Modern Pharma - 16-30 April 2013 by Infomedia18

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In Conversation With 10

Special Focus 12

Strategy 19

Event Preview 24

Dr Michelle Carr Director & Company Secretary, Telezon Ltd, Australia

Shortcomings in quality manufacturing Effective guidelines can come to the rescue

Zeroing in on a brand name Nuances of the tricky game

iPHEX 2013

Dr. Reddy’s appoints GV Prasad as Chairman and Satish Reddy as Vice Chairman Dr. Reddy’s Laboratories Ltd recently announced that based on the recommendations of the Nomination, Governance and Compensation Committee, its Board of Directors have appointed GV Prasad, presently Vice Chairman and CEO as the ‘Chairman and CEO’ and Satish Reddy as Vice Chairman in addition to his present role of Managing Director and COO, effective from March 30, 2013.

Fermenta Biotech shows green routes for beta lactam synthesis Fermenta Biotech Ltd (FBL), a pioneer is developing and commercialising enzyme technologies for synthesis of beta lactam antibiotics, has successfully developed and commercialised a range of novel enzyme catalysts to optimise the production of common beta lactam molecules. The company’s enzyme portfolio has been built on the foundations of exclusively licensed technology and patents (CZ 300467, US 8039604, EP 2173892 B8, Indian Patent 253959), which are further evolved through in-house R&D. FBL has successfully demonstrated commercial scale enzymatic production of Amoxicillin and is currently planning to conduct pilot and commercial scale demonstration for Cephalexin. Besides enzyme technology, the company also offers robust support for immobilisation of enzymes on its proprietary platform DILBEADS® (Indian Patent 247630).

Shasun Pharma and Debiopharm sign licensing agreement Shasun Pharmaceuticals Ltd, a global pharmaceutical contracting organisation and Debiopharm Group (Debiopharm) a Swiss-based global biopharmaceutical group with a focus on the development of innovative prescription drugs that target unmet medical needs, entered into a licensing agreement for the manufacturing and commercialisation of Huperzine-A. According to the terms of the agreement, Shasun Pharmaceuticals Ltd will be able to use the Debiopharm technology for the manufacture of synthetic Huperzine-A under GMP quality conditions and commercialise it in pharmaceutical and nutraceutical markets.

Set to provide a booster shot to pharma and healthcare

SC rejects Novartis’S Glivec patent plea The Supreme Court recently rejected Swiss drugmaker’s Novartis’ Glivec patent plea that was filed in 2006. The Court denied an appeal challenging the rejection of a patent for Glivec, a lifesaving medicine for certain forms of cancer, patented in nearly 40 countries including China, Russia and Taiwan. Upholding the Tribunal, Patent body order on the cancer treatment drug; it said the drug is not eligible for patent in India. Novartis will also have to pay cost for filing the case. The company had argued that the molecule imatinib mesylate, on which Glivec is based, required years of research and modification to make it an effective, safe leukaemia treatment. Glivec is Novartis’ top seller generating sales of $ 4.7 billion in 2012. Calling the case ‘not maintainable’, the Apex Court said repetitive patents

are not permissible on the same drug. In 2006, the Indian Patent Office had denied patent to the company which was upheld by the Indian Intellectual Property Appellate Board. Glivec costs about $ 2600 a month, while its generic equivalent is available in India for $ 175. Speaking on the judgement, Ranjit Shahani, Vice Chairman and Managing Director, Novartis India Ltd, said, “We strongly believe that original

innovation should be recognised in patents to encourage investment in medical innovation especially for unmet medical needs.” Commenting on the immediate effect the verdict could have on

the Indian pharma industry, Amit Backliwal, General Manager, South Asia, IMS, said, “The opportunity for the Indian market is quite large and cannot be ignored by any major pharmaceutical company today or in the future. However, for any company to play in India currently, business models have to be adapted and aligned to the prevailing regulatory and market conditions that exist. Larger play involving alternative funding, market access, patient access programs would become more important now than ever as clearly, the market is moving towards a more volume and price sensitive area. All healthcare stakeholders (pharma/ payer/provider) need to start looking at the middle and bottom of the pyramid as well as at innovative solutions to address overall access to healthcare concerns that continue to exist.”

Elder Pharmaceuticals to invest ` 20 crore for cosmetics venture Elder Pharmaceuticals will invest ` 15-20 crore over the next twothree years for its foray into cosmetics manufacturing, an official recently stated. The company plans to manufacture cosmetics at its existing plant in Paonta Sahib in Himachal Pardesh, which is making pharmaceutical products. The product portfolio includes skincare and body care products “We are looking at investment of ` 15-20 crore over the next two-three years for marketing and manufacturing of cosmetics,” said Alok Saxena, Joint Managing Director, Elder Pharmaceuticals. Elder Pharma has recently entered into an agreement with Japan’s Kose

Corporation to form a JV company to manufacture and sell cosmetics in the market. The agreement stipulates that Kose will focus on the Indian market through the JVC for manufacturing and selling cosmetics in India. Kose will hold 60 per cent and Elder the 40 per cent in the proposed JV. Saxena Saxena said, “Elder, by forming the JV, has deviated from its usual strategy of in-licencing products from foreign companies, owing to the huge opportunity in domestic market. India’s facial skincare segment is estimated at around ` 5,500 crore.

Therefore, the target will be in the skincare market. Our incremental revenues could run between ` 30 crore and ` 40 crore in the first year.” “India is a developing consumer market with strong growth potential. Women’s fashion is also diversifying, and tastes in cosmetics are changing dramatically. Almost all the products in the first few years will be skin products in the form of creams, lotions and ointment. The total market in this segment is about ` 18,000 crore,” Saxena added.

Merck Sharp and Dohme ﬁles appeal against interim order in row with Glenmark US pharmaceutical major Merck Sharp and Dohme (MSD) has recently filed an appeal before the Delhi High Court challenging its single bench order refusing to grant interim relief to it on a patent row against Indian firm Glenmark Pharmaceuticals. The US-based company filed the appeal before the bench of justices Sanjay Kishan Kaul and Indermeet Kaur against the April 5 order of the single bench which had dismissed its plea for restraining Glenmark Pharmaceutical

from manufacturing and marketing anti-diabetes drugs Zita and Zita-Met. The single judge had in an interim order dismissed MSD’s plea but had directed Glenmark Pharmaceuticals to ‘diligently maintain accounts of the manufacturing/ production and sales of the infringing products’ and to file the same before it. The order came on a petition by MSD which had alleged that the Indian pharma company has violated its Intellectual Property Right (IPR) over its anti-diabetes medicines, Januvia and Janumet, by

coming in the market with their own drugs containing the same salts. However, the High Court has kept the main petition of MSD pending for adjudication. MSD had sought the High Court’s order to restrain the Mumbai-based firm from manufacturing and sale of drugs Zita and Zita-Met. for treatment of type-2 diabetes. They said it had invented ‘Sitagliptin’ salt, used in the anti-diabetes drugs, and has patent over the molecule.

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CONTENTS In Conversation With

In Conversation With: Dr Michelle Carr Director and Company Secretary, Telezon Ltd, Australia

Special Focus Quality compliance (GMP, GLP and GDP) Shortcomings in quality manufacturing Effective guidelines can come to the rescue

Interface Dr H G Koshia Commissioner, Food & Drugs Control Administration, Gujarat Asif Khan Chairman & Managing Director, Fabtech Technologies International Pvt Ltd

13 15

Roundtable Do compliance and quality issues cast shadow on pharma deals?

16 www.modernpharma.in

Insight & Outlook Policies & Regulations Focussing 21 CFR Part 11: Managing e-records and digital signatures could be the key to success Strategy Zeroing in on a brand name: Nuances of the tricky game

FOUNDER & EDITOR, NETWORK 18 Raghav Bahl PRESIDENT & EDITORIAL DIRECTOR, TV 18 Senthil Chengalvarayan

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Event Preview iPHEX 2013 Set to provide a booster shot to pharma and healthcare

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Editorial

Indian pharma industry: Set to leverage the generic expertise rom being considered a prickle in the spine of Big Pharma to being the major asset, the Indian generics industry has come a long way. MNCs are actively positioning themselves to capture a significant portion of the Indian generics market in the quest to extend their reach into emerging economies. In the coming years, Indian generic industry is set to not only capture the domestic market but also contribute a lot in the international market. Amid this scenario, it is no surprise that a recent report states that Indian pharma industry is being wooed by other countries for its generic expertise. A few years back, experts saw huge potential in pharma exports to the Gulf, with countries in the Gulf Cooperation Council (GCC) depending on imports for 80 per cent of their domestic requirements. And recently, a number of GCC countries are seeking investments from Indian pharmaceutical companies to benefit from their experience in the generics segment, says a report by investment bank – Alpen Capital. The signing of the impending Free Trade Agreement (FTA) between the GCC and India will further open up the market for Indian companies, according to the report. The report provides a long-term industry outlook and proposes recommendations that could help attract higher foreign investments, bring regional drug prices closer to the world average, and aid

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

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

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

the overall market growth. It says that the biotechnology parks and free zones established in the GCC play a major role in bringing the foreign investments and technology required to build local capabilities for manufacturing of patented pharmaceutical products. The GCC pharmaceutical industry is expected to experience sustainable growth in the medium to long term. Increased domestic production, foreign investments and consumption of generics are likely to support the market’s evolution. A few Indian companies have already registered their products with the ministries of health in these countries, while some are in the process of doing so. In hindsight, will such kind of moves be beneficial to the Indian industry in the long run? MNCs setting up base in the country have garnered tremendous benefits for the overall economy; then how would shifting base to other countries help? At the same time, several experts believe that there is a need to address the growing control of MNCs on the Indian pharma market, which can undermine access to medicines. It will be interesting to watch how these developments guide the domestic pharma market.

Manas R Bastia manas@network18publishing.com

Guest Editorial

What is life after the Supreme Court Judgement on Novartis’s Glivec case for India? hen we all heard about the collapse of the Lehmen Brothers in 2008, the initial reaction was that of shock and disbelief. For a common man who had invested in the stock market through several instruments, this news and subsequently the fall out was close to disaster. This financial tsunami affected the lives of millions across. But the world noticed that no banks in India collapsed. So something we did with our policies protected the lives of millions. In my view with the first ripple of the healthcare tsunami has hit us with the Apex Court’s ruling on Novarti’s Glivec the life saving drug as not patentable under section 3 (d). We can continue to deny with our head buried in sand and possibly review India’s credibility in poor light as a nation incapable of protecting Intellectual property. But the reality is quite different. Affordable health is now dear to the heart of every human in the universe and this is going to be the new world order where policymakers will have to toe the line of the sentiments of their people. People want drugs which they can afford. The affordability varies from country to country but illnesses have no such boundaries. Thus, it is evident that today the pharma model has come under considerable stress. I would

equate the Apex Court judgement to the collapse of the Lehmen Brothers in the pharma space. Most countries will now try to emulate stopping ever greening as a popular measure (reports indicate Australia and Canada may begin). When I wrote an article for CII in 2008 that the cost of drug development can be as low as $ 250-400 million, the readers must have definitely felt that I had no clue what I was talking about when the real figures were above a billion dollars. But today this billion dollar number is heavily challenged and people have exposed numbers where the bulk of the cost is not spent on innovation but on marketing. Thus, pharma will come under pressure in the area of innovation, cost of drug development and their business model. Now and then we need brave new leadership and bold ideas to overcome such challenges of the future. We do not want pharma companies to fail to develop new life saving drugs nor activists to believe that they can pressurise anybody to snatch innovative drugs at no cost. We also do not want governments to think they can use compulsory licensing to make drugs available to the needy. We also do not want pharma companies to hold on to their current model and expect the whole world to believe that

there is no alternative. I see enormous opportunities that unfolds for countries like India where we can take leadership position in policymaking for affordable health and also in bringing out a new order in research and development. We did this in telecom.Remember we came in after most developed countries were using mobile telephone but at exorbitant prices? Came India and revolutionised the space completely with affordability and the use of cuttingedge technology. In essence, this verdict is going to shape the destiny of this sector not only for India but for the people world over. Dr Panchapagesa Murali Managing Director & CEO, Evolva India

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News, Views & Analysis

IDMA supports Pharmexcil’s iPHEX 2013 IDMA is supporting Pharmexcil’s iPHEX 2013 inaugural event and is organising a Seminar on ‘India: Destination of Choice for Quality Medicines’ at iPHEX 2013 on April 24-25, 2013. The event is planned to attract the entire Indian pharma industry, as also about 400 foreign buyers and regulators from many countries. Registration is free and interested delegates can confirm their attendance in advance by registering with IDMA. On Day 1, a panel discussion on ‘Hassle Free Exports’ based on the seminar theme will be held with industry stalwarts such as Smitesh Shah, CMD, Calyx Chemicals & Pharmaceuticals Ltd; Dr Milind Joshi, President, Global Regulatory Management, J B Chemicals & Pharmaceuticals Ltd; Dr Ajit Dangi, President & CEO, Danssen Consulting; Dr Raja Smarta, Managing Director, Interlink Marketing Consulting and other experts as panelists.

Utkarsh Palnitkar, Partner (Head of Transactions and Restructuring), KPMG India will moderate the panel discussion. The seminar on Day 2 will have interesting presentations on ‘Pharma Branding’ by Sudarshan Jain, MD - Healthcare Solutions, Abbott Healthcare, ‘Success Stories of Indian companies in Exports’ by Sriram Shrinivasan, Partner - Life Sciences, Accenture India, and others on relevant topics such as ‘Biosimilars – ‘Look before you Leap’, ‘Financing Pharma Exports’ etc. An interactive session with overseas regulators is also scheduled on Day 2, wherein they will be requested to highlight their regulatory framework and how they can help in easing import of medicines from India. This interactive seminar will ensure delegates take home the skills to enable them and their teams to perform to the peak of their abilities, and build ‘Made in India’ pharmaceutical brands for global markets.

