutical formulations based on pepsin 12.50.

Project type New facility Project news Torrent Pharmaceutical, which has interests in pharma and power, is in the process of expansion. It is going to expand its facility at Kadi and will be setting up a green field project at upcoming Dahej SEZ.

Project location Hassan, Karnataka Project cost ` 10 crore Implementation stage Construction

Project location East Sikkim Project cost Unknown Implementation stage Construction Contact details: Lupin Pharmaceuticals, Inc Harborplace Tower 111 S. Calvert Street 21st Floor Baltimore, MD 21202 Tel: 866-587-4617 Fax: 866-587-4627 E-mail:customerservice@lupinusa.com

Project location Kadi, Mehsana district Project cost ` 300 crore Implementation stage Construction Contact details: Torrent Pharmaceutical Ltd Off Ashram Road Ahmedabad- 380009 Gujarat Tel: 079-26585090 Fax: 079-26582100 E-mail: trc@torrentphara.com

Zydus Cadila Project type New facility Project News Zydus is setting up a new unit in SEZ near Ahmedabad. This facility will manufacture transdermal patches and various injectables. Project location Ahmedabad Project cost ` 1000 million Implementation stage Construction Contact details: Zydus Cadila Ltd Zydus Tower Satellite Cross Road Ahmedabad- 380015 Gujarat Tel: 079-26868100 Fax: 079-26862365 E-mail: rashminair@zyduscadila.com

Modern Pharmaceuticals I March 2012

Event List

NATIONAL AHMEDABAD

PUNE

CHENNAI

LUDHIANA

Gujarat, Oct 5-8, 2012

Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

INDORE

AURANGABAD

RUDRAPUR

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Infomedia 18 Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

3rd Annual Biosimilars With a 2-day strategic conference and post-conference workshop on clinical trials, Biosimilars India 2012 will bring together key stakeholders in the biopharmaceutical industry to learn about the latest industry developments and innovative commercialisation strategies that will propel your biosimilar strategies to the next level; March 27-29, 2012, Hyderabad For details contact: UBM India Pvt Ltd Tel: +91 22 4046 1466 Fax: +91 022 4046 1477 Email: conferences-india@ubm.com Website: www.biosimilars-india.com

Herbal International Summit Herbal International Summit-cum-expo on medicinal and aromatic products is a mega event showcasing continental, regional & local competence in this industry & to promote worldwide upcoming business of herbals, spices and finished products. More than 100 prominent companies will be participating in this event including foreign companies. There will be manufacturers, suppliers, exporters, traders of medicinal plants, herbal plants, herbal seeds and products. Further, product development boards and associations related to herbal plants, products, manufacturers and traders; April 14-15, 2012, NSIC Exhibition Complex, New Delhi March 2012 I Modern Pharmaceuticals

For details contact: ASSOCHAM Tel: +91 11 46550555 Fax: +91 11 46536481 Email: s.s.chawla@assocham.com Website: www.assocham.org

Lab Expo & Conferences Pune For many years the Indian government has been conducting this expo in different cities of India. Exhibitors of various lab commodities from all over the world will come to display their newly launched products. Exhibitors will exhibit their products, instruments and equipment. It will play an immense role for broadening their investment market and technology. The participants will also be able to exchange their experiences with the viewers; April 20-22, 2012, Auto Cluster Development & Research Institute Ltd, Pune For details contact: Paramount Exhibitors Tel: +91 172-2274801 Fax: +91172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Lab Expo & Conferences Coimbatore This is an event that focusses on various aspects related to lab equipment manufacturing as well as promoting good lab practices among the fellow professionals. The trade show will

be a two-day affair and will witness attendance from a considerable number of professionals who have been involved with this profession for a long time. This expo will also be supplemented with informative sessions and workshops, which will benefit the participants in a great way. This is an excellent platform for the lab equipment manufacturers and distributors to display their latest technological innovations and creations in front of an international audience. Moreover, this event also takes care of a number of important issues related to lab automation and labware equipment; June 15-17, 2012, Codissia Intec Technology Centre, Coimbatore For details contact: Paramount Exhibitors Tel: +91 172 2274801 Fax: +91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Automation 2012 All leading companies in industry will showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technology, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai For details contact: IED Communications Pvt Ltd Tel: + 91 22 22079567 Fax: + 91 22 22074516 Email: arokiaswamy@iedcommunications.com Website: www.iedcommunications.com

Event List

INTERNATIONAL Adaptive Designs in Clinical Drug Development Adaptive Designs in Clinical Drug Development conference will focus a spotlight on the industry in this rapidly advancing novel technique. There will be discussion on case studies from leading pharma companies on their use of adaptive clinical trials, maximising the benefits of an adaptive design through effective management, tried and tested - case studies of successful adaptive design trials and many others; March 26-27, 2012, The Grange Holborn Hotel, London, UK For details contact: SMi Group Ltd Tel: +44 0 20 7827 6000 Fax: +44 0 20 7827 6001 Email: client_services@smi-online.co.uk Website: www.smi-online.co.uk

Bio IT World 2012 The 2012 Expo plans to unite 2,000 life sciences, pharmaceutical, clinical, and IT professionals from 30+ countries. The expo provides the perfect venue to share information and discuss enabling technology that are driving biomedical research and the drug development process. Spanning three days, the meeting includes 12 parallel conference tracks and 16 pre-conference workshops; April 2426, 2012, World Trade Center, Boston, Massachusetts, US For details contact: Cambridge Healthtech Institute Tel: +781 972 5400 Fax: 781 972 5425 Email: chi@healthtech.com Website: www.bio-itworldexpo.com

Anti-Counterfeiting for Pharmaceuticals 2012 There will be discussions on the global threat of counterfeit medicines and

brainstorming on how to best confront the problem and provide insights into establishing and implementing an anticounterfeiting programme in the global pharma market to ensure that one is in a better position to secure the products against counterfeiters and most of all ensure consumer safety. This will be a unique opportunity to exchanges ideas and address anti-counterfeiting and brand protection matters in an open forum; April 30-May 01, 2012, Philadelphia, USA For details contact: IQPC Tel: +91 80 4322 4100 Fax: +91 80 4322 4103 Email: jai.das@iqpc.com Website: www.anticounterfeitingpharma.com

US-India BioPharma & Healthcare Summit 2012 The event will witness a congregation of biopharma, medical devices, healthcare companies, venture capitalists, policy makers from Europe, the US and India. Panel discussions will cover areas like drug discovery and collaborative research, restructuring R&D in order o maximise productivity and innovation, therapeutic areas like oncology (research areas, investor perspective, market opportunities, challenges and so on). Further, there will be discussion on emerging market opportunities, strtageies, funding innovation, cross border investments, M&A trends in the biopharma & healthcare and so on; May 11, 2012, Hyatt Regency Cambridge Massachusetts, USA For details contact: USAIC Tel: +781 586-1212 Email: info@usaindiachamber.org Website: www.usaindiachamber.org

Biomarkers World Europe This event aims to discuss how to support target identification and eliminate dead-end candidates, how to understand the range of biomarker candidates, how to create sophisticated animal models of human disease to develop biomarkers for proof-of pharmacology, how to facilitate clinical trial stratification and employ early surrogate end points of efficacy, how to define the correlation between biomarker and disease/therapeutic inter vention; May 22-24, 2012, Business Design Centre, London, UK For details contact: Health Network Communications Ltd Tel: +44 0 207 608 7055 Fax: +44 0 207 608 7050 Email: skhamissa@ healthnetworkcommunications.com Website: www. healthnetworkcommunications.com

CPhI Worldwide The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals

Modern Pharmaceuticals I March 2012

Event Report: BioAsia 2012

Targetting the vaccine and drug discovery market To further strengthen the biotech industry and the players entering the space of new drug discovery, BioAsia 2012 stepped into its 9th edition with a focus on vaccines and the potential that the Indian market holds.

