Express Pharma (Vol.10, No.16) June 16-30, 2015

VOL. 10 NO. 16 PAGES 68

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Management Redefining NSQ Research Holy basil decoded

16-30 JUNE 2015,` 40

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CONTENTS MARKET Vol.10 No.16 JUNE 16-30, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

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UL PARTNERS WITH CDSCO WEST ZONE

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JP NADDA RELEASES FICCI’S KNOWLEDGE PAPER ON INDIAN LIFE SCIENCES INDUSTRY

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FERMENTA BIOTECH LAUNCHES AWARENESS PORTAL ON VITAMIN D

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GLOBAL EXPERTS DISCUSS WAYS OF PROMOTING QUALITY OF MEDICINES AT NOMCOL ASIA PACIFIC WORKSHOP IN HYDERABAD

Bengaluru Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua

REDEFINING NSQ Pg29

Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P16: COVER STORY Making a headway

PHARMA ALLY

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar CIRCULATION Circulation Team Mohan Varadkar

P25: INTERVIEW

RESEARCH

“Procurement of authentic and genuine raw material is becoming a problem”

P33: OPINION One year of Modi govt: India Inc, be patient

P44: VENDOR NEWS ACG Pharmapack’s anti-fog Film, NoMist, wins World Packaging Organization’s WorldStar 2015 Award

P63: REPORT Healthcare and pharmaceuticals industry will see a hike of about 11.5 per cent: Teamlease report

PIRAMAL RENAMES ITS OVULATION TEST KIT BRAND AS 'I-KNOW'

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'PMHLC IS 100 PER CENT COMMITTED TO ENSURE ZERO SPURIOUS SUPPLY'

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'THE SOLUTION COMBINES WORKFLOW TOOLS WITH REAL-TIME INFORMATION AND ANALYSIS'

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EXTRACTABLES AND LEACHABLES QUALITY AND RISK STUDIES

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MAXIMISING SOLVENT REMOVAL EFFICIENCY

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HOLY BASIL DECODED

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AMGEN'S REPATHA EFFECTIVE; QUESTION IS FOR WHICH PATIENTS: FDA

STATINS NOT CAUSING MEMORY PROBLEMS: STUDY

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Data integrity ... dil se

T

wo reports, released in early June, have both good news and bad news for the pharma industry in India. The good news is that the sector seems to have become more proactive about addressing data integrity concerns. Over one third of the total data integrity reviews conducted by EY were done proactively by GMP compliance conscious companies.

But the bad news is that lapses in data integrity continue to rise. In a survey conducted by the firm, ‘Analysing the state of data integrity compliance in the Indian pharmaceutical industry’, more than 30 per cent of the over 170 respondents had received inspectional observations such as Form 483s, warning letters, import alerts, statement of non-compliance with GMP etc. issued by global regulators. Clearly this is still a work in progress, with as much as 28 per cent respondents admitting that their organisations did not have a fraud reporting mechanism in place. These laggard companies run the very real risk of whistle blowers turning to social media platforms.

In fact, 76 per cent of the respondents in Deloitte India’s survey report, 'Managing Growth Through Better Compliance Management', indicated that their organisations relied on whistle blowing channels to detect fraud, non-compliance and malpractice. That may be good news, but not all companies took this further: on detection of fraud, 85 per cent of respondents representing 33 companies said they launched an internal investigation by a specially appointed committee, while 82 per cent confirmed that some form of disciplinary action was initiated.

The change from a reactive to a proactive stance has been recent but fast, says Rajiv Joshi, Partner, Fraud Investigation & Dispute Services, EY. It would seem that there's a realisation that prevention is better than cure. Joshi even goes so far as to say that promoters/top management in these proactive pharma companies are looking at the increased monetary spend on such compliance reviews as an investment for the future, almost like insurance against future regulatory risk.

But the numbers of such proactive pioneers is still small. Dr Ajaz S Hussain, former Deputy Director at US FDA's Office of Pharmaceutical Science and now an advisor to EY, puts this dithering down to a lack of confidence and the fear of even greater regulatory scrutiny. His answer is that if regulators see that you are proactive, they will be more encouraging, because they realise that you are trying to correct your systems. Over time, a sincere and sustained effort to improve will

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Hussain also has a message for all regulators: reduce the heterogeneity between regulators.

Clearly,this is one message he wants his former colleagues at the US FDAto hear

rebuild the trust between global regulators and Indian pharma companies.

Hussain also has a message for all regulators: the heterogeneity between regulators needs to be reduced because it is sending mixed messages to the industry. Inspectors need to be trained to have a uniform approach to inspections. Clearly, this is one message he wants his former colleagues at the US FDA to hear.

The interesting thing is that when it comes to becoming more proactive about compliance, size does not matter. Drawing on his observations in the past few years as an advisor to Indian pharma companies facing the brunt of regulatory noncompliance, Hussain says that he sees leadership at smaller companies changing the mindset of their employees much faster than at their bigger older peers, possibly because the latter come with a larger set of legacy problems while the smaller ones can leapfrog older technologies. In fact, Joshi sees a lot of SMEs as front-runners in compliance systems because it is a 'comply or die' situation.

With just two or three manufacturing facilities, a single import alert could cripple them financially.

Born and educated in India, Hussain spent more than three decades in the US, and was with the US FDA from 1995-2005 . So, he is in a unique position to put his finger on the nub of the issue.

Indians are brought up to respect, nay obey seniors and therefore do not raise the red flag often enough. Also, he points to how regulators in India chose to blame processes rather than people for compliance lapses. But he's happy to report that attitudes are changing fast. He says clear and precise communication from the leadership, both corporate and policy makers/regulators, can change mindsets overnight.

And we don't need to lose our Indianness in the process. Hussain's LinkedIn blog post, 'Dil Se; don’t be too quick to discount our wisdom traditions' talks about discovering that a quality mindset is not alien to our culture. So citing the famed 'chalta hai' attitude is nothing but a cop out.

Put that way, my take is that millions of Indian families still churn out homemade pickles, chutneys and other sun-dried savouries that stay uncontaminated till the next season, often without recourse to any refrigeration. Thus, quality SOPs and GMPs are very much part of our DNA. All it takes is a discipline, dil aur dimage se (from both the head and heart.)

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

UL partners with CDSCO West Zone UL to provide robust regulatory and compliance training to inspectors UNDERWRITERS Laboratories (UL), a global safety science organisation, has recently signed up as a knowledge partner with the Central Drugs Standard Control Organization (CDSCO) West Zone (comprising the states of Maharashtra, Goa, Gujarat, Madhya Pradesh, Chhattisgarh and UT of Daman & Diu and Silvassa).

CDSCO works under the administrative control of India’s Drug Controller General, Directorate General of Health Services: Ministry of Health & Family Welfare.

Under this partnership, UL will help train CDSCO’s Western Zone officials. UL EduNeering, the compliance education and training serv-

ices business division of UL Life & Health, will lead this initiative. The specially designed online training courses, based on international regulatory guidelines, will empower the CDSCO officers with the appropriate training on good manufacturing practices for pharmaceuticals and medical devices as well as good clinical practices.

UL will also build custom training modules for the CDSCO West Zone to suit the learning needs of their investigators. In the first phase, 10 investigators will be trained on 40 online modules.

“UL's focus on quality is based on the expertise we have garnered from more than a

UL will build custom training modules to suit the learning needs of investigators. In the first phase, 10 investigators will be trained on 40 online modules

century of testing, certifying products and developing standards. Through this association, we will be training CDSCO inspectors across the Western region on what is essential in the inspection and standardisation process. This association is another extension of the MoU we recently signed with the Gujarat Government. We are happy to see the increase in quality awareness amongst the pharma industry across the region. We will further continue our focus on the sector and expand our presence within industry and across regulators, said Suresh Sugavanam, Managing Director and Vice President, UL South Asia.

“UL EduNeering is a leader

in providing regulatory and compliance learning solutions to the life science industry.

Our CFR 21 Part 11 validated platform is used globally by top pharma and medical device companies. We partner with organisations to help them build an effective quality and compliance training programme that best suits their needs,” stated Scott Barnard, Vice President, Life Sciences, UL EduNeering.

Barnard further said, “UL EduNeering will continue the programme throughout the year utilising a blended approach to learning through continuous improvement and training.”

EP News Bureau-Mumbai

Stempeutics gets Japan process patent for its stem cell drug Stempeucel Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors; it is used for the treatment of CLI STEMPEUTICS Research, a group company of Manipal Education and Medical Group and a joint venture with Cipla Group, has been granted process patent from the Japan Patent Office (application no 2012-540529) for its novel stem-cell based drug Stempeucel. The novelty covers the method of preparing master cell banks, working cell banks and the final therapeutic product ‘Stempeucel’ based on the novel pooling technology.

Stempeucel will initially be

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used for the treatment of critical limb ischemia (CLI), a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself.

Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. Reportedly, the company proprietary pooling approach allows an efficient man-

ufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients.

This approach also allows more than one million patient doses from a single set of master cell banks. The proprietary technology allows Stempeucel to extend the therapeutic potential of the drug across multiple disease categories.

Commenting on the Japan patent, BN Manohar, CEO of Stempeutics said, “The new patent strengthens our posi-

tion in Japan, which have created an accelerated development path for stem cell therapies. The new regenerative medicine law implemented in Japan allows conditional approval of stem cell products thereby enabling more rapid entry into the Japanese market. We are actively evaluating the potential for accelerated development of Stempeucel product for critical limb ischemia and osteoarthritis indications in Japan with strategic collabo-

rations.”

Chandru Chawla, Head, Cipla New Ventures said, “Japan is showing great leadership in innovating a regulatory framework for regenerative medicine thereby addressing major unmet medical needs faster. We would like to leverage this new framework for rapid development of our Stempeucel product for the benefit of patients along with a potential partner.”

EP News Bureau-Mumbai

Piramal Enterprises renames its ovulation test kit brand as 'i-know' i-know is an extension of the ‘i’ range which includes ‘i–can’ and ‘i-pill’ under Piramal’s extensive portfolio

QUALITY EXCIPIENTS

IN ADVENT of the court ruling and its compliance, Piramal Enterprises will change/rename the brand name of its ovulation test kits. Henceforth, ‘i-know’ brand name will be adopted for the company’s product for ovulation test kits.

Reportedly, PEL has already stopped billing of the old brand name and the transition will be completed by August 25, across the entire spectrum of sales, marketing and operations.

The new brand name represents the USP of the product. i-know helps women know the two most fertile days of every month, the time when she ovulates. i-know is an extension of the ‘i’ range which includes

for the PHARMACEUTICAL INDUSTRY Consistent investments has ensured that our products are recognized worldwide for their quality and efficiency

EXCIPIENTS MICROCEL® Microcrystalline Cellulose

SOLUTAB® Croscarmellose Sodium

EXPLOSOL® Sodium Starch Glycolate

TABDONE® CL

i-know helps women know the two most fertile days of every month

Crospovidone

SORB-CEL® Effervescent Base

TABULOSE SC®

i–can and i-pill under Piramal’s extensive portfolio.

Currently, the brand contributes to less than one per cent of consumer products sales and will have negligible impact on the financials of Piramal Enterprises, inform a company release.

Microcrystalline Cellulose & Carboxymethylcellulose Sodium

Manufacturing Plant: Brazil

Tel.: (+91 22) 2806 – 3526/27 Fax: (+91 22) 2806 – 3528

EP News Bureau-Mumbai

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Commercial Contact: India

www.blanver.com

sales@scope-india.com mumbai@scope-india.com www.scope-india.com

MARKET

JP Nadda releases FICCI’s knowledge paper on Indian life sciences industry Vision 2030 builds on the successful trajectory of the Indian life sciences industry JP NADDA, Union Health & Family Welfare Minister released the FICCI knowledge paper titled ‘Indian Life Sciences: Vision 2030, Expanding Global Relevance and Driving Domestic Access’ at Lifesciences Conference 2015, organised by FICCI in New Delhi, recently.

Vision 2030 builds on the successful trajectory of the Indian life sciences industry. It lays out the path forward to unlock the industry’s true potential, which can become a reality if all the stakeholders collaborate and build on the strengths, claims FICCI.

FICCI believes that by achieving this Vision 2030, the industry will continue making significant contribution to the economy and healthcare outcomes FICCI believes that by achieving this Vision 2030, the industry will continue making significant contribution to the economy and healthcare outcomes. The industry will sustain its growth trajectory of 11 to 12 per cent and grow seven

to eight times to a size of $190 billion to $200 billion, driving five to six times growth in trade balance contribution to around $55 billion to $60 billion, reduction in energy imports and will also create nearly four million new jobs

for the country over the next 15 years by the year 2030.

The report mentions that the industry will provide every Indian access to high-quality, affordable drugs by adopting innovative models, and government support can aspire to drive a three to four times increase in the number of treated patients across disease areas. It will also help built a global position for India in the innovation space and driving significant economic upside (exports of around $16 billion to $18 billion by 2030).

EP News Bureau-Mumbai

Sun Pharma in distribution agreement with AstraZeneca for brand Axcer Sun Pharma will be promoting and distributing Axcer brand in India ASTRAZENECA PHARMA India Ltd (AZPIL) and Sun Pharma have entered into a distribution services agreement in India for AstraZeneca’s brand ‘Axcer’, a new brand of ticagrelor, a drug used for the treatment of acute coronary syndrome (ACS). AZPIL already has a brand under the trademark

‘Brilinta’, for ticagrelor molecule, launched and marketed by AZPIL in India since 2012.

Abhay Gandhi, Chief Executive Officer – India Business, Sun Pharma said, “Such collaborations are also a part of our stated policy of becoming the partner of choice for promotion and distribution of innovative pharma products in the coun-

try.” Sanjay Murdeshwar, Managing Director, AZPIL said, “Ticagrelor works by preventing the formation of new blood clots and maintains blood flow in the body, helping reduce a patient’s risk of another heart attack or cardiovascular-related death.”

Sun Pharma will be promoting and distributing Axcer

brand in India. This collaboration enables AstraZeneca to expand usage of this molecule through wider reach to physicians and thereby benefitting a greater number of ACS patients. It strengthens Sun Pharma’s cardiology portfolio with the addition of a new patented therapy.

EP News Bureau-Mumbai

Govt proposes 1000 more Jan Aushadhi stores The stores will be opened on one single day GOVERNMENT OF India proposes to soon open 1000 more stores under the ‘Jan Aushadhi Scheme’ to make available quality generic medicines at affordable prices through these spe-

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cial outlets. Speaking at a function organised by the Indian Social Responsibility Network (ISRN) a facilitation network to build the corporate social responsibility (CSR) space in In-

dia, at New Delhi, the Union Minister of State, Ministry of Chemicals and Fertilisers, Hansraj G Ahir said that these stores will be opened for the underprivileged who would be provided medicines at a price of 60-70 per cent less than the market price.

According to a PIB release,

Ahir said that his ministry is working on opening 1000 stores under the ‘Jan Aushadhi Scheme’ on a single day. He said that the stores will be renamed, rebranded and will increasingly involve B Pharma and M Pharma qualified unemployed populace.

EP News Bureau-Mumbai

India and Netherlands sign MoU for development of vaccines A MEMORANDUM, of Understanding (MoU) was signed between India and Netherlands for development of vaccines. The MoU, signed under ‘Make in India’ initiative of Government of India, will enable the Bharat Immunologicals and Biologicals Corporation (BIBCOL), a Central PSU under Department of Biotechnology, to develop Measles – Rubella vaccine at its plant at Chola, Bulandshahr, UP. Translational Vaccinology (INTRAVACC) a government-based institute of the Netherlands will extend technical support for the development of vaccine.

The MoU was signed in the presence of the Prime Minister of The Netherlands, Mark Rutte during his visit to New Delhi. Under the MoU, cooperation in development of other vaccines and biologicals with DBT Research Institutes shall be explored.

Oudendijk, General Director of Intravacc, welcomed the broader collaboration as agreed upon in the MoU, since it is expected to provide innovative vaccine technology for the benefit of the people of India.

Dr MK Bhan, Chairman, BIBCOL said that this important collaboration between BIBCOL and INTRAVACC will pave the way for manufacture of high quality affordable vaccines, beginning with Measles and Rubella vaccine, and then take on the production of the other needed vaccines for the Immunisation Programmes of India and other developing countries in the world.

EP News Bureau-Mumbai

MARKET

Fermenta Biotech launches awareness portal on vitamin D Aims to build a community of vitamin D conscious health users RECENT STUDIES reveal that 69 per cent of Indians suffer from vitamin D deficiency and a further 15 per cent were found to be vitamin D insufficient. This high incidence of vitamin D deficiency in the Indian population underlines the need for increased awareness and proper guidance. Fermenta Biotech's latest outreach project, a public awareness portal www.vitamindguru.com hopes to fill this gap.

Expanding on the rationale behind the initiative, Prashant Nagre, Chief Executive Officer, Fermenta Biotech said, “Through www.vitamindguru.com, we aim to spread vitamin-D related awareness while engaging with health-conscious individuals and ensuring no one is deprived of the vital nutrient.

With our unfailing commitment to research and development in this field, reaching a wider base of individuals through a knowledge intensive web portal, www.vitamindguru.com is a logical step and a dream initiative of Fermenta. ” Dedicated to spreading awareness about the importance of vitamin D, the site covers its numerous health benefits, the reasons and outcomes of its deficiency and strongly encourages discussion with healthcare advisors to know more about this 'sunshine vitamin'. Through www.vitamindguru.com, Fermenta endeavours to unlock access to the attention of millions of internet users and encourage them to discuss its benefits, deficiency related issues and prevention in consultation with their health care advisors.

The site has sections such as ‘Daily dose’ that suggests various sources of vitamin D ranging from the most abundant ones like sunlight exposure to intake of vitamin D containing food stuff such as eggs, mushrooms, fortified cereals, cod liver oil. Useful bits

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of information including a vitamin D deficiency checker, ‘Fun in the sun’, ‘Sun blog’ and other sections that focus

on a holistic approach in understanding vitamin D are some of the highlights of this website.

www.vitamindguru.com also aims to build a community of vitamin D conscious health users who can share their

experiences with others through this e-initiative.

EP News Bureau-Mumbai

www.merckmillipore.com

MARKET POST EVENT

Global experts discuss ways of promoting quality of medicines at NOMCoLAsia Pacific workshop in Hyderabad Workshop was attended by representatives of the CDSCO as well as drug and quality control officials from countries like Vietnam, Philippines, Indonesia and Laos US PHARMACOPEIA (USP) recently organised a three-day workshop for the Asia chapter of the Network of Official Medicines Control Laboratories (NOMCoL). Members of NOMCoL’s Asia-Pacific chapter met on day-one to discuss the need for harmonisation and collaboration between the pharmacopeias and drug regulatory bodies to ensure quality, safety and efficacy of drugs.

The NOMCoL Hyderabad workshop was also attended by representatives of the Central Drugs Standard Control Organization (CDSC)O) and drug as well as quality control officials from countries like Vietnam, Philippines, Indonesia and Laos.

Discussions focused on current issues faced by the laboratories related to dissolution and high performance liquid chromatography (HPLC), Inter Laboratory Testing (ILT) results from 2014, selection of ILT sample for 2015 and proper ways to test samples from receipt to storage. The discussion also touched upon NOMCoL Asia Pacific’s future sustainability plan and the strategy to enhance network operations.

“Borders are porous for poor quality medicines, which present a real threat to public health.

Communications across regions and a cooperative response are imperative. USP sees an opportunity to support India in a leadership role in the AsiaPacific region: helping to build laboratory capacity among other neighbouring countries, enabling stronger regulatory systems, and protecting millions of patients from harm,” said

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Attendees at the NOMCoL conference organised by USP

Kelly Willis, Senior Vice-President - Global Public Health, US Pharmacopeia.

“We appreciate US Pharmacopeia’s work initiated through NOMCoL and congratulate them for organising this meeting of regulators from South-east Asia that enables collaboration with them. US Pharmacopeia’s presence in India has boosted the confidence of the Indian drug manufacturers who export their medicines and vaccines and we want USP to work with us in the national quality control programme. We are planning to introduce international alert and mobile testing units to maintain the quality of medicines and keep a check,” said Dr GN Singh, Drugs Controller General (India).