Genzyme India and Society for Indian Academy of Medical Genetics collaborate to train Indian doctors in clinical genetics To promote the science and practice of clinical genetics in India, Genzyme, now a part of Sanofi worldwide recently announced a tie-up with the Society for Indian Academy of Medical Genetics (SIAMG) for a joint fellowship programme for Indian medical professionals. This programme of three months duration will be organised at the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, and the first batch is set to begin from July this year. The MoU was signed by SIAMG President Dr Shubha R

Phadke and Sandeep Sahnney, Head of Genzyme for India & South Asia. Under the terms of the agreement, Genzyme India will provide support to IAMG to help spread awareness about medical genetics in the country. The three-month fellowship programme will be supported by Continuous Medical Education (CME) and medical workshops at the local as well as national level. IAMG, with the support of Genzyme, will also be bringing out a quarterly newsletter on genetics under the title of ‘Genetic Clinics.’ Commenting on the

agreement, Dr Phadke, said, “We are pleased to collaborate with Genzyme India to promote clinical genetics in the country. This partnership will have a significant impact on the newly emerging field of genetic research and help strengthen India’s biotechnology capabilities to make a difference to the lives of the Indian people.” Sahney stated, “We are confident that these fellowships in clinical genetics will act as a catalyst for promoting academic excellence and applied research in this discipline in India as well as build clinical expertise.”

MedImmune acquires AlphaCore Pharma MedImmune, AstraZeneca’s global arm for biologics research and development, acquired AlphaCore Pharma, a Michigan-based developer of ACP-501, a recombinant human Lecithin-Cholesterol Acyltransferase (LCAT) enzyme. The acquisition will support the clinical study and development of ACP-50, the novel LCAT therapy to cure cardiovascular diseases. Speaking on the development, Dr Bahija Jallal, Executive VP, MedImmune, said, “As the science in this area continues to evolve, we are committed to exploring unique pathways that could lead

to new combination or standalone therapies for patients living with chronic and acute cardiovascular diseases. Cardiovascular disease is projected to remain the single leading cause of death worldwide over the next decade and beyond. Through novel approaches such

Dr Jallal

as LCAT, we hope to shift the treatment paradigms in this area to help prevent and treat these conditions.” CVD and metabolic disorders constitute small and large drug portfolio of AstraZeneca. In 2012, the outcomes of Phase I clinical study of ACP-501 met the basic safety and tolerability criteria without causing any serious adverse events. ACP501 also complied with the trial’s secondary endpoints by quickly and substantially enhancing HDL cholesterol levels. The results from this study support the current clinical development of this drug.

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News, Views & Analysis

Bayer’s Stivarga® tablets approved in Japan to treat advanced or recurrent colorectal cancer Bayer HealthCare announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan approved Stivarga® (regorafenib) tablets for the treatment of patients with unresectable, advanced/ recurrent Colorectal Cancer (CRC). The approval of Stivarga by the MHLW is based on results from the pivotal phase III CORRECT study that demonstrated a statistically significant improvement in overall survival and progressionfree survival compared to placebo in patients with metastatic CRC (mCRC) whose disease had progressed after approved standard therapies. Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumour growth and progression – angiogenesis, oncogenesis and maintenance of the tumour microenvironment. “The approval of Stivarga in Japan is significant, as it provides an important treatment avenue for patients with advanced colorectal cancer whose cancer has returned despite treatment

with other approved therapies,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “Bayer is committed to developing new therapies for patients and their physicians in hard to treat diseases such as mCRC where there continues to be an unmet medical need for additional treatments, and we are delighted that Stivarga provides a potential new option for Japanese physicians to offer their patients.” “The incidence of colorectal cancer is increasing in Japan and we are limited in the number of treatment options available to patients with advanced disease,” said Takayuki Yoshino, Chief of Department - Gastroenterology and Gastrointestinal Oncology at the National Cancer Center Hospital East, Japan. “Regorafenib has been shown to prolong overall survival and slow the progression of cancer and provides an important treatment advance for patients with mCRC who have no further treatment options.”

The most frequently observed adverse drug reactions (equally or greater than 30 per cent) in patients receiving regorafenib were asthenia/ fatigue, decreased appetite and food intake, hand-footskin reaction/ palmar-plantar erythrodysesthesia, diarrhoea, mucositis, weight loss, infection, hypertension and dysphonia. The most serious adverse drug reactions in patients receiving regorafenib were hepatotoxicity, haemorrhage and gastrointestinal perforation. Full results from the CORRECT study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012 and published online in the journal The Lancet in January 2013. In Japan, CRC is the third most common cause of cancer death, with over 40,000 people dying every year and almost 100,000 newly diagnosed cases per year. Research also shows that the incidence of CRC has risen dramatically in Japan in the last 20 years.

In Brief Piramal Enterprises Ltd and Tata Memorial Centre forge alliance to advance understanding of cancer biology Piramal Enterprises Ltd (PEL) and Tata Memorial Centre (TMC) recently announced a collaboration to enable the development of valuable tools to better understand disease biology and predict responses to various treatments for cancer patients. The new alliance between the two organisations will focus on the development of preclinical cancer models to enhance the understanding of disease biology, treatment response/resistance Dr Piramal and biomarkers as they relate to diagnosis, prognosis and response to drugs. These models will be based on tumour tissues from cancer patients and are predicted to have better translational relevance than the currently used human cancer cell line models. Scientists at TMC and PEL hope to gain a better understanding of the mechanisms through which various drugs work on different cancers. Commenting on the development, Dr Swati Piramal, Vice Chairperson, Piramal Enterprises Ltd, said, “We are excited to begin this collaboration with Tata Memorial Centre, which is India’s leading centre associated with cancer treatment. We hope that the insights we gain from this alliance will ultimately lead to new treatment options for cancer patients.” The New Chemical Entity (NCE) Research division of Piramal Enterprises focuses on the discovery and development of innovative medicines to improve the lives of patients suffering from cancer, diabetes, metabolic disorders and inflammatory conditions.

Dr. Reddy’s launches Zoledronic acid injection in US Dr. Reddy’s Laboratories recently launched Zoledronic Acid injection (5 mg/100 mL), a therapeutic equivalent generic version of Reclast® (zoledronic acid) injection 5 mg/100 mL in the US market following the approval by the US FDA of Dr. Reddy’s ANDA. Reclast® had total US sales of approximately $ 355 million for the most recent twelve months ending February 2013, according to IMS Health. This injection will be available in a single-use vial for intravenous infusion.

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News, Views & Analysis

Roche introduces Elecsys Simbionix receives unique US patent Calcitonin marker for improved for PROcedure Rehersal Studio™ management of thyroid cancer Simbionix USA Corporation, a global major supplier of medical education and simulation training, received a US patent for the PROcedure Rehearsal Studio™ (PRS), the patient specific simulation product of then company. This follows a similar patent granted in the UK and is the first such patent ever granted in the US. PRS is a first in industry product that incorporates company’s revolutionary technology, for enabling physicians to rehearse a complete endovascular procedure on a virtual 3D anatomical model based on a specific patient’s CT data. Later, this virtual model can be used for the purpose of simulating, evaluating and analyzing preoperative surgical treatment alternatives prior to performing the actual procedure that may enhance

physician’s confidence in the upcoming procedure. Once the 3D model has been exported to the Simbionix ANGIO Mentor™ simulation environment, the physician can practice numerous times to evaluate different techniques, while using true-tolife tools and endografts. Speaking on the development, Boaz Tal, Simbionix CFO said “With this key patent and three FDA 510(k) clearances granted for the PROcedure Rehearsal Studio applications (Carotid, EVAR and TEVAR), Simbionix once again demonstrates its key position as a market leader and innovator in the field of medical simulation. Having been granted the patent is an additional sign of recognition for the Simbionix comprehensive line of products, which provide innovative solutions to enhance clinical performance and advance patient safety.”

The patent was granted on Simbionix’s concept and proprietary core technology used in order to simulate an image guided angioplasty procedure based on input from a patient’s 3D medical image, allowing a hands-on planning and rehearsal experience. Unique to Simbionix simulation systems, the 3D segmentation model can be exported to the Simbionix ANGIO Mentor practice environment. The results are an advanced method of creating an ever expanding library of unique clinical case studies for training and postoperative debriefing. The patent also covers various broad uses for the technology including use in DICOM format, use of 4D data, use as a study case (ie, post-operative use), demonstration of a planned procedure to a patient etc.

Roche introduced Elecsys Calcitonin, a new laboratory test for the diagnosis and lifelong monitoring of medullary thyroid cancer patients after thyroid surgery, outside the US market. Calcitonin is a specific tumour marker, which may help healthcare professionals diagnose medullary thyroid carcinoma early, as elevated concentrations of calcitonin in the blood are associated with the onset of this type of cancer. Emphasising on the importance of new marker, Roland Diggelmann, COO, Roche Diagnostics, said, “The development of new laboratory tests for cancer management reflects our key goal of diagnostic solutions that support healthcare

professionals with clear, actionable information and can thus contribute to increasing patient survival.” The new test is an important component of medical assessment, especially when the patient’s symptoms are not specific. When performed alongside further examinations, the calcitonin test supports final clinical clearance. Patients can be treated at an earlier stage with greater chances of success. Designed for use on Roche’s cobas modular analyser platform, Elecsys Calcitonin offers healthcare professionals an integrated solution for accurate diagnosis and reliable patient monitoring, significantly improving medical decision making and treatment planning.

SoloFlow® outperforms steel needle suggests preliminary studies

Melbourne-based medical device maker Telezon Ltd announced the results of ISO 7864 tests for its flagship product SoloFlow®. SoloFlow is a US FDA and EU approved non-injection needle and commercially attractive alternative to steel draw-up needles and reconstitution needles. Results of the preliminary fragmentation test suggested that SoloFlow does not generate any fragments after insertion into a vial rubber stopper while a typical steel hypodermic needle generated four times more fragments. This anti-coring needle can reduce the potential risk to the patient and may compete healthily with competitors offering anti-coring vial access needles, which are typically sold at higher prices. The test assessed the number of fragments (or coring) that occurs after the insertion of SoloFlow needle into a vial rubber stopper and compared to other commercial needles. Although coring issues have reduced drastically over past few years still available data testifies that coring is a health hazard for patients globally. Delighted with such positive outcomes, Dr Michelle Carr, Director and Company Secretary, Telezon Ltd, said, “We are extremely pleased with the outstanding performance of SoloFlow against commercially-available counterparts. It continues to demonstrate the company’s ability to be responsive to patients and market needs.” Company is also pursuing capital investment to accelerate commercialisation of other world-patented products and technologies. “We look forward to deliver products and technologies from our unique and competitive portfolio in the near future as we infuse more funds,” added Dr Carr. - Hardik Ashar

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News, Views & Analysis

India joins the International Trademark System at WIPO On behalf of Government of India, Anand Sharma, Minster for Commerce and Industry deposited country’s instrument of accession to the Madrid Protocol for the International Registration of Marks at World Intellectual Property Organization (WIPO), Geneva, Switzerland bringing the total number of members of the international trademark system to 90. The treaty will enter into force with respect to India on July 8, 2013. The Madrid System for the International Registration of Marks offers trademark owners a cost effective, user friendly and streamlined means of protecting and managing their trademark portfolio internationally. “We recognise that this instrument will provide an opportunity for Indian companies, which are increasing their global footprint, to register trademarks in member countries of the Protocol through a single application, while also

allowing foreign companies a similar dispensation,” said Sharma. He also took part in a high level policy dialogue at WIPO, where he spoke on the subject ‘Innovation and Development: The Indian Experience.’ Members of the Geneva diplomatic community, including ambassadors, took part in the dialogue. Francis Gurry, Director General, WIPO,

Sharma

Non-toxic StabilOx oxygen-absorbing canisters provide good drug stability Recently, an uncharacteristic odour associated with a competitor’s oxygen absorbing canister caused a voluntary drug recall by a major pharmaceutical manufacturer. Multisorb’s non-toxic StabilOx® oxygen-absorbing canisters were neither the cause nor were involved with this drug product recall. The substandard oxygen absorbers are a systemic issue in the industry. Though not the fault of the pharmaceutical manufacturers that closely adhere to regulatory requirements, recalls like this create a long-lasting, negative impact for the manufacturer as well as for the consumers, which rely on the drug product. For pharmaceutical manufacturers concerned about oxygen absorbers creating off odours and potentially contaminating their drug products, Multisorb Technologies continues to supply the pharmaceutical industry with its non-toxic StabilOx oxygen-absorbing canisters. These do not exhibit the unpleasant odour that initiated the recall. Multisorb’s StabilOx canisters offer a minimum 100cc of oxygen capacity and can be used with standard High-Density Polyethylene (HDPE) bottles. StabilOx canisters reduce oxidative degradation of drug products and stabilise the pharmaceutical formulations by managing the package headspace moisture and drug product free-moisture. When used within a foil-laminate heat induction sealed standard HDPE bottle, StabilOx canisters will effectively reduce oxygen to levels below 1per cent while maintaining humidity levels to <30 per cent, thereby preventing over-drying and balancing the drug product’s chemical and physical stability profiles. For added value, Multisorb’s StabilOx system combines the protection of its product with the reliability of its APA-9000 StabilOx canister dispenser, offering an unparalleled system for reliability and ease.

welcomed India’s accession, noting that “India’s accession to the Madrid system is a major milestone in bringing us closer to transforming the Madrid System into a system with truly global reach.” He noted that India’s participation in the Madrid system gives brand owners around the world the ability to extend their protection to the important Indian market, through a single, simplified and cost-effective procedure. India is the 14th of the G-20 economies to accede to the Madrid Protocol. “India’s accession to the international trademark system, as with the recent accessions by Colombia, Mexico, New Zealand and Philippines, signals an era of significant geographical expansion of the Madrid system, which offers greater benefit to right holders worldwide,” Gurry added.