(L-R): Dr K V Raghavan, Vice President, Federation of Asian Biotech Associations; Ali; Dr Berkley; Prof Vitarana; N Kiran Kumar Reddy; Dr Reddy; Dr Ella; Dr Raja Sekhar Vundru, Joint Secretary, Dept of Pharmaceuticals; Kantipudi; and N R Munjal, Chairman, Pharmexcil

Jasleen Kaur Batra

ith the theme ‘Optimising Opportunities’, BioAsia 2012 was seen in a new avatar in its 9th edition as an advocacy and networking platform. The event was held from February 0911, 2012 at Hyderabad International Convention Centre. It was inaugurated by N Kiran Kumar Reddy, Honourable Chief Minister, Andhra Pradesh; Dr J Geeta Reddy, Honorable Minister of Major Industries GoAP; Tissa Vitarana, Honourable Senior Minister - Scientific Affairs, Government of Sri Lanka; Dr Seth Berkley, CEO, GAVI Alliance, Geneva; and Kevin Ali, President, Merck & Co Inc, NJ, USA. Talking about the developments made in the industry of biotechnology and the plans for the future Kumar Reddy said, “Biotech companies have a crucial role in the society and will have to keep the quality and affordability of medicines in mind. To support the industry grow better we are in the process of improving our policies to make the industry more industry

March 2012 I Modern Pharmaceuticals

friendly.” Highlighting on the footfall of the event Karikal Valaven, IAS, Convener of the event, remarked, “The precise number of registered delegates for the event was 598; in addition over 450 visitors also thronged the three-day global bio-business event. Sri Lanka participated as the country partner for the event and more than 40 countries took part in BioAsia 2012 with major delegations from USA, Korea, Belgium, Pennsylvania, Germany, Iran, Singapore, Nepal and Africa. The international tradeshow at BioAsia 2012 attracted about 75 companies from across the globe wherein the Biobazaar (International Buyer Seller Meet) had over 45 sponsored international buyers from 17 countries. We are extremely grateful for the support received from the Government of India through Department of Biotechnology, Department of Pharmaceuticals, Department of Commerce, Department of Science & Technology etc.”

A congregation of industry stakeholders With panel discussions instead of technical

sessions, the event was an instant hit with the industry primarily as the panels had industryfocussed deliberations while encompassing the research and academia elements as well. The panel discussions held at the event included Vaccine policy: Recommendations and challenges; Vaccines grand challenges programme; Investing in Asia: Enabling vaccine industry success; Supply chain importance in the vaccine market: Impact of cold chain logistics and more. The other panel discussions held were on Vaccine exports – will highly regulated markets be on the radar? Rising importance of contract research organisations, innovative partnership models in outsourcing: CROs, CRAMs, CMOs and research cost effectiveness – long term solution to the industry? Furthermore, about 50 high profile speakers shared their thoughts at this event. Focussing on vaccines, BioAsia 2012 was successful in assembling the key stakeholders of the sector both globally and from India. Prominent participation of the Indian vaccine manufacturers such as Bharat Biotech International, Shantha Biotech, Biological E, Serum Institute of India, Panacea Biotech, Indian Immunological Ltd, etc in addition the global vaccine majors such as GSK, Sanofi, Pfizer, Novartis, etc highlighted the importance of the event. Hyderabad companies such as Bharat Biotech Intl, Biological E and Shantha contribute to more than 60 per cent of the Indian vaccine produced. It was perhaps therefore befitting that vaccines was one of core focus areas for this year’s event. On the second day of the event, a CEO Conclave in partnership with Frost & Sullivan was held with focus on Mega trends: The new frontier. The objective of the conclave was to provide focus to companies on the evolution of the global trends and help them drive growth and innovation in a rapidly changing environment. A white paper from Frost & Sullivan on the mega trends of the industry is being prepared based on the deliberations during BioAsia 2012 Conclave and will be released during end of March 2012.

A platform for many Talking about their association with BioAsia, Manni Kantipudi, CEO, GVK Bio, said,

BioAsia 2012 FORM IV Statement about ownership and other particulars about Modern Pharmaceuticals, as required to be published in the first issue every year after the last day of February. 1. Place of Publication: Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400028 2. Periodicity of Publication: Monthly 3. Printer’s Name: Mr Mohan Gajria Nationality: Indian Address: Infomedia 18 Ltd, Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400028 4. Publisher’s Name: Mr Lakshmi Narasimhan Nationality: Indian Address: Infomedia 18 Ltd, Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400028 5. Editor’s Name: Mr Manas Bastia Nationality: Indian Address: Infomedia 18 Ltd, Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400028 6. Names and addresses of Individuals who own Modern Pharmaceuticals & partners or shareholder holding more than 1% of total capital: Infomedia 18 Limited (formerly known as Infomedia India Limited), Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400028 is the owner of Modern Pharmaceuticals. Details of the shareholders of Infomedia 18 Limited who are holding more than 1% of the paid up equity share capital of the company as on 20-02-2012: 1. Network18 Media & Investments Limited, 503,504 & 507, 5th Floor, Mercantile House, 15 Kasturba Gandhi Marg, New Delhi - 110001 2. Acacia Conservation Fund LP, Citibank N A, Custody Services 3rd Flr, Trent House, G Block, Plot No. 60, BKC, Bandra (East), Mumbai - 400051 3. Pramod Premchand Shah, Kalpana Pramod Shah, Agra Building, 1st Floor, 121/4 M.G.Road, Mumbai - 400023 4. Acacia Institutional Partners, LP, Citibank N A, Custody Services 3rd Flr, Trent House, G Block, Plot No. 60, BKC, Bandra (East), Mumbai - 400051 5. SPS Capital & Money Management Services Pvt Ltd, 66,Tamarind Lane, 4/5,Haji Kasam Bldg, 1st Floor, Fort, Mumbai - 400023 6. Sanjiv Dhireshbhai Shah, 201-203, Sapphire Complex, Nr. Cargo Motors, C.G. Road, Ahmedabad - 380006 7. The Oriental Insurance Company Limited, Oriental House, P B 7037, A-25/27, Asaf Ali Road, New Delhi - 110002 8. Accurate Finstock Pvt Ltd, 9th Floor, Shikhar, Adani House, Nr. Mithakhali Six Road, Navrangpura, Ahmedabad 380009 I, Lakshmi Narasimhan, hereby declare that all particulars given above are true to the best of my knowledge and belief. Dated: 20th February 2012 Lakshmi Narasimhan Signature of the publisher

