VOL. 9 NO. 23 PAGES 72
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Cover Story Pharma marketing: In need of a reboot Market ‘Quality is a philosophy regardless of geographies’ Management Indian generic pharma and global regulatory challenges 1-15 OCTOBER 2014,` 40
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CONTENTS MARKET Vol.9 No.23 OCTOBER 1-15, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma
ADOPTING NEWAVENUES
Pharma marketing is undergoing a metamorphosis,aided bydigital technologywhich has not onlyopened up newvistas for brand building but also emerged as an effective tool for encouraging transparencyand ethical practices in the industry | P29
14
‘QUALITY IS A PHILOSOPHY REGARDLESS OF GEOGRAPHIES’
16
NPPA WITHDRAWS INTERNAL GUIDELINES ON DRUG PRICING
17 21
ASTRAZENECA TIES UP WITH LILLY ABLE TO HOST 11TH EDITION OF BIOINVEST
PHARMA ALLY
Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West
P26: COVER STORY
Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta
P35: CLINICAL UPDATES
PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia
Code of conduct: A pill to cure corruption?
Merck Serono to discontinue clinical development programme of tecemotide
MANAGEMENT
32
THE POLITICS BEHIND PHARMA
33
INDIAN GENERIC PHARMA AND GLOBAL REGULATORY CHALLENGES
P36: RESEARCH UPDATE Sanofi, Regeneron drug may halve heart risk
Scheduling & Coordination Rohan Thakkar
P39: INSIGHT
CIRCULATION Circulation Team Mohan Varadkar
Drug recalls due to dissolution failures: What can be done?
38
‘FUJITSU AIMS TO DIFFERENTIATE THROUGH ITS APPLICATION KNOWLEDGE’
PHARMA LIFE
62
PIRAMAL FOUNDATION SUPPORTS J&K’S DISASTER RELIEF OPERATIONS
Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
EDITOR’S NOTE
Beyond pricing and patents
E
merging market strategies of Big Pharma have been defined by two Ps: pricing and patents. To this already volatile mix, we now need to add a third P: payments, alluding to the transactions between pharma companies and the medical community. This hydra-headed issue has reared its head from time to time, seems to disappear and then reappear with a vengeance. But industry observers are predicting that MNC pharma will be forced to re-think their strategies and not just in China. Putting forth some lessons for the industry, Graham Erion, Weiguo (William) He and Matthew Kersten of Davis LLP point to Brazil’s Clean Companies Law, India’s Lokpal Act and Prime Minister Modi’s corruption crackdown as well as many other developing countries instituting and better enforcing their own anti-bribery schemes. There are lessons for India’s regulators too. GSK’s Statement of Apology to the People of China hints that the company has avoided harsher indictment by promising to continue “to invest in China and supporting China’s scientific development; and by further development of innovative new medicines and vaccines for diseases prevalent in China.” Increasing access through increased manufacturing and price flexibility is another commitment. As the cover story in our current issue points out (Express Pharma Oct 1-15, 2014), India already has a Uniform Code of Pharmaceutical Marketing Practices (UCPMP) but getting individuals to adhere to it, both pharma industry executives as well as doctors, remains a huge question mark. (Code of conduct: A pill to cure corruption?, pages 26-28). The problem is that these codes are voluntary and depend on reporting of such practices. No whistleblowers have come forward to report such cases but NDTV recently did an expose and it has also been a topic on Aamir Khan’s Satyamev Jayate, which is due to start its third season shortly. So also, pharma marketing strategies could adopt new technologies to reach doctors but unless these are
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Were these two moves a prelude to setting the stage for dialogue,to signify an open mind? If so, that’s a good sign because there is no alternative but to find common ground.For that,both sides will have to move from their high-moralground arguments and explore all options
transparent and ethical, they will fall in the same trap. (Adopting new avenues, pages 29-31) As we go to press a day after PM Modi’s rock star like reception at New York’s Madison Square Garden, it is fair to say that the pharma industry is waiting to see how he will stand up to pressure on the first two Ps: pricing and patents. Clipping NPPA’s wings might seem like a capitulation on the pricing front and Commerce and Industry Minister Nirmala Sitharaman’s comments on September 8 indicated that the Government was reconsidering its stance on intellectual property rights. Were these two moves a prelude to setting the stage for dialogue, to signify an open mind? If so, that's a good sign because there is no alternative but to find common ground. For that, both sides will have to move from their high-moral-ground arguments and explore all options. For instance, if the US wants increased patent protection, can they give way on pricing and increasing access? One only has to look at Gilead’s collaboration with seven Indian companies for the manufacture and sale of its hepatitis C drug Sovaldi to understand the new-found pragmatism. But even though this deal is a good example of a pharma MNC balancing profits with patients, nations like China and Brazil, with large populations needing this drug, have been left out of the deal. On the patents front, the re-evaluation of our IP laws could also cheer home-grown companies, as they are working on (or would like to invest in) new drug research and incremental innovations. So the question is, what are the real pain points? The use of compulsory licensing (CL)? If the Gilead-Sovaldi deal becomes the norm, CL cannot be invoked. Better data protection has been a long standing grouse; could stronger measures on this front convince the global pharma fraternity of our good intentions? Will PM Modi find the right balance between industry and the healthcare needs of our nation? VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com
MARKET I N T E R V I E W
‘Quality is a philosophy regardless of geographies’ Dr Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs - Glenmark Pharmaceuticals, talks about the regulatory scenario in India, need for standardising GMP, highlights of DIA India 2014 conference and more, in an interview with Express Pharma
From a global perspective, looking into India, how do you view the changes on the clinical trials regulatory front? Industry bemoans the slowdown in approvals, and the increased stringency as far as patient safety is concerned. Your comments. Clearly, there has been a lot of change in the way clinical trial applications are evaluated in India as a consequence of the Parliamentary Standing Committee Report. There was a need for it to become much more rigorous to improve the standards both in terms of the quality of the data and more importantly safeguarding patient welfare. A number of measures have been taken by the Government to ensure these aspects – like increasing the number of specialists taking part in investigations, limiting the number of clinical trials investigators can participate in at one time as well as taking steps to ensure that the patient understands the informed consent process correctly. Proper implementations of these measures will ensure that the regulations and processes will be broadly in line with developed markets. But there is no denying the fact that the process has become extremely bureaucratic with multiple layers of review from different committees.
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So, there needs to be a way of streamlining the process so that not only the goal of patient welfare is maintained, but it also allows for valid scientific questions to be answered through clinical trials. How does the Pharmacovigilance Programme of India (PvPI) measure up to global PV regulations? I am of the opinion that the standards of reporting of PV in India, in light of the recent measures, brings the country broadly in line with developed markets. In some cases, I feel the reporting requirements and the timelines are actually more stringent than even some developed markets. The area which needs to be addressed is under reporting of adverse events both for marketed and investigative products. The system is there to handle adverse events, but the authorities in the first place need to receive the reports to act on them. So, in India there needs to be greater efforts by the authorities to educate physicians and investigators to report adverse events. On the manufacturing side, India-based manufacturers who export to different geographies find it extremely difficult to cope with differing GMP regulations and standards. There are increasing
A challenge for India-based manufacturers undertaking global pharma supply is there is no single standard for GMP
efforts to share inspection findings between global regulators so how should such manufacturers cope with these challenges? As we aware, approximately 40 per cent of generic drugs sold in the US are from India. Regulatory authority expectations have been increasing exponentially globally in recent years putting pressure on India-based manufacturers to comply with national cGMP requirements, including FDA, whilst remaining competitive. A challenge for Indiabased manufacturers undertaking global pharma supply is there is no single standard for GMP. Different approaches may be taken by different national authorities and a single facility may be inspected by multiple authorities. This results in a single facility holding multiple GMP licenses including: ◗ FDA, EMA ◗ WHO ◗ National Regulators who are not PIC/S members ◗ National Regulators who are PIC/S members, but who may or may not perform their own inspections regardless There are a number of collaborative exercises between FDA and EMA, including information sharing to increase monitoring and reduce duplication in the fields of: ◗ API
◗ Finished product manufacture where the facilities are located on each other’s territories leading to deferment or waiving of some inspections. ◗ GCP inspections of information in generic applications In January, 2014 the Drug Controller General (India) DCG(I) asked India-based manufacturers to inform him instantly of alerts and restrictions by other countries regulatory authorities and also instructed the state licensing authorities (SLAs) to hold inspections in such cases. In addition, it has recently been announced that unannounced inspections will be conducted by SLAs of domestic and overseas facilities with the aim of achieving a level playing field. In addition, it was announced in January that the Indian Government is considering revising the Indian good manufacturing practices guidelines (Schedule M) at par with WHO-GMP which is the mandatory requirement for global market entry and specifically for countries with no dedicated regulatory authority. So, clearly absence of a single standard for GMP is clearly a road block for Indian manufacturers supplying to the global markets. Is setting up
manufacturing plants in overseas locations the only solution to meeting global GMP standards? Absolutely not. There are excellent manufacturers based out of India who are manufacturing for the entire world. I am of the opinion that quality is a philosophy regardless of geographies. It’s about how you approach GMP and apply those standards. As the programme co-chair of the upcoming DIA India Conference 2014 (October 16-18, Mumbai) how does the theme, ‘The Future of Indian Health Care: Patients, Access and Innovation’, tie in with these concerns? India’s life expectancy has
The healthcare policies pursued by the Government have been effective and they have been able to make medicines and treatment available to large sections of the population increased considerably in the last two decades or so. So, the healthcare policies pursued by the Government have been effective and they have been able to make medicines and treatment available to large sections of the population. However, there are still challenges. The most critical aspect among these is ensuring safety,
efficacy, quality, affordability and accessibility of medicines and treatment to patients at all times. The key imperatives to overcome these continual challenges and catalyse the transformation include putting patients first, fostering innovation, and enhancing access. The 9th Annual DIA India
Conference will bring together leading local and global experts in healthcare, pharma industry members, academia, researchers, regulators and patients under one roof to deliberate on the emerging trends, opportunities and challenges. I along with my programme Co Chair Professor Ranjit Roy Chaudhury, Chairman for the
Task force for research at Apollo Hospital are really excited that that we have the commitment of experts who will be discussing the ‘patient first’ approach that will cover innovation and access of Indian healthcare. In addition, important topics such as clinical trials, quality and manufacturing, health economics, healthcare delivery, public-private partnership in innovation and healthcare access, and case studies on Indian innovation will be shared. A true demonstration of opportunities that lie before us here in India. So, I invite all stakeholders in the pharma and healthcare industry to be a part of the conversation at DIA India Conference 2014 in Mumbai.