FDA approves ACIPHEX® Sprinkle™ for use in children ages 1 to 11 Eisai Inc announced that the US FDA has approved ACIPHEX® Sprinkle™ delayed-release capsules 5 mg and 10 mg for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks. “We are proud to offer a new treatment option for young children who suffer from GERD,” said Lonnel Coats, President & CEO, Eisai Inc. The approval of ACIPHEX Sprinkle is based on the results of a clinical trial

of paediatric patients 1 to 11 years of age. The clinical trial was a multi-center, doubleblind, parallel-group study conducted in 127 paediatric patients with endoscopicallyproven GERD that consisted of a 12-week treatment and a 24-week extension period of two dose levels of rabeprazole. Overall, 81 per cent of patients achieved healing during the 12-week treatment period and 90 per cent retained healing during the ensuing 24-week extension period.

EMA accepts marketing authorisation application for empagliflozin Boehringer Ingelheim and Eli Lilly and Company recently announced the European Medicines Agency (EMA) has accepted for review a marketing authorisation application for the investigational Sodium Glucose Co-Transporter-2

(SGLT2) inhibitor empagliflozin for the treatment of type 2 diabetes mellitus (T2D) in adults. The acceptance of the application marks the beginning of the review process in the EU for this potential oral diabetes treatment.

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In Conversation With

There are always solutions, no matter how challenging the problem …says Dr Michelle Carr, Director and Company Secretary, Telezon Ltd, Australia. In this tête-à-tête with Modern Pharma, she reveals her journey in quest for innovative medical devices and how Telezon is now offering unique products and technologies globally. Read on the full chat...

Hardik Ashar hardik.ashar@network18publishing.com

Kindly tell us about the initial days in your current role. I was blessed to have a thorough education, both in Ireland and in Australia. After completing PhD in International Marketing in 2003, I decided to move into business. My father was an entrepreneur and so I was surrounded by business while growing up. We were always taught to observe, ask questions and more importantly find the solution – as a result, all of my professional roles have incorporated these elements. My current role epitomises this upbringing – we are always looking to improve on what we have developed, finding out the core challenges of the markets and how they can be resolved. What brought you to the field of medical device & technology? I was invited to be a Director of Telezon a number of years ago which introduced me to the world of medical devices, and I have enjoyed every day since – learning more about the global markets and how Telezon can address some of these unmet needs. What were the challenges that you faced to reach the current role? Challenges are there to help you become better at what you do (of course, we do not always feel that during those times!). I believe one of the biggest and most influential challenges has been learning not to become complacent either about what

you do or the market in which you operate. Brief us about Telezon’s operations, products and manufacturing facilities. Telezon Ltd is an Australian publicly listed, medical device company, based in Melbourne, Victoria. We design and develop injection solutions and their related technologies. One of the many unique aspects of what we do is that these injection solutions are made of medical grade polymer. Our flagship product, the SoloFlow® Reconstitution Needle, is US FDA registered, CE mark certified and is produced by our contract manufacturer in Germany. This product is currently being sold to the Serum Institute of India for vaccine kits. We have six families of patents which include a unique advanced moulding technology for polymer cannulae (CoreIT®), a plastic hypodermic needle with unique benefits such as the ability to melt the tip after use (PolyDermic®), and an injection solution that simplifies the injection process (DuoDraw®). Business plans ahead? Our business plan is consistent with previous years, and based on delivering shareholder value through increased commercial activity. Specifically, to accelerate the commercialisation of our technology and products so they reach the market in a timely fashion; continue to build exposure of the Company’s brand; and pursue global discussions around licensing and corporate partnerships.

Off beat Favourite Sport: Swimming Favourite dishes: Anything with chilli! Hangout places: Nearby great restaurants Dream destination: Okavango Delta, Botswana

What are your offerings to India? Currently, we are offering SoloFlow Reconstitution Needle to the Serum Institute of India and work closely with Hindustan Syringes and Medical Devices Ltd, India. These partnerships began over two years ago. We have built a healthy working relationship within those years and we look forward to further strengthening these relationships into the future.

We love what we do, we believe in our technologies and products and we enjoy working and learning from one another.

What are some immediate challenges that Telezon is currently facing. Your strategies to tackle them? One of the main challenges in the market has been the misconception about polymer needle. We recognised this challenge through our ongoing market research and developed CoreIT Technology and the SoloFlow Reconstitution Needle to educate the market with a non-injection plastic needle and its benefits, such as being cost competitive, recyclable and safer. We brought this technology and product to market, culminating in US FDA registration, in a speedy 15 months. As a result, we have found a dramatic positive change in both the perception and acceptance of polymer needles within the market place. As a company, Telezon is at a very exciting time in its development. Also, we are seeking investments to accelerate commercialisation of our products and technologies in the global market. In

addition, this investment will support our existing commercial agreements, two of which are with Indian companies. What growth areas have you identified within your business units? It is no surprise that global healthcare is a growing industry with an ageing population. This growth and demographic shift puts a greater demand on healthcare companies to supply the right products for the right market at the right price. Therefore, there is increased attention paid to products or technologies, for example, that might provide better, safer, cheaper or easier alternatives for medical groups and the end user. Our product and technology portfolio answers many of these growing market demands. How do you retain the best talent for your company? We work collaboratively on many aspects of the business, so each member is able to be a part of the ‘bigger picture’ for our business. Of equal importance is the fact that we love what we do, we believe in our technologies and products and we enjoy working and learning from one another. How do you describe your leadership style? How does that reflect in your organisation? A great deal of what we do is collaborative, so my leadership style has been strongly shaped by this style of working. I believe that no one person has all the answers (no matter how experienced) and so learning is a critical element of both growth and continued innovation. If you stop collab orating, le ar ning or sharing knowledge, innovation is at a risk of being lost.

What would have Telezon achieved in the next 2-3 years? I believe Telezon would have demonstrated its value in the market in the next 2-3 years. I hope that our technologies and products at that point would have already had a positive impact on global challenges such as infection reduction through minimising re-use of needles, as well as reducing waste and increasing recyclability. With our flexibility and agility, I would expect that our CoreIT Advanced Moulding Technology would have been applied across a number of applications; that our SoloFlow is being produced in significant volumes globally, along with our other products; and that we have established additional long-term partnerships across the world. What do you call as your most treasured possession? There are a lot of ‘things’ that I would miss but the most important elements in my life are my family and friends. How do you rejuvenate yourself? I enjoy spending time with my friends and family. Melbourne has a great range of activities from sports to eating, so I have a great selection at my doorstep. Mantra of success... Perseverance, passion, and above all laughter and a sense of humour! Your advice to budding entrepreneurs... Never take no for an answer. Continue to ask ‘is there another way to think about or do this?’ There are always solutions, no matter how challenging the problem.

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Special Focus

Shortcomings in quality manufacturing

Effective guidelines can come to the rescue Quality is an intrinsic attribute in pharmaceutical industry and always remains on the priority radar of policymakers, audit companies and responsible manufacturers. However, the most desirable attribute of a drug cannot be 100 per cent met without bearing its constraints on the cost side; especially when efforts are inclined towards designing a cost-effective product.

Nikunj Sharma nikunj.kumar@network18publishing.com

efore entering the manufacturing process, a molecule travels through extensive R&D, drug discovery and patient studies; which obviously makes ‘production’ a part of highly scrutinised processes across the entire line. Recently, a parliamentary committee linked to the Ministry of Chemicals and Fertilisers advised the Ministry to address the need of bringing CDSCO under the administrative monitoring of the Department of Pharmaceuticals (DoP) for

Quality remains an indispensable parameter for deciding on drug availability and pricing, which is hampered without a quality check tool in place under direct control. improved quality testing of drugs. The move is expected to widen the role of DoP to decide over availability and pricing of the drug, through quality control under its purview. Quality remains an indispensable parameter for deciding on drug availability and pricing, which is hampered without a quality check tool in place under direct control. Dr Manu Chaudhary, JMD & Director- Research, Venus Remedies Ltd, says, “Quality

PQS elements

is the creative outcome of dedicated, habitual team efforts articulated skillfully since inception. It bears a cost. Pharma is the most regulated industry in the world. All compliances guide towards an excellent quality product that involves skilled manpower, design, staging and validating. Every input has a cost and hence a low-priced product cannot come with 100 per cent quality commitment.”

Technology transfer

Pharmaceutical development

Product discontinuation

Pharmaceutical development

Investigational products

Shortcomings Various approaches to drug quality control comprises inspections performed by different government bodies, formulating and sticking to a detailed SOP and regular collection and quality testing of samples by the company staff. Assessment of the manufacturing plants and product assays carried out by outside firms is considered to be the best strategies to control the quality. There are several points in manufacturing process that may impact the quality of a drug such as: Inadequate cleaning of the facility: The most basic and important aspect of a pharma facility, which ensure keeping particulate impurities out of the work premise and this needs to be followed at each and every step as mentioned in guidelines. Lack in adherence to SOPs: Every company have clear in-house and regulatory SOPs to maintain the quality aspects. Missing one step may cost significantly depending upon its importance and stage of application. This also includes maintaining proper record of logs and laboratory equipment handling.

Good Manufacturing Practices

Inconsistent calibration of lab devices: Another sensitive area of concern, which is

Enablers Quality risk management

often skipped. However, some companies ensure it on a daily basis or using the device each time they log on to. Purity of ingredients: Ingredients being used either in form of raw material, catalysts and purification solvents, their purity is bound to play a part in final drug quality.

ICH Q10 PQS All compliances guide towards an excellent quality product that involves skilled manpower, design, staging and validating. Dr Manu Chaudhary JMD & Director- Research, Venus Remedies Ltd

Process performance & product quality monitoring system Corrective Action/Preventive Action (CA/PA) system Change management system Management review

Knowledge management

Source: ICH Q10 PQS

ICH Q10 PQS

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has latest guidelines for pharmaceutical quality called as ICH Q10 PQS. This model is an extension of previous versions ICH Q9 Quality Risk Management and ICH Q8 Pharmaceutical Development and equipped with latest GMP, ISO and QC standards. The guidelines cover following aspects: The ICH Q 10 guidelines for pharma are designed to attain product realisation, set up and maintain a state of control, and support continuous improvement. The concept provides a roadmap to drug quality by adopting essential steps of GMP including pharmaceutical development, technology transfer, commercial manufacturing and product discontinuation. The scope of guideline document extends to application to the systems facilitating the development

and production of pharmaceutical drug substances such as API and drug products, including biotechnology and biological substances. In addition, the standards ensure its application is adequate and proportionate to lifecycle stage comprising of new and present products. Next step to GMP covers management responsibility defining the task related to management commitment, quality policy, quality planning, resource management, internal communication and management review apart from managing outsourced activities and purchased materials. Further, another important aspect consists of proper follow up of change in product ownership.

Management responsibilities Although several pharmaceutical business follow high standards for quality by putting every possible effort to deliver an outstanding medicinal product, but it is not the universal practice. One cannot guarantee about the integrity of a particular supplier or manufacturer, as it is evident that fake versions of drugs are being circulated in the market. Authorities also sometimes indulge in negligence, resulting in backlogging of the inspection work, in turn encouraging malpractice in drug manufacturing.

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Special & Focus: Interface

A leadership with effective communication abilities and resource optimisation skills are the need of the hour Pallavi Mukhopadhyay

…says Dr H G Koshia, Commissioner, Food & Drugs Control Administration, Gujarat. Here, he talks about the importance of quality control and recent changes being made in this sector.

pallavi.mukhopadhyay @network18publishing.com

Tell us about the recent technological upgradation for quality control that is taking place in the biotech sector throughout India. Quality control as a function is under the challenge of productivity, automation and data integrity compliance in line with global regulatory expectations. The biotech sector is increasingly opting for use of techniques and instrumentation for rapid isolation and identification of microbial flora. Functions such as quality control and R&D are also required to cope up with the speed and accuracy of industrialisation.

A strong orientation and aptitude towards application of modern technology for resource mobilisation and usage are expected from modern leadership. What kind of risk management solutions are pharma/biotech companies today availing? Risk management is an approach to preview the risks associated with any process or activity and thereby progressively identifies, evaluates risks in terms of significance, magnitude, probability and device systems/techniques and technological tools to mitigate them. Risk-based approach is now being followed right from the stage of project planning upto its execution. Accordingly the design, processes and equipment are selected with a pre-identified but acceptable quotient of risk. What type of leadership skills does this sector need? A leadership with effective communication abilities and resource optimisation skills are the need of the hour. A strong orientation and aptitude towards application of modern technology for resource mobilisation and usage are expected from modern leadership. What new policies or plans should the industry or the government implement for better streamlining quality control operations in pharma? The harmonisation of Good Manufacturing and Good Laboratory practices as well as standard approach to quality evaluation by regulators across the world will facilitate the streamlining of operations of industry and thereby reduce the scope for non-standard operations. This will also facilitate the process of approvals, accreditations. Do you believe there is appropriate allocation of resources in this sector? What more can be done in this regard? The sector is vocal and dynamic per se and hence has sufficient propensity to mobilise the resources with modern concepts of financing and use of global

resources. However, the policymakers can support the new initiatives based on R&D as well as venture capital initiatives with a positive thrust. What kind of further training of pharma personnel is required for better quality control? Training needs are in the area of subject matter expertise at the operational level. This indicates that doers have to be well versed with the operations and principles of operations which they perform. The training in the areas of re-engineering, process improvements and cost reduction approaches can also improve the overall quality of work and hence the quality of product and services.