“BioAsia provides a platform for companies to exhibit, launch and showcase their products and services. GVK Biosciences has been associated with BioAsia for the past several years as it provides an opportunity to network and forge new business relationships. BioAsia 2012 was well attended this year due to greater industry participation (domestic and international) and better marketing by the organisers.” Adding to this Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech said, “Over the years, BioAsia has become an industryoriented event while the Bangalore India Bio event has remained research oriented. Hyderabad is the biggest manufacturer of biotech products and vaccines in the country and this explains the focus of BioAsia on elements such as strategy and markets, while the Bangalore event is focussed on research.” For the ﬁrst time, BioAsia also hosted one of its kind workshop on ‘ labs of the future’ workshop in addition to limited group workshops like Bio-manufacturing and Cleaning Validation in association with Hyde Engineering, Workshop on Bioinformatics for students in association with NIPER and a Tech Transfer Summit in association with MSME & ICICI Knowledge Park were also conducted which received an overwhelming response from the industry and academicians. But the most novel factor of BioAsia 2012 was the Power 20 Breakfast meeting with Dr Seth Berkley, Chief Executive Oﬃcer, GAVI Alliance as the guest and the Indo-German Power Breakfast meeting.

Promoting young minds In order to promote investigative spirit in young school children and scientists, BioAsia instituted ‘Innovation and Young Minds’ award in areas of Biotechnology/Life sciences including Biomedical/ Pharmaceutical technology, Bioinformatics, Biomechanics, etc. This year, out of 61 proposals received from India and from 7 countries abroad, 13 proposals were short listed. BioAsia Innovation Award for 2012 consisting ` 1 lakh cash and a memento was presented by Dr T Ramasami, Secretary to Government of India, Department of Science & Technology, during the event. The award was shared between Dr Shailaja Tiwari from Dr H S Gour Central University, Sagar, MP for her project titled‘Recombinant protein based liposomal combination vaccine for intranasal immunisation against Hepatitis and Inﬂuenza’ and Dr Nooruddin Khan from the Dept of Biotechnology, University of Hyderabad for his project titled- ‘Development of ELISA based approach to detect active Tuberculosis including smear-negative pulmonary and extra-pulmonary TB cases’. The BioAsia Young Minds award for 2012 was presented to N Koushika from The Ashok Leyland School for her project titled ‘Comprehensive health check up kit.’ Regarding plans for BioAsia 2013, Shakthi M Nagappan, CEO, BioAsia 2012 said, “Our attempts to re-strategise the 2012 edition has been successful and is evident from the overwhelming response received so far. We are currently evaluating the areas that need improvement and are also in discussions with various stakeholders on their interests including the structure, theme, etc. Based on these discussions the 2013 event will be announced. The event will be designed in tune with the demands and expectations of the biotech and bio-pharma industry.” (jasleen.batra@infomedia18.in)

Modern Pharmaceuticals I March 2012

Book Review HardKnocks For the Greenhorn Author: Anup Soans Price: ` 599 The Indian pharma industry has seen a phenomenal growth in recent years. This has created employment opportunities in the field with respect to sales, marketing, research and management. This book brings forth the necessary skills required by Pharmaceutical Sales Representatives (PSRs) in performing their daily duties. The author has in a clear and lucid language tried to elucidate the application of basic principles of marketing to the job of these PSRs. The book tries to focus on bringing out the finer skills hidden within an individual with the help of illustrations and examples and their importance in sales. The first part of the book is an introduction to the Indian healthcare delivery system and the pharma industry in detail. The second part outlines the roles and functions of PSRs and their importance in the marketing chain. The next parts try to inform the PSRs on the knowledge that they should possess anytime during the performance of their duties. The concepts of industry, customers, territory and competitor’s knowledge have been put forth in a brilliant yet simple way. The PSR being the next frontline manager in future, there is a section product position, differentiation, branding, pricing, new product launch and public relations. The book ends with a section on personal skills like presentation, dressing, attitude, communication skills, personality, ethics, etc, which assist in holistic development of a PSR. Overall an excellent read for aspiring pharma sales professionals, existing PSRs, pharma trainers, and pharma management students.

Supervision for the Superwiser Front-Line Manager Author: Anup Soans Price: ` 799 The second book in the series for pharmaceutical sales professionals, ‘Supervision for the Superwiser Front-Line Manager’ is dedicated to the roles, responsibilities and skills of a front-line manager in the pharmaceutical sector. This makes a unique reading as unlike management books the principles of management are illustrated via anecdotes, stories, case studies and cartoons, etc. The book begins by illustrating the importance of the front-line manager in the growing pharmaceutical industry and the important link that they are in between the sales force and the management. It then expands into the ideal qualities of a good front-line manager and ways to achieve them. The stress of the book is on the leadership role, managerial role, motivational role and teaching role played by a front-line manager towards his team of sales representatives. The section on how to manage customers and how to achieve breakthrough performance uses simple life skills and management principles applied to the job of the front-line manager. The concept of emotional intelligence and its application in team management and customer management is of practical use to existing and potential front-line managers. The concluding section on progression in the chain of management beyond front-line managers and grooming of successors serves as an inspiration to front-line managers. Overall, a unique book dedicated speciﬁcally to the needs of a front-line manager and utilising all the principles of management towards personal and professional growth. Reviewer: Dr Mandar Kubal Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC)

March 2012 I Modern Pharmaceuticals

Products Industrial panel PC

Gas flow adsorption analyser

To satisfy the stringent standards required in food, beverage, clinical, chemical or pharmaceutical applications, Advantech oﬀers the IPPC-8151S 15” XGA TFT LCD Celeron M fanless industrial panel PC designed with 316L stainless steel, food-safe sealing materials and an anti-corrosive and chemical resistant touchscreen. Its fanless design and NEMA4X/IP66 waterproof and dustproof protection ensure reliable operation in most hazardous environments. With the optional enclosure kit and IP66 I/O connector kit, the IPPC8151S can provide a fully enclosed IP66 protection for all sides.

The model SGA-100 is a continuous gas flow adsorption instrument specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version), 250°C (high-temperature version), at an ambient pressures. The term symmetrical refers to a design feature where by both the sample side and the reference side of the microbalance is subjected to identical temperature, relative humidity and flow rate. This provides significant stability and accuracy and allowing the possibility of performing absolute or differential adsorption experiments. The instrument is used in industries such as catalyst, chemicals, pharmaceuticals, foods, electronics, etc.