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October 1-15, 2014
MARKET
Merck Serono partners with Sutro Biopharma
COMPANY WATCH
NPPAwithdraws internal guidelines on drug pricing Industry hails news, awaits further details THE NATIONAL Pharmaceutical Pricing Authority’s (NPPA) recently withdrew the internal guidelines of May 29, 2014. The guidelines pertained to the fixation/revision of prices of scheduled and non-scheduled formulations regarding Paragraph 19 of the Drug Price Control Order (DPCO) 2013. These relate to guidelines that gave NPPA the power to fix drug prices in certain circumstances in public interest. Though no reason has been given for the withdrawal, the fact is that it came a few days before the Prime Minister’s visit to the US. Industry has reacted positively to the news, with an official statement from Ranjana Smetacek, Director General, The Organisation of Pharmaceutical Producers of India saying, “We appreciate Government’s decision to withdraw the guidelines on fixation/revision of prices of scheduled and non-scheduled formulations under Para 19 of the DPCO 2013. This welcome
move tells us we are being heard and we look forward to working with the Government toward a common goal. We are still trying to understand the precise impact of this order on our member companies.” Daara B Patel, SecretaryGeneral, IDMA too reacted positively, “The Government’s decision to withdraw the guideline to the fixation/revision of prices of scheduled and non-scheduled formulations regarding Paragraph 19 of the DPCO 2013 is a right step and will be beneficial to both the industry as well as to the patient. Now companies will not be reluctant from manufacturing those medicines which were put under DPCO regime and patients can avail them without any hurdles.” According to an Angel Broking analysis, the drugs impacted include Gliclazide, Glimepiride, Sitagliptin, Voglibose, Amlodipine, Telmisartan and Rosuvastatin, Heparin and Ramipril,
covering an estimated market of around ` 5,500 crores. These drugs had witnessed a price reduction from 10-15 per cent to as high as 35 per cent, with the average reduction around 12 per cent. The biggest positive impact will be felt for companies like Sanofi (~` 139 crore gain), Zydus Cadila (~` 40 crore gain), Ranbaxy (~` 38 crore gain), Cipla (~` 19 crore gain), Lupin (~` 32 crore gain) , DRL (~` 14 crore gain in sales) and Sun Pharma (~` 25 crore gain in sales), on the basis of AIOCD AWACS. Thus, amongst domestic and MNC players, the latter would be impacted the most positively, as they mostly price their products much higher than the competition and then derive their 100 per cent of the sales from domestic markets. The domestic companies not having very huge exposure to the domestic market, will be insulated to a large extent, as pricing is not the key growth driver for their growth. Their products
are therefore competitively priced. “Invoking Para 19 of DPCO, NPPA had extended price control to drugs outside of National List of Essential Medicines (NLEM). Pharmaceuticals lobbies had contested NPPA order in Bombay High Court,” commented Sarabjit Kour Nangra, Vice President Research - Pharma, Angel Broking. Commenting on the NPPA’s role, Patel continues “It is a good step taken by the Government and we are happy and looking forward positively. However, I feel that NPPA should only be considered about the fact of overcharging activities practiced by pharma companies and should not increase (the number of ) products under the National List of Essential Medicines (NLEM). I hope the new NPPA chairman will strike a balance between industry, government and patient.” EP News Bureau-Mumbai
MERCK SERONO and Sutro Biopharma, San Francisco, a bio-pharmaceutical company developing antibody drug conjugates and bispecific antibodies, announced a collaboration and license agreement to develop antibody drug conjugates (ADCs). The collaboration will allow Merck Serono to take advantage of Sutro’s technology platforms in its oncology programmes to develop ADCs for multiple undisclosed targets. Under the terms of the agreement, Sutro and Merck Serono will collaborate to discover and develop multiple ADCs utilising Sutro’s cell-free protein synthesis platforms, Xpress CF and Xpress CF+. Sutro will be responsible for delivering ADCs for phase I clinical trials. Merck Serono will be responsible for clinical development and commercialisation of any resulting products. Both companies believe that ADCs have the potential for directly targeting cancer cells while safeguarding healthy tissue, and will combine Merck Serono’s knowledge about target biology with Sutro’s technological and discovery capabilities to jointly develop ADCs. EP News Bureau-Mumbai
Silver Leaf Oak acquires stake in Syngene International The stake will be acquired from BRL at a valuation of `3800 crores SILVER LEAF Oak (Mauritius) (Silver Leaf), an investment vehicle advised by India Value Fund Advisors (IVFA) has agreed to acquire a minority 10 per cent stake in Syngene International (Syngene), Biocon’s Research Services subsidiary. Silver Leaf will acquire the stake from Biocon Research Limited (BRL), a
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wholly-owned subsidiary of Biocon at a valuation of ` 3800 crore. The transaction is subject to standard condition precedents including regulatory approvals. Post the completion of this transaction, Biocon and BRL will jointly hold 85.54 per cent stake in Syngene. Kiran Mazumdar-Shaw,
Chairman and Managing Director, Biocon said, “We are pleased to welcome Silver Leaf as a shareholder. This investment reflects Syngene’s leading position in the contract research and manufacturing space in Asia, acknowledging its comprehensive multidisciplinary capabilities. This transaction is part of the overall
strategic plan for Syngene and sets a new benchmark as we prepare the company for listing.” Vishal Nevatia, Managing Partner, India Value Fund Advisors said, “We had partnered with Biocon through our first fund in 2003. We are excited to partner with them again. Syngene has emerged as one of the
leading service providers globally for integrated discovery and development with a marquee client base. This deal showcases the IVFA investment philosophy of working with high quality entrepreneurs and management teams.” EP News Bureau-Mumbai
MARKET
AstraZeneca ties up with Lilly Announces alliance to develop and commercialise BACE inhibitor AZD3293 for Alzheimer’s disease ASTRAZENECA and Eli Lilly and Company (Lilly) have signed an agreement to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50 million in the first half of 2015. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues postlaunch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a phase II/III clinical trial in patients with early Alzheimer’s disease. Lilly will lead clinical development, working with researchers from AstraZeneca’s Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of AZD3293. The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain, which consists of peptides called amyloid beta. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Mene Pangalos, Executive Vice
The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain, which consists of peptides called amyloid beta President, Innovative Medicines & Early Development, AstraZeneca, said, “Alzheimer’s disease is one of the biggest challenges facing medical science today and BACE inhibitors have the potential to target one of the key drivers of disease progression. We are looking forward to working with Lilly, an organisation with a long-term commitment to and expertise in treating Alzheimer’s disease. We believe that, by combining the scientific expertise from our two organisations and by sharing the risks and cost of late stage development, we will be able to accelerate the advancement of AZD3293 and progress a promising new approach to support the treatment of Alzheimer’s patients around the world.” “Lilly has been committed to research in Alzheimer’s disease for more than 25 years, and we’re dedicated to developing new medicines that can change and modify the course of this devastating disease. This alliance moves us one step closer to achieving our goal of making Alzheimer’s dementia preventable by 2025,” said David Ricks, Senior Vice President and President, Lilly Bio-Medicines. EP News Bureau-Mumbai
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MARKET
Indian pharma could gain from China-India MoUs MoUs aimed at facilitating market access, cooperation on drug regulations could increase inroads into China pharma market PHARMACEUTICAL PRODUCTS from India could gain easier entry into the China market, thanks to two of the many MoUs signed between the two countries as part of Chinese President Xi Jinping’s visit to India. One MoU was part of the effort to balance the long standing trade deficit, currently skewed in favour of the dragon nation. Along with pharma, agri products and IT services are the sectors where China has agreed to take specific measures to enhance market access. Another MoU was a work plan on drug administration and cooperation between the drug regulators of both countries on drug standards, traditional medicine and drug testing. Both sides will exchange delegations to enhance cooperation in these areas. These two MoUs address two of the major pain points: market access and approvals, faced by Indian pharma companies trying to make inroads into the China market. Proper and speedy implementation of both MoUs could have a very positive impact on pharma companies in India. Currently, only a handful Indian pharma companies, including Dr Reddy’s Labs, Ranbaxy, Sun Pharma and Aurobindo are present in China. Most trade associations in India have been articulating the need for such measures for quite some time. Reacting to the MoUs, Dr PV Appaji, Director General, Pharmaceuticals Export Promotion Council said, “This is a huge opportunity for both countries to share quality, affordable generics. If China follows
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The second MoU which will impact the sector was a work plan on drug administration and cooperation between China Food and Drug Administration of the People’s Republic of China and Ministry of Health and Family Welfare of India. It was signed by Ministry of Health and Family Welfare Secretary Lov Verma and Ambassador of China to India Le Yucheng. Under this MoU, the two sides will carry out cooperation in fields of drug standards, traditional medicine and drug testing, etc. Both sides will exchange delegations to enhance cooperation in this area.