Speaking more about mobile testing units, Singh said, “We have already launched a pilot mobile testing unit in Gujarat.

We will look at its success and make the required changes. We plan to introduce atleast 20 mobile testing vehicles over the period of next one year. Approximate investment per mobile unit is around one crore. Currently, we are in the process of studying the instruments that will be used insides the mobile vehicles. These instruments are going to be of special quality and dimensions as they will be used inside the mobile vehicles.”

“NOMCoL offers unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonise their drug analysis methodologies and help in the quality control of essential medicines, detect substandard and counterfeit drugs.

As a standard setting organisation and Global Public Health as our mission, we would like to promote good quality medicines

across the world. NOMCol is one such initiative,” said Dr KV Surendranath, Senior Vice President, International Site Operations; Senior Vice President, USP–India.

NOMCoL networks have been established to provide a forum for sharing best practices and address issues surrounding quality of medicines at regional and national levels. These networks offer unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonise their drug analysis methodologies.

There are currently four OMCL networks: The External Quality Control Programs (EQCP) network, created in collaboration with the Pan American Health Organization (PAHO) and OMCLs from Latin American and Caribbean countries (2001); and the Networks of

Official Medicines Control Laboratories (NOMCoL) in Africa (2009), Middle East/North Africa (MENA) (2010), and Asia Pacific (2013).

NOMCol-Asia Pacific was established in the region with the aim of strengthening the technical and procedural capacity of members to achieve and maintain international medicines control laboratory standards.

NOMCoL network objectives include: ◗ Strengthening the performance and technical skills of staff ◗ Promoting communication and the exchange of information ◗ Harmonising methodologies to facilitate acceptance/recognition ◗ Ensuring compliance with Good Laboratory Practices (GLP) ◗ Eliminating substandard and counterfeit drugs EP News Bureau-Mumbai

EVENT BRIEF JUNE -AUGUST 2015 18

InnoPack Pharma

INNOPACK PHARMA Date: June 18-19, 2015 Venue: ITC Maratha, Mumbai Summary: InnoPack, a global brand of CPhI Worldwide, into its fourth year, has established itself to be the platform for pharma packaging innovations.

Visitors at InnoPack Pharma Confex will find all major categories of pharmaceutical packaging, learn about the latest innovations, technologies, trends and developments in pharma packaging at the conference, network and gain access to one of the world's fastest growing pharma markets. More than 20 suppliers and 250 pharma professionals will attend the exhibition.

Contact details Suvidha Shetty suvidha.shetty@ubm.com +91 (0) 22 6172 7001

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3rd Annual Pharma Project Management Conference 2015

3RD ANNUAL PHARMA PROJECT MANAGEMENT CONFERENCE 2015 Date: June 29-30, 2015 Venue: The Westin Mumbai Summary: CPhI will host 3rd Annual Pharma Project Management Conference 2015. The key highlights of the event are as follows.

Workshops and practical case studies, international pharma professionals, risk identification and mitigation for NDDS projects, application of PMO in entering foreign markets, bridging cultural gaps in projects and showcasing issues that can be caused by misunderstandings of cultural differences.

Contact details Suvidha Shetty suvidha.shetty@ubm.com +91 (0) 22 6172 7001

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2nd Annual Advanced API Convention

2ND ANNUALADVANCED API CONVENTION Date: July 20 - 23, 2015 Venue: Mumbai Summary: CPhI 2nd Annual Advanced API Convention will focus on the development of high quality API’s for the Indian pharma market. To counter India’s 90 per cent dependency on China for essential drugs, this conference will focus on quality, technology and cost efficiency in the processes for making the API drugs.

Contact details Phone: +44 (0)20 7921 5000

GLOBAL GREEN NANOTECHNOLOGY CONCLAVE 2015 (GIGANTIC 2015) Date: August 6-7, 2015 Venue: Ahmedabad Summary: The conclave

brings together technologists, scientists, academicians, policy makers and end-users of the nanotechnology platform for discussing the various aspects of development and characterisation, exploring the possibilities of Indian industry to take part in nanotechnology research, product development, growth and initiating new ventures through partnerships with foreign players who are leader in the field. Objectives of the conclave are to provide a platform for researchers and industrialists to interact with each other and share knowledge, create awareness among the endusers and consumers on nanotechnology, to facilitate the technology requirement and other related needs of the industry through national and international networking, to

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Global Green Nanotechnology Conclave 2015

interact with the Government to establish policy and standards for nanotechnology processes, to facilitate the training needs of the start-up companies in nanotechnology field, facilitate knowledge flow by working with international organisations through bilateral/multi-lateral cooperation mechanism and discuss scope, challenges and future application of nanotechnology.

Contact details Gaurang Patel Executive Centre of Excellence in Nanotechnology Confederation of Indian Industry, CII House, Gulbai Tekra Road, Near Panchwati Ahmedabad – 380 006 Contact No.: 08460464349 Tel. (079) 40279994; Fax. (079) 40279999 Email. Gaurang.patel@cii.in

cover )

AYUSH RELOADED

India's ancient holistic healing traditions take centre stage on the first World Yoga Day. But the AYUSH sector is riddled with regulatory bottlenecks in the domestic market. In addition, manufacturers and practitioners often face a backlash from mainstream medicine, both global and domestic, citing lack of scientific evidence. How can the AYUSH sector counter these allegations and cash in on the growing global demand for traditional holistic healing products and services?

Express Pharma reviews some of the progress in the past few years

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16 MAKING A HEADWAY

18 REVIVING AYUSH

21 MADHAVBAUG:

CARING FOR HEARTS

(

THE MAIN FOCUS

...

INTERVIEW

UTTARWAR 23 VIJAY President and Chief Executive Officer, Naturell India To subscribe: bpd.subscription@expressindia.com

INTERVIEW

VIJAY DOIPHODE 25 DR Managing Trustee, Ayurveda Rasashala

27 THE PUTRANJIVAKA CONTROVERSY

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cover )

MAKING AHEADWAY Maharashtra Ayurved Centre, which has just begin operations, has ambitious plans of bringing the benefits of Ayurveda to the masses. A report on the progress made so far and plans underway

BY SHALINI GUPTA

n 2008, the AYUSH department, under the health ministry selected two statesMaharashtra and Kerala, as the ones leading in propagation and practice of age old ayurveda, that is increasingly finding global acceptance. As a part of this, a public-private partnership (PPP) project was to come up in Pune, with a modern drug laboratory to ensure quality control of ayurvedic products in addition to facilities for raw material processing, packing and labelling of the drugs. 60 per cent of the project cost was to be borne by the Union Government, while 40 per cent of the capital investment was expected to come from private partners.

Maharashtra Ayush Cluster based in Pune as it is known today, also joined the scheme

by Bharati Kisan Sangh (BKS), so that its member farmers could cultivate ayurvedic medicinal plants which were then processed at the cluster.

I

A cluster-based approach With ayurveda being a micro small and medium enterprises (MSME) industry, there are challenges such as huge investments, manpower costs, time constraints and administrative issues in setting up a facility under one roof. A cluster based approach was thought to be an

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effective and sustainable strategy for competitiveness enhancement of MSMEs, since it leverages the geographical proximity of the enterprises on ‘collaborating while competing’ principle. This ensures that the process is participatory, cost effective and provides critical mass for customisation of interventions. Today Maharashtra Ayurved Centre (MAC) has its head office at Pune and factory at Kolewadi, (25 km from Pune on Mumbai-Bangalore National Highway No. 4) spread over three acres. Approximately, 16 crores has been invested in the facility with 53 entrepreneurs already holding equity in the project from all the sectors of ayurveda. The centre received approval in 2009, construction began in 2010 and the project got ready only in 2014.

While the operations began this year, the same year when it also received licenses.

Elaborates Sunita Belgamwar, Chairman, MAC, “The project is designed in such a way that all the stake holders of the ayurveda industry will have something to share and grow. Cluster being the conglomeration of

stake holders is based on the principles of collective growth and inclusive capitalisation.

MAC is focussed on skill building, branding and entrepreneurship. We have received `600 lakhs worth of grant till now which has been fully utilised.” A paeditrician by profession, she was always eager to explore natural treatment modalities for her patients with tender immunity. Ten years back, the phenomenal results which she received during her trials with some ayurvedic medicines awakened her inquisitiveness and she hasn’t

looked back since then. “ I always wished of doing an ayurveda project which has huge socio-economic value and is connected from the bottom of the pyramid to the top. This came true when the cluster scheme was announced. Meeting thousands of ayurveda physicians, students, manufacturers, traders, farmers across India and abroad in the last 10 years, has provided a lot of insight in the system and some clarity on what is needed for the 21 st century to adopt the principles of this beautiful life science to stay healthy on this planet. After Herculean efforts for the last few years, the dream has become reality now with the cooperation of all the companions who walked in,” she says emphatically. The facility has manufacturing set up for all dosage forms like powders, tablets, capsules, oils, ghee, kadha, awaleha etc., and has just begun operations.

Belgamwar adds that MAC will only launch products which are proven to have impact on the masses while improving their health. Regular proprietary products will

not be manufactured by MAC. The centre currently is home to 25 manufacturers associated with ayurveda, vriksha ayurveda and veterinary ayurveda. MAC Pune has signed MOUs with ASSOCHAM, TAFSA (South Africa), EUAA (Germany), AIPCE (UAE), NAMA (US) and AILATMA (Latin America).

The facility has a common quality control laboratory which has testing facilities like analytical lab, toxicology centre, process and product validation laboratory, raw material testing and standardisation laboratory to enable better quality assurance and control to compete globally at affordable cost. “We are working on nutritional products based on millets as well as nutritional drinks which can replace coffee and tea habits and reduce addiction alongwith nutritional grain mixes which are wholesome. In the pipeline are formulations for herbal cigarette and ghutka with powders of medicinal plants based on concept of dhumvarti and tambul in ayurveda which enhances capacity of lungs thus reducing the incidence of lung and oral cancers,” informs Belgamwar. Many fundamental research formulations are underway to replace daily chemical exposure of the people.

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A preventive science When asked if she finds the marketing of ayurveda products difficult, given that the branding of modern medicine has since trumped this ageold science, she says, “Ayurveda is to be promoted as preventive healthcare and branding a product for curative purposes, will hamper its traditional value. Being an individualised treatment based on prakriti, any mass produced formulation branded by a company will act on 40-50 per cent of patients and not all, as in the case of allopathy which is a generalised curative therapy.” “I sincerely appeal to all ayurveda physicians not to dilute its individualised treatment approach, which is the essence of ayurveda. There is no need to revive it as the world has understood it’s importance.”

The manufacturing facility includes a common platform for tableting, capsulation with high speed GMP machines, soft gel capsuling and a common packaging and labelling facility to improve product presentation, reduce costs towards individual investment and address the issue of capacity utilisation. With this approach, it has tried to address any gaps that may arise.

Belgamwar is strongly defiant of those who are of the view that ayurveda is not evidence based. She feels that there is enough subjective evidences for thousands of years including text book references and testimonials around the world. “A herbal source which is organic or live in nature, makes it very difficult to know its exact composition, for e.g. all the active ingredients present in tulsi in a lab-based setting. Does the absence of such objective evidence mean the science is not evidencebased?,” she questions. “Allopathy formulations are dead chemical material and hence non organic, so very easy to prove. It is a generalised science treated on signs and symptoms (all types of fever will be treated by paracetamol) whereas ayurveda is

SKILL DEVELOPMENTAND TRAINING Beginning August this year, MAC will begin two fellowship courses to train personnel mainly for meeting the needs of industry. In the raw material course the students will be acquainted with various types of the raw material including their Identification, storage, processing and packaging so that it is ready for manufacturing of ayurvedic drugs. The drug manufacturing course will acquaint students with all the machinery usage as well as regulations in the manufacturing of ayurveda drugs, principles and methodology used during manufacturing, FDA licensing issues etc. Each course shall have an intake of five students from BAMS, BPharm and shall run for a duration of one year.

MAC team during the launch of Ayurways brand

View of the MAC factory at Kolewadi, Pune

The laboratory at the factory

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individual specific and disease specific (every fever will have different medicine based on prakruti and disease pathogenesis),” she reiterates further. Unlike allopathy, ayurveda uses preventive healthcare methods with drug usage being only 20 per cent of it. Hence comparing it to allopathy is not fair.

In a bid to promote the products manufactured, she has also tapped the power of e-commerce through the website www.ayurways.biz which shall help the stakeholders showcase their products for global sale. She also talks about the concept-based ayurvedic stores MAC aims to bring to Pune within next year. “Using ayurveda principles and herbal raw material , industry is producing thousands of FMCG products, nutraceuticals, supplements, OTC products for humans ,animals and plants. If all these are brought under one roof and used daily, it can reduce chemical exposure substantially. This is the objective of Ayurways health store which shall focus on holistic lifestyle through products. We are planning to open 10 stores in Pune in this fiscal year along with e- commerce support,” she adds.

She is confident as well optimistic about the future, though there have been challenges in the past. She explains, “It has been a great learning so far despite the challenges faced with the fact that it was a government funded project, PPP concept etc. The sector too is secretive and hasn’t opened up. Coming together for betterment of the science for global spread is missing. Patience, perseverance and hard work were the key elements to handle them”.

“I strongly believe that ayurveda can bring our nation in the leadership role across the globe earning billions of foreign exchange if government capitalises the opportunity by a systematic plan,” she concludes. shalini.g@expessindia.com

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REVIVING AYUSH Regulatory woes continue to plague the AYUSH sector in India and hamper its progress despite measures to revive the traditional forms of medicine

BY USHA SHARMA

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yurveda or ayurvedic medicines, are one of the oldest forms of treatment which traces its origin to India. In ancient times, this form of medicine was largely practised by vaidyas, the equivalent of modern-day doctors. Other forms of traditional medicines such as unani, siddha and homeopathy too were commonly practised in the yesteryears.

However, over the years, traditional medicines lost out in popularity to the more modern forms of medicine and were sidelined until recently.

Renewed focus on the traditional medicines came when the government of India realised that, if properly regulated, these forms of medicine could help in increasing access to health in the country.

Hence, ayurveda, unani, siddha and homeopathy (AYUSH) is on the path of revival, though a lot of bottlenecks continue to hinder its progress. Dr Amit Agarwal, Vice President, Ayurvedic Drug Manufactures Association (ADMA) shares some insights on the semi-matured AYUSH industry and says, “According to the draft National Strategy for Management of Medicinal plant – an inter-sectoral approach, 2014, prepared by the Foundation for Revitalisation of Local Health Tradition (FRLHT) and funded by the Ministry of Environment, Forest and Climate Change (MoEFCC), the total AYUSH market is estimated to be `15,000 crores in 2014-15.

Of this, only about `1500 crores are perhaps exported.

There are over 8000 manufacturers of licensed ayurvedic, siddha, unani, homeopathy and swarigpa medicines of which ayurvedic manufacturers constitute the majority. The export is mainly contributed by raw herbs, extracts, oils, oleo-resins and other forms of processed botanicals with only a small contribution coming from

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( finished products. The lack of reliable figures is primarily because of the confusion that prevails in the Indian HS-Coding system.”

Explaining the situation further, Dr Nandini K Kumar, Former Deputy Director General Sr Grade (ICMR) says, “The Indian AYUSH market is quite large but what is exported as dietary supplements is much less compared to China.”

Making a comeback The current government, led

by Prime Minister Narendra Modi, has been putting a lot of efforts to revive the industry. One instance is the PM's recent visit to China and Mongolia. He signed memorandums of understanding (MoUs) with these two countries to create awareness about ayurvedic medicines on a global platform.

According to media reports, the Union Cabinet chaired by the PM Modi, also gave its approval for extending the tenure of an MoU signed between India and the China State Administration of Traditional Chinese Medicine (SATCM) on cooperation in traditional medicine. The MoU is expected to immensely benefit both countries.

PM Modi has also given his approval for signing an MoU for cooperation in the field of traditional systems of medicine and homoeopathy between India and Mongolia.

These measures certainly indicate that the government is keen on promoting Indian-origin traditional/ alternate medicines in the global market. Yet, the recently released new Foreign Trade Policy 20152020 released by the Minister of Commerce and Industry, Nirmala Sitharaman seems to have overlooked this sector.

Agarwal informs, “The recent FTP has discontinued Vishesh Krishi and Gram

THE MAIN FOCUS

The Biodiversity Act covers research, foreign collaboration, IPR and exports of all bioresource-based products. The Act has a huge impact on AYUSH manufacturers DR AMIT AGARWAL, Vice President, ADMA

Udyog Yojana (VKGUY) and has introduced a new scheme called Merchandise Exports from India Scheme (MEIS). In the present form, the new MEIS scheme supports only a few botanicals.

Our association has recently brought this to the knowledge of the Ministry of AYUSH with a request to rectify this omission. This, we hope, will be fixed shortly and the exporters of botanical preparations would stand to gain some financial relief (close to five per cent of the export invoice value).”

Regulatory woes The AYUSH industry is governed by different Acts like Drugs and Cosmetics Act, Weights and Measurement, Magic Remedies Act, regulated by different governing bodies. “In all, there are over 100 government bodies with which an AYUSH industry needs to interact,” informs Agarwal.

Despite this, lack of their effectiveness has been a major obstacle in the progress of this sector.

Quality and credibility also remain grave issues in the traditional medicines industry. A major reason for it is the manner in which the

bio-resources are procured.

Elaborating on this theme, Arun Kedia, Managing Director, VAV Life Sciences says, “Currently, the active ingredients or significant markers of the herb are not defined or controlled in the finished formulation and every manufacturer is free to choose the raw material quality and to interpret the preparations in his own wisdom. This means, the same formulation from different manufacturers can have widely differing concentrations of actives or sometimes a completely different proportion of ingredients to what was originally intended.”

He opines, “Currently, India follows a liberal good manufacturing practice (GMP) standard for ayurveda, siddha and unani (ASU) medicines compared to modern medicine. Far too many ASU preparations are made at facilities with a low level of hygiene and controls.

While this change may reduce the number of smaller units making ASU medicines under questionable conditions, over a period of time it will significantly expand the market of ASU products to a global scale.

it is very clear that AYUSH is in desperate need of a standarised quality process to enable and ensure safe output

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Myopically, most existing producers of ASU resist this change, which severely restricts the overall growth of the market.”

Kedia further states, “One of the biggest factors holding back Indian systems of medicine and homoeopathy from becoming main stream medicine in India for most of the common diseases is lack of credibility.

There is a strong need to bring Indian medicine systems to the same level of credibility as modern medicine to expand its reach in India and the global market.”

Thus, it is very clear that AYUSH is in desperate need of a standarised quality process to enable and ensure safe output.

However, meeting certain standards require a considerable amount of investment and small and mid-sized players do not have enough financial support. Kumar feels, “The problem is that such standards cannot be maintained by small and medium entrepreneurs (SMEs) due to financial constraints.” He further informs, “There was earlier a move by the Ministry of Chemicals and Fertilisers to create regional facilities for them to use for manufacturing standardised product with appropriate quality control.”

Dr Vijendra Prakash, Senior Manager, Domestic Regulatory Affairs, Himalaya Drug Company adds his views, “AYUSH manufacturers procure bio-sources

One of the biggest factors holding back Indian systems of medicine and homoeopathy from becoming main stream medicine in India for most of the common diseases is lack of credibility Arun Kedia Managing Director, VAV Life Sciences

The process needs to be simplified such that the communities benefit, environment is protected and conserved and the industry is also able to procure biosources at a competitive price Dr Vijendra Prakash Senior Manager, Domestic Regulatory Affairs, the Himalaya Drug Company

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cover ) from various traders and vendors after ensuring complete compliance including paying taxes.

With the access sharing benefit, there will be an additional financial burden that manufacturers will have to accrue. In effect, it will be dual taxation.

The process therefore needs to be simplified such that the communities benefit, environment is protected and conserved and the industry is also able to procure bio-sources at a competitive price.”

The Biodiversity Act aimed to do exactly that as an attempt to simplify matters.