Advantech India Bengaluru - Karnataka Tel: 080-23374567 Email: info.in@advantech.com Website: www.advantech.in

Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123, Mob: 09323509969 Email: smartins@vsnl.net Website: www.smartinsrument.com

Walk-in-cooling chamber The walk-in-cooling chamber has double walled insulated PUF modular panels, which can easily be assembled at site without any major hassles. Interior is made of stainless steel and exterior is either made of mild steel ﬁnished with powder coating or stainless steel. The unit is provided with perforated stainless steel trays. Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

Liquid-ring vacuum pump The single and double-stage liquid-ring vacuum pump is silent in operation. Design of the mechanical shaft seal ensures adequate protection to the shaft and provides for ease of maintenance. This leads to minimal time required for servicing thereby cutting down time to the barest minimum. The pump is rugged in design, reliable in performance and easy to maintain. Acmevac Sales Pvt Ltd Mumbai - Maharashtra Tel: 022-28375837, Mob: 09223388105 Email: acmevac@vsnl.com Website: www.acmevac.com

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Liquid filling/capping and sealing machine The monoblock piston filling/ROPP-cumsealer is a combination of rotary multiheads volumetric liquid filling and rotary multi-heads RO/ROPP capping and sealing machine. Due to its compact model it reduces space and manpower utilisation. A single synchronised drive mechanism couples the multi-heads filler and sealer on a common base. It is suitable for glass, tin and PET bottles/containers. The machine is provided with no-bottleno-fill and no-bottle-no-cap mechanism and with attachments suitable for any one size bottle and cap. The Master Mechanical Works Mumbai - Maharashtra Tel: 022-26493459 Email: mmworks@vsnl.com

Pellet The multi-unit pellet of vitamins and minerals and medicine in capsules include those of vitamins and minerals, pellets of cough and cold preparations, pellets of hyperacidity, antiulcer, anti-ﬂatulant, anti-emetic preparations, pellets of cardiovascular drugs, pellets of antimicrobials & adjuvants, pellets of anti-asthamatic drugs, pellet of NSAIDS, pellets of anti-malarial drugs, etc. Pelltech HealthCare Mumbai - Maharashtra Tel: 022-28662980 Email: pelltech@vsnl.net Website: pelltech-healthcare.com

Modern Pharmaceuticals I March 2012

Products Hydraulic orbit motor

Suspension centrifuge

The hydraulic orbit motor is available with maximum peak power rating of 20 kW. It provides high-torque low-speed performance with limited overall dimensions. The orbit motor is made with a system of lobe shaped geroter/ geroller. Some of the features include well-designed compact structure, good weight to power ratio, reversible rotation direction, excellent eﬃciency, uniform torque, standard mounting ﬂanges, etc. The orbit motor is used in applications like road sweepers, agricultural and forestry machines, plastic injection moulding machines, wood working machinery, printing machines, conveyor, mining equipments, food & textiles processing, etc.

The four-point suspension centrifuge is mounted on an inertia plate with antivibration mounts, thus eliminating the cost of heavy foundation. It also eases relocation of the machine. Only a few bolts are to be grouted to prevent lateral movement of the machine during operation. Maintenance of suspension system associated with pendulum suspension machine is eliminated. The centrifuge is employed in medium-to-high output processes in bulk durgs, pharmaceuticals, food, ﬂavours and chemical industries. It is oﬀered in complete stainless steel construction and conforms to GMP standards.

Pioneer Transmission Solutions Bengaluru - Karnataka Tel: 080-51273369 Email: pioneer123@touchtelindia.net

United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990 Email: uenggent@gmail.com Website: www.united-centrifuges.com

Ointment manufacturing plant The ointment, cream, toothpaste, shampoo, gel and lotion manufacturing plant has all contact parts made out of SS-316 and all pipelines electro-polish from inside. Joints are DIN standard, with easy openable fittings after cleaning. The plant is provided with inline filters to ensure filtration and PLC-based control panel for process automation. It is equipped with CIP and SIP facility and loadcell for online weighing. All transfers are done under vacuum to avoid any hand touch and contamination. The intensive mixing by semi-contra design anchor stirrer avoiding dead zones by teflon scrapper and bottom entry angular homogeniser for micronising. Arsee Engineering Works Navi Mumbai - Maharashtra Tel: 022-56053602 Email: sales@arsee.com Website: www.arsee.com

Continuous band sealer The is a versatile and high-production pouch sealing machine for plastic heat sealable materials like PP, LDPE, HMHD, polyester, polylaminates, etc. It is provided with nitrogen gas flushing arrangement for chips, wafers, savouries, flour, food items, etc. The machine is a tabletop model suitable for pouches up to 2 kg weight and consists of Teflon belt used for driving the already filled pouches at fixed speeds through heating and cooling zones. At the bottom is a heightadjustable conveyor for up to 16” height pouches. Ace Industries Mumbai - Maharashtra Tel: 022-28732530, Mob: 09324481285 Email: info@aceindus.com Website: www.aceindus.com

Horizontal pull-action clamp Insulation materials These insulation materials include flexible foam produced from melamine resin. The three dimensional structure of the foam is made up of a microscopic, slender skeletal structure that delivers insulation properties. As a result of its unique design and inherent nature of the design, it offers properties such as high temperature resistance, low bacterial growth, 25/50 fire rating, ASTM C-1410, etc.

The model PA-H horizontal pull action clamp has holding capacity with easy operation. The treated Ubolts permit easy simple adjustment and provide a positive connection with the supplied latch plate. The clamp finds application in machine tool positioners, welding fixtures, production fixtures, inspection/ gauging fixtures, chemical machinery, lathes of container lids, pharmaceutical machinery, assembly jigs and fixtures, etc.

IUS Equipments Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-56116626, Mob: 09960110373 Email: iusequip@vsnl.net Website: iusequip.com

Chamunda Equipments Ahmedabad - Gujarat Tel: 079-27522437 Email: clamps@chamundaequip.com Website: www.chamundaequip.com

March 2012 I Modern Pharmaceuticals

Products Temperature and process controller

Spectrophotometer

Fuji Electric’s self-tuning temperature and process controller has low-cost options that include RS485 communications, digital input, timer function, heater burnout alarm, dual outputs, and programmable alarms. The faceplate is watertight and corrosion-resistant. The three-button keypad allows programming and the screw-terminal on the back eliminates the need for sockets. In addition to auto-tuning and fuzzy control, it has self-tuning control, which automatically retunes the controller under certain conditions, without the need to revert to autotuning. It accepts temperature & process inputs and oﬀers two control outputs and two programmable alarms.

The spectrophotometer is designed for versatility in various applications. It is a portable integrating sphere spectrophotometer incorporating numerical gloss control. It simultaneously measures specular component included and specular component excluded and displays the data on the LCD in only 1.5 seconds. The relativity gloss value can be displayed by using numerical gloss control. The spectrophotometer ﬁnds applications in pharmaceuticals, cosmetics, printing, building materials, textiles, food, etc.