CIPLA HAS signed an agreement with Salix Pharmaceuticals, a US-based speciality pharmaceutical company. Under the agreement, Cipla has granted Salix exclusive rights under certain patent applications in the ‘Rifaximin Complexes’ patent family controlled by Cipla. Timothy Crew, Chief Executive Officer, USA and Canada said, “We are delighted to be partnering with Salix Pharmaceuticals and to expand on our existing license to Salix to introduce rights to the ‘Rifaximin Complexes’ patent applications.” Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla said, “As we look to go-live with our own front end presence in North America, we are happy that through this association we can demonstrate to the wider industry that we are open to global partnerships for the development and commercialisation of complex products in order to benefit all patients. This deal signifies our ongoing commitment to provide access to innovative treatments to patients worldwide.” The grant is on a worldwide basis, excluding the countries of Asia (other than Japan) and Africa. Salix is required to make an up-front payment and, upon achievement, additional regulatory milestone payments to Cipla in respect of the new license agreement regarding the ‘Rifaximin Complexes’ patent rights. Salix also will pay a royalty on net sales of products covered by the ‘Rifaximin Complexes’ patents licensed to Salix.
EP News Bureau-Mumbai
EP News Bureau-Mumbai
The MoUs lay the ground work for a five-year Trade and Economic Development Plan, for promoting balanced and sustainable development of economic and trade relations between China and India, on the principle of equality and mutual benefit
UK MHRA and US FDA guidelines, this will encourage Indian pharma companies to focus on the China market.” Daara Patel, Secretary General, Indian Drug Manufacturers Association, too notes that this has been a long-standing demand from IDMA and the Association is happy that these MoUs have been signed as formulations are a strength area for India. Looking ahead, he makes the suggestion that translation of the Chinese Pharmacopoeia and making the rules more user-friendly would further encourage Indian pharma companies to export to China. China’s healthcare budget can be hugely reduced if access to Made-In-India formulations is increased and approval timelines are improved. Industry observers point out that it takes about five to six years for even well known Indian pharma firms to register their products in China. On the other hand, approvals for Chinese APIs are granted in four-six months. This imbalance in the licences and registration timelines is a major pain factor for Indian pharma companies.
Improving the trade balance The agreement is a key part of the MoUs signed by India’s Minister of State for Commerce and Industry Nirmala Sitharaman and China’s Commerce Minister Gao Hucheng. The MoUs lay the ground work for a five-year Trade and Economic Development Plan, for promoting balanced and sustainable development of economic and trade relations between China and India, on the principle of equality and mutual benefit. One of the MoUs, the fifth of the 16 signed on the third day of the Chinese premier’s trip, was the agreed Minutes of the Tenth Session of IndiaChina Joint Economic Group on Economic Relations, Trade, Science and Technology (JEG) which was held in Beijing on September 2. During the JEG, both sides had held detailed discussions on issues to promote broad and deep bilateral trade and economic cooperation between India and China and agreed to undertake measures to achieve sustainable and balanced trade. Specific measures to enhance market access to Indian products such as agricultural,
Cipla in agreement with Salix Pharma
pharma and export of services will be expedited. The main objectives of the plan are reduction of bilateral trade imbalance; strengthening of investment cooperation to realise $20 billion investment from China in five years, a transparent and stable and investor-friendly business environment, and enhanced cooperation between Chambers of Commerce and financial sectors.
Cooperation between drug regulators
MARKET GROWTH TRACKER
IPM clocks ` 7097 cr in Aug 2014 10 therapies have outgrown the IPM growth and six therapies have double digit growths THE INDIAN pharmaceutical market (IPM) clocked ` 7097 crores in August 2014 and has grown at 8.4 per cent. Amongst the top 10, Mankind grew by 15.6 per cent followed by Cipla at 14.8 per cent and Sun Pharma at 13.3 per cent. Macleods grew at 31.6 per cent to be the 10th biggest corporate. 23 corporates have crossed the growth of IPM amongst top 50. Amongst the top 50 corporates, Akumentis has the highest growth of 57.7 per cent followed by Apex at 39.4 per cent and Macleods at 31.6 per cent. 20 cor-
porates showed double digit growths amongst the top 50. Amongst the 11-20 ranked corporates, Macleods has the highest growth of 31.6 per cent followed by Ipca at 27.4 per cent and Intas at 19.4 per cent. Amongst the 5160 ranked corporates, Panacea grows at 27.8 per cent followed by Allergan at 18.2 per cent and Pharmed at 16.7 per cent. Amongst the 61-75 ranked corporates, Boehringer grew by 53.8 per cent followed by Corona at 28.8 per cent and RPG at 12.6 per cent. Indian pharma companies
have grown at 9.9 per cent versus 4.4 per cent for MNCs in August 2014. Amongst the top 50 in MNCs Merck grew by 14.4 per cent followed by Ranbaxy at 10.1 per cent and Abbott at 7.8 per cent. Under the non-NLEM category Indian companies grew at 11.2 per cent whereas MNCs grew at 5.2 per cent. The DPCO 2013 containing molecules market grew at 2.9 per cent whereas the non-DPCO market grew by 9.6 per cent resulting in an overall growth of 8.4 per cent for August 2014. The
NLEM category showed positive unit growth at 4.3 per cent. The DPCO 2013 portfolio for Pfizer de-grew at 17.9 per cent, GSK grew at 14.2 per cent and Ranbaxy grew by 19.5 per cent. From therapy perspective, 10 therapies have outgrown the IPM growth and six therapies have double digit growths. Gastrointestinal market grew at 10.8 per cent, pain and analgesics market grew at 10.6 per cent, respiratory market grew at 8.5per cent whereas the anti-infectives grew at 6.4 per cent. The anti-diabetic market grows at
17.6 per cent and cardiac at 6.9 per cent in chronic business. The derma market grew by 9.8 per cent and the urology market at 17.3 per cent. From regional perspective, 14 regions have outgrown the IPM growth. The Jharkhand market grew the highest at 21.2 per cent followed by Madhya Pradesh market at 17 per cent and Uttarakhand-UP West market at 16 per cent. One region had negative growth in August 2014. Amoxycillin + Clavulanic Acid market grows at 24.4 per cent whereas Glimepiride
The Standard of Comparison
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EXPRESS PHARMA
19
October 1-15, 2014
MARKET + Metformin grows at 6.9 per cent at number two. The markets of paracetamol grew at 19.5 per cent, Atorvastatin 13.8 per cent, Azithromycin at 22.2 per cent, Probiotic Microbes at 21.2 per cent, Montelukast + Levocetrizine at 21.1 per cent, Glimepiride + Metformin + Pioglitazone at 40.8 per cent, Vitamin-D at 27.6 per cent, Hydroquinone + Mometasone + Tretinoin at 18.9 per cent, Voglibose + Metformin + Glimepiride at 30.1 per cent, Telmisartan + Metoprolol at 39.8 per cent. Mixtard continues to lead the pack with ` 32 crores in August 2014 with a growth of 17.5 per cent. Augmentin grows at 72.8 per cent, followed by Becosules at 29.2 per cent and Dexorange at 17.7 per cent amongst the top 10 brands. Amongst the brands who have gained ranks include Augmentin & Lantus (+9), Galvus Met (+22), Skinlite (+14), Moxikind CV (+6), Zincovit (+12), Thyronorm (+41), Novomix (+10), SpasmoProxyvon Plus (+191), Panderm Plus (+104), Dolo (+21), Jalra M (+28), amongst top 100 Brands over August 2013. Brands broken into top 200 include RB Tone, Econorm, Onglyza, Sporlac, Montair LC, Refresh Tears, P(Apex) over last year August 2013. Amongst the top brands in the IPM, Galvus Met (47.6per cent), Duphaston (29.2 per cent), Lantus (19.7 per cent), Pan (18.2 per cent), Glycomet GP (17.7 per cent), Skinlite (17 per cent) grew fastest amongst top 30 brands over August 2013. A total of 147 brands were launched in August 2014. Cefokem, Glimisave Max and Normoz are the top NIs for the month of August 2014.
About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.
Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage. For more information, visit http://www.aiocd.net
20 EXPRESS PHARMA October 1-15, 2014
(Val in Crs)
WITH BONUS UNITS AT FULL VALUE Val in Crs CORPORATE
Rank MAT
MAT Aug -14 MTH
IPM
Aug-14
Val (Cr)
MS%
GR%
Val (Cr)
MS%
GR%
79117
100.00
7.1
7097
100.00
8.4
Abbott + Abbott HC + Novo
1
1
4966
6.28
4.1
441
6.21
7.8
Sun Pharma
2
2
4312
5.45
15.6
372
5.24
13.3
Cipla
3
3
3916
4.95
6.8
358
5.05
14.8
Zydus + Biochem
4
4
3445
4.35
7.0
297
4.19
4.8
Ranbaxy
5
6
2871
3.63
3.1
261
3.68
10.1
Mankind
6
5
2827
3.57
6.6
271
3.82
15.6
Alkem + Cachet + Indchemie
7
8
2705
3.42
6.8
245
3.45
2.4
Glaxo
8
7
2695
3.41
-14.3
248
3.49
0.7
Lupin
9
9
2668
3.37
12.1
231
3.26
8.5
Pfizer
10
11
2305
2.91
4.2
204
2.88
3.2
Macleods
11
10
2205
2.79
17.1
222
3.13
31.6
Emcure + Zuventus
12
14
2179
2.75
11.4
186
2.63
-0.3
Intas
13
12
2072
2.62
14.8
191
2.69
19.4
Sanofi India
14
15
1962
2.48
-1.8
174
2.46
2.9
Aristo
15
13
1957
2.47
15.6
191
2.69
18.3
Torrent
16
16
1753
2.22
3.6
154
2.17
8.3
Glenmark
17
18
1715
2.17
15.4
152
2.14
9.0
Dr. Reddys
18
17
1698
2.15
8.6
153
2.15
15.2
Micro + Bal
19
19
1610
2.04
12.2
140
1.98
7.7
Ipca
20
20
1446
1.83
24.1
135
1.90
27.4
USV
21
21
1421
1.80
8.0
117
1.65
2.0
Novartis
22
24
1130
1.43
-2.5
94
1.33
-0.6
Alembic
23
23
1076
1.36
9.8
97
1.36
8.1
Wockhardt
24
22
1062
1.34
4.1
101
1.43
13.9
Val in Crs
MAT Aug 14
Month Aug-14
Super Group
VAL IN CRS
GR%
VAL IN CRS
GR%
IPM
79117
7.1
7097
8.4
ANTI-INFECTIVES
12750
-0.2
1219
6.4
GASTRO INTESTINAL
9047
8.4
834
10.8
CARDIAC
9844
8.9
824
6.9
VITAMINS / MINERALS / NUTRIENTS
7042
7.8
641
9.2
RESPIRATORY
6115
7.8
534
8.5
PAIN / ANALGESICS
5694
6.1
527
10.6
ANTI DIABETIC
5793
18.5
519
17.6
NEURO / CNS
4952
7.3
418
5.8
DERMA
4471
14.6
399
9.8
GYNAECOLOGICAL
4104
2.4
353
3.4
OPHTHAL / OTOLOGICALS
1433
9.8
127
9.9
ANTI-NEOPLASTICS
1278
26.6
119
27.5
HORMONES
1319
2.9
115
7.1
VACCINES
1142
-9.0
89
-15.3
BLOOD RELATED
988
3.5
86
0.6
OTHERS
924
5.7
85
4.8 17.3
UROLOGY
802
15.0
75
ANTI MALARIALS
615
2.5
67
5.1
SEX STIMULANTS / REJUVENATORS
447
2.7
35
-0.3
STOMATOLOGICALS
357
10.9
31
10.1
MARKET PRE EVENT
ABLE to host 11 edition of BIOINVEST th
The event in Bangalore will discuss about the importance of investing in biotechnology in India THE ASSOCIATION of Biotechnology Led Enterprises (ABLE) will host the 11th edition of 2014 BIOINVEST on October 17, 2014 in Bangalore. Dr Goutam Das, Chief Operating Officer, ABLE will give the introductory speech and the key note address will be given by Dr PM Murali, President, ABLE. Panel discussions will be held on ‘The art of a biotechnology deal’, which will be moderated by Utkarsh Palnitkar, Partner, Head of Advisory, Head Life Sciences KPMG, where Dr Rashmi Barbhaiya, Chief Executive Officer and Managing Director, Advinus will share the insights on the Advinus-Takeda deal. The panel discussion on 'Investing in intellectual capital creation (education and training)' will have Dr PM Murali, President, ABLE, Dr PK Khosla, Vice Chancellor, Shoolini University, Vijayanti Margassery, Associate Director Human Resources, Biocon as the panelists. The panel discussion on 'Investment trends in mature biotech markets Lessons for India' will have Sanjay Singh, Director -Corporate Finance, KPMG, Dr Renu Swarup, Managing Director, BIRAC, Ravi Tyagi, General Manager, SIDBI; Former Head SME Project – NSE, Vikas Dawra, MD-Investment Banking, Yes Bank and Sunny Sharma, Senior Managing Director, Orbimed Advisors, as the panelists. Swaminathan Dandapani, Executive Chairman, Manipal Hospitals, Dr Abhay Jere. Associate Vice President & Head - Persistent Labs| Persistent Systems, Dr Anu Acharya, Chief Executive Officer, mapmygenome, Ati Ranjan Kumar, AVP, Investment Research Aranca will take part in the panel discussion on 'The ‘big data’ healthcare business revolution.’ EP News Bureau-Mumbai
EXPRESS PHARMA
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MARKET POST EVENTS
Pharma Legal and Compliance Summit 2014 concludes in Mumbai Leaders discuss legal issues and challenges related to the pharma industry at the event Usha Sharma Mumbai LEX WITNESS recently organised its third annual edition of the Pharma Legal and Compliance Summit (PLCS) in Mumbai. The event provided a platform to the pharma regulatory fraternity, both Indian as well as global, to discuss various legal issues and challenges related to the industry. The day-long event saw the presence of eminent speakers from the pharma fraternity who discussed about the recent regulatory affairs in the domestic market. The inaugural session provided a brief description of pharma compliance practices and its requirements in India. The summit was chaired by AS Kumar, General Counsel and
Counsel and Executive Vice President, Dr Reddy’s Laboratories. The other speakers and panelists included Debolina Partap, Vice President and Head Legal, Wockhardt; Jayshree Swaminathan, Chief Executive Officer and Head Legal Compliance Chess Management Services; Sanjay Kumar, Head Legal, Piramal Imaging SA; Sanjay Sharma, Associate Director, Regional Security - Asia Pacific, Global Security Group MSD – Merck, Sharp & Dohme Corp; Ghanshyam Hegde, Associate Director - Legal, Abbott India; Vinod Kumar Dhall, Former Chairman, Competition Commission Of India and Executive Chairman; J Sai Deepak, Senior Associate, Saikrishna and Associates and Harpreet Singh, Partner, Governance Risk and
The day-long event saw the presence of eminent speakers from the pharma fraternity Compliance, Pricewaterhousecoopers. The panel discussion focused on mergers and acquisitions (M&A) and foreign direct investment (FDI). It also touched on the government’s move towards encouraging FDIs in the pharma sector and
allowing 100 per cent brownfield and greenfield investments with specific guidelines. Partap discussed on inbound investment. In the last five years there have been a total 30 M&As, worth over $30 billion in the industry. During 2013-14, 25 per cent of M&As world over were done in the pharma sector. She also stressed on analysing the risk assessment strategies before accomplishing a deal. Hegde presented the outbound investment spectrum of the pharma sector. “Companies need to do quality analysis of process of documentations, marketing practices and IPR related activities for due diligence before finalising outbound investments and also needs to build safeguards. Besides these, one of the key things that in-
vestor needs to consider is the protection provided by the state government to investors,” informed Hegde. Dhall informed about the basic precautions that need to be taken into consideration while following the procedures for applying government clearance. “Pharma is a very sensitive sector for the commission. And I would like send a message to the pharma community that when companies are approaching CCI they should come along with detailed information,” said Dhall. He also briefed about the usage and requirements of the long and short forms. The key takeaway of the event was that there is a need for clarity when it come regulatory affairs in the pharma sector. u.sharma@expressindia.com
4th National Health Writers and Editors Convention held in Goa Union Health Minister shares plans for launch of national health insurance cover in the country Usha Sharma Mumbai AIMING TO create better awareness among health journalists on issues related to the sector, Heal Foundation recently organised the 4th National Health writers and Editors Convention in Goa. Laxmikant Parsekar, Health Minister, Goa was the Chief Guest for the event. The two-day national convention started with a discussion on the affordability and accessibility of healthcare in the Indian scenario. Dr Harsh Vardhan, Union Minister of Health and Family Welfare, Government of India, via tele conferencing took part in
22 EXPRESS PHARMA October 1-15, 2014
the event where he said, “We are working to improve the healthcare system in our country. I appreciate the efforts taken by health journalists towards polio eradication. We are coming up with big plans for national health insurance and there are plans to launch the Universal Health Insurance cover in India.” Vardhan further said, “We would like to boost our traditional treatment methods. Bangladesh has already adopted Siddha, Unani and Ayurveda methods for their medical treatment. We are in talks with the Bangladesh Government to sign an MoU. In Bangladesh, we will be meeting the South East Asian representatives. Both India and
Bangladesh are rich in medicinal plants and we would like to ensure that this opportunity can be utilised.” Parsekar in his speech shared the key milestones of the state's healthcare scenario. Panel discussions and presentations at the event touched on the affordability and accessibility of healthcare, strengthening quality and innovation for effective healthcare, the dearth of talent and effective management of health resources, misconceptions surrounding health insurance, and the need for inhalation therapy for asthma management. Fighting adulteration in food items, and healthy snacking too were topics on the agenda.
DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) gave an update on issues being faced by the Indian pharmaceutical industry due to Drugs Price Control Order (DPCO) 2013. Ameera Shah, Managing Director and Chief Executive Officer, Metropolis Healthcare spoke about the need for guidelines in the diagnostic sector to reduce the wide variation in test results across various labs in the country. In order to generate awareness about the accreditation procedures for hospitals, Dr KK Kalra, Chief Executive Officer, National Accreditation Board for Hospitals (NABH) informed
that there are more than 3000 hospitals in the country and only 240 hospitals have received an accreditation so far from the NABH. Dr Sujeet Rajan, Consultant Chest Physician, Bombay Hospital Institute of Medical Sciences highlighted the importance of breathometer which helps to monitor respiratory diseases. Gaurav Malhotra, Managing Director and Chief Executive Officer, Bourn Hall Clinic India informed about the myths related to infertility in India. He mentioned that behind infertility both male and female are involved and female patients are not be blamed alone. u.sharma@expressindia.com
EVENT BRIEF OCTOBER 2014 - MAY 2015 16
9th Annual Conference of DIA
9TH ANNUAL CONFERENCE OF DIA Date: October16-18, 2014 Venue: Mumbai Summary: DIA will organise 9th Annual Conference where national and international speakers are likely to participate. The theme of the meeting is ‘The Future of Indian Healthcare: Patients, Access and Innovation,’ which will be chaired by Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research Apollo Hospitals Group and Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals. The programme will include sessions on topics including patient
8
health safety and compliance for prescription medicine, patient participation in clinical trials, universal health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing, innovations in healthcare solutions. Contact details: Drug Information Association A-303, Wellington Business Park - IMarol, Andheri - Kurla Road Andheri (East) Mumbai - 400 059 Tel: +91.22.67417625 Website: www.diahome.org
ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu Interna-
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Asia Pharma Expo-2015
tional Conference Centre, Dhaka, Bangladesh Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo-2015. The exhibiting companies from more than 26 countries across the world are expected to participate. The expo will be accommodating 400 booths to the exhibitors. Major OEM suppliers from Asia, Europe and the US are likely to participate. Contact details: Tel: +91 7940008233/ 53 Mob: +91 8000481114 Email: ceo@GPEexpo.com Website: www.asiapharma.org
18
PHARMA Pro & Pack Expo 2015
PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Mumbai Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors' profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/
marketing services, purchase officers, equipment suppliers and distributors, quality assurance/ quality control, maintenance engineering, R&D professionals, manufacturing/ production engineering, regulatory officers, operations management, validation, packaging engineering, vendor development, pharmacists. Contact details: Indian Pharma Machinery Manufacturers’ Association (IPMMA) 52, 1st floor, Suyog Industrial EstateLBS Marg, Vikhroli (West) Mumbai - 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108
EXPRESS PHARMA
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October 1-15, 2014
cover )
PHARMA MARKETING
of INNEED
AREBOOT WILL CHINA’S RECENT CRACKDOWN ON THE PHARMACEUTICAL INDUSTRY’S UNETHICAL MARKETING PRACTICES RESULT IN ANY LONG LASTING CHANGES? AS THE PHARMA INDUSTRY TURNS TO NEWER TECHNOLOGIES TO INCREASE MIND SHARE AND MARKET SHARE, WILL ETHICAL LINES BLUR INTO OBLIVION?
24 EXPRESS PHARMA October 1-15, 2014
(
THE MAIN FOCUS
HIGHLY ATTRACTIVE pharma market with more than 20,000 pharma firms, 60,000 distributors and significantly larger retailer base
$29.4 $490 M I L L I O N
fine was levied on Eli Lilly & Co, for allegedly bribing government officials like hospital administrators and doctors
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M I L L I O N
to be paid by GlaxoSmithKline (GSK) in China
EXPRESS PHARMA
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October 1-15, 2014
cover )
CODE OF CONDUCT:
APILL TO CURE
CORRUPTION? Unethical means of promotion employed by pharma firms have underlined the importance of a Uniform Code of Pharmaceutical Marketing Practices (UCPMP). Yet, the willingness of the industry and doctors to adhere to the code would determine its effectiveness and success BY SACHIN JAGDALE
26 EXPRESS PHARMA October 1-15, 2014
(
W
ith frequent reports of prominent pharmaceutical companies indulging in unethical practices, corruption in the pharma industry is no longer a breaking news. In recent years, governments of various countries have taken stern actions against pharma companies, the most stringent been China. China has recently fined GlaxoSmithKline (GSK) $490 million. A court found the company guilty of bribing doctors and hospitals to promote their products. This is not an isolated case for GSK. In July 2012, GSK
agreed to plead guilty to criminal charges and pay a $3 billion settlement of the largest healthcare fraud case in the US. Though GSK has emerged as a leader in pharma frauds, other pharma bigwigs are also close behind. Almost a year back, as per reports appeared in the Chinese newspaper, The 21st Century Business Herald, Novartis' eye care unit, Alcon, bribed more than 200 Chinese hospitals. Another large global pharma player, Eli Lilly & Co, was accused of bribing government officials like hospital administrators and doc-
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It is a matter of practice. In practice when you find examples of punishment and reward then a code of conduct like this in a given situation would make a difference Dr RB Smarta Managing Director Interlink Marketing Consultancy
THE MAIN FOCUS
tors, and agreed to pay $29.4 million to resolve federal allegations. The pharma industry deals with life and death of the consumer. Any sort of compromise on the services front would impact the patient as well. However, as per industry experts, pharma industry alone should not be isolated. Almost every case against any pharma company also points the finger at doctors who are prime beneficiaries of the bribes offered.
Why a code of conduct? It is often said that a business runs on relations. Offering
gifts, travel packages, hospitality etc. to doctors has always been a way of maintaining relations and increasing business for pharma marketers. However, these activities have also invited constant criticism for ignoring ethical practices. But criticising the pharma industry alone will be a biased move and as mentioned before, the healthcare fraternities should get equal blame. Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in the pharma industry is widely seen as a tool to keep check on corruption in the pharma sector which in turn would also help
EXPRESS PHARMA
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October 1-15, 2014
cover ) in minimising engagement of doctors in such activities. “Although the pharma industry and its marketing methods, tactics for unethical practices are blamed, competitive compulsions and the recipients are equally responsible. Greed is an universal phenomenon and if it is stretched you have these consequences! So both recipients, inclusive of doctors, stockists and even some other stakeholders, are equally responsible for this unfortunate practice,” says Dr RB Smarta, Managing Director, Interlink Marketing Consultancy. India is one of the largest pharma markets for generic medicines. The large size of the market and competition among pharma companies give ample scope for illegitimate activities. Over the last many years, the Organisation of Pharmaceutical Producers of India (OPPI) has been continuously striving towards making interactions/business activities between pharma industry and doctors ethical in the country. It has laid down rules to ensure ethical behaviour of its members. “Ethics and compliance is a core focus area for us and all our members follow OPPI’s Code of Pharmaceutical Practices, based on International Federation of Pharmaceutical Manufacturers and Associations Code 2012. Our code was created to ensure that our interactions with healthcare professionals, medical institutions and patient organisations is at all times ethical and transparent and always in the interest of the patient,” informs Ranjana Smetacek, Director General, OPPI. Though the code of conduct is in place for both the pharma professionals and doctors, doubts have been raised over its effectiveness. Smetacek adds, “A uniform code of medico-marketing practices will help regulate pharmaceutical marketing in India. UCPMP is a draft document, created by the Department of Pharmaceuticals (DoP). Currently, this code is voluntary,
28 EXPRESS PHARMA October 1-15, 2014
Currently, this code is voluntary, but we would welcome the government making this a statutory code. A statutory code would bring an increased level of transparency and accountability across the healthcare industry and remove ambiguity on all aspects of pharma marketing Ranjana Smetacek Director General OPPI
A one-sided effort will not help in the successful implementation of a uniform code of pharma marketing practices in the pharma industry. Responsible behaviour from the doctor community and government initiatives in framing strict policies/laws will indeed help the cause but we would welcome the government making this a statutory code. A statutory code would bring an increased level of transparency and accountability across the healthcare industry and remove ambiguity on all aspects of pharma marketing. It would also serve to address the recent concerns voiced against the industry and level the playing field for all drug manufacturers.” According to Smarta, it is not a matter of policy, code of conduct etc. He explains, “It is a matter of practice. In practice when you find examples of punishment and reward then a code of conduct like this in a given situation would make a difference.”