Biodiversity Act According to the National Policy on Indian Systems of Medicine and Homoeopathy-2002, there are restrictions on extraction and procurement from the wild. Hence, the trade is secretive and exploitative, leading to unsustainable practices in the quest for profit. Even today, most medicinal plants used by the herbal industry are largely cultivated and sourced from the wild forests. In the absence of a scientific system for collecting and fostering regeneration of medicinal plants, several species have either been completely lost or become endangered. The industry constantly faces the problem of raw material supply and its quality. Hence, in a bid to set standards that are at par with international standards for home grown traditional medicines without disturbing the natural resources, India signed the Convention on Biological Diversity (CBD) which came into effect from December 29, 1993. Under the obligations to CBD, the President of India acceded to the Biological Diversity Act-2002 (Act no. 18 of 2003) on February 5, 2003.

Giving more details of the Act, Prakash informs, “Biodiversity Act aims to conserve biological diversity, promote sustainability, and support fair and equitable sharing of the benefits

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arising out of the use of biological resources and traditional knowledge, it was framed in 2002. AYUSH falls under the ambit of the Act because most of the resources used by AYUSH industries are from biosources.”

The Act, in general, targets all sorts of manufacturers using biological resources (BR) as raw materials. ASU formulations, herbal veterinary products, herbal extracts and related phyto-pharma sector are targeted by authorities like National Biodiversity Authority (NBA) and State Biodiversity Boards (SBBs).

Agarwal further explains, “The AYUSH manufacturers use biological resources as raw material which is governed by the Act. The Act covers research, foreign collaboration, IPR and exports of all bioresource based products.”

He points out, “The Act has a huge impact on AYUSH manufacturers. To begin with, the raw material procurement needs to happen with the consent of Biodiversity Management Committees (BMCs) which are yet to be formed by village panchayats in each Village and SBBs from whose jurisdiction the bio-resources are being obtained. The BMCs are empowered to levy access fees while the SBBs claim to be empowered to charge benefit sharing fees.”

Monetary implications As per the procedure laid down under the Act, the buyer/manufacturer is required to provide prior intimation. The format prescribed for this purpose (Form-I) was borrowed from

The Indian AYUSH market is quite large but what is exported as dietary supplement is much less compared to China Dr Nandini K Kumar Former Deputy Director General Sr Grade (ICMR)

central rules by all the state governments. This form is specially meant for those companies intending to bioprospect. There have been instances where the fee payable along with this form is as high as ` 10,000/- in some states.

This system of charging highamount of application fee was borrowed by the States concerned from the processes followed by NBA, whereas, under the law, there is no empowerment to SBBs to collect any royalty/ABS/access fee. Yet, many SBBs are pressurising companies to share their profits. This has stirred up a storm in the industry.

Agarwal elaborates, “The main issue is with the interpretations adopted by the regulatory bodies. It appears that the focus seems to have shifted from conservation/ sustainable utilisation/equitable benefit sharing to rev-

enue collection for filling the National Biodiversity Fund/ State Biordiversity Fund/ Local Biodiversity Fund.”

“The Act requires prior permission of NBA, before patent applications can be processed, by the applicant under Form III. NBA is demanding additional benefit sharing fees over and above what is already paid for accessing the bioresource.

This is accompanied with complicated ABS agreements which have several one sided clauses which leave the applicants vulnerable. All these “well meaning” measures have a long term impact on research happening in the AYUSH sector. There was very little research happening in this sector. Now the overall research will drastically declinewith these new regulations in place. Any sector which does not have ongoing research support is likely to suffer in the long run. Thus, it is important that the NBA/SBBs are not allowed to make ‘revenue centric’ interpretations of the Act or the regulations published in the Gazette of India on 21 November, 2014,” opines Agarwal.

Hence, Agarwal feels, “If India chooses to take leadership in this sector (which is what has been said time and again for several decades) then India will need to match its actions (including regulations) with its words. There is no purpose in gloating about our rich biodiversity and traditional knowledge if at ground level, counterproductive regulations and extreme bureaucracy (license raj) is being implemented.”

Need for clarity

The Act targets all sorts of manufacturers using biological resources as raw materials. ASU formulations, herbal veterinary products, herbal extracts and related phyto-pharma sector are targeted by authorities like NBA and SBBs

Commenting on need for clarity, Agarwal stresses, “Clarity is essential for assessing impact on exports. Though as of now the exports has been happening as before, however, it is anticipated that exports can be severely impacted when the SBBs start implementing the Act. This is largely because the NBA is trying to treat value added products like herb powders, essential oils, oleoresins, extracts, phytocompounds etc. as bioresources instead of value added products. It should be noted that the Act is applicable only to bioresources and not to value added products.

If the oils, oleoresins, extracts, etc. are treated as bioresources then the buyers or the exporters will have to seek prior approval of NBA, through Form IV after payment of ` 10,000/- per application as application processing fee, for every consignment of export. Such approvals from NBA will need minimum six months to one year or more.”

He further explains, “There is no clarity at SBB level as to what botanical substance is a bioresource and when does it become a value added product. The industries have been searching for answers since many years.

AYUSH products are likely to become more expensive in the coming times due to a significant increase in our raw material prices (because of ABS).”

Thus, as is the case with a lot of our measures, despite good intentions, we seem to stuck on the execution or implementation as far as the Biodiversity Act is concerned.

AYUSH industry is in need of a push from the government, however it's struggling to understand the regulatory process laid down by the government. It is the need of the hour to bring more clarity to the regulatory process and streamline its implementation to propel the growth trajectory of AYUSH in India and overseas. u.sharma@expressindia.com

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MADHAVBAUG

CARING FOR HEARTS

Sane Care Madhavbaug uses a blend of yoga and ayurveda to treat heart patients.

Its scientifically proven methods have not just got global acceptance and but also helped establish yoga and ayurveda as reliable ways of treating patients

By Sachin Jagdale

n i t e d Nations General Assembly (UNGA) declared June 21 as International Day of Yoga and in the true sense, Yoga got its much deserved and waited global recognition. In fact, even before this declaration, across many parts of the world researchers were busy judging yoga on a scientific basis. As India is the birth place of yoga, this development is a proud moment for its countrymen.

While rest of the world took a long time to accept yoga as a science-based method, in India, it has long been practised as a scientific technique to cure or improve various diseases conditions. There are many healthcare setups in the country that have combined yoga with ayurveda to treat patients with some complicated forms of health ailments. One such healthcare set up is Sane Care Madhavbaug which is an BSEN ISO 9001:2001 certified, Ayurvedic Cardiac Rehabilitation Center. They claim to be

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world’s first and largest organisation that treats heart patient with the help of ayurveda and yoga.

Making ayurveda mainstream Dr Rohit Sane, Founder, Madhavbaug, is an MBBS graduate from Aurangabad University.

Besides bagging a fellowship in Cardiac Rehabilitation from Apollo Hospitals, he is also an Ex-Fellow of Royal Society of Health (UK). In the quest of treating heart patients with ayurveda, he started his first venture, Vaidya Sane Ayurvedic Panchakarma Center in 1999. The response was good and it paved the way for his entrepreneurial journey.

However, taking ayurveda mainstream did not prove to be a cakewalk for Sane. In the initial days, Sane had to expend a lot of energy to convince his own medical staff about the potential of ayurveda. He worked hard to keep ayurvedic therapies safe and hygienic.

Ayurveda has always been perceived as a traditional form of treatment and making people

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Madhavbaug is offering state franchisees to expand its footprints in the country. Though currently Madhavbaug does not have any international presence we are in talks with few international healthcare firms for the same Rohit Sane Founder Sane Care Madhavbaug

believe in it to treat heart ailments was a Herculean task. But Sane, with his scientific approach, slowly and steadily managed to garner the support of the patients. Today, besides heart ailments, Madhavbaug also treats diseases like diabetes, blood pressure, high cholesterol, obesity, stress etc.

Holistic healing and yoga Modern ways of treating heart blockages are generally invasive and these techniques would not just give physical discomfort to the patient but also drain him emotionally and financially.

Madhavbaug’s holistic treatment gave the patients a sientificallyproven alternative to take care of their hearts.

Sane explains how exactly Madhavbaug helps heart patients get rid of their blockages. He says, “Madhavbaug treats heart diseases with copyrighted ayurvedic panchakarma

therapies in addition to diet, exercise, yoga, and pranayam. Blockages appear due to excess accumulation of cholesterol in the inner lining of the blood vessels.

These blockages may or may not hamper the blood supply to the heart. None of the therapies in the world remove blockages, neither angioplasty, nor bypass nor Madhavbaug. All the therapies are aimed to increase the blood supply to the heart by either widening the affected artery or bypassing the affected artery with a new one.”

He adds, “Madhavbaug, with the help of panchakarma, diet, yoga and prananyam aims to increase the blood supply to the heart by improving the endothelium of the affected artery. Yoga and exercise also help to generate coronary collaterals, building coronary reserve of the heart.

Moreover, as per reverse cholesterol transport mechanism, the fats stuck in the internal lining of the artery can be reversed by exercises and yoga leading to reversal of blockages.”

International recognition The Western world has always

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cover ) looked at Indian traditional treatments with scepticism.

However, Madhavbaug’s cardiac treatment, with the combining ayurveda and yoga, has been lauded by global authorities as well. Madhavbaug has presented several research papers in national as well as international allopathic cardiac research journals like Lancet, Circulation etc.

Spreading its wings Over its more than a decade long journey, Madhavbaug has treated over one lakh heart patients through its two hospitals in Khopoli and Nagpur and has more than 130 centres all over Maharashtra. The Khopoli branch has features like 160 metres jogging track, 1,20,000 sq ft of lush green lawns, 25 self contained studio apartments, nine mud cottages, meditation centre, eight cabins of panchkarma centre, intensive cardiac unit with defibrillator, ambulance on call, 24-hours in-house doctor and well equipped kitchen with dining room. The Nagpur branch is spread over six acres of greenery. The Panchkarma Department has the capacity to treat 20 patients. Other amenities include a walking track, well equipped ICU, cardiac ambulance, examination rooms panchmahabhoot temple, yoga and meditation hall, spacious canteen, a residential building with 20 patient rooms and a spacious car parking facility.

Paving the road ahead According to Sane, a huge chunk of the Indian population is still in need of affordable and effective heart care. He wants his scientifically proven holistic way of cardiac care to reach as many heart patients as possible. Sane says, “I want to improve quality and quantity of life of heart patients.

Performing one lakh free stress ECG/ stress tests for senior citizens this year is also one of my goals. I want to reduce the three year mortality and hospitalisation rate of chronic heart patients below 10 per cent. Madhavbaug is striving towards combining modern scientific cardiology with ayurvedic science for the upliftment of human health. I find delivering afford-

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ACHIEVEMENTS ◗ July 2010, Beijing: The copyrighted procedure “Sampurna Hriday Shuddhikaran” got accreditation at the World Cardiology Conference held in Beijing, China by the American Heart Association (AHA). ◗ July 2011, Hong-Kong : Madhavbaug’s “Sampurna Hriday Shuddhikaran” has been accepted by the world’s most renowned medical Journal Lancet / JACC in coordination with the journal of American Association of Cardiology.

Heart patients during a yoga session

◗ April 2012 : Dubai: “Improving cardiac effort tolerance in chronic heart failure: Role of the noninvasive herbal procedure Sampurna Hriday Shuddhikaran” has been accepted as an Oral Abstract Presentation at the World Congress of Cardiology, 2012 held in Dubai-UAE by the World Heart Federation.

able, safe, non invasive cardiac care for chronic heart patients through a wide network of multidisciplinary cardiac care clinics as one of the most important targets for us. My staff of 1400, which includes 200 doctors, is well equipped to take care of our patients.”

He informs, “Madhavbaug is offering state franchisees to expand its footprint in the country.

Though currently Madhavbaug does not have any international presence we are in talks with few international healthcare firms for the same.”

There are many holistic healthcare centres across India, however, very few of them have attained Madhavbaug’s stature. Its treatments are scientifically proven and that is why they are accepted globally.

Other such healthcare centres need to follow Madhavbaug's footsteps. India has millions of patients in the country who cannot afford modern therapies. They will benefit if many more Madhavbaugs emerge to help them. sachin.jagdale@expressindia.com

Madhavbaug, Khopoli

Madhavbaug, Nagpur

Announcement of June 21 as International Day of Yoga was the result of India's constant efforts towards showcasing Yoga on a global platform. Some of the key developments that led to the announcement are as follows. ◗ United Nations General Assembly (UNGA) declared June 21 as International Day of Yoga.

This declaration came after a call by Indian Prime Minister, Narendra Modi while addressing UN General Assembly. ◗ More than 177 countries supported this move with 175 countries co-sponsoring the resolution.This initiative found support from

many global leaders.At first, the Prime Minister of Nepal Sushil Koirala supported Modi’s proposal. More than 177 countries including US, Canada, China have supported this move. ◗ It had the highest number of co-sponsors ever for any UNGA Resolution of such nature. On Dec 11, 2014, the 193-member U.N. General Assembly approved by consensus a resolution establishing June 21 as 'International Day of Yoga'.

Source: Wikipedia

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I N T E R V I E W

'The market share for Naturell India is 55+ per cent in 2014-2015' A nine-year old nutritional bar manufacturing company, Naturell India has introduced various healthy bars to the Indian market. Vijay Uttarwar, President and Chief Executive Officer, Naturell India shares more details about his company and its products, with Usha Sharma

What are the ongoing activities of Naturell India?

Naturell India started its business in 2006 for nutritional bars under the brand name of RITEBITE. The current activities involve focussing on increasing the consumption of RiteBite bars through various awareness programmes to target working professionals, weight watchers, fitness freaks and majorly all the health conscious people. Along with launching new products every six to eight months, we are also aggressively expanding our retail outlet distribution network to improve RiteBite awareness and availability to targeted consumer groups.

Which products do you offer to end consumers and what are its benefits?

Naturell offers a wide range of RiteBite premium products to keep up energy levels. Naturell provides

nutritious products with superior quality. RiteBite Nutrition Bar comes in a convenient pack, so wherever you go, whatever you do, RiteBite makes a perfect on-the-go snack. Switch to a healthy lifestyle with RiteBite.

Our other products include: ◗ Herbal protein bars ◗ Ritebite Eazy Slim Herbal bars ◗ Ritebite Eazy Immune Herbal bars ◗ Ritebite Eazy Calm Herbal bars ◗ Protein bars ◗ Healthy snacking and diet bars Tell us about your herbal protein bars. What quality tests do you follow and how conventional are they?

Naturell India performs various researches, leading to the final launch of an innovative product. It goes through a rigorous product development cycle, starting from lab formulation to pre-launch consumer feedback. The products are then further tested for various

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cover ) elements such as shelf life, nutritional content, taste parameters and feedback. At manufacturing, various steps are taken to provide the highest quality products including selection of raw material, manufacturing process and post manufacturing storage and shipping. Naturell India also has an edge over others in terms of quality – ISO – 22000 : 2005, wide range of nutritional bars in variety of flavours catering to different market segments, taste, availability and price.

In case of herbal protein bars or any of our bars, we always maintain high standards of quality. For example, in Ritebite Eazy Herbal Bars we are using high oleic oil which has 83 per cent cleic content, which is higher than olive oil.

High oleic oil is known to help reduce bad cholesterol and lower the risk of heart diseases. The herb such as yerba mate, passion flower, lemon balm, which are believed to be highly beneficial to the body and mind, are sourced from different countries.

What are the company's marketing strategies and who are your target consumers?

RiteBite is the market leader in the entire granola bar/nutrition bar market. For taking the brand equity further, some of our marketing efforts to be put in for promoting the brand are as follows: consumer awareness, approaching the influencers – like gym trainers, dieticians, one-toone approach with social media and website. Online consumer programmes – Facebook, Blogs, Youtube, BTL activity, PR activity, events and promotions.

Our marketing strategy mainly revolves around awareness programmes and events where we also have a lot of sampling sessions. Our major target consumers for these nutrition bars are

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working professionals, weight watchers, fitness freaks, gym goers, people with busy lifestyle, people on diet, in short people who are health conscious.

recommending our products.

We also do various activities/seminars with IDA – Indian dietetic association and other various institutes and clinics.

Elaborate more on the company's vision.

Rising obesity levels, awareness about the advantage of leading a healthy life, rising demand for products boosting health benefits, rising exercise participation, wide appeal for nutrition/sports and herbal products are major contributors for widening the weight management industry. Green tea is very popular for weight management, it's first time in India that green tea herb will be added in a nutrition bar. In addition to the benefits of green tea, this bar contains 14g protein, 8g fibre, low carbs, prebiotic, non-GMO, low glycemic with no added sugar.

There are many new players venturing into these segments who provides diabetic-friendly cookies and bars. Who are your competitors and what signifies your company from the rest of them?

There are many products in markets which caters to diabetic segments, the key to a diabetic diet is eating in moderation, sticking to regular mealtime and most importantly having a complete balanced meal which is high in nutrients, high in protein, high in fibre, low on fats, low or no sugar and moderate in calories.

Regarding competition with other brands, we have got the first mover advantage, Naturell India was the first company to introduce the concept of granola bars in the country in 2006 and has cracked the market quite successfully under the brand Rite Bite.

Today, there are many competitors who have entered the market including Nature Valley and other local players in related markets.

However, Rite Bite still holds major market share of the entire granola bar market in India, we are the market leaders. Naturell India have an edge over others in terms of quality – ISO 22000: 2005, wide range of nutritional bars in variety of flavours catering to different market segments, taste, availability and price.

PM Narendra Modi is encouraging preventive healthcare methods. Are you working in line with it?

PM Narendra Modi talked about the changing nature in the health sector including the importance of specialisation in the sector.

Naturell India is working in line with this vision of providing the finest naturebased products that will help Indian consumers adopt a healthier lifestyle. With the recently launched innovative products, we are reaching to the specific Indian market segments with special products for special health needs, these products are a blend of nature (Indian traditional herbs) and nutrition. In addition to this vision, we are proud to be the first healthy lifestyle company manufacturing nutrition bars in our mother land, promoting health, wellness and fitness nutrition in India.

Do you have any tie-ups with nutritional institutes

Naturell has maintained the market leadership position even after seeing new product launches in the same segment and dieticians?

Why there is a need to reach out to the influencers in this industry will be the right question to ask.

Reaching out to the influencers like dieticians, nutritionists, fitness gurus and association with nutritional institutes is vital for our business. Consumers trust recommendations from a third party more often than a brand itself.

If we talk about dieticians, they have good networks.

Dieticians also referred to as clinical or therapeutic dieticians, these titles vary across the workplace. To name some of the weight management/slimming centres, we are associated with Pretti slim clinics in Mumbai, Qua Nutrition at various locations across

How many new products do you plan to launch in the Indian market and by when?

Leveraging on the popularity of Ritebite Max Protein, we have planned to come up with brand extension, this bar will be launched as Ritebite Max Protein – Professional, a 100g

bar will have 30g protein, 10g fibre, 2g glutamine, 5.5g BCAA – branched chain amino acids which helps in more muscle mass retained, and a greater percentage of lost body fat. Seeing the great potential in protein and weight management markets, our focus is now hitting the tapered niche target market segments rather than going in for masses.

What are the company's corporate plans?

Naturell India has grown by approximately 25 per cent this financial year 2014-2015 as compared with previous year. The market share for Naturell India is 55 + per cent in 2014-2015. It is expected that the market will continue to grow at 35 per cent to reach `150 crores in 2018-19.

The key to maintain the market leadership position is innovation and introduction of new products for specific segments. Naturell has maintained the market leadership position even after seeing new product launches in the same segment by few of the local players, they were unable to dent into our market share.