Procon Technologies Pvt Ltd Ahmedabad- Gujarat Tel: 079-27492566, Mob: 09824310188 Email: info@procon.co.in Website: www.procon.co.in

Pallet shrinking tool

Spheroidiser The spheroidiser consists of a round disc mounted on a vertical shaft spinning at high-speed at the bottom of a cylindrical chamber or drum. The cylindrical drum is called the bowl and the spinning disc is called the chequered plate. The chequered plate has a grooved pattern to increase the friction with the product and break the extrudates to length. When the extrudates are charged into the spheroidiser, they are thrown on the edge of the spinning plate by centrifugal forces.

Jay Instruments & Systems Pvt Ltd Mumbai - Maharashtra Tel: 022-23526207 Email: ctpsales@jayinst.com Website: www.jayinst.com

The pallet shrinking tool is used for shrink wrapping. Shrink wrapping of export pallets, giant pallets, giant articles, big articles/machinery are used to avoid damage during transportation. Boxes on pallets and other products can be shrinkpacked within minutes. It provides ﬁve-sided protection for any size or shape load from small uneven pallets to large machinery and more strength than stretch wrapping. The tool is compact, portable and handy weighing 950 g. Dharmesh Enterprises Mumbai - Maharashtra Tel: 022-55233591 Email: heatgun@vsnl.com Website: hotairguns.com

Lyophiliser Umang Pharmatech Pvt Ltd Dist Thane - Maharashtra Tel: 0250-6450835, Mob: 09764998260 Email: info@umangpharmatech.com Website: www.umangpharmatech.com

Digital temperature indicator The digital temperature indicators is available with features, such as auto shut-oﬀ circuit, built-in-lineariser, open sensor indicator, low battery indicator, 3½ digital 0.5” LCD display, low power cosumption, compact moulded ABS cabinet, etc. Instrument Research Associates Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-61484000 Email: subrat@agsinfotech.com

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The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyophilisation is the preferred drying process, for heat labile substances or where any physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system oﬀers optimal ﬂexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar. Machinfabrik Mumbai - Maharashtra Tel: 022-25555596 Email: machinfabrik@vsnl.com Website: machinfabrik.com

Modern Pharmaceuticals I March 2012

Products Remote I/O system The RIX CANopen remote I/O system is designed to be mounted near ﬁeld elements like junction boxes and in push-button panels for individual I/O connections. RIX units are connected to Messung’s Nexgen-5000 PLC Master using a network cable. So, there are no snaking wires and no unnecessary loss of space and productive time. These are compact in size and easy mounting. Auto network baud rate can be detected by RIX base units. There is data transmission on I/O status change to reduce network traﬃc. Diagnostics and I/O status LEDs are there on each module. Messung Systems Pvt Ltd Pune - Maharashtra Tel: 020-27102000 Email: marketing@ms.messung.com Website: www.messung.com

Vibratory finishing system The vibratory finishing system incorporates a rubber or polyurethane lined bowl of U-cross section mounted on precisely calculated springs. This system is driven by a highly efficient vibratory motor. The open top of the bowl can be loaded with suitable ceramic/ plastic or steel media and parts to be processed. Vibratory finishers shake parts and media at high speeds, causing the media to scrub the surface of the parts in an action similar to lapping. Since the parts and the media are moving at small increments on each stroke, the parts are not subject to severe stress or damage. Niraj Optical Machinery Ahmedabad - Gujarat Tel: 079-29295747, Mob: 09909904148 Email: badrakia@rediffmail.com Website: www.nirajopticalmachinery.com

Rotary cone vacuum dryer The rotary cone vacuum dryer consists of a jacketed double conical shell rotating around 6 rpm with provision for application of vacuum inside the shell and circulation of heating media in the jackets during the rotation of the cone. Large

March 2012 I Modern Pharmaceuticals

heating surface area presented by the internals of the cone ensures uniform drying of the product, as the product gently tumbles while the cone rotates slowly. The diﬀusive action induced by the tumbling cone constantly presents a fresh layer to come into contact with the indirectly heated walls of the shell. Bhuvaneswari Pharmach Pvt Ltd Chennai - Tamil Nadu Tel: 044-22641267 Email: bhucorp@md2.vsnl.net.in

Automatic powder filling machine The automatic powder filling machine is used in filling of pharmaceutical powder medicine. It fills any type of powder/ granules and is made of stainless steel. The technical output of machine is 20-60 fills per minute depending upon the material characteristic and filling volume. Filling volume is 5 gm to 500 gm with different size of auger and funnels. The power consumption is 3 phase/440 V, 1 hp, with four core wire system and the 25 ltr hopper capacity. Virajka Machinery Mfg Co Ahmedabad - Gujarat Tel: 079-25894985 Email: info@virajka.com

Products Cooling chamber

FRP cooling tower These cooling chamber is provided with perforated stainless steel trays for sample mounting. This unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It has forced air circulation for uniform temperature, safety thermostat, hermetically sealed compressor, with electronic time delay to safeguard compressor.

Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

High-pressure washing unit The high-pressure washing unit consists of a robust and sturdy high-pressure tripled plunger pump. This unit is designed to perform under extreme duty condition. The beneﬁts of the machine are product quality greatly increased by eﬀective and through cleaning of the system, simplicity makes the cleaning less tedious task, where a layman can operate it easily, reduces energy, water, manpower and time consumption, etc. Dupoly Marketing Pvt Ltd Ahmedabad - Gujarat Tel: 079-26577389 Email: dave.dupoly@gmail.com Website: www.dupoly.com

Pusher centrifuge The pusher centrifuge provides continuous filtration for separation of suspended, fast draining, crystalline, granular or fibrous solids from the liquid. Crystalline product has particle size of 0.1 mm to 20 mm and feed solids from 30 to 70 per cent by weight. Solids are washed as they are transported through the basket. Features include: complete separation of mechanical unit from the process area, single or multi-stage according to product, cylindrical/cylindro-conical basket with long and short lengths, hydraulic pusher mechanism with variable stroke & stroke length, slurries are fed via feed pipe and non-flowable products are conveyed by a screw conveyor into the feed distributor, counter current wash and wash by displacement for high washing efficiency. Rotofilt Engineers Ltd Ahmedabad - Gujarat Tel: 079-25712861 Email: rotofilt@rotofilt.com Website: www.rotofilt.com

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The maintenance-free crossflow FRP induced draught cooling tower provides higher range (cooling) with the advantages of minimum water loss. It is suitable for any type of water cooling application. It eliminates maintenance of rotating sprinklers, spray nozzles, choking of fills, changes in water pressure, etc. Higher air volume aluminium fan with lower power consumption and special design fill packing gives maximum cooling efficiency. Water distribution with non-clog water splitting polymer nozzles work effectively even with gravity pressure. The fill packing is reusable and cleanable. Crystal India Ahmedabad - Gujarat Tel: 079-25833965, Mob: 09824013727 Email: info@crystalcoolingtower.com Website: www.crystalcoolingtower.com