Mission impossible? In an era of cut throat competitions, a sense of insecurity always looms over company managements which in turn perhaps the paves way for unethical practices. With many companies offering drugs for the same diseases, making space for your business is bound to get tough. There are
possibilities of marketing professionals changing their modus operandi while offering gifts to give a slip to rules/code of conduct. In one such prominent example, a few years back, Pfizer agreed to pay more than $60 million to settle a US Federal bribery investigation. Pfizer was accused of illegal payoffs to win business overseas such as bribing doctors, hospitals, regulatory bodies across many countries in Europe and Asia. Moreover, the company tried to hide bribery by including them in the accounting books as legitimate expenses such as freight and training. Is it indeed possible to completely stop these unethical practices in both pharma and healthcare sector? “It is possible to stop these practices when there is transparency and compliance. Transparency can be brought by online transactions and compliance can be achieved by system through online transactions,” opines Smarta. Smarta’s views may ensure ethical practices to a some ex-
tent, however, on the other hand, implementation of any new system would require big investment and resources. In India drug manufacturers who are already compelled to sell drugs at cheaper price may not vote in favour of any new expenses.
Joint responsibility A one-sided effort will not help in the successful implementation of a uniform code of pharma marketing practices in the pharma industry. Responsible behaviour from the doctor community and government initiatives in framing strict policies/laws will indeed help the cause. Smarta says, “In my opinion, pharma industry not only wants to provide quality products, both generics and patented, but is also interested in building brands, both at the therapy level and also at the corporate level.” While speaking about the government’s role in this regard, Smarta says, “The role of the Indian Government would be taking up stakeholders as-
sociation such as Pharmaceutical Industry Association, Indian Medical Association, Distributors and Stockist Association and their board members to form a group along with lawyers who are dealing with the pharma industry. The government also has to make them accountable and suggest actions against those who deviate from ethical practices. With industry co-operation, the government can insist on disclosure of transactions which happen due to compulsion or deviation. Disclosure will not have any penalty for a given period of time, but will be a moral pressure. With the help of media professionals and chosen state wise stockists, the same transparency can be rewarded and also questioned through government intervention at the industry association’s level.” Reiterating Smarta’s suggestion Smetacek says, “For the UCPMP code to be implemented successfully, the government needs the support of all stakeholders, in particular, members of the Medical Council of India (MCI) and the Indian Medical Association (IMA).” Smetacek signs off, saying, “Both medical practitioners and the healthcare industry carry the responsibility to safeguard the health of all patients.” Implementation of uniform code of pharma marketing practices is seen as a step towards curbing unethical practices involved in the marketing of pharma products. However, pharma industry alone can not influence the prescriptions unless doctors are ready to play their part. As said by Potter Stewart, former Associate Justice of the United States Supreme Court, ethics is knowing the difference between what you have a right to do and what is right to do. Unless the pharma and healthcare professionals understand this difference, success of any such code of conduct would perhaps remain a distant dream. sachin.jagdale@expressindia.com
(
THE MAIN FOCUS
ADOPTING NEWAVENUES Pharma marketing is undergoing a metamorphosis, aided by digital technology which has not only opened up new vistas for brand building but also emerged as an effective tool for encouraging transparency and ethical practices in the industry BY USHA SHARMA
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EXPRESS PHARMA
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October 1-15, 2014
cover )
T
he Indian pharmaceutical market is highly attractive despite its fragmentation. It comprises more than 20,000 pharma firms, 60,000 distributors and significantly larger retailer base. The cost of research and developing new products is becoming more challenging day-by-day due to increased input costs and regulatory hurdles. It takes 8-10 years to successfully develop a new chemical entity (NCE) with an average investment of $800-1,000 million. Even after the product launch in the market, the regulatory requirements are comprehensive in terms of pharmacovigilance and reporting. Salil Kallianpur, a senior executive in an MNC pharma firm, speaking in his individual capacity, points out that over the years, doctors have decreasing regard for information provided by pharma companies. Some pharma corporate chieftains have identified trust as the number one challenge that the industry faces. In light of this, doctors offer less time for one-on-one interaction with medical representatives while preferring to access information at their own convenience. Digital technology has thus offered pharma an alternate medium to reach out to customers at times that are convenient to them and also to customers who could not be covered due to capacity constraints by companies. Pawan Chaudhary, Chairman and Managing Director, Venus Remedies says, “Today’s modern means of communication are good in their own way
30 EXPRESS PHARMA October 1-15, 2014
as they are fast, easily accessible and effective. The new means of communication offer various platforms to explain a particular product. For instance, 3D modelling can be easily explained on a laptop or tablet, while a piece of paper will only allow demonstration of 2D models.”
New technology complements the old... The trend of opting for less literature and more interactive mediums like demos, e-detailing and so on is in vogue in the pharma industry because are highly efficient, easily accessible and less time consuming. Chaudhary explains the necessity of having a tech touch and says, “The pharma and healthcare industry is highly competitive, because of which medical representatives from various companies do not get much time with doctors to explain to them the details of a particular product. Due to this, many big pharma firms have started adopting this trend and are exercising it at various levels.” As the usage of technology evolved over the last decade, its application was touted as a mantra to control manpower costs the largest head under selling costs. Understandably, pharma marketers were reluctant to substitute tried and tested sales forces with newer and less familiar
It is all about positioning the product correctly to save, preserve and improve human lives. This is the reason why marketing and promotion cost is more in the pharma industry Pawan Chaudhary Chairman and Managing Director, Venus Remedies
Investment with full disclosures that ensure transparency must be ensured so that the intent is clear to all stakeholders and there is no lack of information leading to misinformed medical treatment or loss of patient lives Salil Kallianpur, Senior Executive in an MNC pharma firm
technology. This didn't happen even in the developed markets where products are patented and exclusive, hence it was considered totally inapplicable in generic markets like India where a very high share of voice is required to stay relevant with customers. Gradually the understanding has shifted towards accepting technology as a complementary tactic to the sales force. “This means that the limitations of a sales force (such as reach to customers, use of multi-media, ability for customers to access information at their convenience and interactivity) is effectively met through technology. At the moment companies are more comfortable with this method and are not actively considering reducing the size of their sales forces and shifting over completely to modern methods,” informs Kallianpur. Highlighting the importance of a tech-driven marketing approach in today's world, Vinay Pinto, Executive Director, Wallace Pharmaceuticals says, “Today as companies expand across oceans and countries, communication has new challenges as it has to travel across many barriers including culture and language. Newer communication methods help standardise communication across these vast geographies and groups of people. It helps everyone speak the same marketing language.”
… but full disclosure is vital Use of new media technologies and solutions are growing as they allow information to be shared in a convenient and interactive manner. But now companies are also investing in key opinion leaders (KOLs). Kallianpur, while defining the role of KOLs in pharma companies, says, “Independent observers consider any financial transaction between doctors and the industry as an inducement and an incentive to prescribe their products rather than anything else. These maybe independent research grants for clinical studies or honoraria paid out to opinion leaders for their time at advisory boards or industry meetings where they are invited to share their experience with a company's products.” Chaudhary elaborates further and states, “KOLs are capable of influencing other clinicians through their professional status and updated scientific knowledge. They also play a vital role in the drug development stage and the pre and post-launch phase by providing valuable suggestions and bridging the gap between clinical needs and research.” The industry also funds academia for fundamental research leading to breakthrough therapies. KOLs have also helped in clinical data publication, thereby supporting and boosting the scientific value of the drug. “The problem begins when either the funding or its true intent remains undisclosed leading to a clear conflict of interest. In the recent past there have been a
( spate of such incidents that have badly damaged the reputation of the industry and sullied the reputations of independent and very capable researchers. Investment with full disclosures that ensure transparency must be ensured so that the intent is clear to all stakeholders and there is no lack of information leading to misinformed medical treatment or loss of patient lives,” Kallianpur informs. Forecasting the increasing need for KOLs in pharma industry, Chaudhary says, “The pharma industry have been and will be relying heavily on KOLs in future too, be it developing a new research product, targeting a unique segment of clinicians for drug promotion, taking first-hand clinical inputs to upgrade the scientific information of the drug, training and education programmes, symposiums or conferences.” If pharma companies follow new trends and adopt the KOL system then will it be a threat to the medical representative (MR) community? Will pharma companies wipe out the MRs? Or will their importance decrease? The answer remains NO! Chaudhary stresses, “Pharma companies should not reduce the number of MRs and opt for modern methods as technologies and modern means of communication cannot replace humans. Since pharma marketing is based on relationship building, physical meetings will always be a part of this business.”
Transformation Pharma companies find it difficult to sustain and build high value of their brands as a number of generic competitors enter each segment and newer molecules offer alternatives and substitutes. Besides these, regulators have defined the marketing strategies and violating the guidelines is an offence. Drug pricing policy hasbecome a big challenge to pharma companies and they are cutting down expenditure on printing product literature and adopting technologies to
THE MAIN FOCUS
Newer methods help standardise communication across these vast geographies and groups of people. It helps everyone speak the same marketing language Vinay Pinto, Executive Director, Wallace Pharmaceuticals
educate doctors about their products. Doctors play an important role in building up the brand image of pharma companies. Pharma companies try to make as big an impact on doctors so that they prescribe their drugs. In the late 70s and 80s traditional marketing practices was the only mode of communication. To educate doctors about company’s latest their therapeutic solutions and breakthroughs, companies conducted continuing medical educations (CMEs) and seminars and it became a popular method of learning. The scenario has not changed drastically as doctors still prefer such traditional marketing practices. Chaudhary informs, “There are many doctors in the industry who still prefer traditional means of communication over the modern ones, especially for R&D-driven pharma compa-
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nies like ours where the differentiation of products needs to be explained thoroughly.” Kallianpur opines, “It is important for brands to maintain a high share of voice to remain relevant with customers. Often, strong brands help to serve as an anchor to hold customer loyalty for newer products introduced by the company. In a highly cluttered market this is a definite advantage for companies.” Chaudhary informs that they spend 8-10 per cent of their total sales budget on promotional activities and indicate thatthisis the industry average.