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Special & Focus: Interface

Concept selling is Fabtech’s biggest strength …says Asif Khan, CMD, Fabtech Technologies International Ltd. Here he elaborates about challenges faced by Indian pharma with a pinch of salt. Established in 1996, Fabtech today has achieved many commendable milestones nationally and internationally and is commited towards emerging as an International speciality construction solutions provider.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Tell us about Fabtech’s contribution to the pharma industry. Fabtech has revolutionised the way the Indian pharma factories are constructed. We have made modular partitions affordable and widely available in India. It was a product of the European domain and was exorbitantly priced but is now made affordable to small pharma players. The modular partitions for all of Mylan’s plants have been done by Fabtech. Further, Fabtech has also made isolators available to the

India does not manufacture sophisticated machinery and most pharma clients turn to Europe for high speed, high precision and highly automated machinery.

Indian market by value engineering them. Fabtech has brought speed to the table as far as construction of the factory is concerned. Concept selling is Fabtech’s biggest strength. We have also introduced Plasmolite and Plasswall external and internal walls to the market. While Plasswall is a complete load bearing wall with reinforcement and structural concrete inside, Plassmolite is non-load bearing partition walls with foam concrete. Recently, we have introduced patented ‘Ready to plug’ in building solutions for the masses. What are the loopholes seen in quality manufacturing among small scale pharma industries? About 8,000 small scale pharmaceutical and drug units form the core of the pharmaceutical industry in India. North India is an important region for pharma players However, many pharma companies in the North work with no proper guidelines, no dedicated rooms for specific processes and blending is often done by bare hands. These are hazardous processes and can adversely affect India’s brand image as a pharma hub. Do you think the recently announced Budget is conducive to growth of pharma sector? While the Chinese pharma industry is heavily backed by the government, it has lead to tremendous growth in past few years. Although the recently announced Budget may have been a blessing for some, the Indian pharma industry is growing steadily despite government support.

How can India lead the change and ensure high quality control? The problem with the Indian pharma sector lies in the fact that it lacks invention, research and development. India does not manufacture sophisticated machinery and most pharma clients turn to Europe for high speed, high precision and highly automated machinery. For a long period of time there has been no substantial development in the pharma machinery sector in India. However, India excels in reverse engineering machines already manufactured in the West and making them economically viable and affordable for mid-sized and small pharma players across the country. India can surely lead the world in reverse engineering.

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Special Focus: Roundtable

Do compliance and quality issues cast shadow on pharma deals? Nikunj Sharma

Pallavi Mukhopadhyay

nikunj.kumar@network18publishing.com

pallavi.mukhopadhyay @network18publishing.com

Didier Lacroix

K Vijayaraghavan

Senior VP, International Sales & Marketing, Cognex

Chairman, Sathguru Management Consultants

“India has been one of the most reputed suppliers of cheap and quality drugs to several countries, WHO and many global healthcare groups. The rapid growth of the Indian pharma industry has also made it an attractive destination for multinational drug makers. In the last two years, the industry has faced a tough challenge. Due to past experiences, the global drug makers were more meticulous towards buying or forming partnerships with Indian makers of generic medicines due to the revenue losses stemming from quality and compliance issues over previous acquisitions and tie ups. One of the key obstacles to this trend is the dwindling credibility that the Indian pharma industry has in the global platform Pharma, presently. being a sensitive Also, the adoption of new policies and sector, is highly restrictions on foreign direct investments in existing pharma units and a potential dependent on regulatory expansion of price control on drugs made compliances and proper adherence deal making tougher. The announcement to quality standards. The hype of taking permission from FDI board created by the global markets and prior to making any deals and recommendation of widening scope of players over the quality of generics price control to cover at least 430 tophas made investors conscious while selling drugs from 74 drugs has got an striking a deal in the pharma sector. immense change in decision making of foreign investors both for partnerships Experts from diverse arenas of and acquisitions. the pharmaceutical industry The trend of partnership and acquisition opine about the impact by multinational dealers has seen a setback. of these issues. But we cannot deny that there exist many big pharma companies in India that holds clean reputation throughout. Moreover, India is an attractive market for drug dealers; hence this kind of a situation is not expected to last too long. In 2013, the pharma industries will witness a change from its experience in the last two years experience. It is expected that in this year many large multinational companies will bring forth huge drug deals in the Indian pharma market.”

“As Indian drug producers and allied product producers grow in multifarious segments such as the chemical drugs, bioformulations and recombinant vaccines, reaching wider Indian and global markets, there is a need to bring a new paradigm shift in compliance and quality needs. The graduation of the sector to the centre of the global pharma industry requires all players to be moving to corporate oversight from external oversight. Focus would also have to move to task automation rather than the traditional manual controls and archaic records management. While India provides task management solutions to the OECD countries, internal adoption of these practices within Indian ventures is not far and wide. The service sector such as aseptic fills/finish, prefilled syringe making and lyophilisation services are also catching up requiring very stringent quality standards and compliances to be adopted. We need to focus on five elements to build our global dominance: -Adopt pharmacovigilence practices industry wide -Adopt structured risk management practices to anticipate, mitigate and manage risks including a robust recall system that can significantly enhance the patient safety and use of medicines -Human competency enhancement in compliances including global exposure to best practices. This has to be at all levels, strategic, operational and core compliance management levels -Facility up-gradation in older facilities and compliance focus in designing newer facilities -Strong corporate oversight with critical investments made in such oversight functions with direct reporting to top management on compliances. At the national level, there has to be a serious education and realisation at the policy planning level that would include support to industry to upgrade facilities and human competency with needed investments. There is also need to strengthen the GLP validation centres for clinical assessments and bring in more rigour in industry assimilation of GMP standards.”

Kapil Bhargava Retd Deputy Drugs Controller (I) CDSCO “India has been exporting drugs and formulations for few years now. We export mostly generic formulations to approximately 150 plus countries, this includes US, UK and other European countries. It is well known that India has maximum USFDA approved sites other than USA. For overseeing quality of Indian products and services, US FDA has presence here. We export essential medicines in social markets too through WHO and are supplying to different UN agencies. Our sites are audited by regulatory bodies and many a times by prospective customers from western world through their “qualified persons”. Compliance and quality issues do cast shadow on exports. The manufacturing sites of bigger companies sail through audits successfully, whereas not-so-big company sites are unable to sail through audits successfully. Our sites of SMEs are not in a good compliance of quality requirements of several countries in Africa, South East Asia, North America and Latin America. The reason for this is shortage of good ‘Quality Assurance Personnel,’ company’s management not giving due importance for strengthening QA and a rather patchy regulatory supervision by local drugs control agencies. If this is identified as main hurdle in stunting export growth, one of the ways to overcome this is improve quality of local supervision proactively. Our regulatory bodies must be in constant contact with those country’s regulatory bodies where our products are being exported regularly to understand each other’s operations for improving quality of products and ultimately human health. Our regulators have to demonstrate full transparency in their procedures and actions for increasing confidence in all concerned.”

T S Jaishankar MD, Quest Life Sciences Pvt Ltd “Technically, compliance and quality issues cannot be an impediment on pharma deals. However, the interpretation of compliance and quality criteria does affect the industry; especially after huge investments are made by the industry. The compounded fact that large companies, such as Ranbaxy, have had their product licences cancelled. It is indeed frightening for small and medium companies. Ideally, the companies would prefer single compliance criteria globally. Each country having its own regulations particularly with reference drug and BE standards is making it prohibitive for many pharma companies to enter various countries. Companies are forced to have two standards for the regulated and deregulated market. The regulatory guidelines are periodically changed making it difficult for existing plants to adhere to compliance. In spite of all these challenges, it is creditable that the Indian pharma sector has made great inroads into the global market and has achieved consistent steady growth of nearly 15 per cent annually. Government of India rightly identifies the pharma sector and has brought out favourable finance plants and recognition of research and development.”

Editorial take Despite the huge cry from global communities about the falsely created quality issues, the generics market of India is thriving and serving the low-cost market across the globe. The FDI cap to protect the Indian market will also provide extra support to exercise fair and sustainable deals in this sector.

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18 Insight & Outlook: Policies & Regulations Focussing 21 CFR Part 11

Managing e-records and digital signatures could be the key to success A key challenge for pharmaceutical manufacturers and allied industries is to achieve and maintain compliance as required by the regulatory body. In this feature, we provide an overview of managing electronic data and records in-line with regulatory requirements. Read on further...

Hardik Ashar hardik.ashar@network18publishing.com

T has significantly inf luenced modern world of pharmaceutical production and management. Gone are the days when all kinds of records were maintained on paper. Emerging technologies have positively contributed to let organisations go paperless at the same time maintaining all heavy-cumbersome data on chips few centrimeters long. As required by the Code of Federal Regulations, 21 CFR part 11 entitles the US FDA guidelines on electronic records and electronic signatures. Part 11, as it is known in general, provides criteria for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records. Thus, all users of computerised systems in pharmaceutical, medical device, biotech, blood and biologics companies, and contract research organisations regulated by US FDA are obliged to assess the quality assurance measures for authorisation of the software in use.

Approaches to compliance US FDA defines electronic records as any combination of text, graphics, data, audio, pictorial or other information representation in digital form that is created, modified, m ai nt ai n e d, arch ive d, retrieved or distributed by a computer system. “Compliance to Part 11 brings an opportunity to integrate the business process through process automation. It allows transparency and integrity of the data, documentation and computer systems,” suggests Dr Manu Chaudhary, JMD & Director - Research, Venus Remedies Ltd. “As of now,

An SOP is needed for establishing and maintaining user access to the system and/or network mentioning the individual user ID and password requirement for authorised users.

there are no set standards or widely accepted procedures to ensure long-term data viability and procedure of storage media usage,” she adds. Non-compliances are subject to number of actions by the regulatory agency like receipt of Form 483, a Warning Letter, or a more serious reprimand, such as a Consent Decree, that may result in significant delays to regulatory approval, time-to-market, product recalls or closures of the facility altogether. “Anything that puts data integrity into question can potentially invite regulatory attention,” says Dr Chaudhar y. Following are some of the approaches to achieve and maintain compliance: Signature should include the minimum information and traceable in audit trail Data encryption to ensure the security and integrity of data to end-to-end user Single user ID and password to ensure the data is operated by authorised person System’s Standard Operating Procedures (SOP) should be in place for maintaining and retrieving electronic records A few years ago, agency issued guidance on the scope of Part 11 guidelines. The agency clarified on narrowing down the scope of guidelines to dispel confusion of broader scope which were leading to unnecessary controls and increased costs thereby discouraging innovation and technological advances without any benefit to the public health. Under

the narrow interpretation of the scope of part 11, with respect to records when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when people use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, agency would not consider persons to be using electronic records in lieu of paper records.

Training requirements Basic knowledge and understanding of part 11 regulations is the key to succeed in audit. Training must be available for system users, developers, IT support personnel. Guidelines on compliance suggests that individuals, either the employees, or contractors who develops maintain, or use computerised systems must be educated, trained to perform assigned tasks. Training should be rendered by qualified individuals on a continuous basis, as needed, to ensure familiarity with the computerised system and with any changes to the system during the course of the study. Organisations must understand regulatory expectations for use and control of electronic records and signatures in computer systems and applications. “If trainings are completed and documented in good order, the system is more likely to

be consistent and compliant,” avers Dr Chaudhary.

Challenges and way ahead Organisations are often concerned with the risks and costs involved in ensuring that their electronic systems comply with the current agency’s requirement but there remains ambiguity in practice. “There is often a lack of clarity on what features a software or a system must have to comply with 21 CFR Part 11,” affirms Dr Chaudhary. She adds, “Even when a solution meets all requirements, ensuring that procedural requirements such as SOP, training, record keeping may pose a bigger challenge.” It is easy today to find a CFR Part 11 compliant

Compliance to Part 11 allows transparency and integrity of the data, documentation and computer systems.

Dr Manu Chaudhary JMD & Director - Research, Venus Remedies Ltd

software if one has to purchase a new equipment. The practical problem is usage of old software for which compliance with the requirements is difficult to demonstrate. A way forward is the validation of system to ensure reliability, accuracy and consistent intended performance. Although computer system validation is a requirement and not enforceable, companies should perform the risk assessment of their process and determine the potential impact of the processor or system to affect product quality, safety and data integrity. Another approach is through generation of audit trail. An SOP may be needed to govern retention and archiving of audit trail items. Actual generation of records of performed activity is a responsibility of service provider. Since the document management system automatically manages properties that indicate the status, nature and scope of each document, it is easy for authorised user to locate records needed by auditor. Therefore, the time to respond to a request for records is decreased and confidence in the ability to supply the correct records is increased. In addition, records must be protected. Archiving of documents and eventual destruction should be controlled by a records management policy and an SOP for configurable change control system. Measures should be in place to protect documents against accidental deletion or modification, such as might occur on a file system. In general, an SOP is needed for establishing and maintaining user access to the system and/or network mentioning the individual user ID and password requirement for authorised users. Validation of signature and data encryption to prevent manifestation requires the signature and capturing of the user name, local date and time, universal time coordinated, server date and time, and meaning for signature. Local date and time or server date and time can be displayed in the manifestation as desired. This information is recorded in the audit trail. In this way, companies can stay ‘worryfree’ delivering valuable products and achieving their business objectives.