Radial drilling machine The heavy-duty high precision all-geared drill head radial machine comes with forged steel gears and toughened spindle. This drilling machine has automatic vertical movement of arms. It also provides horizontal automatic movement of man spindle head for face milling as well as keyway milling operations. The machine has arm titling at 360-degrees to get inclined drilling. Accuracy is as per ISI chart. The main spindle runout is within 0.005 mm, ie, within 5 microns. Drilling capacity of the machines is 38 mm in steel. Poly Kraft Machines Ahmedabad - Gujarat Tel: 079-22743639, Mob: 09898003625 Email: pkmdrill@gmail.com Website: www.polykraftmachines.com

Fluid bed dryer The ﬂuid bed dryer includes short drying time, uniform drying, low drying temperature, electric or steam heated, SS heater, digital temperature controller and indicator. This dryer is available from 10 kg to 120 kg capacity. It comes with a digital timer. Technical speciﬁcation include: for 30 kg, 60 kg and 120 kg it is 100, 220, 430 container volume (in ltr), batch capacity (in kg) is 30-40, 6075, 129-140, heating load (in kW) is in the range of 18, 36, 60, electrical heating motor (hp) of the range 5, 10, 15, etc. Sunmach Machinery Ahmedabad - Gujarat Tel: 079-25840230; Mob: 09825008365 Email: sunmach@icenet.net

Modern Pharmaceuticals I March 2012

Products Closure feeding system The fully-automatic, hygienic and sanitation-friendly closure feeding system is used for crowns, PP caps, aluminium rollon caps, etc. This system is suitable for high-speed bottle ﬁller machines up to 600 bpm for industries, like beverages, breweries, distilleries, pharmaceuticals, dairy, etc, which ensures the ﬂow of closure in gentle and controlled manner into the crowner/capper hopper, which nullify the damage and bending of closures remarkably. The system is self-mounted and the dies do not require any foundation. It is moved anywhere in the bottling hall. Alien Fabricon (India) Ahmedabad - Gujarat Email: sanimesh@alienfabricon.co.in Website: www.bottlingplantconveyor.com

Jet mill The jet mill is increasingly used in micronisation and is a critical process for API manufacturers, as all bulk actives in order to go to the next stage of the production processes like, tablets, agglomeration, capsules, creams or aerosols have to undergo process micronisation. This mill has hourly capacities ranging from 2 gm to 200 kg down to D100<5 or lesser. It accepts feed sizes from 750 microns to 3,000 microns. It is used to increase the active surface area of pharmaceutical bulk drugs. A three-dimensional size reduction is also possible. GR International Chennai - Tamil Nadu Tel: 044-22641650,Mob: 09444381252 Email: grail@vsnl.net

Electronic ballast and fixture Acon electronic ballast and ultra slim fixture comes in different models for tubelights, T5 complete fixtures and HPSV, HPMV and MH lamps. These are reliable with minimum rejection, watt loss and electromagnetic/radio frequency interference (EMI/RFI). The ballast has maximum power factor

March 2012 I Modern Pharmaceuticals

and reliability, prevailing over humidity, dust, chemical fumes, voltage irregularities, etc. In-house standardised testing on each and every ballast and quality control on the raw material ensure that Acon ballast do not fail even in neutral fault condition, where voltage can be nearly 415 V. It is tested at ERDA and various labs as per IS:13021. Suveg Electronics Ahmedabad - Gujarat Tel: 079-26583994, Mob: 09327002155 Email: info@suvegelectronics.com Website: www.suvegelectronics.com

Drive and inverter The Teco-7300 CV inverter has sensorless vector control, 150 per cent starting torque, built-in PLC function, LED/LCD keypad display, NPN/PNP digital input, PID function, braking transistor built-in, copy unit, memory pack function, PC (Windows)/PDA (Win CE) link function, RS–485 Modbus RTU/ASCII mode, fieldbus communication modules, built-in EMC filter. It complies with UL, CUL and CE global standards. Kuna Impex Pvt Ltd Ahmedabad - Gujarat Tel: 079-26841523 Email: kipl123@rediffmail.com

Electronic panel timer The electronic panel timer is housed in small industrial grade plastic box. It gives 5 per cent setting accuracy and 1 per cent repeat accuracy. It is available in 415 V or 230 V with one changeover contact. Timing range is 30 sec, 60 sec, and 120 sec. Power and delay indications are provided on the front side of the timer. Potentiometer is provided to set the required time. It measures 102 mm x 65 mm x 43 mm and weighs 250 gm approximately. Gelco Electronics Pvt Ltd Ahmedabad - Gujarat Tel: 079-22200902 Email: info@gelco-world.com Website: www.gelco-world.com

Products Magnetic drive centrifugal pump Lutz magnetic drive centrifugal pump is available in two series range AM and TMR. The materials are in glass-filled PP or carbonfilled ETFE. Unique feature of the TMR series is that the pump can run dry for up to 15 mins without damage. The inlet/outlet for the pump is offered in threaded (BSP/ NPT) or flanged (ISO/ANSI) connections. The TMR series is disassembled without disturbing the motor. Maximum flow rate that achieved is up to 30 m³/hr and heads up to 25 mWc. The strong magnetic coupling made up of rare earth materials and three versions of each model allow pumping of liquids of special gravities from 1.00 to 1.85. Shanbhag & Associates Mumbai - Maharashtra Tel: 022-28346604 Email: shanbhags@vsnl.com Website: www.shanbhags.com

with high-speed backplane serial bus, wide range of I/O modules and embedded intelligence in digital I/O modules. It has IEC61131-3 compatible Windows-based programming package. The PLC has unique oﬄine, online, debugging features, powerful function library management, modem communication FBs, and open serial ports. Messung Systems Pvt Ltd Pune - Maharashtra Tel: 020-27102000 Email: marketing@ms.messung.com Website: www.messung.com

Cartridge seal The UE cartridge seal is inherently balanced, and hence is used for maximum range of pressure. It has multi-springs but the spring does not come in contact with liquid. This seal is used in any kind of contaminated ﬂuids. The seal comes with sleeve and gland plate as one unit. It is easy to install.

Air classifier The air classifier is a screenless machine used for grading offline powder into distinct coarse and fine grades from 60 mesh down to 40 microns. This air classifier-type separating machine is operated in closed circuit with existing equipment, such as feed from the hopper, bins pulveriser, cyclone, etc. It is manufactured in closed tolerance and well balanced to give trouble-free operation. The material is fed through the top input pipe down on a revolving distributor plate. The fluidised particles are propelled to the sides of the inner cone by whizzer blades and separated from the re-circulating air stream between inner and outer ring. Premium Vijimech Pvt Ltd Ahmedabad - Gujarat Tel: 079-40083450, Mob: 09712987467 Email: sales@vijimech.com Website: www.vijimech.com

Programmable logic controller The compact size programmable logic controller (PLC) integrates the compactness of small-sized controllers with the modularity of big-sized PLCs. It oﬀers breadth of power (from 14 I/O to 128 I/O). It has 128 I/O capacity in free mix, 128 KB programme memory and 32 KB data memory. It is provided

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Unicorn Engineers Delhi Tel: 011-22421640 Email: info@mechseal.com Website: www.mechseal.com