Market strategies Pharma companies justify their extensive marketing strategies as a means to recover the amount spent on drug development. According to latest estimates, on an average, a pharma company could spend upto $4 billion for devel-
oping a new molecule. Consequently, it will need to spend more on building the brand value of the new molecule to recover this investment. The total percentage of spending on building brands varies from company to company depending on earning models but the question remains with its necessity. Pinto, highlighted the urge to create brand value and said, “Brands create value for a company and that’s why it is important for the health of any industry to invest in brand creation.” To achieve the goal of building a blockbuster brand, budgeting plays an important role. Commenting on why pharma companies need to allocate abudget for pharma marketing/promotion, Chaudhary says, “The rising competition and survival of the fittest rule requires proper positioning of the product to establish and
make it grow. In the pharma industry, it is all about positioning the product correctly to save, preserve and improve human lives. This is why marketing and promotion cost more in the pharma industry as compared to other industries.” Kallianpur opines, “In my opinion there is no 'ideal' for marketing activities. The marketing budget of a brand/product/company is decided by many factors such as importance of the segment for the organisation, relationships with customers and the entry position of the brand in the category.” He further says, “Typically the highest investments are seen in brands if they are among the first few to enter a lucrative segment. As the order of entry or the company's position in a category moves lower, the budgets are proportionately lowered.” Are all companies convinced that the way forward would be these new models? Will this set a new benchmark for transparency in the system? Kallianpur foresees the opportunities and says, “As early adopters prove that the new models work, regulators make peace with its implementation and the cost of adopting them lowers, the laggards will make sure-footed moves towards the more recent communication models. Technology allows us to tailormake communication so that it remains most relevant to the receiver. This allows it to stand out of the clutter and register better in the minds of the customers. Sadly in India, marketers are more laggards than early adopters for new technology or models. This is because of large businesses at stake.” There is no doubt that technology offers unique and creative ways of interaction as opposed to a one-way rep detail in the doctors clinics. The emergence of big data and analytics are leading to creative ways of predicting customer preferences and the pharma sector is adapting to this in a big way. u.sharma@expressindia.com
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MANAGEMENT
A
few days before Prime Minister Modi’s first visit to the US as PM, pharmaceutical companies in India were pleasantly surprised when the country’s drug pricing authority, the National Pharmaceutical Pricing Authority’s (NPPA) withdrew a set of internal guidelines which allowed it to monitor the prices of drugs that were previously out of its purview citing public interest. (See report: pharma.financialexpress.com/latest-updates/4448-nppa-withdraws-internal-g-lines-on-drugpricing) These guidelines were challenged in court by industry associations like The Organisation of Pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers’ Association (IDMA), as they impacted drugs outside the National List of Essential Medicines (NLEM). Industry has reacted positively but cautiously to the news. Ranjana Smetacek, Director General, OPPI commented that the move meant that they industry is being heard (by the Government) and they look forward to working with the government toward a common goal. “We are still trying to understand the precise impact of this order on our member companies,” according to the statement. Daara B Patel, SecretaryGeneral, IDMA too reacted positively saying that the Government’s decision will be beneficial to both industry as well as to patients as companies will not be reluctant to manufacture medicines put under DPCO regime and patients can avail them without any hurdles. Though no reason has been given for the withdrawal, can be it be a mere coincidence that the U-turn came a few days before the Prime Minister’s visit to the US? It is still unclear if price cuts already announced will be reversed or if the decision will prevent the NPPA from using the public interest clause again on non-NLEM products.
Push from the top The PM’s trip to the US, in end September, comes after his suc-
32 EXPRESS PHARMA October 1-15, 2014
cessful trip to Japan and Chinese President Xi Jinping’s visit to India. The momentum of the first trip impacted the hype around the Chinese delegation’s visit and much was made of the many MoUs signed between the two countries. Though incursions of the Chinese PLA on the border took away some of the sheen from these MOUs, there are two MoUs which raised some hopes among pharma companies in India. One MoU was part of the effort to balance the long standing
dian pharma companies trying to make inroads into the China market. Proper and speedy implementation of both MoUs could have a very positive impact on pharma companies in India. Currently, only a handful of Indian pharma companies, including Dr Reddys Laboratories, Ranbaxy, Sun Pharma & Aurobindo are present in China. (See story: http://pharma.financialexpress.com/latest-updates/4435-indian-pharma-couldgain-from-china-india-mous) These MoUs are in line with
In a press briefing on September 8, Commerce and industry minister Nirmala Sitharaman had indicated that the Government would roll out a revised policy on IPRs and this has raised concerns that the Government considering a change of stance. She has been quoted as saying, “There are different laws (on patents, copyrights, trademarks and geographical indication), but we don’t have a comprehensive IPR policy clearly spelling out our regime for the entire world to
THE POLITICS
BEHIND PHARMA Prime Minister Modi’s decision to review India’s position on IP laws before his first trip to the US has once again brought this debate to the fore. Will the PM stand his ground? An Express Pharma analysis
trade deficit, currently skewed in favour of the dragon nation. Along with pharma, agri products and IT services are the sectors where China has agreed to take specific measures to enhance market access. Another MoU was a work plan on drug administration and cooperation between the drug regulators of both countries on drug standards, traditional medicine and drug testing. Both sides will exchange delegations to enhance cooperation in these area. These two MoUs address two of the major pain points: market access and approvals, faced by In-
PM Modi’s past record of nurturing an industry-friendly environment. But will this stance see him bend where he needs to stand tall? For instance, on the intellectual property rights (IPR) issue, the US has been castigating the country's IP laws, and in May this year, was all set to list India on the Special 301 list of IP defaulting nations. However, objections from two stronger industries, defence and software, overrode the pharma industry’s objections. India escaped being on the Special 301 list and was instead classified as a “priority watch list country.”
know. As a result we have had arbitration matters and court cases on many IPR matters. The lack of a clear policy is hurting us,” the minister said. (http://indianexpress.com/article/b usiness/economy/govt-signals-iprrecast-ahead-of-modis-us-visit/) She clarified that the IPR policy would not be restrictive or regressive, but would only “give clarity and consistency without any overlap or contradictions. It is also to protect at an international level India’s IPR interests, our heritage, our achievements in pharma, especially generics, the advances we
make in science and technology, as well as the patents we file.” Even with these clarifications, sections of the industry are not convinced. In a widely circulated open letter to Modi’s government on the decision to review India’s position on IP laws, a range of stakeholders have urged him “during his visit to the US, not to make any legal or political commitment that compromises flexibilities in the Indian Patents Act for facilitating access to medicines and safeguarding public health, which is based on policies and principles approved by Indian Parliament and is fully consistent with international laws.” The stakeholders range from public health organisations like Jan Swasthya Abhiyan, Dr Amit Sengupta of Jan Swasthya Abhiyan, Leena Menghaney of Campaign for Affordable Trastuzumab and Malini Aisola of Oxfam India. Legal aid groups like Prof Dinesh Abrol, Convener, National Working Group on Patent Laws, Ramya Sheshadri, Lawyers Collective as well as patient groups like Manoj Pardesi, National Coalition of PLHIV in India (NCPI+) and Network of Maharashtra by People Living with HIV/AIDS (NMP+) and Kausalya of Positive Women Network are signatories to the letter. Scientists, diplomats and academicians like Dr Nityanand, Eminent Scientist, Former Director Central Drug Research Institute, S P Shukla, Former GATT Ambassador and Secretary, Ministry of Health and Family Planning, Prof Muchkund Dubey, President Council for Social Development, New Delhi and Former Foreign Secretary, Government of India, BL Das, Former GATT Ambassador, Dr Biswajit Dhar, Professor, Centre for Economic Studies and Planning, School of Social Sciences, JNU and Prof BS Chimni, Centre for International Legal Studies, School of International Studies, JNU too are among the signatories. Will the PM be able to find common ground to address concerns of these stakeholders as well as balance diplomatic ties?
INSIGHT DR GOPAKUMAR G NAIR, Chief Executive Officer, Gopakumar Nair Associates
Indian generic pharma and global regulatory challenges Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates talks about why the regulatory scenario in the domestic markets need more support from the government for developing infrastructure, logistic and manpower as well as technical accreditation to global standards
I
ndian generic pharma has come a long way since the 70’s and 80’s. The then Executive Director of IDMA (Indian Drug Manufacturer’s Association) Dr Venkat Narayan who was earlier Joint Secretary in Ministry of Chemicals including Pharmaceuticals stated in 1987, “If we have atleast 10 to 20 Indian pharma manufactures having more than ` 100-crore turnover, we can be confident that the Indian pharmaceutical industry has found its place in the global map.” We are proud today to have a very large number of pharma companies who have turnovers exceeding ` 1000 crores. The recent merger of Ranbaxy with Sun Pharma has catapulted the merged entity to have a combined turnover exceeding `25000 crores. Others such as Cipla, Dr Reddy’s Labs, Lupin, Cadila, Glenmark, Torrent, Aurobindo, Ipca Laboratories, Strides and few others are already in the `1000crore club. The global success of these Indian pharma companies are mainly due to the entrepreneurial enthusiasm and high standards of quality and regulatory practices adopted and maintained by them. It is heartening to know that all the top Indian pharma companies have their own Active Pharmaceutical Ingredients manufacturing facili-
ties as well as formulation facilities; inspected, audited and approved by top regulatory agencies globally. The large turnover achieved by these companies arise from exports to highly regulated markets. However, the regulatory scenario in their domestic markets need more support from the government for developing infrastructure, logistic and manpower as well as technical accreditation to global standards.