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Insight & Outlook: Strategy

Zeroing in on a brand name

Nuances of the tricky game Unlike in the past, today, every pharmaceutical company has a large basket of brands under its umbrella, each vying to reach the top spot. With globalisation of the Indian pharmaceutical industry, practically every drug company has introduced most of the products similar to their competitors, so as to have a toe-hold in the competitive healthcare market. This glut of brands at the chemist counters has made the job difficult for everyone – manufacturer, marketer, chemist, patients as well as doctors. he manufacturer has a large number of brands of the drug to compete with, while the chemist finds it difficult to store such a wide variety of products in his shelves. The physician is overwhelmed by the number of companies promoting the same molecule so much so that he is hard pressed to give time to medical representatives in their limited clinic hours. Moreover, when the patient arrives, the physician has to mentally select the appropriate drug and then sift through a dozen brand names in his mind. Although there is a wide choice in the number of brands at a range of prices, the patient does not find it easy to locate the brand prescribed for him at the medical shop close to his house! Being an almost life-ordeath situation, every company tries to corner each and every drug prescribed by each doctor across the length and breadth of the country. This aggressiveness gets reflected in the manner in which brands are named.

Name selection Brand names of pharmaceutical drugs are chosen with a great deal of thought. Different strategies are adopted for selecting the brand name. After a drug is launched, it is the aptness of the name that helps the busy physician to recall the right brand when the patient complains of an illness. A wide range of techniques are adopted to arrive at the best name for a drug. Chemical name: The brand name chosen for a drug usually reflects some property of the molecule or its chemical name so as to enable the prescriber to remember it easily. In most cases, the name has the first few letters of the generic chemical. For example, Gabapin for gabapentin, Disprin for aspirin, Betnovate for betamethasone ointment, Ciplox for ciprofloxacin, Alprax for alprazolam, etc. Disease related: Many names try to match the condition for which it is recommended. For example, Migranil for migraine, Candid for candidal infection, Haem Up for anaemia, Febrex for fever, T-bact for bacterial infection, Fungicide for fungal infection, Rashfree for skin rash, Scabex for scabies and so on. Demographic: Drugs meant for children are named

With so many brands starting off with the same three or four alphabets, there is every risk of the chemist making an incorrect reading of the doctors’ prescription. Alternatively the ill-qualified counter boy could be inadvertently dispensing the wrong drug (Cipladin instead of Ciplactin), and the gullible patient may not be aware of it since the spellings are so deceptive.

Ethical issues

incorporating the word ‘kid’ or ‘ped’ from paediatric; eg, Kidpred, Pedmox. Likewise, drugs meant for menstrual problems or concerning other health issues of women are suffixed with ‘Eva’ or Gyno; eg, Gynae CVP, Gynosafe, Keraglo Eva. Company name: Many products are named sounding similar to its manufacturer’s name. Once a pharmaceutical company gets well known among practising doctors, they go on to launch future brands with a name adapted from their own name. Most indigenous companies adopt this technique and they name drugs bearing partially the company’s name and remaining half, the chemical name. Waladrox is cefadroxil, Walavin (griseofulvin), Walagesic (for pain relief), Walacort (cortisone) from Wallace Pharmaceuticals. Also, Cipla Ltd has drugs named Ciplar (propranolol), Cipladine (povidone iodine), Ciplactin (cyproheptadine), Ciplacef (ceftriaxone), Ciplin (co-trimoxazole), Cipcorlin (hydrocortisone) etc. Similarly, HHsone (cortisone), HHmite (permethrin), HHfudic (fucidic acid) etc are brands of H&H pharmaceuticals. Perhaps, the idea is to help their loyal doctors to connect the brand name to their company and thereby target good sales.

Faster recall While there is no detailed scientific study on which type

of brand name is the sure shot winner, most clinicians agree that the one which is similar to the generic name of the drug is remembered without much effort. The reason for this could lie in the fact that medical students as well as practitioners are made to memorise pharmacology ad infinitum, which ensures that the generic name is embedded in the doctor’s permanent memory. Besides, they remain in constant touch with scientific journals which regularly discuss newer molecules under research and new chemical names are repeatedly mentioned in the text.

Drugs which are launched with the company name as the major part of the brand seems like a good idea from the company’s standpoint.

When the drug is eventually launched in the market, if the brand name happens to match what the doctor has recently read about: Hey presto! The brand locks into his preexisting grey matter permanently. The recall of this brand would always be much faster than the others. A probable reason for such a thought process is the fact that medicos are repeatedly taught to think of an answer (meaning, drug) to give relief to the patient. Hence the generic drug comes

to mind faster than synonyms of the disease while examining the patient. Thus ‘Nebivolol’ (the antihypertensive drug, generic name) comes to mind faster than ‘Hypernorm’ (the brand name, sounding such as hypertension). Similarly ‘Flucos’ (similar to generic Fluconazole) is recalled before ‘Fungid’ (fungal infection).

Company name as brand Drugs which are launched with the company name as the major part of the brand seems like a good idea from the company’s standpoint. Often the marketing teams from well established companies have a great rapport with physicians in their area. In this case, with the newly launched baby, the name can be easily explained. The MR feels that the new name will stick to the doctor’s memory as he can recall it each time the former makes his entry into the dispensary or consulting room. Moreover, chemists who are familiar with the company’s past sales record will readily agree to stock the new medicine since the manufacturer has a reputation. He also will dispense the new brand quickly and correctly as soon as it is introduced. The manufacturer’s profits appear to zoom the moment the new products hits the counters. Double edged: While these are inherent advantages, the technique has a fair share of risks too, which may not be too obvious to the manufacturer.

These days a lot of hullabaloo is raised about the issue of unethical practices by physicians and the pharmaceutical companies. Owing to the accusation of a nexus among these two sections of healthcare services the Medical Council of India as well as the Organisation of Pharmaceutical Producers of India (OPPI) have drawn up their code of conduct for their members. Members of the public are now increasingly becoming aware of dishonorable practices by physicians and they approach their doctors with a watchful eye. A senior consultant once had to face an embarrassing situation when he prescribed Tab Zathrin, Tab Zyrtec and Zincoderm cream to a young man. Just as the patient was about to leave, he paused at the door, turned and asked, ‘Doc, are all the 3 drugs of the same company?’ Under such a circumstance, even if a dermatologist was to ethically prescribe Tab Ciplox, Tab Ciplactin, HHsone (a steroid) cream along with HHmite cream and HHfudic cream to a patient suffering from secondarily infected scabies, there would be suspicion of collusion even though the prescription would be scientifically accurate!

Checkmate! As a result, many discerning doctors tend to play safe by refusing to combine similar sounding brands in one prescription, as far as possible. In the ultimate analysis, the net result is the exact opposite of what the ‘intelligent’ brand manager desired. Therefore, it would be wise for the current breed of pharmaceutical marketing managers and the product management teams to find novel ways of naming brands to be launched in future and avoid the easier option of linking it with the name of the company. Dr Rajan T D Pharma Consultant & Practising Dermatologist rajan.td@gmail.com

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

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,lâ&#x20AC;&#x2122;-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease

is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint Venture, technology licensing, research partnerships Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side-effects are reported to be the advantages of this product. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Process of preparation of nanoparticles for drug delivery system The present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application Medical and pharma industry Forms of transfer Technology licensing Pharmaceutical composition for the treatment of ophthalmic disease A company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Areas of application Pharma and medical industry Transfer terms Consultancy, technical services, technology licensing

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

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

Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others

Manufacturing of liquid bio fertilisers An agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered and a procedure of buying the technology along with the cost incurred. Areas of application Biotechnology Transfer terms Others

Extract of medicinal and aromatic plants A company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others IV fluid manufacturing as SME An Indian company needs new and good technology to start which is a subservient of genetic manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others Manufacture of intravenous fluids A company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials. Areas of application Pharma/medical Forms of transfer Others

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

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Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Capacity expansion of Halquinol BP-80 drug unit Project type: Facility expansion Project news: Provimi Animal Nutrition India is planning capacity expansion of Halquinol BP-80 drug unit.

equipment, instruments, ambulance, miscellaneous items, ancillary services namely, kitchen, laundry, CSSD, medical gases manifold system, bio-medical waste management system & furniture for district general hospital at Dickoya/ Hatton, Sri Lanka. Project location: Dickoya/Hatton, Sri Lanka Project cost: NA Implementation stage: Planning

Project location: Bengaluru, Karnataka Project cost: NA Implementation stage: Planning Contact details: Delta Finochem Pvt Ltd, 121, MIDC, Satpur, Nasik 422 007, Maharashtra Tel: +91 (0) 80-3368 0002 Fax: +91 (0) 80- 2846 1520 Email: info@provimi.in Installation, testing & commissioning of medical equipment Project type: New facility Project news: Ministry of External Affairs is planning to install, testing & commissioning of medical

Contact details: Ministry Of External Affairs South Block, New Delhi-110011 Tel: +91-011-23011127,23011165 Fax: +91-011-23013254,23011463 Email: eam@mea.gov.in Installation, testing & commissioning of waste condom shredding machine Project type: New facility Project news: HLL Lifecare Ltd is planning to install, testing & commissioning of waste condom shredding machine at Peroorkada Factory, Thiruvananthapuram.

Project location: Trivandrum, Kerala Project cost: NA Implementation stage: Planning Contact details: HLL Lifecare Ltd Mahilamandiram Road, Poojappura Thiruvananthapuram - 695 012 Kerala Tel: +91-471 2354949 Fax: +91-471 2354949 Email: info@lifecarehll.com Narcotic drugs manufacturing unit Project type: New facility Project news: Sparsha Pharma International Pvt Ltd is planning to install narcotic drugs manufacturing unit. Project location: Hyderabad, AP Project cost: ` 240 million Implementation stage: Planning Contact details: Sparsha Pharma International Pvt Ltd # 8-2-408, D-3, Sri Krishna Apts Road No: 6, Banjara Hills, Hyderabad - 500 034 Tel: 040- 23352581/ 83 Email: info@sparsha.com Planning a fermentation facility to produce corticosteroids Project type: New facility

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Project news: Symbiotec Pharmalab Ltd is planning a fermentation facility to produce corticosteroids. Project location: India Project cost: ` 450 million Implementation stage: Planning Contact details: Sparsha Pharma International Road No: 6, Banjara Hills, Hyderabad - 500 034, Andhra Pradesh Tel: 040- 23352581/ 83 Fax: 040-23352880 Email: info@sparsha.com Set up OTC medicine facility in Gujarat Project type: New facility Project news: Gujarat Israel-based Teva Pharmaceuticals, an $ 18 billion generic drug maker will set up OTC medicine facility in Gujarat in collaboration with Procter & Gamble. Project location: Ahmedabad, Gujrat Project cost: NA Implementation stage: Planning Contact details: Teva Pharmaceutical Industries Ltd 5 Basel, St. Petach Tikva 49131, Israel Tel: +972-3-9267267 Fax: +972-3-9234050 Email: elana.holzman@teva.co.il

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1-15 April 2013 I Vol 1 I No 19 I `100

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In Conversa

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Nathan Sigwort h Co-Founder and CEO, Pharmasecure

Baxter closes haemophili deal for potential a drug

Dear Reader,

Avastin unit dose syring recalled es eye infectiondue to potential

â&#x20AC;&#x2DC;Modern Pharmaâ&#x20AC;&#x2122; solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

Special Focu s 14

Contract manufa cturing Offering cost-effe ctive uncertain econom solutions amid ic scenario

Baxter Interna tional Inc has acquisition closed its of a potenti al haemophilia treatment from Dr maker Ipsen the French drug K Anji Found er and Inspira Reddy , Biopharmaceu and tion ticals Inc. Chairm an Dr. Reddyâ&#x20AC;&#x2122; that could s Laboratories of be worth more in a deal passed away Ltd, recentl million. Baxter, than y based in Deerfie $ 180 Apollo Hospit of liver cancer at had said in the ld, Ill, al in Hydera January it considered bad. He was agreed to buy the drug, as the labeled OBI-1, in pharmaceutic drug discovery pionee manufacturing and related r al industry. operations. in life was to His Ipsen provide innova mission annou nced medicines at tive new Baxter a price that that agreed the could commo afford. $ 50 million to n man pay upfront, Dr Reddy $ 135 million up to obtain ed in milesto from gradu ne payments Unive rsity and a percen ation tage of Mumb specia lisatio is being studied of global sales. OBI-1 n in Pharm ai with as a possibl Science and aceuti cal for people Fine with acquire e treatment PhD in Chem Chemicals and d haemophilia A. OBI-1 later has National Chemical Engineering from orphan drug been designated an ical Labora tory, Pune. and the Europein the United States Dr Reddy will get years an Union, meaning it of if it is approv marketing exclusivity ed.