Ball valve This ball valve comes with pneumatic rotary actuator. The valve is of on/off type with screwed, flanged, socket weld, tri-clover end in threepiece design. It is available in SS-304 and SS-316 investment castings and is fitted with double-acting pneumatic rotary actuator that operators through 90-degrees angular movements of ball valve or butterfly valves. Pneumatic actuator is mounted directly on the shaft of the valve. The actuator is supplied with solenoid valve mounted on it. It is available in different sizes up to 4” to control fluids such as steam, chemicals, oil, air, and water. Madho Controls Pvt Ltd Thane - Maharashtra Tel: 022-25883252, Mob: 09820066046 Email: madho@vsnl.com Website: www.madhocontrols.com

Modern Pharmaceuticals I March 2012

Products Fluid control systems A wide range of precision fluid control systems, like pneumatically operated air pulse dispensers, and allied accessories, such as tips barrels, precision dispense valves (for various applications) pressure tanks, etc, are offered to give a positive control for handling various fluids. Dotting, lining, potting, filling, doming, encapsulating, spraying, coating, etc can be done with ease, efficiency and high degree of repeatability and accuracy. These systems handle any type of fluids like adhesives, anaerobics, light curing, UV curing, moisture curing (cyanoacrylates), latex based, solvent based, etc coating fluids (hard coating of optical lenses), lacquers, dyes, etc. Metering & Dispensing Technologies Dist Thane - Maharashtra Tel: 022-28042189, Mob: 09833783720 Email: amritwalimbe@gmail.com

Temperature data logger This temperature data logger is used for pharmaceutical industries. It has measuring capacity ranging from 35ºC to 80ºC, accuracy of ±0.5ºC and resolution at 0.1ºC with sensor Pt-1000. The measuring rate is selected from 1 min to 8 hours. It stores 4,000 value data in memory. The measuring mode is automatic with loop, start/stop or start with set measuring rate. It comes with a battery life of three to ﬁve years. These data loggers are housed in stainless steel, PEEK. It has IP68 protection class/housing for pharmaceutical industries. Ambetronics Mumbai - Maharashtra Tel: 022-28371086 Email: ambetronics@vsnl.com Website: www.ambetronics.com

Moulded parts and components The machined moulded parts and components are manufactured from industrial and engineering plastics, such as nylon, UHMWPE, delrin, polycarbonate, acrylic, polyurethane, abs, Teflon, PVC, peek, PPO, PPS and Noryl. These are available in various size and shapes in the form of sheets, rods, tubes, pipes, blocks and profiles. Engineering plastics offers a variety of features like light weight, high abrasion resistant, self lubrication, corrosion proof, noise and vibration dampening and

March 2012 I Modern Pharmaceuticals

good dimensional stability. These ﬁnd applications in various industries like bottling & beverages, pharmaceuticals, paper ceramic tiles manufacturing plants, material handling, conveyors, steel, power, cement and chemical industries. Arvind Anticor Ltd Ahmedabad - Gujarat Tel: 079-32918016, Mob: 07878883400 Email: arvindanticor@hotmail.com Website: www.picklingplant.com

Air-cooled single-stage pump The oil-lubricated air-cooled singlestage pump comes with multi-vane built-in anti-suck back system. It is provided with oil recirculation system having exhaust filters to produce mistfree exhaust. The pump is available with capacities ranging from 15 m³/hr to 150 m³/hr. The pump is used in various applications like packaging, bottle filling, pick and place, leak detection, heat treatment, distillation, suction in hospitals, oil purification, degassing and drying, etc. Advantages of the pump are less oil, less power, noise less and pollution free compared to normal oil seal vacuum pumps. Toshniwal Instruments (Madras) Pvt Ltd Chennai - Tamil Nadu Tel: 044-26252716 Email: sales@toshniwal.net Website: www.toshniwal.net

Multi-purpose trolley The specially designed multi-purpose trolley is used for ICU/hospital/surgery. It comes with multi-purpose aluminum extruded legs, heavyduty designed castor wheels, MDF monitor top with anti-skid rubber mat, lockable MDF, scratch-proof painted drawer box. Different boxes or trays are adjusted according to needs due to the specially designed profile of tapped strip. Because of aluminium metallic structure, earthing is affirmative and provides safe working for electrical and electronic appliances. Envair Electrodyne Ltd Pune - Maharashtra Tel: 020-30688117 Email: envairelectro@vsnl.net Website: www.envairelectrodyne.com

The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of

Modern Pharmaceuticals 85

List of Products To know more about the products featured in this magazine, fax us on 022-3003 4499 or tear and post to us the ‘Product Inquiry Card’ by following the 5 easy steps given there. Alternatively, you may also write to us at michael@infomedia18.in or call us on 022-3003 4684, and we will send your inquiries to the advertisers/companies directly to help you source better. Sl No

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AC motors ...............................23 Acoustic enclosure .......................25 Agitator ........................................19 Air classifier .................................84 Air filter .................................15, 17 Air treatment system ...............FGF Air-cooled single-stage pump..........................................85 Analytical instruments........88, BIC Automatic powder filling machine .....................................81 Ball valve .................................84 Batch disperser.............................19 Bbl brake motors .........................23 Biological safety cabinet ........15, 17 Blow-fill-seal machine.................11 Booklet and leaflet label ............ BC Booklet .........................................81 Calorimeter..............................19 Cartridge seal ...............................84 Chlorine gas cylinder/tonner ......57 Chromatography..........................88 Clean attire ....................................6 Cleanroom apparel ........................6 Cleanroom door.....................15, 17 Cleanroom garment ......................6 Closure feeding system................83 COD analyser..............................37 Column ........................................88 Columns and chemistries.........BIC Continuous hand sealer...............77 Cooling chamber .........................82 Cooling tower ..........................FGF Counters and power supplies ...................................FIC DC motor ................................23 Digital temperature indicator......78 Dispensing booth ..................15, 17 Disperser ......................................19 Drive and inverter .......................83 Dry vane pump............................25 Duo label ..................................... bc Electronic ballast and fixture ....83

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41 Electronic chlorine dosing system and chloroscope ............57 42 Electronic panel timer .................83 43 Elemental analysis .......................88 44 Empower...................................BIC 45 Encoder .....................................FIC 46 Fan filter unit ..................... 15, 17 47 Flag label.................................... BC 48 Flameproof motor .......................23 49 Flange mounting motor ..............23 50 Fluid bed dryer ............................82 51 Fluid control systems ..................85 52 FRP cooling tower ......................82 53 Gas chlorinator ........................57 54 Gas conditioning and fire protection...................................39 55 Gas detector.................................37 56 Gas flow adsorption analyser ......70 57 Geared motor ..............................23 58 General pump..............................21 59 Hanger label.............................bc 60 Heating bath................................19 61 Hepa filter terminal housing ................................15, 17 62 High-pressure homogeniser ........19 63 High-pressure washing unit........82 64 Horizontal pull-action clamp......77 65 Hot plate ......................................19 66 HPLC .................................88, BIC 67 Hydraulic orbit motor .................77 68 Industrial control and sensing device ..................................FIC 69 Industrial cooler .......................FGF 70 Industrial panel PC .....................70 71 Informatics ................................BIC 72 Injectable manufacturing line .......................................15, 17 73 Inline disperser.............................19 74 Inspection systems .......................13 75 Insulation materials .....................77 76 Integrityplus attire .........................6 77 Inverter/variable frequency drive ........................................FIC