With the recent launches Eazy Herbal Bars – Eazy Slim – Weight Management Bar, Eazy Immune – Immunity Management Bar, and Eazy Calm – Stress Management Bar, Naturell is currently looking at the weight management market in India. The company has horizontally diversified the RiteBite variant portfolio with many flavours, variants catering to unique taste and specific health requirements for Indian consumers. In addition to this, we are expanding our sales channel from traditionally selling it in A-class retail outlets to reaching out to dieticians, slimming centres, nutritionists, gym trainers, supplement stores, chemists, online platforms and many more. u.sharma@expressindia.com

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I N T E R V I E W

“Procurement of authentic and genuine raw material is becoming a problem�

Established in 1935, Ayurveda Rasashala, based in Pune, is one of the oldest pharmacies manufacturing ayurvedic medicines. Shalini Gupta finds out more in an interaction with Dr Vijay Doiphode, Managing Trustee, Ayurveda Rasashala

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How many drugs did Rasashala start with? How many drugs do you have now? What are your annual sales for last year?

By how much have they increased since inception and what is the year-onyear increase? Tell us about your distributor network and by how has it increased since inception?

Ayurveda Rasashala started with ayurveda's generic products described in our ancient text books withthe noble principle to provide quality medicines at affordable rate to ayurvedic hospitals. Especially, to hospitals affiliated to Ayurveda Rasashala like Sheth Tarachand Ramnath Charitable Trust Hospital and Nanal Rugnalaya. With the passage of time, the knowledge and experience passed on to us by our ancestors, gave way to various proprietary medicines. The number of products which was below 50 grew speedily and crossed the 150-mark. Now, Ayurveda Rasashala manufactures around 160 different types of medicines like Guti-Vati (tablets), Asawa-Arishta, Awaleha, churna, syrup and Siddha Tail. We have sold medicines worth around `12,00,00,000,

keeping in tune with a steady increase of around 12 to 15 per cent every year.

Ayurveda Rasashala has a strong distribution system to keep the consumers happy.

In earlier days, Ayurveda Rasashala had depots, shops dedicated to sell its products. As the market trend changed, to cope with the requirement of consumers, Ayurveda Rasashala had to supply medicines to other distributors and retailers.

This was the moment Ayurveda Rasashala changed its marketing strategy and appointed super-stockists with the help of our strong marketing team. Initially, our sale was limited to some parts of Maharashtra only. After our marketing team's hard work, now medicines are available throughout the state as well as across Goa, Karnataka, Gujarat, Rajasthan, Madhya Pradesh, Delhi and Uttar Pradesh.

What are the challenges in operating the company?

Procurement of authentic and genuine raw material is becoming a problem. Once easily available, raw materials are becoming scarce because of the forest department laws. We agree

that it is not proper to erode the natural grown forests for raw materials, but to procure the cultivated material, requires government approvals. Also, some of the the laws like Bio Diversity Act and the taxes levied by Government are making manufacturing a cumbersome process, with minimum yield and maximum expenditure.

What have been some of the achievements of the Rasashala?

Ayurveda Rasashala is one of the oldest pharma companies. We feel proud when the FDA department recommends us to other companies for authenticity and efficacy of the medicines, specially Bhasma and Aasawa-Arishta, as we are among the very few who are still following the traditional methods for their preparation. We have managed to form a perfect blend of traditional and modern methods as well as machinery. This blend reflects when our traditionally prepared Asawa-Arishta are filled for sale on the ultra-modern fullyautomatic liquid filling line.

The government is to set up

EXPRESS PHARMA

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June 16-30, 2015

cover ) a regulatory regime for AYUSH. What are your expectations for the ayurvedic industry? What kind of regulations would be enabling?

Ayurveda Rasashala expects that this regulatory regime will help upgradation of educational standards, quality control and standardisation of drugs, improving the availability of medicinal plant material, research and development and awareness generation about the efficacy of the system. AYUSH department will be helpful for the ayurvedic industry if regulations from certain raw materials like minerals, poisonous substances will be exempted and allowed to be

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We feel proud when the FDA department recommends us to other companies for authenticity and efficacy of the medicines DR VIJAY DOIPHODE, Managing Trustee, Ayurveda Rasashala

used with proper precautions like Shuddhi Prakriya. The department should collaborate with other government institutes like NMPB, Forest Ministry etc., so that it can be helpful for the buyers and sellers of ayurvedic raw materials and provide standardisation and quality assurance. AYUSH

department should pursue the demand to treat the ayurveda pharma industry with different parameters than other pharma segments.

How important is the marketing of ayurvedic drugs? What is the size of the team at Rasashala?

Which drugs rank high on sales and what therapeutic areas do they address?

Ayurveda's generic products do not need marketing. But the ayurvedic proprietary products do require marketing. Ayurveda Rasashala has a well talented and well informed team of four area sales managers and

22 sales representatives to promote its proprietary products. Samples and informative literature about products is distributed through sales officers. Our sales officers personally convince the doctors about the authenticity of the medicines and provide detailed information about the raw material used and the methods followed to manufacture the medicines.

The same method is followed to convince the retailers, who in turn, convince the end users while selling the OTC products. Varunadi Quath, Prasham, Shatavari Kalpa are the top selling products of Ayurveda Rasashala. shalini.g@expressindia.com

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26 EXPRESS PHARMA June 16-30, 2015

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THE PUTRAJEEVAKA CONTROVERSY Dr Yogesh M Jirankalgikar, Lecturer, Dept of Basic Principles,SHES' AMC Ayurveda Medical College, Gulbarga, and Dr Pravin R Joshi, Lecturer, Dept of Dravyaguna, Gangadhar Shastry Gune Ayurveda Mahavidyalaya, Ahmednagar share their opinions on the recent controversy stirred up by the sale of a medicine which would supposedly ensure the birth of a male child

R

ajya Sabha MP (JDU), KC Tyagi raised a question on the ‘Divya Putrajeevak seed' on the floor of Parliament House on Thursday, April 30, 2015. The question was regarding a claim that this medicine on consumption guarantees conception of a male child. As this medicine is sold by Divya Pharmacy he also demanded a probe against the pharmacy. In reply, the Minister for Health & Family Welfare, JP Nadda, stated that the issue is related to the Department of AYUSH and the Government will look into it and ensure proper action.

Reacting to the MP’s query, Patanjali Yogpeeth, the governing body of the above quoted pharmacy said, “This medicine (Putrajeevaka) is used in treatment of infertility and it only helps childless couples to conceive, has no effect on gender of the would be progeny.” It also rejected the theory of gender selection. It was also reported by media that Madhya Pradesh state government has banned the sale of Divya Putrajeevaka seed and asked Divya Pharmacy to change the name of the product.

This incident has raised several questions, not only from experts of ayurveda

but also for the common man. As experts of ayurveda, we feel that every system of medicine has its own principles and practices. Spontaneous comments without thorough understanding of the subject on such sensitive issues or raising this type of questions will not serve the purpose. On the contrary, it is a sign of immaturity and eagerness to achieve cheap publicity which is increasingly becoming an integral part of current day, imbecilic, political practices.

This issue has three important aspects: social, emotional and political.

Let us start with scientific facts. Sex determination of a foetus is surely and purely dependent on the male partner (23+XY). If the ‘Y’ chromosome from the male pairs with the ‘X’ chromosome of the female (23+XX), then the result will be a male baby (23+XY). Likewise, if the ‘X’ chromosome of the male, pairs with the ‘X’ chromosome of the female, then the baby will be a female (23+XX). Thus, the male chromosome is responsible for determination of the sex of the would be child. Interestingly, the ‘Putrajeevaka’ medicine is prescribed to the female partner in infertile couples and still a ban on the medicine is suggested, which is nothing but mockery of scientific research. Furthermore, by our experience of 10-odd years practising as a ayurveda

‘Putrajeevaka’ medicine is prescribed to the female partner in infertile couples.

Hence a ban on the medicine is nothing but mockery of scientific research EXPRESS PHARMA

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June 16-30, 2015

cover ) consultants for infertility, I can assure that couples suffering from infertility are eager, anxious at times, and desperate for conception and hardly bother about the gender of the would be progeny.

From the ayurvedic perspective, the desired effect of the medicine can only be achieved if selection of the medicine is done on the basis of various aspects like the patient’s constitution (prakriti), dosha vitiation and so on. It is never alike, the result of a medicine varies from person to person depending on kala (time), and the matra (dosage) used.

The same medicine can be used in manifold conditions for different reasons. Thus, claiming one of the various effects of a drug (which is also a misconception) and arguing for its ban is a parody of our revered traditional knowledge of ayurveda.

28 EXPRESS PHARMA June 16-30, 2015

The meaning of word putra in Sanskrit means progeny/ off spring which includes both the male and female gender.

The base of this controversy is illiteracy about the medical terms in Sanskrit which further got diverted into a movement about saving the girl child.

In ayurveda, there are plenty of drugs named on male and female genders, viz Pumkutaja, Streekutaja, Kumari, Taruni, and Vandhyakarkotaki.

The basic principle behind the nomenclature of a medicinal plant in ayurveda has various theories such as its physical appearance, height, shape and size of leaves, flowers and fruits, flowering seasons and important usage. Any arbitrary demand for change of name is to attack these principles and in turn on ayurvedic science itself.

There is a special term for these

names and are referred to as ethno botanical names. Few e.g. Putranjeevaka-Putranjeevaka roxburgiana, Madhuka-Madhuka indica, Dhattura-Dhattura metal, Capsicum-Annona sqaumaosa, Bambu-Bambusa arundunoisa, Shalmali-Shlamaila malbarica.

The naming patterns of herbs is standardised by International Code of Nomenclature governed by International Association for Plant Taxonomy. It is adopted all over the world for unique identification of botanical species and not by any pharmacy itself. Once it is authorised then one cannot question the name of a specific drug. If at all there are controversies or confusions, then one should raise them to the concerned authorities. Such constitutionally empowered authorities in India are FDA of Government of India and Ministry of AYUSH whereas

it is the International Union of Biological Sciences and International Botanical Congress on the international platform. This, and all other ayurvedic medicines marketed in India by any pharmacy, have to undergo a process of obtaining licence for production as well as marketing of these drugs which is controlled by Ministry of AYUSH, Government of India and are exercised under Drug and Cosmetics Act 1972.

Coming to the social aspects, no one has the right to undergo or promote or run away from the responsibility of female foeticide.

It is the moral responsibility of every human being to ensure that by all possible means we abolish this inhuman act of foetal sex determination, which in turn, leads to female foeticide.

One last question is that can any policy or government re-

serve the right for intervention in a private matter, i.e. the desire of a couple to have a child of a particular gender. At present no such medicines are available to help in deciding the sex of a foetus that is not yet fertilised. If in future, medical research enables us to produce medicines, which on administration before conception, will help in deciding the gender of the off-spring that is not yet conceived, then it is up to the law makers to either give the freedom for its use or ban the medicine. MP Ji ball is in your court. What do you think?

About the authors (Dr Jirankalgikar is a practising ayurveda consultant in the field of infertility since 2006.

Dr Joshi has been involved in numerous research, projects in the field of Dravyaguna. He is the author of a book,'Plants for Substitution and Adulteration')

MANAGEMENT

REDEFINING NSQ

India has highest number of US FDA approved manufacturing facilities outside the US and yet the Indian pharma industry faces issues of 'Not of Standard Quality (NSQ) drugs too often. These issues have affected the reputation of the Indian pharma industry adversely. Globally, the image of the Indian pharma industry is getting blurred due to various reason. Hence, the Department of Health, Ministry of Health and Family Welfare has decided to redefine 'Not of Standard Quality’ drugs and proposed certain changes in Section 36AC. The industry and associations share their views on the changes proposed and their potential impact

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MANAGEMENT

'Clear definition of NSQ will give protection to genuine manufacturers of quality drugs'

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he Indian legal system is often fraught with laws which are not adequately thought through and drafted ambiguously, resulting in unintended consequences in spite of good intentions. The matter is often compounded due to the judicial process moving at a snail’s pace. While Indian pharma industry has made phenomenal progress in the past couple of decades and has earned the distinction of being the ‘Pharmacy to the World’, regulatory agencies in the country have not been able to keep pace with this progress. The Drugs Act (Amendment) 2008 defines only three categories of Drugs under section 36AC viz. spurious, misbranded and adulterated. The lack of proper definition for ‘Not of Standard Quality’ (NSQ) drugs often results in genuine and licensed manufacturers getting penalised under the above three categories. Quite often a standard quality drug manufactured by a licensed manufacturer fails in potency or physical appearance (discoloration,

chipped tablets etc. ) due to improper storage or a poor supply chain during distribution.

For instance, it is not uncommon to see a truck carrying thermolabile medicines like multivitamin or antibiotic preparations getting stuck in the hot Indian sun for hours at a toll or octroi booth, resulting in some loss in potency. Imported drugs requiring cold chain often lie on the airport tarmac for hours before being transferred to the cold warehouse, thereby causing break in the cold chain. Also load shedding or power failures often expose thermolabile drugs to high temperatures. Such drugs cannot be classified under the three categories or NSQ drugs, resulting in severe punishment to the good manufacturers. One may argue that such issues should be taken care of while conducting accelerated stability studies during formulation development. However, shelf life study is quite a complex matter and such studies cannot fully predict formulation behaviour during its shelf life.

AJIT DANGI President and Chief Executive Officer, Danssen Consulting

Similarly, barring few exceptions, FDA testing labs in most states suffer from lack of trained analysts, modern analytical instrumentation, proper funding, validation of analytical methods etc. In fact, Mashelkar Committee Report, in 2003, made scathing remarks on the functioning of such labs. Unfortunately, the situation has only marginally improved since then. These labs are very rarely audited by independent authorities for GLP. However, punishment to licensed manufacturers is often based on the analytical reports given by such labs.

While producers of spurious, misbranded or adulterated drugs should be severely punished and heavy penalties should be slapped on them, a genuine manufacturer should not be penalised for ‘unintended consequences’ due to ambiguous definition of NSQ. Clear definition of NSQ will give protection to genuine manufacturers of quality drugs from unnecessary harassment and loss of reputation due to factors beyond their control.

'It is imperative to align the definition of NSQ with the expectations of US FDA'

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BOB RHOADES Vice President, Quality and Compliance Services, Quintiles

30 EXPRESS PHARMA June 16-30, 2015

stablishing regulatory standards is critical in the pharma industry.

Regulatory standards help the industry consistently perform and ensure reliable enforcement by regulators. As part of regulatory standards, definitions and terms must be interpreted and applied uniformly throughout the global marketplace. To enable regulatory compliance, it is imperative to align the definition of NSQ with the expectations of US Food &

Drug Administration and other world regulators. The Indian Drug Manufacturing Association (IDMA) should harmonise with globally recognised regulatory definitions to ensure standards in a global marketplace.

Drug stability has always been a critical product parameter. If products are developed properly and manufacturing processes are validated appropriately, then assurance of drug shelf life should be a natural result. While it may be a

complex technical issue for many drugs, it remains an expectation of the user/patient that the drug's potency and therapeutic value will be consistent throughout its labelled shelf life. If a manufacturer has evidence that it is not, then the only recourse is to remove the product from the marketplace.

This is the expectation of all regulators. The definition of NSQ should include the requirement that the manufacturer has proven its potency across its full claimed shelf life.

Regulator and industry should jointly address quality issues

DG SHAH Secretary General, Indian Pharmaceutical Alliance (IPA)

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hange in definitions do not build the image of an industry. The regulator and the industry need to work hard and jointly to address quality issues. The image of the industry is directly linked to the quality and competence of the regulator also.

The industry needs to focus on the real issues.

MANAGEMENT

'It is necessary to have clear distinction of the terms/activities,with respect to Section 36AC'

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ection 36AC of the Act deals with offences to be cognizable and non-bailable in certain cases. Under this section, offences relating to adulterated or spurious drugs are only cognizable and nonbailable. However, ‘not of standard Quality’ drugs which may be adulterated or spurious are treated separately. With a view to safeguard and to protect the genuine manufacturers from rigid penal actions pro-

vided under this section and to ensure deterrent punishment to scrupulous dealers, it is necessary to have clear distinction of these terms/activities, with respect to Section 36AC. This step will build confidence in the Indian industry and show the rigid intent of the Indian Government against adulterated or spurious drug manufacturers or dealers. It will enhance the image of the Indian regulatory system in protecting

public health .

It is true that manufacturing and ensuring stability of drugs till shelf-life of product is a complex issue and highly technical. Regarding change in NSQ drugs, we observe that the Government has not proposed any change in the definition of NSQ drugs but proposed to classify the ‘not of standard quality’ drugs into various categories.

We believe that such categorisation would enable the Govern-

ment to assess the seriousness of the violation within the group of ‘not of standard quality’ drugs for imposing appropriate penalties depending upon the seriousness of violation. This is also likely to enable the Government to give severe punishment to those who violated by manufacturing NSQ drugs, where safety and efficacy of the drug is adversely effected significantly.

Therefore, this approach is desirable.

DR PV APPAJI Director General, Pharmexcil

'The definition of an NSQ drug has nothing to do with the stability and shelf life of drugs'

I SV VEERRAMANI President, IDMA

f proper definition of ‘not of standard quality’ drugs is not made in the Drugs & Cosmetics Act, there is a possibility of some of the NSQ drugs being interpreted as spurious and adulterated drugs, which will mar the reputation of the genuine pharma manufacturers and provide them penal punishments and jail. For example, if

the assay of the drug is not complying with the specifications, the drug can not be considered as spurious. It may be a case of analytical error or poor storage conditions, etc. It does not mean that there is a substitution of the drug.

In the absence of a proper definition of NSQ drugs, the world community tends to

mix up the same with other serious categories like adulterated and spurious drugs and thereby label India as a country making spurious drugs.

This misconception of the world community can be dispelled. The definition of an NSQ drug has nothing to do with the stability and shelf life of drugs. It is the manufactur-

ers’ responsibility to provide safe and effective drug to benefit the patient. There will be no changes with respect to standards, processes and expectations for providing quality drugs. The definition of NSQ drug is only to differentiate the same from spurious drugs. u.sharma@expressindia.com

MANAGEMENT INSIGHT

Competence in clinical research Dr Martin Robinson, Executive Vice President and International Academy of Clinical Research (IAOCR) Ambassador, talks about patient safety as one of the central principles of clinical research CLINICAL RESEARCH professionals, whether they be investigators, site staff or sponsor employees, all have a responsibility to protect the rights and well-being of trial subjects. Decisions about patients, both individually and collectively, are made on a daily basis to ensure no subject’s rights are infringed and that the care they receive during any clinical trials is justifiable given the risks involved.1 Patient safety is a central principle of clinical research. In other work sectors where health and safety are at risk, some form of certification or accreditation is often required. The Gas Safe Register in the UK is a system for certification of gas engineers that verifies they are competent to work safely and legally on boilers, cookers, and other gas appliances. The International Institute of Business Analysis (IIBA) has a system of accreditation for business analysts. For the operation of pleasure craft, there is an International Certificate of Competence (ICC), which may be issued to anyone who has successfully completed certain national boating licenses.

Industry competence: Current training and practice Clinical research guidelines, like the ICH Guideline for Good Clinical Practice (GCP) E6(R1), make very general references to training. “Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s),” states the document’s Principle 2.8. However, there is currently no set of standards in clinical research for how individuals are trained and assessed to ensure they are competent and working to the required performance standards. The ultimate goal should be to have clin-

32 EXPRESS PHARMA June 16-30, 2015

The ultimate goal should be to have clinical trials conducted efficiently and effectively while protecting the rights and well-being of patients as well as the integrity of the data collected ical trials conducted efficiently and effectively while protecting the rights and well-being of patients as well as the integrity of the data collected.

Regarding suppliers of clinical research training, there appears to be a somewhat unfocussed and disjointed approach.

A simple search on the Internet reveals many clinical research training suppliers including freelancers and individual consultants. Currently, there is no set of standards to verify which of these are credible or proficient to deliver training effectively and impart competence to the learners.

In terms of the training by organisations of their own staff, it might be coordinated and provided by an internal team of trainers, depending on the organisation and its size. Alternatively, some companies may outsource all or some of their training. One of the consequences of a lack of standards is that training by one organisation is often not recognised by another, particularly with respect to GCP training. This results in repetitive and unnecessary GCP training without any competence assessment of staff and is particularly prevalent in training investigators and their teams.

The consequence is wasted effort on the part of both sponsor and investigator, which is an unsatisfying and demotivating experience for both the trainer and the training recipients.