Facility Visit 20

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Soon after his studie s, he the state-o wned IDPL served in founded the before he was honou company in 1984. He red by the of India Government with the Padma one of the highest Civilia Bhushan, India, recogn n Awards in ising his service of distinguished high order of Trade and Indust in the field CNBC TV18 ry. In 2012, confer red the Achievement Award (IBLA Lifetime for being ) on him a visionary who had spent a lifetime building up into a coloss his compa ny us with a puttin g Indian industglobal reach world map. ry on the

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Event List

N AT I O N A L E V E N T S Pharma Pro&Pack 2013 PHARMA Pro&Pack Expo 2013 will offer an opportunity to expand business in the Indian and international pharma industry. Various industry majors from India and across the world will be present at the Technology Show. The event will help facilitate meetings with clients & prospective customers at one place on one platform thus expanding business to new customers locally & internationally; April 24-26, Bombay Exhibition Centre, Mumbai For details contact: GPE Expo Pvt Ltd Tel: 91-79-40008253 Email: contact@pharmapropack.com Website: www.pharmapropack.com

iPHEX 2013 iPHEX plays a major role in introducing the Indian market to the advanced medicinal products. This show covers up the entire medical industry, starting from hospital services, medicines, pharmaceuticals and surgical sectors. 250 companies have already registered to participate in this event as they think that this podium is best way to reach out to the customers and publicize their brand name; April 24-26, 2013, Bombay Exhibition Center (BEC), Mumbai For details contact: Pharmaceuticals Export Promotion Council Tel: +91-40-23735462/23735466 Fax: +91-40-23735454 Email: sales@iphex-india.com Website: www.iphex-india.com

ADME & Toxicology 2013 and â&#x20AC;&#x2DC;Nanomedicineâ&#x20AC;&#x2122; conference and exhibition The conference will provide attendees with a learning and networking environment where they can share and discuss the latest developments in the field of life sciences. This conference will aim to provide a multidisciplinary approach to tackle the fundamental challenges in this specialty, innovative strategies for testing exposure, and techniques for improving the reliability and accuracy of results. The keynote speakers will give presentations on all areas of nanomedicine backed up by a panel of experts speaking on highly relevant and â&#x20AC;&#x2DC;hotâ&#x20AC;&#x2122; topics such as green nanotechnology, nanomedicine in theranostics besides discussing topics such as novel synthetic approaches in nanomedicine, nano-delivery systems and regulatory and toxicology aspects in nanomedicine; May 30-31 2013, Raddison Blue Plaza, Delhi For details contact: Select Bio Ltd Tel: +44 (0)1787 315110 Fax: +44 (0)1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com/ conferences/index.aspx?conf=ND2013

PHARMAbiotika Pharmabiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days

HYDERABAD

Andhra Pradesh, May 31- June 3, 2013 Indiaâ&#x20AC;&#x2122;s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

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Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. R5 &95fhh5iffi5jlkg5R5 295fhh5iffi5jjoo5R5 ' #&95 (! 2*)H( .1),%gn*/ &#-"#(!8 )'

conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives, September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 â&#x20AC;&#x201C; 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

Indian Pharma Expo The Indian Pharma Expo 2013 will be one of the a unique pharma events inIndia that will serve as a perfect platform for pharma entrepreneurs andinvestors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and the largest suppliers and distributors of pharma products under one roof in order to facilitate the exchange of ideas for better growth of the industry; September 20-21, 2013, Pragati Maidan, New Delhi

For details contact: UBM Medica India Pvt Ltd Tel: +91-22-66122600 / 66122673 Fax: +91-22-66122626 Email: info.india@ubm.com Website: www.ubmindia.in

34th International Conference on Bioscience, Biochemical and Pharmaceutical Engineering The main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology and more; December 5-6, 2013, Sheraton, Bengaluru For details contact: World Academy of Science Engineering and Technology Tel: +44-782-4879405 Website: www.waset.org/ conferences/2013/bangalore/icbbpe/

I N T E R N AT I O N A L E V E N T S Pharmaceutical Research Conference for Pharmacy Students & Young Graduates Themed â&#x20AC;&#x2DC;Meeting of the inquisitive minds: translating research into realityâ&#x20AC;&#x2122;, PRC 2013 is set to be the arena for pharmacy students & young graduates to showcase research & interact with other young researchers to ignite interest & exchange ideas. The conference will provide an environment for pharmacy students to present their research work and share their knowledge. Participants can present and discuss the newest developments and breakthroughs in the field of pharmacy. It will set base for more interaction between pharmacy students and young graduates; May 11-12, 2013 Cyberjaya University College of Medical Sciences, Selangor, Malaysia For details contact: Faculty of Pharmacy, Cyberjaya University College of Medical Sciences Email: secretariatprc@cybermed.edu.my Website: http://prc2013.weebly.com/

18th Edition of FCE Pharma FCE Pharma will be held to promote pharmaceutical industry. At the event, exhibitors will get an opportunity to showcase their innovative products and services such as equipment, services, logistic, processes, quality control, outsourcing, analysis, laboratorial, process equipment, valves, automation and technology. The main aim of FCE Pharma will be to bring together

world renowned companies related to raw material and packing. The event will provide the visitors with the latest developments and trends. The event attracts visitors and exhibitors from all over the world; May 14-16 2013, Transamerica Expo Center, Sao Paulo, Brazil For details contact: NĂźrnbergMesse Brasil Tel: +55 (11)-3205-5000 Fax: +55 (11)-3205-5070 Email: fcepharma@nm-brasil.com.br Website: www.fcepharma.com.br/en/

The Clinical Genome Conference Bio-IT World and Cambridge Healthtech Institute will host the 2nd Annual TCGC: The Clinical Genome Conference is inviting stakeholders from all arenas impacting clinical genomics to share new findings and solutions for advancing the application of clinical genome sequencing. The conference will bring together many constituencies for frank and vital discussion of the applications, questions and solutions surrounding clinical genome analysis, including scientists, physicians, diagnosticians, genetic counselors, bioinformaticists, ethicists, regulators, insurers, lawyers, and administrators; June 25-28, Hotel Kabuki, San Fransisco, CA For details contact: Cambridge Healthtech Institute Tel: 781.972.5400

Fax: 781.972.5425 Email: chi@healthtech.com Website: www.clinicalgenomeconference.com

International Congress of Toxicology 2013 The theme for the conference is â&#x20AC;&#x2DC;From Basic Science to Clinical and Environmental Outcomesâ&#x20AC;&#x2122;. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: ict@ict2013seoul.org Website: www.ict2013seoul.org

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11, 2013, Korea

For details contact: Terrapinn Pvt Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email:enquiry.sg@terrapinn.com Website: www.terrapinn.com

3rd International Conference on Environmental, Biomedical and Biotechnology 3rd International Conference on Environmental, Biomedical and Biotechnology is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society Tel: +86-28-86528465 (China Branch) Email: cebb@cbees.org Website: www.icebb.org The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.

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Event Preview

iPHEX 2013

Set to provide a booster shot to pharma and healthcare With the objective of further strengthening the Indian pharma sector, Pharmexcil along with the support of the Government of India is hosting iPHEX 2013 in Mumbai during the month of April. With various big plans in place for this edition, iPHEX is looking at leaving a lasting impression on both the Indian as well as international buyers. Here is a lowdown on what is in store this edition.

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

ndian pharmaceuticals have been showcasing a unique competence and strength when it comes to manufacturing generics. While many countries are facing healthcare challenges such as incoherence with affordability and quality medicines, India has stepped up and emerged as a global leader in generics. With many products going off patent, a huge market opportunity is emerging for Indian manufacturers to tap. Further, the prospects of India as an outsourcing destination for CRAMS, clinical research, biotechnology, bio-informatics etc is steadily growing due to availability of skill, lower costs and delivery advantages. Against the backdrop, Pharmexcil is set to host iPHEX 2013 at the Bombay Exhibition Centre in Mumbai on April 24-26, 2013. The event is supported by the Ministry of Commerce & Industry,

Department of Commerce, Government of India. This exhibition will provide an opportunity for Indian healthcare sector to showcase to the world its strengths and capabilites through its own expo.

drivers - government support & regulatory framework, cost efficiencies, technical capabilities of the sector. Bhavin Mehta, Committee Chief, iPHEX, emphasises, â&#x20AC;&#x153;Through iPHEX, exhibitors can expect good business through interaction with international buyers. They will get an opportunity to interact with about 350-400 hosted overseas buyers. This will generate huge business for the Indian pharma industry. It is an opportunity to connect with all nodal centres in global markets. These nodal points of contact are Embassies, Missions, High Commissions, Chambers of Commerce, pharma associations, and procurement agencies.â&#x20AC;? The event will also witness Rx India technology seminars, international buyer seller meets, product launches, manufacturersâ&#x20AC;&#x2122; presentation and trade & investment seminars alongside

Key objectives Dr Appaji, Director General, Pharmexcil states, â&#x20AC;&#x153;The exhibition will showcase Indiaâ&#x20AC;&#x2122;s developing pharma and healthcare sector. It will serve as a platform to strengthen and promote Brand India. While export promotion and business development will be the driving forces, the expo will also spread awareness about Indiaâ&#x20AC;&#x2122;s pharma success story.â&#x20AC;? Fostering the credibility of Indian pharma industry, protecting it from dubious attacks are also some of the other major objectives. Also, positioning India as a â&#x20AC;&#x2DC;premium value destinationâ&#x20AC;&#x2122; for the global pharma industry and generating momentum in encouraging innovation in pharma in India will remain a priority for the organisers. Further, it aims at increasing business on a sustainable basis and highlights the growth

Expected exhibitor and visitor turnout The event is expected to see buyers and government officials from various profiles.

It is anticipating participation of international buyers from countries such as Africa, LAC, CIS and ASEAN+2, large volume buyers seeking manufacturers, government procurement agencies, hospitals, healthcare services providers and NGOs, drug regulators & FDA officials, officials from

The exhibition will showcase Indiaâ&#x20AC;&#x2122;s developing pharma and healthcare sector. It will serve as a platform to strengthen and promote Brand India. Dr Appaji Director General, Pharmexcil

private sector hospitals, clinics, daycare centers and institutes, agents, distributors, dealers from financial institutions, banks, private equity and venture capital funds, institutional agencies and development aid agencies. The mega â&#x20AC;&#x2DC;India Showâ&#x20AC;&#x2122; will bring the pharma and healthcare sector under one umbrella. IPHEX will showcase the strength of the Indian pharma by focussing on following sectors such as formulations, APIs, Ayush, nutraceuticals, health services, biotechnology and biotechnology products, R&D services, technology & consultancy, government and state pavilion, diagnostics, surgical dressing, medical devices, contract manufacturing, research Clinical Trials Outsourcing (CROs) and custom synthesis. Thus the exhibition, co-located with PHARMA Pro & Pack Expo 2013, a show for pharmaceutical machinery manufacturers, will serve as a good platform to connect, share ideas, generate business thus furthering the growth of the sector.

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13 Special

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Nanotech in pharm Aiming a for sizeab le benefits in India

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tradem arks: the changi ng trends

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MCC-Sou th Africa markets approval opens up for Marck Bioscien key African ces