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Product

Pg No

Jet mill .....................................83 Kneading machine ...................19 Laboratory reactor....................19 Laboratory software.....................19 Laminar air ﬂow workstation ..........................15, 17 Level controller .........................FIC Liquid ﬁlling/capping and sealing machine .........................70 Liquid-ring vacuum pump..........70 Lyophiliser ...................................78 Magnetic drive centrifugal pump......................................84 Magnetic stirrer ...........................19 Mass spectroscopy .......................88 Measuring and monitoring relay.........................................FIC Mills .............................................19 Molecular spectroscopy ...............88 Motion control .........................FIC Motor ..........................................23 Moulded parts and components ...............................85 Multi-purpose trolley ..................85 Ointment manufacturing plant .......................................77 Overhead stirrer ...........................19 Packaging service provider .......53 Pallet shrinking tool ....................78 Pass box..................................15, 17 Pellet.............................................70 Photoelectric sensor..................FIC Pilot plant ....................................19 Pre-engineered and prefabricated modular panel ....15, 17 Programmable logic controller...........................FIC, 84 Programmable terminals ..........FIC Proximity sensor .......................FIC Pump............................................25 Pusher centrifuge .........................82 Quick-change terminal house................................ 15, 17 Radial drilling machine ............82

Sl No

Product

Pg No

113 Rapid endotoxin detection system ........................................81 114 Remote I/O system .....................81 115 Return air riser.......................15, 17 116 RFID.........................................FIC 117 Roots blower ................................25 118 Rotary cone vacuum dryer ..........81 119 Rotary evaporator ........................19 120 Safe change housing ........... 15, 17 121 Safety light curtain ...................FIC 122 Sampling booth .....................15, 17 123 Shakers .........................................19 124 Slipring crane duty motors .........23 125 Solid-liquid mixer........................19 126 Spectrophotometer ......................78 127 Spheroidiser .................................78 128 Spray analysis ...............................39 129 Spray control system ...................39 130 Spray fabrication ..........................39 131 Spray nozzles and accessories .....39 132 Sterilising/depyrogenating tunnel ...................................15, 17 133 Suspension centrifuge..................77 134 Switching relay .........................FIC 135 Technical garments ....................6 136 Tefzel HHS isotactic PP material ........................................8 137 Temperature and process controller....................................78 138 Temperature controller .............FIC 139 Temperature data logger .............85 140 Thermoplastic valves & piping system ..........................................8 141 Thermostats and vacuum dryer/ mixer ..........................................19 142 Timer ........................................FIC 143 Turnkey systems for dust suppression ................................39 144 UHPLC ...................................88 145 UPLC .......................................BIC 146 Vacuum booster pump..............25 147 Vacuum system ............................25 148 Vibratory ﬁnishing system ..........81 149 Vision sensor.............................FIC 150 Walk-in-cooling chamber.........70

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Modern Pharmaceuticals I March 2012

List of Advertisers Advertiser’s Name & Contact Details

Pg No

Aqua Services

T: +91-265-2331748

Advertiser’s Name & Contact Details

IKA India Private Limited

Pg No

Salesworth India Pvt Ltd(Seidenader)

Pg No

T: +91-80-25274495

T: +91-80-26253900

E: aquaas@satyam.net.in

Advertiser’s Name & Contact Details

E: mail@salesworth.com

E: process@ika.in

W: www.seidenader.de

W: www.aquaservicesindia.com W: www.ika.in Ask Enterprises

Spraying Systems (India) Pvt Ltd

53 J B Sez Pvt Ltd

T: +91-9860921110

FGF

T: +91-80-39853200/01

E: ask.ent@sify.com

T: +91-422-3267800

E: ssipl@sprayindia.com

W: www.asktechnopack.com

E: sales@gemindia.com

W: www.spray.com

W: www.gemindia.com

The Indian Electric Co

Charles River

T: +91-20-24474303

T: +91-80-25588175

Omron Automation Pvt Ltd

FIC E: icemktg@indianelectric.com

E: india.customercare@crl.com T: +91-80-40726400

W: www.criver.com Dover India P Ltd-Dfm India Division

W: www.indianelectric.com

E: in_enquiry@ap.omron.com

T: +91-44-26271020

W: www.omron-ap.com

E: sales.psgindia@pumpsg.com

Plus Ventilation

Thermo Fisher Scientific Sid Div

T: +91-22-67429494

E: pradeep.kumar@thermofisher.com W: www.thermofisher.com

W: www.almatec.de

T: +91-40-23812152, 23812153

Everest Blowers

Uniphos Envirotronic Pvt Ltd

E: director@plusventilation.com T: +91-22-6123500

T: +91-11-45457777 W: www.plusventilation.com

E: singhrv@unipos.com

E: info@everestblowers.com Reynders Label Printing India Pvt Ltd

W: www.everestblowers.com Eng Expo

E: india@reynders.com

E: engexpo@infomedia18.in

W: www.reynders.com

W: www.uniphos-she.com UNP Polyvalves India Pvt Ltd

T: +91-149-3305400

T: +91-09819552270

T: +91-265-2649248

E: mktg@polyvalve.com W: www.polyvalve.com

W: www.engg-expo.com Salesworth India Pvt Ltd(Rommelag) Fabtech Technologies Intl Pvt Ltd

15,17 T: +91-80-25274495

T: +91-80-28371900

E: mail@salesworth.com

E: waters_india@waters.com

W: www.rommelag.com

W: www.waters.com

T: +91-22-61592900

E: mails@fabtecheng.com W: www.fabtecheng.ae

BC-Back cover, BIC-Back inside cover, COC-Cover on cover, FGF-Front gate fold, FIC-Front inside cover March 2012 I Modern Pharmaceuticals

Waters (India) Pvt Ltd

BIC

Our consistent advertisers

Modern Pharmaceuticals

RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month

March 2012

Presents

Supplement with Modern Pharmaceuticals - March 2012

Modern Pharmaceuticals - Supplement I March 2012

March 2012 I Modern Pharmaceuticals - Supplement

Modern Pharmaceuticals - Supplement I March 2012

March 2012 I Modern Pharmaceuticals - Supplement

Modern Pharmaceuticals - Supplement I March 2012

March 2012 I Modern Pharmaceuticals - Supplement

Modern Pharmaceuticals - Supplement I March 2012

March 2012 I Modern Pharmaceuticals - Supplement

Modern Pharmaceuticals - Supplement I March 2012

March 2012 I Modern Pharmaceuticals - Supplement

RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month