Some progress has been made by TransCelerate which is a collaboration between bio-

pharma companies to design and facilitate the implementation of solutions to drive efficiency and effectiveness in the development of new medicines.

One of the TransCelerate initiatives concerns Site Qualification Training. This initiative is centred on minimum criteria for GCP training content that will enable member companies to mutually recognise one another’s training. The focus is on the content of the training rather than learning outcomes. While this is a welcome step, the initiative does not go far enough, focusing only on inputs rather than the all-important outputs expressed as competence.

Using a competency-based approach Competence can be defined as an observable demonstration of knowledge skills or behaviours.

A competency framework is a management tool which is designed to help assess an individual performance objectively across all levels of the organisation2. These frameworks can be used to identify performance gaps and hence specific learning needs. This enables training to be targeted and avoids the ‘sheep dip’ approach where, for example, everyone is given annual GCP training without any regard to their actual learning needs.

Another crucial element is to ensure that any learning intervention (e.g. a training course) meets the required standards and, when delivered, has the potential to fill the compe-

tence gaps. Each learning intervention should have measurable learning outcomes. Having these learning outcomes independently recognised using some form of accreditation would make the system suitably robust. This would enable individuals to gain an accreditation/ certification providing they could prove that they demonstrated the level of competence required by the learning outcomes of the training course.

Delivering performance across geographies Clinical research is a global industry, with many studies being not just international but intercontinental. Organisations need to be able to operate worldwide whilst still having local knowledge and expertise.3 Internationally recognised accreditations would provide a more flexible workforce, thereby ensuring a better match between supply and demand globally. It would also give confidence to employers when hiring or contracting staff and give individuals the ability to explain and demonstrate evidence of their competence to potential employers.

Sponsors would benefit from having confidence and reassurance when hiring contract research organisations (CROs) whose staff were accredited, and CROs could demonstrate the potential of their capabilities by having accredited people.

Along side, developing and verifying competence allows new talent to be developed efficiently and effectively with the

DR MARTIN ROBINSON Executive Vice President and International Academy of Clinical Research Ambassador

result that new intake of hires is fully and rapidly productive. It is vital that the clinical research sector has a steady stream of new talent to meet the demands and challenges of the future in the various developing geographical regions.

Summary Having a systematic and robust system of competence-based accreditation has great potential in ensuring that individuals working in clinical research are competent. Each individual working in clinical research should have an obligation to develop themselves against performance standards and to gain recognition of competence wherever possible.

The desired effect is to be able to conduct clinical trials quicker, more efficiently and with fewer errors. This represents a great opportunity for the clinical research sector to make a major step forward in developing a talented, flexible and global workforce that is equipped to meet the challenges of conducting top-quality clinical trials globally. This results not only in the potential positive impact on public confidence in clinical research but also helps to protect the rights, safety and well-being of trial subjects, as well as to verify data integrity.

References 1. US Department of Health and Human Services. 2009. Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (Internet) http://www.fda.gov/downloads/Drugs/.../ Guidances/UCM187772.pdf [Accessed 08/05/2015] 2. Peter Schueler, Brendan Buckley, 2014.

Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process. Academic Press, London 3. Umakanta Sahoo, 2012. Clinical Research in Asia: Opportunities and Challenges. Woodhead Publishing, Cambridge

MANAGEMENT OPINION

One year of Modi govt: India Inc,be patient

KIRAN MAZUMDAR-SHAW, Chairman & Managing Director, Biocon

Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon, remains optimistic about her expectations from the Modi government and advises the rest of India Inc to keep faith as well PRIME MINISTER Narendra Modi has just completed a year in power and he has been able to achieve a fair amount in thattime. His ‘Make in India’ campaign has set the tone for transforming India into a global manufacturing hub; the Jan Dhan Yojana has taken financial inclusion to the heart of rural India; the Swachh Bharat Abhiyan has put cleanliness on the top of the nation’s agenda; and his Digital India initiative has laid the groundwork for a digitally empowered society and knowledge economy.

Importantly, Modi has arrested the policy paralysis that had hit the nation and brought in a new dynamism to the corridors of power. The government has demonstrated its commitment to convert intent into action through various measures aimed at opening up the insurance sector, lifting controls on diesel pricing, bringing transparency into the allocation process for natural resources, such as coal, addressing the menace of black money, holding successful telecom spectrum auctions and making progress on tax, land and labour reform.

The government’s initiatives have revived global investor confidence in the India growth story. Data from the Centre for Strategic and International Studies shows that during the last year, January 2014-15, USIndia bilateral trade rose by over four per cent, FDI jumped 40 per cent and FII inflows soared 400 per cent.

The positive change in investor sentiment is also an outcome of Modi’s efforts to take the resurgent India story to the

Modi has arrested the policy paralysis that had hit the nation and brought in a new dynamism to the corridors of power global stage. From Washington to Paris, Tokyo to Sydney, the PM has travelled extensively to convince foreign businesses about the immense opportunity offered by this billion-strong market. Today, Brand India is shining again.

In order to improve business sentiment and spur investment by domestic as well as overseas players, the government has been trying to bring in key tax and land legislation. The introduction of the goods and services tax (GST) could be a gamechanger. By replacing a plethora of federal and state taxes, the GST will remove tax distortions and facilitate business potential.

Similarly, the Modi government’s land bill aims to make the acquisition of land for infrastructure projects easier by moderating some of the restrictive provisions in the previous land acquisition law of 2013. This will, in turn, boost manufacturing and job creation. Through the new land bill, the government has taken an approach that balances the interests of farmers and the ease of land availability for development projects. The proposed law increases the likelihood that the landowners will be compensated fairly, not only in terms of their land but also in terms of their jobs and livelihood. It seeks to not only ensure compulsory employment for one member of

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the family affected by the land acquisition, but also proposes a hassle-free grievance redress mechanism for them. However, political partisanship has resulted in these two key pieces of legislation getting stuck in Parliament.

On financial inclusion, especially in rural areas, the Modi government has made rapid strides with 12.5 crore accounts having been opened under the Jan Dhan Yojana. This initiative is not only helping bring a large swathe of Indians into the financial mainstream but will also allow the government to directly transfer welfare payments to intended beneficiaries. The government has also, in a relatively short period of time, launched schemes aimed at providing life insurance, accident insurance and pension to those outside the social security net. The Jan Dhan Yojana will facilitate the collection of monthly charges and premiums for these schemes.

What is unique about these social inclusion schemes is that they have been carefully engineered to introduce a greater sense of stakeholder ownership among beneficiaries while reducing the burden on the exchequer.

There are other small yet significant steps that the government has taken towards the goal of ensuring stronger, more inclu-

sive growth: the Adarsh Gram Yojana that tasks parliamentarians with establishing model villages and the Skill India campaign aimed at providing training and skill development to 500 million youth of our country by 2020, covering every village. In rolling out these initiatives, the Modi government has shown that it understands the aspirations of a new India that wants a hand up, not handouts.

While the government has walked the talk in most areas, there are some where it could and should have done more.

The biotech industry is worried about the government’s failure to embrace this new technology and bring in transformative change. Despite assurances from the government, the meetings of the Genetic Engineering Appraisal Committee (GEAC) haven’t been happening. These meetings are extremely important to enable field trials of GM crops, which can raise agricultural productivity. Indeed, biotechnology presents an unprecedented opportunity to ensure food security along with the economic wellbeing of farmers.

Similarly, the government is yet to provide the necessary policy push for a cohesive pharma research and development ecosystem to innovate new drugs. By lending support to the

local pharma industry’s capital investment needs, incentivising R&D investments and providing significant tax exemptions for innovation, the government can enable a culture of ‘Innovate in India’. Also, despite the intent to create an integrated healthcare system to ensure affordable and accessible healthcare for all, the allocations to healthcare in the last two budgets have been anything but encouraging.

Overall, Modi government has covered a fair deal of ground in a year’s time. The pace and intensity of reforms may have disappointed sections of India Inc, but one must factor structural bureaucratic challenges and fierce political opposition. One must also keep in mind that a lot of unrealistic expectations were built around Modi’s ability to fix the Indian economy overnight.

That is why the NDA’s achievements in the first year are being measured against the same yardstick typically reserved for governments that have served a full term. This is unfair. It also means that the government needs to do a better job of managing expectations.

India Inc, for its part, needs to be patient with the Modi government’s long-term roadmap of incremental reform.

I am aware of significant behindthe-scenes activity to improve the ease of doing business in the country. Greater engagement between the government and the private sector will ensure that the policies unveiled are truly enabling in nature. It is time that the government, opposition and corporate India were aligned in pursuit of the development agenda.

EXPRESS PHARMA

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June 16-30, 2015

RESEARCH INSIGHT

Holy basil decoded Holy basil or tulsi is for long known to be a wonder herb. In a first of sorts, a scientist decodes its genome to lend more credence to its medicinal value. He shares more insights with Shalini Gupta

I

n a breakthrough research, a scientist from Central Institute of Medicinal & Aromatic Plants (CSIR-CIMAP), Lucknow, has published whole genome sequence of Ocimum sanctum, also known as ‘Holy basil’ or ‘Tulsi’, revered as ‘Vishnupriya’ and worshipped for over more than 3000 years through the sacred traditions of Hindu culture. This is the first report of the complete genome sequence of the plant, using composite next generation sequencing technologies. Not only is this the first step to understand and unravel the secrets of this ‘mother of all herbs’, but will also provide scientific validity to the traditional claims of its medicinal usage.

Dr AK Shasany, a principal senior scientist from the biotechnology division of CIMAP, who is behind this development, has been curious about the herb since a very long time. Talking about it, he says, “Since tulsi has been a repository of a plethora of biochemicals and finds a distinguished place in all the ancient traditional medicinal systems including Ayurveda, Greek, Unani and Roman, I was curious. My inquisitiveness increased when I started the literature survey of the genes responsible for the biosynthesis of the important medicinal compounds. I found that very less data was available for holy basil as far as the molecular biology studies were concerned;

34 EXPRESS PHARMA June 16-30, 2015

major studies were based on the chemical profiling and the biological activity testing of the plant.” This is what triggered his interest into an in-depth study.

He has significantly contributed to analysing genomes of more than 900 accessions belonging to 40 different plant species for genetic diversity estimation, evolutionary relationships and marker identification. He is also responsible for the release of 33 commercially important varieties with 22 US plant patents, using genomics as well as breeding tools. His contribution in research related to Mentha and Artemisia won CIMAP technology awards in 1999 and 2012. He isolated and determined the function of several novel genes from medicinal and aromatic plants and is also associated in determining the efficacy and mechanism of action for novel uses of phytomolecules, leading to different product formulations having economic/commercial importance. He has collaborated with CDRI and SGPGI to understand the antigen proteins of several pathogens with the objective to use those for targets to screen plant compounds for human health.

Shasany combines his understanding on plant diversity for identifying economically important genotypes for conservation, cultivation and understanding metabolic

biology including the applied aspect of MAPs on human health and benefits.

He started his professional career after graduating from Indian Agricultural Research Institute (PhD. Molecular Biology and Biotechnology) along with a Post-Doctoral degree from Purdue University, US. He also secured highest Overall Grade point average(OGPA) (8.81/10.00) in MSc with two awards and studied Agricultural Biotechnology. Having a Bachelor’s degree in Agriculture and trained in National Academy of Agricultural Research Management (NAARM) as an ARS (ICAR) scientist, he blends very well with recent approaches on plant molecular biology. His research interest includes, plant diversity, metabolic engineering in medicinal and aromatic plants and bioprospection for human health.

The genome of holy basil, assembled de novo in this study, presents the smallest nuclear genome in the family Lamiaceae (386 Mb) and smallest chroloplast genome in the order Lamiales (142,245 bp). A total of 107,785 contigs were assembled into 22,776 scaffolds and finally super-scaffolding after gapclosing resulted in 9059 super-scaffolds. Out of 85,723 protein coding loci from a total of 53,480 got annotated, but only 22,270 protein coding genes were found to be

unique and the rest are of unknown function. 136 proteins were identified as homologous to five important plant genomes with 142,601 simple sequence repeats (SSRs) predicted, with the highest being mono-repeats. The pathway analysis indicated an abundance of phenylpropanoids while phylogenetic analysis for chloroplast proteome placed Salvia miltiorrhiza as the nearest neighbour.

Although, both these plants predominantly produce phenylpropanoids, and both have the identical diploid number of chromosomes (2n = 16), the genome size of O. sanctum (386 Mb) is a little more than half of the genome size of S. miltiorrhiza indicating that O. sanctum genome is more compact than that of S. miltiorrhiza.

The availability of the genome sequence now opens the possibility to identify genes involved in producing therapeutic molecules and to produce them in vitro. This will also facilitate identification of not yet identified genes involved in the synthesis of important secondary metabolites in this plant.

Elaborates Shasany, “The presence of large number of homologs of certain protein coding genes in genome indicates the possibility of finding newer biomolecules having potential bioactivity not implicated so far. The genomic information generated in this investigation not only is an important resource for evolutionary studies but will also catalyse modern genetic research by

ACHIEVEMENTS ◗ Total publications: 117 (International: 60); Citations: 1730 (Google Scholar) ◗ Cumulative Impact factor: More than 164.28 ◗ Granted US Patents: 50 (DNA sequences 3, Plants 22, 10 processes, 15 compositions). ◗ Variety Development: 38 (Most of the plants are now cultivated by the farmers). ◗ Involved in 30 projects from which led 16 projects as Principal Investigator/Co-PI. Principal Investigator for major CSIR project NWP 008 (11th Plan, System biology), BSC0203 (12th Plan,Aroma Genomics). ◗ Now leading the major project ChemBio of CSIRCIMAP

augmenting the data available for plant comparative genomics, thus accelerating identification of important secondary metabolite-synthesising genes, not identified yet from this medicinal and aromatic plant.

“Specific pathway related genes identified or mined in this genome could be used for the production of secondary metabolites following synthetic biology approaches, as well as genetic markers developed

‘PATENTS NEED NOVELTY, NON OBVIOUSNESS AND COMMERCIAL UTILITY’

AWARDS

The patent of turmeric to US got annulled and appeared as a headline in the a daily newspaper, dated January 28, 2013 that “India foils US firm bid to patent turmeric”.This was possible with the help of The Traditional Knowledge Digital Library (TKDL), a unit of Council of Scientific & Industrial Research (CSIR) which is repository of prior submitted art evidences in the DR AK SHASANY form of references in books from 18th century to the 20th century citing Principal Senior Scientist evidences that turmeric, apple, basil, kalamegha and licorice have been used alone or in combination with a few other ingredients for the treatment Biotechnology Division, CIMAP of inflammation, psoriasis, gastritis and as anti-inflammatory in the Indian systems of medicine. Patents need novelty, non obviousness and commercial utility. I wonder how the composition of re-blend of two known compounds of turmeric reported by Kerala-based company got that patent approved as it again was based on the medicinal properties that already are well known in Indian traditional knowledge. I’m also aware of the patent granted to the Avesthagen was revoked in 2012 by the Indian Government against the composition for treatment of diabetes.The composition consisted of jamun, lavangpatti and chandan came under attack in view of public interest under section 66 of the Patent Act, 1970 and also because the patent infringed upon the TKDL of India. Considering these examples, I feel that there should be stringent laws and learned patent experts to keep a check on those who defy the patent laws.We already have a US patent for the variety‘CIM-AYU’which was used for the whole genome sequencing. Genome sequence cannot be patented as such, but can be used by all to validate the properties of tulsi. Hence, the revered plant of our country will reach more populations of the world.

based on these genome sequences for studies involving genetic map construction, positional cloning, strain identification and markerassisted selection. These molecular tools and genomic resources will accelerate molecular breeding and ultimately holy basil’s utility in medical community”, he adds.

The draft National Health Policy 2015 suggests greater integration of AYUSH with modern medicine, a type of ‘cross-

pathy’ that the Indian Medical Association has strongly opposed. Recently, it has also been suggested that traditional medicine needs to be more evidence based in order to reaffirm its effectiveness. “As allopathy emerged, it stole all the attention from all other medical treatments as it gave fast results. Everyone wants to have a faster recovery from their ailments. However, as people get aware of the side effects and the long term effects

of allopathic treatments, they are again towards the traditional medical treatments. Our age-old medicinal system developed on the basis of practice and experience. But, today for better acceptability of this medicine all over the world, we need scientific validation and more evidence to spread of these medicinal systems beyond Indian boundaries,” he stresses.

◗ Dr Kumud Chandra Bora Memorial award for securing highest Overall Grade Point Average in M.Sc. (Agcultural Biotechnology) ◗ Prof Deveswar Pathak Memorial award, for securing highest Overall Grade Point Average in M.Sc. (Agriculture) ◗ IARI Merit medal for outstanding Academic performance during Ph.D Molecular Biology and Biotechnology (1996) ◗ CSIR Technology prize for Biological sciences and Technology (1999), for development of early maturing disease and pest resistant menthol mint ◗ CSIR-Technology Awards 2012 for Biological sciences, Development and commercialisation of antimalarial drug plant Artemisia annua technology package facilitating industrial growth, societal health and rural prosperity ◗ CSIR young scientist award in biological sciences (2000) for research on mint ◗ Prof Umakant Sinha Memorial award (Indian Science Congress Association) 2003, for genome analysis and IPR protection

shalini.g@expressindia.com

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EXPRESS PHARMA

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June 16-30, 2015

RESEARCH RESEARCH UPDATE

Statins not causing memory problems: Study Statins are one of the most commonly prescribed drugs PEOPLE ARE more likely to report short-term memory loss after starting cholesterollowering drugs known as statins, but the finding probably has nothing to do with the medications, a new study suggests. "It’s a completely false alarm that doesn’t look like it’s real and shouldn’t enter into the equation of whether or not someone should take their statins," said Dr Brian Strom of Rutgers University in Newark, New Jersey. Previous reports and studies suggested memory problems may be tied to statins, which are a popular

class of cholesterol-lowering medications, Strom and his colleagues write in JAMA Internal Medicine. Statins are one of the most commonly prescribed drugs. They lower LDL or "bad" cholesterol, and ultimately prevent cardiovascular problems like heart attacks and strokes. For the new study, the researchers used 1987-2013 medical record data from the UK on more than 482,500 people not taking any drugs to lower their cholesterol, a similar number of people who were taking statins and nearly 26,500 people who

were taking other types of cholesterol-lowering medications.

The researchers checked the records to see whether people in the study had told their doctors about short-term memory loss.

Overall, 0.08 per cent of statin users had some sort of memory problem noted in their medical record within 30 days after starting statins, compared to 0.02 per cent of those not taking cholesterol-lowering medications. But when the researchers compared people taking other kinds of cholesterol-lowering medications to

those not taking any such drugs at all, they found a similar pattern. "When you look at the two together" - statins and other cholesterol medications "you see no difference." The

researchers believe the increase in short-term memory problems is probably related to what's known as a detection bias.

Reuters Health

No heart, other safety risks seen with Sanofi diabetes drug: Study The results were presented at the American Diabetes Association meeting in Boston A LARGE study demonstrated the heart safety of Sanofi's injectable type 2 diabetes drug lixisenatide and appears to rule out other potential health hazards as well, according to data presented at a medical meeting.

The results pave the way for the French drugmaker to file for US approval of the medicine, which it said it plans to do in the third quarter of this year.

Lixisenatide is sold in Europe under the brand name Lyxumia.

Sanofi withdrew its original US application in 2013, deciding to wait for final results of the study called Elixa to prove it does not increase serious heart problems

36 EXPRESS PHARMA June 16-30, 2015

in diabetes patients. Sanofi, under new Chief Executive Olivier Brandicourt, has been working to expand its diabetes portfolio beyond its top-selling Lantus insulin product. Chris Viehbacher lost the CEO job last year in part due to flagging US Lantus sales.

In the study of 6,000 highrisk heart patients, most of whom had had a previous heart attack, adding lixisenatide to other standard diabetes treatments did not increase major adverse heart events any more than adding a placebo. The study tested the rate of cardiovascular death, non-fatal heart attacks, non-fatal strokes and

Lixisenatide, a GLP-1 receptor agonist, mimics a naturally occurring hormone that stimulates insulin secretion

hospitalisation for unstable angina. After just over two years, 13.4 per cent of lixisenatide patients had experienced one of the major adverse events versus a nearly identical 13.2 per cent in the placebo group.