Pulin Shroff Managing Director, Charak Pharma

Marck Biosciences chapter in Africa has opened a 3QFY13 of the new Preview with Marck Biosc Earnings Medicines South Afric the award the oppor iences, the appro an sustained momentum to be approval Control Coun tunity of val large-cap by most cil accessing carries appro manufacturfor six produ Africaâ&#x20AC;&#x2122;s some of val, Bhave cts Accordinggenerics ed at its most Volume sh Patel, Biosc economies. stable growt to Kotak Equit ies Parenterals Small MD, h Africaiences, said, Institution facility â&#x20AC;&#x153;The MCC Marck (SVP) MCC -Sout at Khed approval expected earni ngs a, Gujar grow th al -Sout for will The certif icatio h Afric at. y-o-y for to stay over MCC is aâ&#x20AC;&#x2122;s currenprovide furthe our Kheda facilit h 20 will also appro val recog nised n is r impet y t expan Ranbaxy. large-cap gener per cent also us to our Biosc ience enable Marc region and sion efforts ics excep The strong participatin by will be performan t g autho 43 also augm PIC/S count in the African immediate s to achie k driven of the ries. We by launc rities share ve ce access gains markets would hes/market filing and ent our effort Inspe ctionPharm aceut ical in including to key s by growth licensing Botsw ana, in SA. in dome the US, stable Conv entio Namibia, and with new our own I and a stic see n Phar strong partners formulation Zimb abwe Patel favou Swaz iland in these mace utica Inspection revenue and Lupin rable curren s , , l believ under-serve potential Zambia, Co-o cy. Leso tho, Scheme d acquisition will also benef Cadila Malawi (PIC/S). peration contr e that we can markets and MCC s and facilit we it This on a y-o-y make ibutio approval from ate expor EBITDA may is expec Madagascar. waiver these countn to healthcare a quantum basis. margin ted to result of to PIC/S Biosciences of t by Marck expand too is expec The products ries.â&#x20AC;? of these inspection by y-o-y Six produ in ted to the autho in well as participating certified SVP weak base/c for Cadil count cts have obtain a (350 registration authorities ries rities from non-PIC/S urrency), bps, accept product ed appro as sterile MCC-South of certifi and an easier autho GMP mix/curren Cipla (150 bps, ed produ water for Africa, includvals participatin certificates rities who bps, Trico cy), Lupin cts. For ml; ciprof from PIC/S ing injections g (260 product r) and Glenmark Speaking authorities. mix). Dr. timolol loxacin eye drops BP 5/10 (244 bps, on the (0.25 and expected Reddyâ&#x20AC;&#x2122;s MCC-Sout ml; lidoca 0.5 %) eye 5/10 ml; to remai margi h Africa n flat y-o-y n is Abbo tt and lidoca ine injection BP drops 5/10 . Domestic (1%) ine inject separ ation has comp ion BP)2% 5/10 ml A growt growth to rema ) 5/10 ml. of its leted based h the Abbo in stable pharm is expec in domestic formu tt is aceut icals resea rchted to be whic h lations Pharma scien ce-ba one of the becam the e AbbV busin ess, indep enden large st (20 perce highest for Sun sed, reported healt ie, nt diver t y-o-y hcare a new bioph arma AbbV ie a sified than Bioch 24 per cent growt ). Cadila mark et-lea comp anies that speci ality is a resea comp any. , with h, highe is underlying em, which is expec diagn ostics ding offer r alrea dy biop harm rch-b ased ings in maki ng comp any growth ting an Lupin, nutri tiona , medi cal a devic es, differ ence, signif icant medi cines with a broad aceu tical s Glenmark of 18 per cent. ls and also likely gener ic portf olio and Cipla focus sing bran ded on highl immu nolog, inclu ding pharm to post leade rship of are (17-18 y â&#x20AC;&#x153;We wish aceut icals. healthy y and per mark et-leaspeci alised , pipel ine growt our is expec cent y-o-y). of break virolo gy, and in at AbbV Dr. Reddy h thera pies ding ted to ie conti collea gues throu gh a as grow in industry â&#x20AC;&#x2122;s thera pies. for some they becom nued succe of the growth line with ss world Ranbaxyâ&#x20AC;&#x2122;s new, indep of 15 per e part diffic ult-to â&#x20AC;&#x2122;s most cent and of a growth ende nt (11 per comp any White disea ses,â&#x20AC;? -treat cent y-o-y may stay muted ). said D Whit Miles MĂŠdecins US appr e, and CEO, Chair man welcomed Sans Front may holdovals, competitio iĂ¨res (MSF Abbo tt. of bedaq the approval by ) this n stock perfothe key to uiline, the impor against Tuber the first new US FDA For Lupin rmance as possib tant medical advan le. since 1963. culosis (TB) to drug active , the launc Tricor use bedaq The onus is on ce as soon be registe h of has uiline to TB in 50 â&#x20AC;&#x153;The first new red regim all In with focus been an expec generic devise new of us to develo addition years is an drug to ens for treat said Dr to bedaq treatm drug-r ped competitionshifting to entry ted event shorter, Manica immense milest uiline, more tolerabesistant TB that ent drug that by Janssen, a Balase one,â&#x20AC;? Director, second OC produ . The launc of further are more are TB MSF Acces garam, Execu is active new h effective,â&#x20AC;? le for patients fact that tive â&#x20AC;&#x153;With called delam s Camp against key factor cts and ramp of more the drug MDRbetter treatm said Dr Balase and Otsuka, anid, develo up will resistant is active aign. â&#x20AC;&#x153;The garam. is US launc s. Dr. Reddyâ&#x20AC;&#x2122;s should be agains forms ent under ped on the way, t drugexecu be all the of the going registr the Europ hes by potential there more Additional has gained mom tion of up ean Medic game chang disease makes ation by expected ines Agenc it a Theour efforts to treat incentive to scale entum Todayâ&#x20AC;&#x2122;s er.â&#x20AC;? limited to launches y and is MDR treatment scale competitio . Together, be approved for resistant for multid pipeline (in 4QFY13) huge, with of the DR-TB -TB today.â&#x20AC;? n TB (MDR an unprethe two new drugsuse in 2013. rugvisibility epidemic course and US 310,000 -TB) is likely trigge of in 2011. cedented repres for But global new cases notifie is improve day and up to 20 differe a two-year rs. A stable FY2014 are opportunity ent treatm for the of people around ly, only nt pills d ensur perfor quarter eight month injections. 19 per per receiv thoug ing the ent for MDR-TB, to the US and execu mance drugs are s of daily ing treatm ht to be infecte cent introd and pipeline excruciating Patients are tion on uced comb d are ent. Cadila. will be subjected â&#x20AC;&#x153;Scal The is extrem in the most effecti ined and the key permanent side effects, to treatm e-up of for ely base busin quarter will ranging ve mann globa deafness ent has provide from nausea er Access to urgent. and remained l DR-T B the after the ess performanc low, to psych large degree new drugs will e 48 per osis. Globapersistent curre to a large shockingly over the benefit from escitafor Cipla depen degre cent on lly, nt treatm the d to a e becau calls on of peopl past two only treatment lopram se the the manu manufacturers. ent regim will be quarters. complex e who for MSF required drugs facturers start programmes DR-TB are cured. en is and costly to sustai Glenmark earnings to progr so develo available for , the cure n research make the â&#x20AC;&#x201C; 53 per rate is slightlIn MSF for ammes and difficu for health p shorte heightened performance its strong cent â&#x20AC;&#x201C; in order patients,â&#x20AC;? r, more to registe lt to tolera to effective expectation given the â&#x20AC;&#x153;Ministries but still unacceptably better Leade said Dr r them in te as Francis r - TB s. high-burden regimens, y low. of regulators quickly Varaine, Working â&#x20AC;&#x153;With need to health and drug Group, been appro as possible once countries simpler, work sure people MSF. effective shorter ved, and they have with MDR together to make afford treatment and to -TB benefi be able regimens, more neede able in countries ensure they are t from to d most. we will where they more peoplscale-up treatm MSF patients ent e with in 36 countr treated 26,600 are DR-TB.â&#x20AC;? and cure of TB ies in 2011 whom had â&#x20AC;&#x201C; drug-resistan 1,300 the diseas e. t forms of

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Book Review

Sethis’s Quantitative Analysis of Pharmaceutical Formulations: Methods with Reaction Mechanism. Volume 1 – 4 If there was ever a text which would make the life of a pharmaceutical analyst a bit simpler, then this is it. A rich text now in its fourth revised edition, this book serves as both a revision of basic principles as well as a daily reference guide. The entire text is divided into 4 volumes. Majority of the text is a compilation of monographs detailing analytical techniques related to active drug entities. A good analyst should have a sound knowledge of chemistry and this is what the book serves to achieve. The first volume begins with an introduction to pharmaceutical analysis and its main principles. The basic analytical techniques of chemistry are explained in detail in addition with chemical structures of drugs described in later volumes. Chapter 2 of volume 1 details the principles of good laboratory practices to be followed. The chapter describes every component of GLP in exquisite detail. A great deal of text is devoted to the human element ‘the analyst’ in GLP. The investigation into an Out of Specification (OOS) result makes it an interesting read. The chapter ends with SOPs for analysts and labs with respect to GLP. Chapter 3 describes in detail calibration of commonly used instruments in pharmaceutical analysis. Chapter 4 goes on to describe the process involved in development of an analytical method. It also details the process of optimisation, validation, transfer and quality control involved in process development. Chapter 5 ends the basic introductory text by describing the reference standards for pharmaceutical analysis and ways to procure and preserve them. The monographs start from chapter 5 onwards. Monographs are compiled in chapters with respect to their systemic use. Every monograph starts with explanation of different types of methods of estimation, reagents required for the same, procedure involved and the reaction mechanism. The stress is on chemical structures and reactions explained in illustrations. Chapters 5 and 6 describe various cardiovascular and anti inflammatory drugs, respectively. Volume 2 deals with analgesics, antipyretics, antibiotics, sedatives and tranquilisers. Volume 3 describes various respiratory drugs and alimentary drugs. The last volume 4 deals with topical preparations and miscellaneous other drugs to complete the entire compilation of drug analytical methods. The compilation of four volumes serves as daily ready reference in analytical labs during estimation analysis. The text is easy to read, serves facts based on sound chemistry basis, and is must for every student of pharmaceutical sciences.

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

Editor: P D Sethi Price: ` 5,995

Publisher: CBS Publishers & Distributors Pvt ltd Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

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non-sterile form. They comply with international standards. Schott Kaisha Private Limited Daman - India Tel: (260) 2221192, 2220378, 2221047 Mob: 09978444241 Email: anil.narvekar@schott-kaisha.com Website: www.schott-kaisha.com

Sterilisation and depyrogenation tunnel AX / VX series tunnel is specially designed for ampoules and vials with various capacities. The tunnel is energy efficient and suitable for online production in

conjunction with washing and filling machines. The receptacles are treated with sterile air through entire travel for thermal treatment. It features a control system, data recording facility and infeed/outfeed chutes. Sterilisation and depyrogenation is based on 3 Log reduction cycle at 296.4° c. Also present is programmed cycles for auto / manual operation, shutdown and temperature mapping. Some of the optional features are: sleep mode during non-productive hours, cool zone sterilisation before startup, separate cooling module for cooling zone air re-circulation. Venera Biotech Systems Pvt Ltd Pune – Maharashtra Tel: 251 - 2552993 Fax: 251 - 2569695, 2559695 Email: sales@venera.in, venera@vsnl.com Website: www.venera.in

Flexible screw conveyor The helix ﬂexible screw conveyor has only one moving part. The conveyor can be disassembled in less than 20 minutes for cleaning and maintenance. It can achieve lengths up to 80 ft long. A wide range of auger styles and sizes ranging from 2 to 8 inches in diameter is offered. The product meets stringent standards and has USDA certiﬁcations. It is one of the most economical conveyors and can be used in many applications. Hapman Systems Pvt Ltd Vadodara – Gujarat Tel: 0265-2517505 Email: info@hapman.in Website: www.hapman.in

Cold cabinets The REMI cold cabinets are designed for bio sample storage. The intelligent controller helps maintain temperature in case of sensor failure. The data stored in PC server with Lan connectivity can be monitored on any PC with password authentication. The machine is filled with PUF insulation to eliminate void pockets and the powerful fan motor is for forced air circulation to maintain uniform conditions inside the chamber. Remi Elektrotechnik Ltd Mumbai – Maharashtra Tel: 022-40589888 Mob: 09820627422 Email: sales@remilabworld.com Website: www.remilabworld.com

In-line homogeniser system I n - l i n e homogeniser system allows s m o o t h changeover from laboratory to production plant. It allows the user to select from seven different mixing technologies using a variety of available mixing heads, all with programmable speed control to determine the best mixing function for the process. This laboratory machine offers a great variety of applications for many different mixing and particle size reduction processes. It eliminates the need to purchase separate mixers and operates as both a batch mixer and in-line mixer. The compact, tabletop design minimises space requirements. Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 22-67162224 / 2222 Fax: 22-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

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Products

Internal gear pumps Internal gear pump is a positive displacement pump with linear flows and is widely used in the chemical industry which is ideal for transfer of thin, viscous liquids and slurries. They are self-priming with dry suction lift of 0.5 bar and wet lift of 0.8 bar. Pumps are available with integral single and double pr relief valves and in CI, carbon steel, SS and other materials of construction. Soft packing or mechancial sealed versions can be offered based on liquids being handled. Jacketed or electrical heat tracings can be provided if required. Magnetic gear pumps are ideal for hazardous, corrosive liquids handling them in a leak-free manner and more cost-effective when compared to pumps requiring specialised sealing options. The flow rates vary from 0.5 m3/hr to 340 m3/hr with pressures upto 14 bar and upto pump sizes to 10” flange sizes. KING pumps can handle upto 3,80,000 cSt liquid viscoties and can work with operating temperature upto 370 degree centigrade. SHANBHAG & ASSOCIATES Mumbai – Maharashtra Tel: 022-28346604, 28340071, 28218008 Fax: 022-28388334 Email: info@shanbhags.com Website: www.shanbhags.com

Dynamic light scattering system Zetasizer Nano ZSP dynamic light scattering system is useful for highly sensitive measurement of the zeta potential, or electrophoretic mobility of proteins. The instrument delivers unique performance speciﬁcations for both size and zeta potential measurement, employing an approach to zeta potential measurement that accords with the latest industry guidance. It uses the company’s patented Diffusion Barrier Technique

which protects the sample by isolating it from the electrode. Consequently the applied voltage can be switched on for longer periods to generate more reliable measurement data. The method involves the use of a unique, disposable folded capillary cell which allows measurements to be conducted on samples as small as 20 microliter. Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596 Fax: 022 - 39183562 Mob: 09867368075 Email: soloni.gosalia@malvernaimil.com Website: www.malvernaimil.com

Chemical resistant diaphragm vacuum pump Chemical resistant diaphragm pump are the best suited oil free vacuum option for laboratory and pilot scaled application. Typical applications for chemical resistant diaphragm pumps include evacuating chemically aggressive gases and vapours from equipments such as rotary

evaporators, vacuum drying cabinets and centrifugal concentrators. Most i m p o r t a n t l y, diaphragm pumps are oilfree, for vastly reduced service d e m a n d s compared with oilsealed pumps. They eliminate the water waste of water-jet aspirators, and the contaminated waste-oil disposal of rotary vane pumps. The diaphragms are available in various options of materials like EPDM, neoprene, viton and teﬂon coated neoprene rubber. These vacuum pumps are available in the range of 15 lpm to 33 lpm and they generate a maximum vacuum of 30Torr. Chemical resistant vacuum pumps are also supplied with 3phase ﬂame-proof motors. Sri Vishnu Pumps Mfg Co Thane - Maharashtra Tel: 022 - 28458372 Fax: 022 - 28457073 Email: vishnupump@rediffmail.com Website: www.minivacpumps.com

Molecular weight detector Zetasizer μV is a versatile size and molecular weight detector that can be added to any system to boost experimental productivity by maximising information ﬂow from a single experiment. It is a dual integrated light scattering system with particular value for protein characterisation. It uses dynamic light scattering to secure precise molecular size measurement while at the same time offering static light scattering for absolute molecular weight measurement. It allows the characterisation of discrete samples with only 2 μL of material. The instrument can be added to any protein SEC system to bring absolute molecular size and molecular weight capability to the chromatography experiment, and avoid the need to calibrate the column.

Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596 Fax: 022 - 39183562 Mob: 09867368075 Email: soloni.gosalia@malvernaimil.com Website: www.malvernaimil.com

Work bench The work bench features steel frames, panels and shutters made from prime quality CRCA steel. This steel is coated with epoxy paint and a special encapsulated powder that has a ﬁlm thickness of 40-60 microns. This imparts a high scratch-resistance and the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum efﬁciency in the cabinet drawer. Godrej & Boyce Mfg Co Ltd Mumbai - Maharashtra Tel: 022-67964363, Mob: 09920113138 Email: arunp@godrej.com Website: www.godrej.com

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Products

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

AODD PUMP

Stainless steel pipe and tube

The pump sizes range from 1/4” size to 3”size. Pump housings are available in polypropylene, PVDF, nylon, aluminium and stainless steel. Internals are available in teflon, EPDM, nitrile rubber or viton. The Pumps run on dry, non-lubricated, clean air. The pumps are in bolted construction and are designed for a variety of industrial applications. They are self-priming and can carry solid particles/slurries without any damage. It is useful in industries like pharma, glass and fiberglass, oil & gas, marine/shipbuilding, metal and steel, effluent treatment, paint, aircraft, electroplating/surface treatment, food and beverage, automotive, chemical, clay and ceramics. Major advantages are that it is lube-free, non-stalling operation, corrosion-free, weight reduction, air valve body available in corrosion-free engineered plastics, commonality of spares across models and sizes.