Researchers also looked for other safety concerns that have been raised in the past with other diabetes medicines. They found no increase in acute pancreatitis, pancreatic cancer or hospitalisations for heart failure.

"That was the first thing we looked for and it seems absolutely clean," Rachele Berria, head of Sanofi's US diabetes medical unit, said of the lack of a

heart failure issue. "And the risk of hypoglycemia is just not there," she added, referring to potentially dangerously low blood sugar.

The results were presented at the American Diabetes Association meeting in Boston. Lixisenatide, which is injected once daily to control blood sugar levels, belongs to a class of diabetes drugs called GLP-1 receptor agonists that mimic a naturally occurring hormone that stimulates insulin secretion. Elixa was the first major heart safety study for a medicine from this class, Sanofi said.

Reuters

RESEARCH

Amgen's Repatha effective; question is for which patients: FDA The safety database submitted by Amgen was adequate but long-term data was limited AMGEN'S EXPERIMENTAL drug Repatha lowered cholesterol in clinical trials and did not cause a marked disparity in deaths or serious adverse events but showed potential safety issues that should be explored, according to a preliminary review by the US Food and Drug Administration.

The review was published on the FDA's website before a meeting of outside advisers to the agency who will discuss the drug and recommend whether it should be approved. Repatha, also known as evolocumab, is designed to be given in biweekly doses of 140 mg or a monthly dose of 420 mg, along with statins, another type of cholesterol drug, or to patients unable to tolerate statin therapy.

The safety database submitted by Amgen was adequate but long-term data was limited, the FDA reviewer, Dr Eileen Craig, found. A 52-week trial enrolled many patients who were not at high risk of cardiovascular disease and therefore were arguably not representative of

the most appropriate patient population. Potential safety issues, including an imbalance in the number of cases of pancreatitis and serious kidney disorders and a possible increased incidence of new onset diabetes in certain patients, could be adequately addressed in the

drug's labeling and by appropriate monitoring by healthcare providers, Craig said.

She added that if approved "these issues should be thoroughly explored in on-going studies." The agency asked the panel to consider whether dosing options for the drug allow sufficient flexibility to healthcare providers to titrate dosing downwards if needed. The FDA is not obliged to follow the advice of its advisory panels but typically does so. Repatha is one of a new class of cholesterol-lowering drugs known as PCSK9 inhibitors. Another drug in the class, Praluent, made by Sanofi SA and Regeneron Pharmaceuticals will be considered by the panel.

Reuters

US FDA panel supports female libido drug with risk management plan The benefits of the drug are marginal A DRUG to treat low female sexual desire should be approved with strict measures in place to ensure patients are fully aware of its risks, an advisory panel to the US Food and Drug Administration concluded recently. Eighteen panelists voted in favor of approving the drug with a risk management program. Six voted against approval. None voted to approve the product without such a program.

The benefits of the drug are marginal, panelists said, but meaningful for some patients.

Serious side effects include the risk of fainting at unpredictable

times, accidental injury and low blood pressure.

The FDA, which has twice rejected the drug, flibanserin, is not obliged to follow the advice of its advisory panels but typically does so. The panel's recommendation follows months of lobbying by the drug's developer, privately held Sprout Pharmaceuticals, aided by a number of women's advocacy groups which accused the FDA of gender bias, a charge the agency rejects. The drug works differently from Viagra, which is used to treat erectile dysfunction and has been available since 1998. Flibanserin works

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on the brain while Viagra affects blood flow to the genitals.

Potential risk management measures suggested by the panel included requiring physicians to be certified before being allowed to prescribe the drug and requiring pharmacies to confirm the physician's certification.

Recommendations also included establishment of a patient registry and additional safety studies after the drug is on the market. Some panelists recommended a warning against the use of alcohol when taking the drug. Dozens of women spoke to the panel

about the distress caused by their low sexual desire and urged the FDA to approve the drug, whose proposed trade name is Addyi. Others characterised Sprout's lobbying campaign as an attempt to bully the FDA into approving a drug with modest benefits and real safety concerns. Some panelists said they were concerned that patients could faint while behind the wheel of car or in other circumstances that could lead to serious injury or death.

Flibanserin is a pill that must be taken daily.

Reuters

FDAstaff: Sanofi/Rege neron drug lowers LDL; is well tolerated AN EXPERIMENTAL drug made by Sanofi SA and Regeneron Pharmaceuticals effectively lowers bad LDL cholesterol and is generally well tolerated, according to a preliminary review by the US Food and Drug Administration. The review was published before a meeting of a panel of outside advisers to the FDA who will discuss the drug and recommend whether it should be approved.

The FDA is not obliged to follow the advice of its advisory panels but typically does so.

The drug, Praluent, also known as alirocumab, is one of two in a class known as PCSK9 inhibitors that will be considered by the advisory panel next week. The other, Repatha, is made by Amgen. The panel will be asked to consider whether the drug's benefit outweighs the risks in one or more patient populations, for example those with different degrees of risk for cardiovascular problems, patients with family histories of high cholesterol and high triglycerides, or patients who are or are not also taking statins, another type of cholesterol drug. In an introductory memo to panel participants, Dr James Smith, deputy director of the FDA's division of metabolism and endocrinology products, noted that for two decades the agency has used a reduction in LDL as a surrogate for a reduced risk of heart attacks, strokes and other cardiovascular events. Several statin trials have shown a cardiovascular benefit but not all LDL-lowering drugs have.

Reuters

EXPRESS PHARMA

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June 16-30, 2015

PHARMA ALLY I N T E R V I E W

'PMHLC is 100 per cent committed to ensure zero spurious supply' PM Health and Life Care (PMHLC) will soon launch an online market place which connects chemists and druggists with consumers. Hemant Bhardwaj, Co Founder and Chief Executive Officer, PMHLC, reveals more to Sachin Jagdale Don't you think that purchasing drugs online also makes customers more vulnerable towards buying spurious drugs?

The source of medicines is the key to determine the extent of spurious drugs in the supply chain. It's immaterial whether the seller is selling online or offline. PMHLC is 100 per cent committed to ensure zero spurious supply. It will not just strive to partner only those retailers who enjoy massive trust of the consumers, but will also put in use technology and processes to ensure spurious drugs don't seep into its supply chain.

Does acquiring drugs online offers any cost benefits to the customer? Will your services be cost effective?

The three key expectations of a consumer, from a pharmacy retailer, are 1) high probability of availability of the medicines, prescribed by his doctor 2) no fake or spurious medicines and 3) quick delivery. Our marketplace will ensure that we delight him on these fronts. Having said that, we will surely have schemes that will reward our loyal customers.

If I am pushed to evaluate it from cost benefit

38 EXPRESS PHARMA June 16-30, 2015

perspective, I will say there will be huge saving for those customers who value time. An online channel enables the consumer to order anytime from where ever he is and he can receive the medicines in the quickest possible time at the time and the place he prefers. It's just that in our case, at the time of the delivery, one has to present the original prescription so that it can be stamped, as per the regulations.

What are the ways for the patient to verify whether the seller is authentic with all necessary approvals in place? Have you made any special arrangements in this regards for your customers?

Ours will be a 'managed market place'. Only those retailers, who commit to remain fully compliant with our government regulations and our terms and conditions, will be signed up to be part of our network. In addition, we will do surprise checks. If we will find any of our partners, flouting any norm or rules, they will no more remain part of our network. And I am sure they would not like to lose such voluminous business.

The convenience of buying

medicines online will not replace the direct interaction between patient and the doctor. What do you think? Will doctors also be the part of your business?

I don't see why one should try and replace the direct interaction between the patient and the doctor. We strongly believe that the role of a chemists and druggists is to dispense medicines as prescribed by a registered medical practitioner. That's why we won't allow any kind of substitution of medicines, on our platform.

We will launch our services in Q3 of 2015, and plan to cover 100 cities, within a span of two years

In which parts of the country you are going to launch your services and when?

We will launch our services in Q3 of 2015, and plan to cover 100 cities, within a span of two years.

Do you think that in future online drug stores will pose major competition for retail drug stores?

Pharma retailing market, in India, is going to become US $ 56 billion by 2012. It will offer enough opportunity for every player, big or small, online or offline. Moreover, PMHLC plans to target only those consumers who prefer to buy products and services

online.

Online pharmacies is still not that popular concept in India. Still you see the business potential here?

Currently 40 million Indians are shopping online.

Soon this tribe is going to cross 100 million mark. If retailers in other categories are benefiting from this new channel, why should pharma retailers get left behind?

PMHLC's endeavour will be to build a technology platform that is compliant with the law of the land, so that both consumers and providers transact without any hassle.

What is going to be your growth model over the next few years?

Our long term goal is to build a 'health exchange'. The health exchange will meet the latent need of the consumers, pharmacies, clinics, hospitals, home care services, emergency services, diagnostic centres and doctors, to make quality healthcare accessible and efficient to a large population.

Our online managed marketplace for chemists and druggists is the first step in that direction. sachin.jagdale@expressindia.com

PHARMA ALLY I N T E R V I E W

'The solution combines work-flow tools with real-time information and analysis' After successfully launching ONESOURCE Global Trade solution in various countries, Thomson Reuters has recently introduced it to the Indian market as well. Taneli Ruda, Senior Vice President and Managing Director, Global Trade Management, Tax & Accounting business and Prashant Pillai, Country Head, Tax and Accounting business, Thomson Reuters, South Asia share more details about the product's features and its advantages to pharma firms, in an interaction with Usha Sharma

Thomson Reuters recently launched ONESOURCE in India. What is the USP of the product and how has its performance been in the Indian market?

Taneli Ruda: Thomson Reuters ONESOURCE global trade is the world’s first truly global trade automation and management solution. We recently launched the product in India to help corporations to efficiently manage trade compliance and supply chains in new and existing markets by combining trade information with technology tools. This solution enables multinational corporations to tie together key supply chain information to gain complete visibility of their end-to-end global trade process — reducing risk, maintaining regulatory compliance, enabling quick and accurate movement, and maximising profit.

Recently, the Ministry of Commerce, Government of India announced the New Foreign Trade Policy 20152020. It has several modifications/amendments.

Does your product follow the

recommendations? Based upon regulatory requirements, how quick can the solution be updated?

Prashant Pillai: The new Foreign Trade Policy aims to increase India’s share in world’s exports from two per cent to 3.5 per cent and achieve export revenue of $900 billion by 2020.

The new policy has emphasised several measures for strong egovernance and ease of doing business, to name a few: ◗ Several initiatives in moving towards paperless environment, ◗ Self certification to avail preferential duty under FTA/PTA ◗ Facility to upload documents in importer/exporter profile ◗ Opening the DGFT website for interface, to start with Import Export Code (IEC) application as first project All these measures require organisations to embrace technology. Organisations requires a solution to automate processes, which can also help them to be up-to-date with the changes in the regulatory environment.

Thomson Reuters ONESOURCE global trade has

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Our product comes with a rich set of ‘out-ofthe-box’ functionality TANELI RUDA Senior Vice President & Managing Director, Global Trade Management, Tax & Accounting business

a dedicated team of trade experts to monitor the changes from a regulatory perspective and make necessary upgrades in the solution to help organisations be compliant.

The solution combines workflow tools with real-time information and analysis.

ONESOURCE global trade solution offering is through the cloud, which enables us to update these changes promptly, without much of an effort required for the organisations to maintain. With work-flow management tools, the system facilitates information exchange between a corporation’s trade team and their logistics, compliance, finance, and strategic planning departments. It also connects trade teams with external partners responsible for managing a complex global supply chain, including customs brokers, freight forwarders, customs, shippers, regulators, and banks.

The product is already available in Brazil, Argentina and Mexico. What is it success story in those markets. What are your

expectations from the Indian market?

Taneli Ruda: ONESOURCE global trade was initially launched in Brazil and expanded into other parts of Latin America (LATAM). We have more than 1,200 customers, including 350 multinational corporations across various industries, including pharma. Over the past few months, we have held discussions with a large number of companies operating in India across a variety of industries, and it has become apparent that Indian companies sorely need a global trade automation system which is deeply localised for the Indian market. I believe our product can become an instrument to support Indian companies as they increasingly reach for global markets.

The company is targeting pharma companies who are working in line with the 'Make in India' campaign.

What is the rationale behind this and how will it boost their plans?

Prashant Pillai: Prime Minister Narendra Modi

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June 16-30, 2015

PHARMA ALLY launched ‘Make in India’, which focuses on making India a global manufacturing hub and we are a key player in the global pharma market. Pharma companies operate in a complex and stringent regulatory environment. In order to meet the compliance requirements, pharma companies that import and export have to maintain strong process controls to monitor the batches, licensing requirements for importing and exporting of certain items, planning and keeping track of all shipments to monitor the shelf life of drugs imported and exported to meet the needs, etc.

With all the complexity in meeting the compliance needs, organisations are intended to make use of all export and import benefits provided by the government such as Chapter 3 schemes, duty drawback, export benefit licenses etc.

Thomson Reuters ONESOURCE global trade solution helps multinational companies cope with the increasing complexity of global trade and automate the trade compliance process by providing an end-to-end solution with global best practices and domestic capabilities. Of the list of our customers, we serve large multinational pharma companies in international trade space. The solution helps pharma companies manage compliance more efficiently and reduce the risk. This also

40 EXPRESS PHARMA June 16-30, 2015

results in increasing the bottom-line by making use of several benefits/incentives given by the government.

Which other markets have you have identified for the launch and why? By when will you be launching in these markets?

Taneli Ruda: The solution has been localised for Brazil, Argentina, Mexico, Chile, China and India. In 2015, Thomson Reuters will launch ONESOURCE global trade in the US, Japan, Korea, Colombia, Peru, Singapore, and Thailand. We are already working on a large number of product localisations targeting additional Asian countries in 2016 as well as extending our offering to Europe, Middle East, and Africa. Our goal is to keep expanding our offering's footprint to over 50 countries by the end of the decade so that globally operating companies can cover their entire supply chain with one automated solution worldwide.

Is it a cost-effective solution?

And what additional features do you offer to your clients?

Taneli Ruda: Processes that slow down trade operations may result in lost time, work stoppages, and reduced margins. Additionally, if a good is misclassified or a declaration improperly passed to a broker, the result may be increased fees, taxes, and tariffs, or revoked export

The solution helps pharma companies manage compliance more efficiently and reduce the risk PRASHANT PILLAI Country Head, Tax and Accounting business, Thomson Reuters, South Asia

licenses. Making matters more difficult, many corporations rely upon disparate internal information programmes to manage the growing complexity of global trade.

Thomson Reuters ONESOURCE global trade solution combines work-flow tools with real-time information and analysis. With work-flow management tools, the system facilitates information exchange between a corporation’s trade team and their logistics, compliance, finance, and strategic planning departments. It also connects trade teams with external partners responsible for managing a complex global supply chain, including customs brokers, freight forwarders, customs, shippers, regulators, and banks.

The product has functionalities such as landed cost analysis to analyse the cost of movement including compliance and logistics cost. It has several other functionalities such as Free Trade Agreement (FTA), export benefit license tracking, which helps organisations not just be compliant but also to improve the bottom line.

Do you customise the product based on clients' requirements?

Taneli Ruda: Our product comes with a rich set of “out of the box” functionality, which reduces the need for customisations. Our solution is

readily localised for each country – including India – with content and workflows that correspond to the local regulations, and is kept up-todate by our trade experts. In addition, many customers choose to customise our solution for their specific processes and work-flows, including integration with legacy IT systems, creating custom reports, and supporting company-specific approval processes. Majority of such customisations can be done with lightweight configuration changes, which are a standard part of our implementation process. We also support deeper customisations for customers who need more comprehensive custom functionality.

What are the company's corporate plans for the next two years?

Taneli Ruda: We are on track to launch localisations of our product in about 10 countries per year in the foreseeable future in an effort to serve our customers with the first truly global trade automation solution. We are also working on adding various new exciting capabilities to our suite, including automated HS classification engine, integration with indirect tax and transfer pricing workflows, and various machine learning and analytics features. u.sharma@expressindia.com

PHARMA ALLY INSIGHT

Extractables and leachables quality and risk studies

DIANE PASKIET, Director, Scientific Affairs, West Pharmaceutical Services

Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services, elaborates on the key quality considerations when designing drug product compatibility studies THERE ARE multiple types of components to be considered throughout the manufacture, storage and delivery to patients. Primary classes of materials used to manufacture and store drugs and biologics include elastomers, plastics, glass, metal and paper board components. These components must be compatible with the final product and function properly for intended use as well as provide protection over the drug’s shelf life.

Extractable substances from packaging components have the potential to leach into a pharmaceutical products at any point in the supply chain and throughout the product’s lifecycle. Constituents that migrate from primary packaging into the final product when manufactured and stored under its normal conditions are referred as leachables.

A pharma product can be affected by chemical substances migrating from material into final product with distinct outcomes. The leached substance can be toxic, affect the product stability or react with active pharma ingredients or excipients to form a new chemical entity. Patient risk needs to be assessed and mitigated based on understanding potential for leaching.

This is accomplished by designing systematic studies to identify and quantitate extractable substances.

An extractable and leachable strategy consists of multiple steps in which voluminous information is acquired and builds until final drug product stability studies are completed.

This can span a period of five years or more from discovery to confirmation.

The goal of an extractable study is to provide evidence that materials are suitable for intended use by understanding how risk for leaching correlates to patient harm and eliminating or mitigating that risk Why invest that many resources in such deep research?

Materials that have direct or indirect contact with a drug or biologic product can leach harmful substances into the final pharma product. Identifying and communicating risks that can be correlated to drug/biologic safety and quality ultimately benefit the patients who will use the drugs contained within a product.

Extractable and leachable (E&L) studies should be designed so the various components evaluated are commensurate with the level of risk to final product quality and safety.

Criticality should be justified based on the likelihood of component interaction with the drug or biologic product during manufacture, storage or when in contact with a patient.

Risk variables to consider and acceptance limits ◗ E&L risk can be affected by several factors, including: ◗ Component proximity to the final product ◗ Area of direct contact ◗ Dosage form ◗ Conditions of use throughout material processing, manufacturing, filling and storing Risk for leachables can be indicated based on identifying those extractable compounds

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with the highest propensity to leach into final product. The extraction and analysis methods should be aggressive enough to reveal the chemical nature of the materials but not so harsh to create anomalies.

Not are extractables will be leachables and targeted studies in actual drug product based on real time stability will ensure potential leachable levels are below quality and safety concerns. This allows risks to safety or poor quality to be identified and mitigated.

It is not practical to assume a standard method or even suite of methods can provide all the essential evidence.

Nonetheless, a standard strategy has been conceived by the Product Quality Research Institute (PQRI). In 2006, Recommendations for Safety Thresholds and best demonstrated practices for L&E in Orally Inhaled and Nasal Drug Products (OINDP) was published (www.pqri.org). This is currently being extrapolated for parenteral and ophthalmic drug products (PODP). Recent USP guidelines <1663> Assessment of extractables ass ociated with pharma packaging and delivery systems; and <1664> assessment of leachables associated with pharma packaging and delivery sys-

tems were also published in USP PF 39 in September 2013 and are consistent with PQRI approaches.

Typically, leachable compounds are found in trace amounts yet can have a negative impact on pharma quality with potential to compromise patient safety. Any component used during manufacture, storage, shipping and administration to the patient can be implicated as a source of leachables.

Once risks are established, it’s important to understand how much of a risk they pose, and what’s an acceptable limit of risk for the drug product contained within a delivery system. There are limits in various compendia for certain materials used in pharma and medical device industries; however, these limits are considered a starting point to identify materials that might be acceptable.

To set acceptance criteria for extractables and/or leachables, relevant data must be collected and assessed. It is important to justify specifications based on impact to final product and patient. Control points can be considered early on, but the nature of leaching often occurs over time. Variability will exist from component to component as well as the extracta-

bles’ propensity to leach.

Control points are not easily derived until there are multiple lots of components representing full shelf-life stability studies. Once an analytical target profile (ATP) is established for leachables methods should be optimised and measurements fully validated. Statistically relevant data is necessary to establish acceptance criteria.

The final drug or biologic product will influence appropriate specifications and acceptance criteria. ICH guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances, New Drug Products (Q6A); Biological Products (Q6B guidance establishes the criteria to which a drug and biologic product should conform to be considered acceptable for its intended use.

There is a provision for control of extractables from container/closure systems in which parenteral products are considered significantly important.

The guidance indicates that where development and stability data show evidence that extractables are consistently below levels demonstrated to be acceptable and safe, the elimination of this test can be accepted but should be reinvestigated if the container/closure system or formulation changes.

The guidance also recommends collecting data for components as early in the development process as possible.

This is consistent with quality guidelines on pharma Development (ICHQ8 (r2), Risk Management (ICHQ9) and Pharmaceutical Quality Systems (ICH Q10).

Continued on Page 43

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PHARMA ALLY

Maximising solvent removal efficiency Solvent drying process errors can have significant upstream and downstream repercussions; magnetic sector mass spectroscopy offers the precision to help avoid them.

Graham Lewis, Technical Consultant, Thermo Fisher Scientific Environmental and Process Monitoring explains in detail

SOLVENT REMOVAL is a key stage in many pharmaceutical processes. It commonly occurs through a drying process, in which the solvent evaporates from the product in a process vessel such as a vacuum, tray or rotary drier. Historically, labs confirmed successful solvent removal by testing a sample at the end of the process. The test, known as loss on drying (LOD), measured the amount of residual solvent in the sample, and a failing result meant that the lab must repeat the drying process, a costly and disruptive rework.

Solvent removal is a rate-limiting step in many pharmaceutical manufacturing processes. This means that drying errors can have consequences that affect the efficiency of the entire operation.

PAT Development To make the solvent drying process more effective and efficient, many companies have turned to process analysers â&#x20AC;&#x201D; analytical instruments that take regular readings of solvent levels while the process is occurring, rather than only at the end.

In 2004, the US Food and Drug Administration (FDA) validated this approach when it launched its process analytical technology (PAT) initiative.

Many techniques are used for analysis during the drying process. One, near-infrared (NIR) spectroscopy, is unique because it uses probes to sample drying materials directly.

Making physical contact with the active pharmaceutical ingredient (API) in mid-process has several drawbacks, however. First, driers with moving parts (such as paddle driers) usually must be temporarily stopped to allow the sampling probes to safely reach the sample. Probes can also become

42 EXPRESS PHARMA June 16-30, 2015

coated with the API over time, causing them to lose accuracy.

Finally, NIR sampling probes only measure the dryness of the small percentage of the total sample they physically touch; though data from several probes can be aggregated to give a reasonable estimate of the total residual solvent in a sample, such an estimate can never be entirely accurate.

Another analysis technique used for solvent drying processes is gas analysis mass spectrometry (MS), which offers several benefits as compared to NIR spectroscopy. Instead of using sampling probes to measure the residual solvent in the API, MS systems sample the headspace above the drying material and measure the concentration of solvent evaporation byproducts. This is a significant improvement over NIR for several reasons. First, MS analysis is non-contact and, therefore, it does not require any interruptions in the drying process for sampling. Second, MS systems are not affected by heterogeneity in the drying product because they sample gases escaping from the API (and not the API itself, as NIR systems do). Lastly, because process mass spectrometers use non-contact sampling, it allows them to analyze gas continuously, which lets laboratory technicians save time and money by identifying the exact moment when the desired solvent concentration has been reached.

Gas analysis mass spectrometers are a significant improvement over NIR solutions, but they are prone to problems of their own â&#x20AC;&#x201C; particularly early models based on quadrupole analysers. These instruments were notoriously susceptible to contamination by headspace

sitivity, minimising background interference and maximising contamination resistance.

Figure 1 shows a schematic of the magnetic sector contained within the Thermo Scientific Prima PRO process mass spectrometer analyser. The broad flat-topped peaks that characterise this technique are optimised for long-term stability. Magnetic sector mass spectrometers have a proven track record of monitoring high percent-level concentrations of organic compounds without experiencing drift or contamination.

Vacuum drying sampling

gases, especially gaseous hydrocarbons. Over time, this contamination causes analyser drift that eventually requires the instrument to be taken offline for cleaning.

The problems with quadrupole-based analysers have largely been addressed by magnetic sector mass spectrometry.

Magnetic sector MS offers several advantages over quadrupole MS, including resistance to contamination, longer intervals between calibrations and improved precision and accuracy.

Depending on the complexity of the gas mixture being analysed,

magnetic sector MS offers analytical precision between two and 10 times better than that of a quadrupole analyser.

Beyond the inherent value of the technology, several design improvements can increase the performance of a magnetic sector MS system even further.

Systems with laminated magnets, for example, can scan at speeds equal to those of quadrupole analysers, offering both rapid analysis and the low maintenance previously mentioned.

Enclosed ion sources can also improve magnetic sector MS performance by increasing sen-

The fact that magnetic sector MS analysers operate at high vacuum makes them ideal for monitoring vacuum drying processes, but this is only true if technicians follow procedures correctly. It is vitally important that the pressure in the MS remains constant as the process pressure falls down to the vacuum levels required to dry the product. Poor control can cause the MS signals to rise and fall with sample pressure, which makes the collected data inaccurate.

Early magnetic sector MS vacuum drying systems struggled with this, especially when the vacuum process was complex. Many used only a single control valve â&#x20AC;&#x201D; typically a voltage sensitive orifice (VSO) valve linked to a gauge monitoring the sample pressure. This worked well for simple processes: the VSO valve would open and close in response to sample pressure changes, keeping the pressure within the MS constant. Unfortunately, this technique suffered valve malfunctions and loss of control at pressures below 10 millibars.

This problem can be easily solved with the addition of a sec-

PHARMA ALLY ond control valve that works in opposition to the first — as one closes, the other opens. Together in a variable pressure inlet, a dual valve system allows an MS analyser to handle sample pressures as low as 0.3 mbar.

Process instruments, no matter how capable and welldesigned, are only effective when they are installed and calibrated correctly. Meeting the demanding standards of the pharma industry requires particularly rigorous testing. For MS systems, this testing is typically carried out at the production facility by connecting the new MS to the pharma company’s vacuum dryers. Testing on the production line obviously has a negative effect on throughput, which in turn can cause the testing process to be rushed.

The end result includes inadequate testing, post-installation problems and damaged prod-

ucts. Understandably, going through this process has caused many pharma companies to lose confidence in MS systems.

To solve this problem, many producers of process magnetic sector MS analysers are applying a widely used concept in the

pharma industry: quality by design (QbD). Instead of testing the quality and capabilities of an MS system post-installation, as is traditional, producers ensure quality pre-installation by improving analyser designs and performing more rigorous

offsite testing.

Testing designs in-house — rather than on customer product lines — allows manufacturers to test MS designs over a much wider range of sample pressures, solvent combinations and solvent concentrations. Difficult challenges that push the limits of a magnetic sector MS — for example, switching between a dryer at the start of its drying run with high pressure and solvent concentrations and another reaching the end of its drying run, with opposite conditions — are much easier to test at a solvent drying test facility than on an actual pharmaceutical production line.

Offsite testing also allows engineers to change the design of an instrument, if necessary, based on observations from testing. Using a practical process improvement (PPI) approach, engineers can use test

facility data to further ensure that quality is designed into the instrument. Most important, a combined QbD/PPI methodology helps ensure that finished magnetic sector MS analysers can be installed in production lines with minimal process interruption.

Because they are rate-limiting, errors in solvent drying processes can have significant upstream and downstream repercussions for pharma production processes. Magnetic sector MS improves efficiency of the solvent drying process because it does not interrupt the drying process and is not affected by heterogeneity in the drying sample, as is true of LOD and NIR testing. Magnetic sector MS instruments are also several times more precise than quadrupole analysers and require significantly less maintenance.

In certain applications, it can be an advantage to simulate or mimic final product under exaggerated conditions to define targets better. The purpose of an extractable study is to provide comprehensive data to indicate risk for leaching and guide a leachables assessment.

Methods need to be optimised to measure and trace leachables that are easily masked and difficult to detect in a complex matrix. Spiking and recovery studies are necessary to confirm the presence or absence of target compounds. Correlation of the component extractables with confirmed leachables under worst-case conditions will lead to the necessary control strategy.

enough to indicate the basic chemical ingredients and byproducts of the material; however, this is not often indicative of actual leachables.

A wide range of sophisticated analytical technologies can be employed for extractable and leachable testing.

While all-purpose methods can be a starting point, these will not address distinct applications. Pertinent information is acquired by understanding the materials and intended use to enable specific extraction and analytical methodology to be justified.

Upcoming advances may be a combination of improving technologies for identifying / qualifying leachables along with development of new materials that are engineered to fit a purpose in a quality by design (QbD) paradigm. Accurate and precise analytical measurements will be the means to enable the future of applying the right knowledge – at the right time – to materials used in the manufacture, containment and delivery of highquality pharma products.

Continued from Page 41

Extractables and Leachables...

Acquiring appropriate evidence to demonstrate suitability of materials is necessary for each pharma product. Extractables are a function of the material chemical make-up, physicochemical properties, configuration of the delivery systems, various environments and length of exposure.

Safety as it relates to component profiles Component profiles have many levels of complexity, which may become more varied once the component is formed, washed, sterilised and assembled. Common sources of extractables include residuals and by-products from the material.

Processing aids and additives such as stabilisers, antioxidants, lubricants, curatives and their breakdown products are all examples of species contributing to the chemical profile. An extractable study will establish the chemical profile, which reflects risks relative to potential safety and incompatibility issues.

Safety will depend on the

leachable concentration in the final product and patient total daily intake; incompatibility is fundamentally dependent upon the pharmaceutical matrix and conditions of use. Often compatibility issues are manifested by different end points such as pH shift, degradation, oxidation, aggregation, foreign particles and other impurities that can become evident over a period of time.

All materials will leach to some degree under certain conditions. The goal of an extractable study is to provide evidence that materials are suitable for intended use by understanding how risk for leaching correlates to patient harm and eliminating or mitigating that risk.

Once the components are deemed critical for evaluation, the chemical make-up of each material should be understood.

This will feed into the component sampling, preparation of extracts and analysis techniques. Multiple solvents that encompass organic as well as aqueous solutions should be em-

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Acquiring appropriate evidence to demonstrate suitability of materials is necessary for each pharma product ployed to explore a comprehensive chemical profile. Multiple analytical techniques and those that are orthogonal should detect a wide range of extractable species with various sensitivities. Analytical methods should be robust and fit for purpose; that is, having a system capable of detecting certain predetermined targets at specified levels as well as detecting unexpected extractables.

E&L testing technologies evolving, improving Understanding a material’s chemical profile is necessary to enable detection of leachables. The chemical characterisation of a component should include extraction solvents and conditions that are aggressive

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PHARMA ALLY VENDOR NEWS

ACG Pharmapack’s anti-fog Film,NoMist,wins World Packaging Organization’s WorldStar 2015 Award The film, which is specially-designed for pharma diagnostics instruments and food diagnostic test kits, won the award in the pharma & medical category at a ceremony held in Milan, Italy ACG PHARMAPACK has received the prestigious WorldStar 2015 Award from World Packaging Organisation for its innovative product, NoMist. An anti-fog packaging film, NoMist bagged the Award in the pharma & medical category, after having won the IndiaStar (organised by the Indian Institute of Packaging) and AsiaStar (organised by the Asian Packaging Federation) awards. The award ceremony was held in Milan, Italy.

The judging took place on November 19, 2014 when representatives from 17 packaging associations and members of World Packaging Organisation, judged 265 packaging projects, from 37 countries, that applied for WorldStar Awards 2015. Companies from 37 countries entered 264 packaging projects in the international competition.

NoMist combines the barrier features of traditional pharma and medical diagnos-

ACG Pharmapack’s NoMist has also won the IndiaStar and AsiaStar awards

tic packaging films with specially designed anti-fog properties. This technology has been especially designed for pharma diagnostic instruments and food diagnostic test kits where the chances of fogging on the packaging are high, and where in addition to barrier against moisture and or oxygen, see-through clarity is required for detection of sensitive parameters. The parameters could be drug efficacy levels, PH levels, protein

levels, etc. It can also be customised for packaging of refrigerated or microwaveable food product where fog or mist builds up on the inside of the packaging material.

In 2013, too, ACG Pharmapack won the IndiaStar, AsiaStar and WorldStar Awards for its innovative product Alukbliss (a packaging film identical to Cold Form Blister (CFB) foils in appearance yet with the barrier of PVC.) EP News Bureau-Mumbai

Contact details Raj Kiran .CH Marketing Communication Associate Phenomenex India Laxmi Cyber City, Ground Floor B Block, Survey no: 10

Kondapur, Hyderabad 500 084 India Tel: 040-3012 2400 Fax: 040-3012 2411 Email: RajK@phenomenex.com Website: http://www.phenomenex.com

PRODUCTS

Phenomenex enhances Kinetex core-shell family PHENOMENEX HAS launched 2.6μm and 1.7μm EVO C18 particle sizes, expanding the company’s Kinetex core-shell column family. The Kinetex EVO C18 columns provide a unique C18 selectivity offering excellent peak shape for bases, 100 per cent aqueous stability and rugged pH stability from 1 to 12 by incorporating a patented organo-silica grafting process that utilises uniform stabilising ethane cross-linking.

Kinetex EVO C18 delivers the performance advantages of Core-Shell Technology at low, neutral and high pH ranges, making it an excellent addition to any lab’s current reversed phase column portfolio.

44 EXPRESS PHARMA June 16-30, 2015

The new, smaller particle sizes extend the versatility and scalability of this media, which was introduced initially in 5μm particles for HPLC and preparative HPLC work. Overall, Kinetex EVO C18 columns are suitable for virtually every industry that relies on chromatography, including pharmaceutical drug discovery and development, clinical research, forensic toxicology, food safety and quality and environmental analysis.

The rugged EVO C18 columns are an extension of the Phenomenex Kinetex coreshell line, which delivers improved results, increased productivity, easy transferability

and significant cost savings compared to traditional HPLC/UHPLC media. The new 2.6μm EVO C18 columns offer performance comparable to sub-2μm fully porous particles on both standard LC and UHPLC systems, but at lower backpressures. The new 1.7μm particle size is designed for use with UHPLC systems and delivers on average 20 per cent greater efficiencies than fully porous media. Both of these new particle sizes are directly scalable to each other and to the existing 5μm size, making method transfer between UHPLC, HPLC and preparative HPLC techniques straightforward.

PHARMA ALLY

High purity water generation and distribution system RO-EDIsystem ◗ Hot water sanitisation. ◗ Complete pure water generation on one skid. ◗Fully pre-validated to FAT Compliance with latest USP and Ph European Specification. ◗Compliance with CGMP/ CGAMP and ISPE design Standards. ◗Fully automated with SCADA.

Automatic demineralisation plant ◗Instantaneous flow rate up to 20 m3/hr ◗Conductivity less than 1μs/cm with low running cost ◗Automatic PLC Control with continuous display readout of system status. ◗ Short cycle (4 hours), rapid regeneration (35 mins) ◗High chemical efficiency, smaller foot print and higher flow rates than conventional plants. ◗Near neutral effluent reduce disposal cost.

PURE WATER QUALITY COMPARES WITH USP REQUIREMENTS EP

USP

TOC

Ppb

< 500

< 500

Conductivity

@20°C (μs/m2)

< 4.3

< 1.3

Nitrate

ppm

< 0.2

-

Heavy Metal

Ppm as Pb

< 0.1

-

Microbial contamination

CFU/ml

< 100

< 100

Tube cutters from Germany, TIG Argon welding machine from Italy and all other tools and tackles. ◗Boroscopy done by NDT qualified inspectors. ◗Complete installation is done as per ISPE guidelines. ◗Proper slope measurements done to ensure 100 per cent drainability ◗ Complete site as built isometric is done mentioning TAG No, Weld No andBoroscopy joint details.

RO-EDI system

Infrastructure : Piping and distribution system ◗All pipes procured are from reputed brands and having internal finish of < 0.5 Ra. These are lesser welded pipes. ◗Pipe fittings are procured from same manufacturer wherein they are made from parent pipes. ◗Pumps are of sanitary design and of reputed brand with all documentation. ◗Complete PLC based panel provided with instrumentation provided to measure all critical parameters. ◗Tanks are manufactured at state of an art facility wherein only SS fabrication is done and automised mechanical polishing is done. ◗Complete site fabrication is done using world class machinery like orbital welding machines from Germany,

◗Aqua Mech putting up a world class fabrication facility to manufacture all these vessels/ equipments with completely automatic machines right from coil cutting, sheet rolling, dish making, welding, and polishing to the inspection and then dispatch. ◗ Site fabrication like orbital welding from Germany , TIG Argon welding machine from Italy, tube cutting from Germany ,all tools and tackles ◗Fabricate all types of process tanks for pharma industry. ◗Design and fabricate double tube heat exchanger(shell and tube type) from 0.2 sq.mtr to 50 sq.mtr ◗ Design and manufacture CIP/SIP system for all vessels. ◗Design and manufacture of solvent transfer system. ◗ Design and manufacture of process vessel.

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Piping and distribution system

Automatic demineralisation plant

Contact details AquaMech Engineering Corporation 186/187, Central facility Building II, APMC Market II, Phase II, Sector 19, Vashi, Navi Mumbai -400703 T : +91-22-40490800/ +91 7506344641 F : +91-22-40490825 www.aquamech.co.in

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PHARMA ALLY

Waters launches novel separations and ionisation technologies to high resolution mass spectrometry WATERS CORPORATION has introduced of new technologies and innovations for mass spectrometry, intended to give laboratories greater levels of detail for every analysis.

The introductions include the new Waters Vion IMS QTof Mass Spectrometer, a new bench-top tandem mass spectrometer featuring ion mobility and REIMS Research System with iKnife Sampling, combining direct-from-sample ionisation with high-performance time-offlight (ToF) mass spectrometry.

Waters also expanded its family of solid phase extraction products with the first-of-itskind Oasis PRiME HLB and added to its portfolio of protein separation columns with the ACQUITY UPLC Glycoprotein BEH Amide Column for glycan analysis.

Combining the benefits of high-resolution tandem mass spectrometry and ion mobility separation in a bench top instrument, the Waters Vion IMS QTof Mass Spectrometer brings clarity and confidence to routine analyses. Ion mobility removes spectral interferences and generates collision cross-section (CCS) values for every ion, giving scientists more information than they can get from traditional LC-MS experiments.

Waters intends to commence shipments of the Vion IMS QTof Mass Spectrometer in the second half of this year.

As routine analyses involve increasingly complex samples, scientists often rely on highresolution mass spectrometry.

However, increasing mass resolution alone does not always lead to better answers. By separating ions from one another based on their shape, mass and charge, ion mobility provides an additional dimension of separation.

The selectivity of ion mobility refines spectra and allows the instrument to discriminate sample ions from chromatographically co-eluting compounds and background interferences -

46 EXPRESS PHARMA June 16-30, 2015

bringing clarity to every spectrum, and enabling the confident characterisation of compounds.

The UNIFI Scientific Information System, Version 1.8, is a new release of the software with features intended to enhance laboratory productivity. Today's announcement coincides with the introduction of the Vion IMS QTof Mass Spectrometer which is the first Waters mass spectrometer to be fully supported on UNIFI. New features of this release of UNIFI software include: Support of the Vion IMS QTof MS System; native atmospheric pressure gas chromatography (APGC) control, time-offlight (Tof) multiple reaction monitoring (MRM) support, support of collision cross section (CCS) data, and Tof quantitative

and qualitative workflows providing a comprehensive, single software solution.

Combining direct-from-sample ionisation with high performance time-of-flight mass spectrometry and powerful, intuitive analytics, the Rapid Evaporative Ionization Mass Spectrometry (REIMS) Research System with iKnife Sampling System eliminates the need for sample preparation and chromatographic separation, providing food, microbiology and tissue researchers with near-instantaneous data acquisition.