Stainless steel seamless welded pipe, tubes and ‘U’ tubes, large diameter w e l d e d pipe in various sizes, grades and speciﬁcations are available. Materials used are austenitic, ferritic, duplex and super duplex stainless steel. They conform to ASTM, ASME, DIN, NFA, JIS standard. Size range for welded ranges from 6.0 mm OD – 1016 mm OD and for seamless 6.0 mm OD – 323.9 mm OD. Similarly thickness varies from 0.6 mm – 25 mm for welded and 0.8 mm – 25 mm for seamless. Length is upto 30 metre long. Application industries include reﬁnery, petro-chemical, food, pharmaceutical, fertilizer, oil & gas, breweries, sugar, ship building.

Shanbhag & Associates Mumbai - Maharashtra Tel: 022-28346604, 28340071, 28218008 Fax: 022-28388334 Email: info@shanbhags.com Website: www.shanbhags.com

Digital test gauge The digital test gauge AccuCal Plus is ideal for pressure measurement and for calibrating p r e s s u r e t r a n s m i t te r s , switches and gauges. Accu-Cal Plus digital test gauge offers outstanding accuracy, resolution and stability for pressure measurement and calibration requirements. It is used extensively in process monitoring and control industry. It is housed in waterproof casing of polished stainless steel and rated IP65/NEMA4. Accurate stainless steel pressure sensors offer models to cover from vacuum up to 10,000 psig with accuracy up to 0.05% of full scale. It provides numerous userconfigurable features including adjustable sample rates, dampening, tare, custom engineering units, minimum/maximum and password-protected field calibration. A five digit rotating backlit display with oversized digits, 20 segment bar graph and high contrast provides superior resolution and excellent readability in poor light conditions or bad viewing angles. Temperature compensation circuitry and multi-temperature calibration provides outstanding accuracy over a temperature range of 0 to 50° C. Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 022-67162209 / 2222 Fax: 022-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Suraj Limited Ahmedabad – Gujarat Tel: 079 - 27540720/21 Email: suraj@surajgroup.com Website: www.surajgroup.com

Ultra-low temperature freezer Ultra-low temperature freezer provides outstanding sample protection, sample storage capacity and energy efﬁciency for ultra-low temperature storage requirements. The freezer is equipped with a unique touch screen control panel that features an event log, health monitoring system and controlled access options which provide constant updates on sample integrity and the health of the freezer compartment. It has a built-in USB port to download freezer temperature and event logs or transfer freezer settings from one freezer to another. Its capacity ranges from 421 - 949 ltrs (14.9 - 33.5 cu. ft.) and has a number of options to suit most storage and lab space requirements. The new cabinet design and vacuum panel insulation of the freezer can store up to 70,000 2 mL tubes or 118,300 1 mL cryobank tubes. Thermo Fisher Scientiﬁc India Pvt Ltd Mumbai – Maharashtra Tel: 022 – 67162200, 67162259 Fax: 022 – 67162244 Website: www.thermoscientific.com

Automatic labelling machine Automatic labelling machine is suitable for the application of the vignette label onto the main panel and of two self-adhesive tamper evident seals on the closure point of formed cartons. The machine is designed for carton Track

& Trace by means of 2D datamatrix codes printing on line and subsequent veriﬁcation with camera vision systems. It is an ergonomic balcony-design machine that offers full access to ensure cleaning and management comfort and guarantees a full view of the entire production process. The labelling machine works by steps, consequently guaranteeing high precision in label application and the ﬁnished result. Size change over is precise, easy and quick. Marchesini Group India Pvt Ltd Mumbai - Maharashtra Tel: 022 - 67082755/64 Fax: 022 - 67082761 Email: info@marchesini.com, philippe@marchesini.in Website: www.marchesini.com

Liquid ﬁlling machine The four-head liquid filling machine is a highly versatile machine for filling foamy as well as other liquids into containers. It has a unique bottle separation method in which no turret or holding slides are used. This machine fills the liquid using the syringe principle and is very easy to use. Turntable is provided for bottle filling. This liquid filling machine is provided with variable speed conveyor and is suitable for filling all types of liquids with less density. It is equipped with 1.5 HP motor with gear boxand the diving nozzles is used for prevention of spillage and for foamy liquids. Harshika Industries Dist Thane - Maharashtra Tel: 0250-3246533, Mob: 09869457909 Email: harshad.g@rediff.com Website: www.filling-machinemanufacturer.com

Mini vac pneumatic conveyor The pneumatic conveyor comes with a complete integral blower which eliminates the need of an expensive plant air or a separate compressor. The regenerative blower provides the highest conveying efficiency. It has a standard reverse pulse jet filter cleaning system that keeps the filter clean and at optimum operating efficiency. The access doors which are of standard size enable you to replace the filters in less than 5 minutes without the use of any tool. The compact and integral blower eliminate the need for air piping and makes installation easy. Hapman Systems Pvt Ltd Vadodra – Gujarat Tel: 0265 – 2517505 Email: info@hapman.in Website: www.hapman.in

Pouch sealing machine Pouch sealing machine ( r o t a r y sealer) can be used in all hospitals for ETO sterilisation process. The machine has a continuous sealing process to seal any heat sealable rill or pouch with a 6 - 12 mm sealing width at a speed of 0 - 12 mtr/min. It is suitable for BOPP, multi layer, laminated, polyester poly, aluminium foil, LD, PP, HD, HM and all types of sealable materials available in all thickness combinations. It has a name and logo embossing facility, unlimited sealing length and reliable sealing quality. The machine is compact in design having dimensions of 17 x 34 x 12 inches and weighs about 30 kg. It requires a single phase power supply of 220V/ 50 Hz and its power consumption is around 500 Watts. Monarch Appliances Rajkot - Gujarat Tel: 0281-2461826, 2462585 Email: info@monarchappliances.com , monarchrajkot@gmail.com Website: www.monarchappliances.com

PP-R plumbing system Plumbing pipes and fittings is produced out of polypropylene r a n d o m copolymer material. The physical characteristics of material such as working temperatures upto 95°C along with excellent chemical resistance as well as providing a definite solution for oxidation and calcification, makes it an ideal material, primarily for hot and cold water plumbing systems in buildings and industrial piping installations ensuring a high quality performance. Various advantages are no leakage, no corrosion, no scaling, no maintenance, no insulation, low frictional resistance, low hammering effect and low cost in installation. They certify DIN 16962 - Part 5 and IS15801 specification for GREENFIT polypropylene random copolymer pipes for hot & cold water supplies. Application industries are pharmaceuticals, textile, paper pulp and sugar factory. Prince Pipes & Fittings Pvt Ltd Vadodra – Gujarat Tel: 022 – 66022222 Fax: 022 - 66022220 Email: sales@princepipes.com Website: www.princepipes.com The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

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30 List of Products & Advertisers Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

Pg No

Product

Pg No

Product

Pg No

Product

Pg No

Acoustic enclosure............................................. 6,21

Dehumidiﬁer rental..................................................... 13

Laboratory equipment ........................................ 29

Softening unit ............................................................BIC

Activated carbon ﬁlter...............................................BIC

Demineralisation plant .............................................BIC

Laboratory glassware................................................... 11

Spectrophotometer ...................................................... 29

Air sterilisation............................................................BC

Digital differential pressure transmitter and indicator29

Laminar air ﬂow unit................................................FIC

Stainless steel pipe ....................................................... 29

Analytical instrument ................................................. 11

Digital GPS clock......................................................... 29

Large diameter welded pipe ....................................... 29

Stainless steel pipe and tube....................................... 28

AODD pump ............................................................... 28

Digital magnahelic gauge ........................................... 29

Liquid ﬁlling machine................................................. 28

Sterilisation and depyrogenation tunnel .................. 26

Atlantis .......................................................................... 29

Digital test gauge ......................................................... 28

Liquid handling product .......................................11,29

Synchronized digital clock.......................................... 29

Automatic labelling machine ..................................... 27

Dissolution testing......................................................... 7

Metal doorset ......................................................FIC

Tablet inspection machine .................................... 3

Bearing................................................................... 15

Dry van pump .......................................................... 6,21

Mini vac pneumatic conveyor ................................... 28

Temporary cooling ...................................................... 13

Blow-ﬁll seal machine ................................................... 9

Dynamic light scattering system................................ 27

Modular clean room .................................................FIC

Trained manpower ...................................................... 13

Cable carrier ......................................................... 15

Dynamic pass box .....................................................FIC

Molecular weight detector.......................................... 27

Tray dryer ....................................................................... 3

Cable connector ........................................................... 15

Electro de ionisation ..........................................BIC

Octagonal blender .................................................. 3

Tube............................................................................... 29

Chain............................................................................. 15

Fire resistant door ..............................................FIC

Physical testing ....................................................... 7

Turnkey solution for biotech and pharma

Chemical resistant diaphragm pump ....................... 27

Flameproof clock ......................................................... 29

Portable hygrometer.................................................... 17

industry........................................................................BC

Chromatography instrument..................................... 29

Flexible screw conveyor .............................................. 26

Pouch sealing machine ............................................... 28

U’ tube.................................................................... 29

CIP/SIP system and efﬂuent treatment plant ............ 8

Fluid bed dryer .............................................................. 3

PP-R plumbing system ............................................... 28

Ultra ﬁlteration system .............................................BIC

Clean room clock ........................................................ 29

Glass preﬁllable syringe ...................................... 26

Pressure sand ﬁlter ....................................................BIC

Ultra low temperature freezer.................................... 28

Clean room door .......................................................FIC

High purity water treatment system for injectibles ..... 8

Professional humidity meter ...................................... 17

Vacuum booster pump ..................................... 6,21

Clean room monitor ................................................... 29

Humidity temperature and differential

Pump.......................................................................... 6,21

Vacuum system ......................................................... 6,21

Cold cabinet ................................................................. 26

pressure indicator ........................................................ 29

Pure water and steam process...................................... 8

Water analysis instrument .................................. 29

Connector..................................................................... 15

Humidity and temperature transmitter ................... 29

Rapid mixer granulator ......................................... 3

Water’s sunﬁre.............................................................. 29

Container sterilisation................................................BC

HVAC all rounder ....................................................... 17

Reverse laminar air ﬂow ...........................................FIC

Welded pipe.................................................................. 29

Content uniformity testing .......................................... 7

HVAC and MEP .........................................................BC

Reverse osmosis unit .................................................BIC

Wireless clock............................................................... 29

Cool Chain Strategies Summit 2013......................... 14

In-line homogeniser system ............................... 26

Roots blower ............................................................. 6,21

Work bench .................................................................. 27

Data logger ............................................................ 29

Internal gear pump ..................................................... 28

Seamless pipe ........................................................ 29

X Select HPLC column ........................................ 29

Data logger series for humidity ................................. 17

International exhibition for pharma and healthcare26

Semi auto coater ............................................................ 3

X’Bidge .......................................................................... 29

Advertiser’s Name & Contact Details

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Advertiser’s Name & Contact Details

Pg No

ACE Instruments T: +91-40-23078848, E: sales@alwaysace.com W: www.alwaysace.com

Chemical & Process World 27 T: +91-022 3003 4650 E: cpw@network18publishing.com

Advertiser’s Name & Contact Details

Pg No

GMP Technical Solutions Pvt Ltd FIC T: +91 -22 66083790 E: prashant@gmptech.net W: www.gmptech.net

Loba Chemie Pvt Ltd T: +91-022 66636663 E: info@lobalife.com W: www.lobalife.com

Igus India Pvt Ltd T: +91-1-80-39127800 E: info@igus.in W: www.igus.in

P R Corporation 29 T: +91-22-24109921 E: prc_rcshah@yahoo.co.in W: www.indiamart.com

Suraj Limited

Technical Drying Services (Asia) Pvt Ltd 13 T: +91-124-4012851 E: tdsmarketing@pahwa.com W: www.tdsasia.net

Everest Blower 6 T: +91-11-45457777 E: info@everestblowers.com W: www.everestblowers.com

Indo German Pharma Engineers 3 T: +91-0250-2200070 E: indogmbh@vsnl.com W: www.indogermanpharma.net

Praj Industries Ltd T: +91-020-2290 5000 E: info@praj.net W: www.praj.net

Everest Blower Systems

Iphex 2013

Salesworth Synergies Pvt Ltd (Rommelag) 9

T: +91-11-45457777

T: +91-22 24938750

E: info@everestblowers.com W: www.everestblowers.com

Fabtech Technologies Intl Pvt Ltd BC T: +91 - 22 61592900 E: sales@fabtecheng.com

Pg No

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

29 T: +91-79-27540720 E: suraj@surajgroup.com W: www.surajgroup.com

Testo India Pvt. Ltd.

T: +91-80-25274495

T: +91-20-65600203

E: sales@iphex-india.com

E: mail@salesworthsynergies.com

E: info@testoindia.com

W: www.iphex-india.com

W: www.rommelag.com

W: www.testo.in

Kamikaze B2B Media 14 T: +91-022 61381811 E: Bhumika@kamikaze.co.in

W: www.fabtecheng.com

Sunjay Technologies Pvt Ltd 29 T: +91- 22 6662 4330 E: info@sunjaytechnologies.com W: www.sunjaytechnologies.com

W: www.kamikaze.co.in

Sotax India Pvt Ltd T: +91-022-42950191 E: sotaxindia@sotax.com W: www.sotax.com

TSA Process Equipments Pvt Ltd T: +91-022-28593808 E: base@tsapepl.com

BIC

W: www.tsawatersystems.com

Our consistent advertisers

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