Using Waters REIMS Research System with iKnife Sampling, researchers can quickly and easily differentiate samples from one another and confidently identify the differen-

tiating features, allowing greater insight into the chemical and biological systems under investigation. In REIMS, direct, rapid heating of the samples leads to the formation of vapour that is rich in sample-specific chemical information. The vapour is taken directly into the mass spectrometer (Xevo G2-XS QTof or SYNAPT G2-Si HDMS) where the molecules are analysed by time-of-flight mass spectrometry.

The Oasis PRiME HLB, a first-of-its-kind, next-generation solid phase extraction (SPE) product that provides cleaner samples in less time and with less effort for LC and LC-MS analyses. Oasis PRiME HLB cartridges and multiwell plates simplify and speed up extraction

protocols to ensure consistent, reproducible LC and LC-MS results. Laboratories can now process samples up to 40 per cent faster and deliver samples that are up to 70 per cent cleaner with fewer LC-MS matrix effects than samples prepared using other extraction techniques. Oasis PRiME HLB Sorbent is available immediately worldwide. The new ACQUITY UPLC Glycoprotein BEH Amide 300Ă&#x2026; 1.7-Îźm Column enables biopharmaceutical companies to better understand where glycan molecules are located within the therapeutic proteins they are developing. Identifying the precise location of glycans within a protein structure is essential to delivering safe and effective biotherapeutic proteins.

The novel, patent-pending ACQUITY UPLC BEH Amide technology, assists scientists in obtaining reproducible glycanrelated chromatographic and mass spec information at the intact protein, fragment, or peptide levels. Designed to be used with Waters ACQUITY UPLC systems, this new glycoprotein analysis column provides unprecedented resolution using MS-compatible HILIC separations. Laboratories can now resolve different glycoproteins and glycopeptides, determine where both N-linked and O-linked glycans are located within the protein, as well as better understand glycan modifications and patterns. Combining these capabilities with mass spectrometric analysis provides far greater information about glycoprotein structure than has been previously available.

Contact Dayamani Santosh, Sr Admin Officer, Waters India 36A, II Phase, Peenya Industrial Area, Bangalore 560 058 [T] 080-49292200-03 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@waters.com

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Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr

Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers

MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

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MB-150 Multi Track

Sachet Packer with Servo Auger Filler All operation controls are located on the front of machine. l Stainless Steel finish as standard. l Automatic web tracking., Quick size change over. l Sensor controlled Motorized Auto Web alignment system. l Possibility of shaped pouches., User-friendly. l Customised to meet stringent Pharma and other International Standards. l High accuracy even at very low grammages (0.25 g).

Filling Range: For powder From 0.5 g to 30 g; For Liquid & paste from 1g to 100g

www.wrapmachines.com

Pack Size: W - 40 to 60 mm & L - 50 to 150 mm

Wraptech Machines Pvt. Ltd.

Plot No. D-273 & D-274, T.T.C. Industrial Area, M.I.D.C., Turbhe, Dist. Thane, Navi Mumbai - 400 705, INDIA. Tel.: +91 22 2761 1648 to 53 l E-mail: abm@wrapmachines.com

Associates

Rotary & Fixed Spray Balls

Diaphragm Valves

Centrifugal Pump

Aseptic Sampling Valves

Drain Trap

Product Range : Associates

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June 16-30, 2015

Sight Glass :

Lobe Pump

Powder Ventury Sanitary Manually & Triblender Pneumatically Butterfly Valve

Sanitary Fittings

Steam Water Sanitary Mixing Battery Pneumatic Valve Elliptical Manhole Manually Controlled

Sanitary Pumps Sanitary Auto / Manual Valves

Sanitary Fittings Stainers

Safety Valve

Manholes Sight Glass

S. No. 28/27, Near Pari Company, Dhayari - Narhe Road, Pune - 411 041. Ph. : + 91 - 020 - 6500 1482 / 2469 0268 Fax : + 91 - 020 - 2469 0268 Mob. : + 91 90287 16622, + 91 99231 24949 Email : swastikpune@gmail.com / sales1swastik@gmail.com

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EXPRESS PHARMA MACHINERY FOR SALE STABILITY CHAMBERS

1 CONDITION

CHAMBER SIZE (H x W x D in cm)

VOLUME OF THE CHAMBER

125 x 60 x 60 125 x 60 x 60 70 x 50 x 50

40°C/75%RH 30°C/75%RH 25°C/60%RH

2

450 liters 450 liters 175 liters

COMPANY NAME

EIE INSTUMENTS PVT.LTD

CLASS 100 TYPE DHS

Chamber size:

1120 (W) x 1400 (D) x 1280 (H)

Heater:

39 KW

Working Temp.:

275°c

Motor:

7.5 HP

Electric supply :

415V-3PH-50HZ AC

Make:

Triton Engg. P. Ltd.

Make

Name of Machine

3

Nos.

Multicolumn with part Machine Febric

1

Capacity/Technical Specification

Capacity - 150 Ltr/ Hrs. Connected load – 1.5HP , 415V

4 Ampoule Inspection 5 DHS

Envee Pharma

1

6 Head

Machine Fabrics

1

Capacity - 1250 Ltrs.

6 Auto cleave

Machine Fabrics

1

Gopinath

1

Techno

1

York Scientic Industries

1

Not available

1

7 8 9 10

Steam Ketal Half Lift Incubator Small Blower

11 Automatic visual inspection m/c

Envee Pharma

2

Size - 450(W) x 450(H) x 600(D) connected load – 3 HP, 415 volt Working Pressure – 2.2Kg/cm2 50 Ltr. Kg 1500 Kg (Aprox) 90 Ltr. (Aprox) 300 CFM (Aprox) 1) No. of head: 6 head with loading & unloading hopper facility.

2) Capacity: 2600 Amps./hr 3) Magnifying glass for better viewing of rejection.

4) Six nos. of rejection switch for the auto removal of individual rejection.

5) Suitable for 1 to 5 ml Amps. with different change part for each size of amps.

6) Three phase supply

Troikaa Pharmaceuticals Ltd. Please contact: Mr. Bhavin Upadhyay-09879615621, 079-26856242-45. Email.: bhavin@troikaapharma.com

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Uniformity, Applicability and Efficacy – Regulatory Satisfaction Whilst generic pharmaceutical development often requires less investment in clinical trials to meet market approval, in vitro characterisation is arguably of even greater importance than for an innovative medicine. To market our generic, we must fully understand how it compares with the innovator.

Malvern’s pharmaceutical toolkit gives the confidence in your product that is required to bring your drug to market.

Particle Size

Shelf-life

Applicability

Particle size controls the dissolution characteristics of tablets and delivery uniformity in suspensions.

Malvern’s Mastersizer 3000 (pictured) and Zetasizer systems allow sizing over the entire micrometric and nanometric range.

Comprehensive understanding of stability reduces the cost of batch expiration. Malvern’s Zetasizer ZSP systems characterise electrostatic stability, whist the Kinexus range is used to characterise the sedimentation-propensity.

Flow characteristics define the applicability of a drug. Ophthalmic emulsions, for instance, must be able to be added to, to be retained by, and to fully permeate the eye.

Malvern’s Kinexus (pictured) range has the versatility to assess flow properties of a sample under application-relevant conditions.

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EXPRESS PHARMA Advertise in

Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Arun J 91-9940058412 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

The Next Generation Data Acquisition System for Thermal Validation Master Module • Flexible configuration from 4 to 40 channels • Slots for one high power ( 100mA/5 V) 4 channel sensor array and three low power (40mA/5 V) 12 channel sensor array • 10 sessions with 40 channels, 1 sec. sample rate • LAN port Performance • Measuring range:-200°C to 1,300°C ( ready for -270°C to 1,820°C) • Resolution: 0.01°C • Accuracy of the E-Val pro module ( sensor array) is +/-0.05°C Interchangeable Sensor Array • Contains precision Voltmeter • 4 channel multipurpose, accommodates: TC type, 4-20 mA, 0-10 V and I/O relay • 12 channel TC type as well as other low power analog/digital inputs Smart USB Connectors • Memory for Calibration offsets • Internal PT1000 sensor for cold junction compensation ID# for traceability • Full sealed/mounted TC or optional plug with screw terminals

For further information, please contact us:

E-mail: delhi@aimil.com Tel: 91-11-3081 0244 www.aimil.com Offices at : • Delhi (H.O.) • Mumbai • Bengaluru • Kolkata • Chennai • Vadodara • Hyderabad • Chandigarh • Guwahati • Bhubaneswar • Indore • Nagpur • Lucknow • Kochi 54

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Aimil/Ad/A&I/15-16/06/16

E- Val PRO

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AVAILABLE DIRECTLY FROM THE MANUFACTURER AT HIGHLY COMPETITIVE PRICES < Ortho / Para Anisic Acid < Ortho / Para Cyano Phenol < 2 – Ethoxy Benzoic Acid < 1 / 6 – Hydroxy – 2 – Napthoic Acid < 3 / 4 / 5 – Methyl Salicylic Acid & Ester < 3 / 4 / 5 – Chloro Salicylic Acid < 3 / 4 / 5 – Amino Salicylic Acid < 6 – Methoxy – Naphthaldehyde < All types of Paraben & Mixtures thereof.

AN ISO 9001 : 2008 & 14001: 2004 COMPANY OUR PRODUCTS ARE STAR K-KOSHER & HALAL CERTIFIED

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Tel : +91-22- 43625500 Fax : +91-22-24974886 E-Mail : gujorg@gujaratorganics.com Web : www.gujaratorganics.com

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

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PHARMA LIFE REPORT

Healthcare and pharma industry will see a hike of about 11.5 per cent: TeamLease report Ranking fourth in salary hikes among sectors, pharma sector has seen an increase of 1.5 per cent over last year

THERE IS an increasing demand for talent across sectors with employees expected to received double digit salary growth, if the latest report by Teamlease is to be believed. Teamlease Annual Salary Primer, released recently, analysed a variety of attributes that govern the dynamics of the employment market – skills, salaries, increments and longevity (which is a measure of the time period for which a profile would stay in a job – the inverse of attrition).

The report, which covers 15 key industry verticals, also goes on to say that candidates undergoing appraisal this year will witness a double digit salary growth ranging between 10.5 per cent to 15 per cent across industries and functions, setting in a upbeat tone for the year.

“The healthcare and pharma industry will see a hike of about 11.5 per cent in 2015-16 up from 10 per cent in 2014-15.

This can be attributed to a substantial degree of expansion of healthcare businesses across the country and, especially, in the tier-I and tier-II cities,” says Rituparna Chakraborty, Senior Vice President & Co-founder TeamLease Services. The sector stands fourth in rankings this year, and is behind IT, retail and telecommunications. Salaries in retail and telecom industries are expected to grow at about 12.2 per cent. Chakraborty stated that the relatively modest growth in salaries in healthcare and pharma is due to the fact that the industry is

KEY FINDINGS OFTHE SURVEY ◗ Talent demand peaks, and salaries rise substantially: Salaries have risen significantly for about 37 per cent of all profiles surveyed, incrementally for 44 per cent. Double digit salary growth – ranging from 10.5 per cent to 15 per cent – is more the norm than exception with about half the industries. ◗ Salary variance between temp and perm jobs narrows sharply across a slew of job profiles and across industries.The most equitable unified salaries have a sliver-thin variance of between 2.2 per cent and 2.5 per cent - down from last year’s low of between 4.7 per cent and 5.5 per cent. ◗ Mumbai does not just steal a march over Bengaluru

almost perpetually a positive growth machine, hence, annual rates of growth are bound to be moderated.

The hike will be different across different levels. While graduate starting salaries still lag behind, starting at `350,000 (5.8 per cent hike) across sectors, those with Masters will draw `470,000 (7.4 per cent hike) across sectors. Senior management salaries are expected to beat the average across job levels, at 11.9 per cent, while middle management professionals can expect an increase of about 11.1 per cent. There are citywise salary trends as well for different sectors. “While Mumbai still leads in terms of pharma jobs, Bengaluru has been offering higher salaries as well as steeper salary hikes.

Proliferation of healthcare facilities in the city has led to an increased demand for

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and Delhi, it is also the top salary paying city across as many as seven industries. Delhi leads across four industries and Bangalore in one. In all, each of the three cities feature in about 10 of the 15 cities covered by the analysis. ◗ City-industry clusters are proving to wield enormous clout: Bengaluru-IT (14.7 per cent), Mumbai-FMCG (13.6 per cent), BengaluruHealthcare & Pharmaceuticals (13 per cent) and Pune-Power & Energy (12.5 per cent) are the cityindustry clusters that dominate this scene.The clusters are characterised by a mature talent demand-supply scenario where businesses are comfortably ensconced in cities with high quality talent pools.

The report says that candidates undergoing appraisal this year will see a double digit salary growth ranging between 10.5 per cent to 15 per cent across industries and functions

healthcare professionals and support staff,” Chakraborty chips in.

Detailed analysis throws light on the salary trends across blue collar profiles.

Median salaries for some of these profiles are around 30 to 50 per cent higher than the minimum wages. The study also highlights that apart from the hard skills, soft traits such as honesty, personal hygiene and mannerisms are increasingly gaining demand.

“Healthcare companies emphasise on both soft and technical skills, while pharma companies stress relatively more on the latter. Soft skills sought are listening and counselling, relationship/rapport building, transactional and interpersonal skills. Hard/ technical skills sought are problem solving, critical thinking, technology acquaintance, and goal orientation,”

RITUPARNA CHAKRABORTY Co Founder & Sr Vice President, TeamLease Services

she explains.

Specific job profiles are also more in demand as compared to others and it seems as if R&D in pharma is going full steam ahead. Pharma scientists, radiologists and clinical research associates are being highly sought after because of the increasing specialisation that the industry is transforming itself into, stresses Chakraborty. Technologically innovative profiles such as pharma technology and life sciences, SMAC: social networking, mobile computing, business analytics and cloud computing, Hadoop etc will see more demand in the future. Approximately, 55 pharma companies were considered in the analysis with 20 being MNCs, rest, domestic. The former offer about 20 per cent better salary hikes compared to the latter.

The unified salary report covers 15 key industry verticals namely agriculture & agrochemicals, automobile & allied industries, consumer durables, power & energy, FMCG, manufacturing & allied industries, BFSI, telecommunication, hospitality, healthcare & allied industries, BPO & information technology, ITeS, retail, construction & real estate as well as media & entertainment. The functional domains analysed are accounts, administration blue collar, support services, engineering, human resources, IT and sales & marketing while the locations covered are Ahmedabad, Kolkata, Bangalore, Hyderabad, Chandigarh, Mumbai, Chennai, Pune and Delhi.

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PHARMA LIFE ACHIEVEMENT

Dr Vikramaditya G Yadav in 100 most influential people in drug development and manufacturing He is one of eight Indian-origin achievers to be recognised and is the youngest member of this illustrious list DR VIKRAMADITYA G Yadav, Assistant Professor in the Department of Chemical & Biological Engineering at the University of British Columbia (UBC) in Canada has been recognised by Medicine Maker for his formalisation of 'biosynthonics', a novel paradigm for drug discovery and development based on metabolic and enzyme engineering.

Youngest Indian in list Yadav is one of eight Indian-origin achievers to be recognised and is the youngest member of Medicine Maker’s illustrious list.

Incidentally, Yadav shares the Medicine Maker honour with three of his professors from MIT— Dr Robert Langer, Dr Charles Cooney and Dr Bernhardt Trout. He was Cooney’s teaching assistant for a course on downstream processing, and Yadav’s experience in the laboratory of Langer greatly shaped his scientific views. Trout taught thermodynamics and statistical mechanics to Yadav during the latter’s first year at MIT.

Contributing to progress Significant advances have been made in analytical chemistry, genome sequencing and assembly, flow chemistry, chemi- and bioinformatics, metabolic engineering and synthetic chemistry; and the raw computing power that is available for drug research has witnessed exponential improvements.

Biosynthonics, Yadav’s field of work, integrates these parallel innovations into a single platform in order to translate a vastly higher number of small molecule

64 EXPRESS PHARMA June 16-30, 2015

drugs to the bedside. The platform could prove to be particularly effective in tapping into the chemistry of natural products, a veritable treasure chest of therapeutic compounds.

Biosynthonics comprises four principle domains: (1) Design (2) Synthesis (3) Exploration (4) Integration Design encompasses the selection of electronic features and their steric optimisation onto a rigid molecular framework in order to ensure optimal binding to a specific biological target. The conceptual underpinning this exercise is rooted in fragment-based pharmacophore modeling and all steps are completed in silico.

The pharmacophores so-designed are then synthesised in a microbial chassis that has been carefully constructed via metabolic engineering. The third domain of biosynthonics – exploration—expands the biosynthetic ensemble for metabolic engineering through a systematic search of nature’s metabolic landscape. In the fourth domain, the biosynthesised pharmacophores are employed as inputs for conventional target-oriented chemical synthesis (TOS). This integration facilitates access to precise regions of chemical space – either a single molecule or a small assortment of molecules exhibiting minor variations on a chemical theme.

Yadav has also been recognised for his pioneering work on the development of more accurate and rapid pre-clinical screening platforms for identifying drugs targeting neurode-

He has been a pioneer in development of more accurate and rapid pre-clinical screening platforms for identifying drugs targeting neurodegeneration

generation. He is collaborating with colleagues from the biopharma industry and the Faculty of Pharmaceutical Science to construct artificial human brains in a variety of formats, one of which is a brainon-chip. His team is employing stem cell and tissue engineering, micro-manufacturing and mathematical modeling to design and assemble a brain-onchip device that mimics the human brain. A brain-on-chip is a type of organ-on-chip device, the kinds of which have already attracted the attention of the pharma industry. Organs-onchips are miniaturised, threedimensional models of human tissue that recapitulate the spatiotemporal complexities of the tissue microenvironment as they occur within the body. This provides a highly context-specific platform to test and validate lead compounds, which improves the success rate of compounds in the clinic.

Yadav plans to utilise this device to investigate fundamental details about neurotransmission and test lead compounds targeting two prominent neurodegenerative disorders, chronic traumatic encephalopathy (CTE) and frontotemporal degeneration (FTD) in a high-throughput manner. The co-application of mathematical modeling and analysis with key concepts from stem cell bioengineering, micromanufacturing and engineering design represents a methodological advancement that will potentially open new frontiers in biomedical engineering.

An illustrious career His achievements in the course of his glorious career have been many. His work has gained

international recognition. He took a keen interest in lowcost science and translational research, and authored a business plan to commercialise a pharma manufacturing technology in resource-constrained settings. This earned him prestigious awards like the ACS Kauffman Foundation Entrepreneurship Prize and the MIT Legatum Fellowship for his business plan, both in 2012.

At MIT, Yadav also flourished as a teacher, author and opinion leader, and was bestowed with the Edward Merrill Prize for Teaching Excellence in 2010, the gold medal from the Biochemical Society, UK in 2012 for his authorship of a general interest article on drug discovery and development, and the SciFinder Future Leader in Chemistry prize in 2012.

He currently serves as the Vice-Chair of the Biotechnology Division of the Chemical Institute of Canada, and was recently honoured by Green College at UBC as one of its first Green College Leading Edge Scholars. He was also awarded the Wall Scholars Award by the Peter Wall Institute for Advanced Studies earlier this year for the Interdisciplinarity and wide-ranging impact of his research.

Moving forward Yadav, a strong advocate of philanthropic science, hopes to play his part in ensuring people throughout the developing world, especially in his homeland, have access to the very best therapeutics at the lowest prices. He hopes that his team continues in similar stead and successfully translates technological innovations to the pharma industry.

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.

IDEAL CURES

BECOMES FIRST INDIAN COMPANY TO RECEIVE EXCIPACT

CERTIFICATE

Ideal Cures has received Excipact certification for two of its manufacturing plants.

CORPORATE OFFICE & R & D CENTRE - II Ideal Cures Pvt. Ltd. Unit No. A/223 to A/229, 2nd Floor, Virwani Industrial Estate, Western Express Highway, Goregaon (E), Mumbai - 400 063. Tel.: +91-22-42688741 Fax : +91-22-42688713 Visit us at : www.idealcures.com / www.idealcures.co.in