To ICH or not to ICH Even though India has proclaimed itself as the 'pharmacy of the world' there is international pressure on India as a whole to improve the quality and regulatory standards in the country. It is interesting to note that a working paper on “Where is the pharmacy to the world? International regulatory variation and pharmaceutical industry location' from Harvard Business School do mention India and China as having potential to offer competition in future. However, such competition is possible only with world class regulatory establishment at home. In AEI Paper on 'Pharmacy to the world: India and the global prescription drug trade,' the panelists state that the product quality largely depends on the overall maturity of a country’s
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Experts in Pharmaceuticals, Cosmetics and Nutraceuticals Products
MANAGEMENT pharma industry and that of the regulators. The ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) has brought together the regulatory authorities and pharma industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation, to ensure that safe, effective, and high quality medicines are developed and registered in the most resourceefficient manner. ICH is conducting many workshops and seminars in China on the various ICH Guidelines. As per a report in ICH website, the ICH Steering Committee has agreed to open ICH technical working groups for active participation from experts from non-ICH member regions and countries of the ICH GCG (Global Cooperation Group). Experts from countries include Australia, Brazil, China, Chinese Taipei, India, Russia, South Korea and Singapore, and other harmonisation initiatives, such
As per a report in ICH website, the ICH Steering Committee has agreed to open ICH technical working groups for active participation from experts from non-ICH member regions and countries of the ICH GCG (Global Cooperation Group) as Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), Gulf Cooperation Countries (GCC), Pan American Network on Drug Regulatory Harmonization (PANDRH) and Southern African Development Community (SADC), will now have the opportunity to have technical experts participating in many ICH technical working groups thereby actively contributing to ICH Guideline development. The Deputy Director General and Head of Regulatory Affairs at the European Generic Medicines Association pointed out that, the vast majority of ICH guidelines become regulatory requirements and guidance that are directly applicable to generic and bio similar pharmaceuticals manufacturers. It is imperative that Indian regulatory authorities have to take note of the increasing clout
and importance of ICH and join the initiative atleast as an observer as early as possible. To become an ICH member, the country’s regulator has to join as an observer and eventually upgrade the domestic regulatory framework to meet ICH standards and offer for inspection and approval.
ICH AND IGDRP The availability of quality generic drugs, also known as multi-source medicines or pharmaceuticals, play an increasingly important role in helping to address rising healthcare costs and in promoting access to essential medicines worldwide. This, however, has led to significant pressures on medicines regulatory authorities (RAs) charged with the review and approval of these products. In addition to an increased workload associated with the growing number
of generic drug applications, RAs must now also contend with more sophisticated generic drug products and complex global production and distribution chains. Given these challenges, the need for regulatory cooperation and convergence has long been recognised. This has led a group of regulators to launch the International Generic Drug Regulators Pilot (IGDRP). The threeyear pilot entails a series of concrete measures to facilitate the timely authorisation and availability of safe, effective and quality generic medicines. But it is also being warned that a scheme’s success will stand or fall on the support of pharma and other interested parties-although the incentive is that generics should be authorised in different territories in a co-ordinated way at around the same time. Further, sharing assessment reports in real time
with participating agencies outside the EU will accelerate the process and make the science of the process more robust. Since the start of the IGDRP, when the first meeting was held on Ottawa in October 2011, considerable progress has been made along with, heavyweight support of the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organisation (WHO) overseeing it as observers. As the initiative enters its third and final year as a pilot, the RAs are also examining the possibilities of work sharing in active substance master file, inspection of sites conducting bioequivalence and bio-analytical studies, and on pharma quality issues. It is expected that work underway should lead to advancing regulatory convergence and the piloting of new models of cooperation prior to the end of 2014. It is, however, unfortunate that the leading high quality generic pharma manufacturing and exporting country, India, is neither a member of IGDRP nor the member of qualifying organisation, ICH. In the light of India’s leadership as global generic source and supplier, India need to become at least an observer in ICH as well as IGDRP at the earliest.
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34 EXPRESS PHARMA October 1-15, 2014
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RESEARCH CLINICAL UPDATES
Merck Serono to discontinue clinical development programme of tecemotide The results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals MERCK SERONO will discontinue the clinical development programme of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) as a monotherapy in stage III nonsmall cell lung cancer (NSCLC). Luciano Rossetti, Global Head of Research & Development, Merck Serono said, “While the data from the exploratory subgroup analysis in the START trial1 generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals. Therefore, we have decided to discontinue the development of tecemotide as a monotherapy in NSCLC in order to refocus our efforts on other promising candidates in our pipeline, like our anti-PD-L1 antibody MSB0010718C. Merck
Serono remains committed to developing new treatment options for patients with difficultto-treat cancers.” The company’s decision to discontinue the current clinical programme in NSCLC, which includes the phase III START2 and INSPIRE studies, follows recent results from a planned analysis of EMR 63325-009, a randomised, double-blind, placebo-controlled phase I/II study in Japanese patients with stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose =50 Gy. Of the patients included in the phase II part of the study, the majority had received concurrent CRT. The results indicate that no effect has been observed for either the primary+++ end-
point, overall survival (OS), or for any of the secondary endpoints (progression-free survival [PFS], time to progression [TTP] and time to treatment failure). An analysis of the reported adverse events has not identified a clinically meaningful difference in the frequency between treatment groups. Al-
though the trial was not powered to demonstrate a statistically significant difference in benefit between the two arms, Merck Serono made the recommendation to stop the investigational treatment for patients in the EMR 63325-009 study in Japan. Merck Serono has made the
decision to discontinue all other Merck Serono-sponsored clinical trials with tecemotide in NSCLC worldwide. Those patients on active treatment with tecemotide can undergo an individual assessment by their treating physician and apply to receive further treatment outside of the studies. The company will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with Merck’s agreements with the sponsors of these studies. Merck Serono continues to evaluate a number of investigational compounds for difficult-to-treat cancers, and remains committed to improving the lives of cancer patients and their families.
References 1.Butts C, et al. Lancet Oncol 2014;15(1):59-68. EP News Bureau-Mumbai
Glenmark’s TRPA1 antagonist shows positive data TRPA1 is an ion channel expressed on peripheral and spinal sensory neurons and it mediates pain signal transmission GLENMARK PHARMACEUTICALS' first in class Transient Receptor Potential Ankyrin 1 (TRPA1) antagonist, GRC 17536 has shown positive data in a phase 2a double blind, placebo controlled, multi-centre, proof of concept study conducted on 138 patients in Europe and India. A statistically significant and clinically relevant response was seen in a prospectively-identified, substantial sub-group of pa-
tients with moderate to severe pain who had relatively intact sensory responses as detected by a standardised testing methodology. GRC 17536 was well-tolerated with no evidence of CNS or other drug related side effects. Patrick Keohane, Chief Medical Officer, Glenmark stated, “Diabetic neuropathy remains a difficult to manage chronic clinical condition with limited thera-
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peutic options. These initial efficacy and safety data with GRC 17536, a peripherally acting novel therapeutic, are encouraging, and Glenmark intends to be ready to file for a phase 2b dose range finding study in patients with neuropathic pain before the end of this financial year. This announcement also reaffirms our position globally in the development of novel pain therapies.” Commenting on the result,
Dr Michael Buschle, Chief Scientific Officer & President - Biologics, Glenmark Pharmaceuticals mentioned, “This is promising and GRC 17536 may be useful for several indications which we will pursue.” The Glenmark TRPA1 programme includes indications in pain as well as respiratory. inhaled doses of GRC 17536 are also being tested in a phase 2A proof of concept study in pa-
tients with chronic cough. TRPA1 is an ion channel expressed on peripheral and spinal sensory neurons and it mediates pain signal transmission. It functions as a cellular sensor for detecting painful mechanical, biochemical and thermal stimuli that cause sensory nerve hyperactivity during chronic pathologies including chronic pain, inflammation, itch and cough. EP News Bureau-Mumbai
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RESEARCH
Bone Therapeutics receives clearance To investigate Allob’s potential to improve spinal fusion surgery outcomes BONE THERAPEUTICS has received clearance from the Competent Authorities and Central Ethics Committee in Belgium for a phase II proof-ofconcept study to assess safety and efficacy of its allogeneic1 osteoblastic cell therapy product Allob in spinal fusion procedures for degenerative lumbar disc disease. Bone Therapeutics aims to investigate Allob’s potential to fulfil this unmet medical need and improve spinal fusion surgery outcomes. Allob has already shown the required osteoinductive, osteogenic and osteoconductive features for bone formation enhancement as well as excellent safety and efficacy in preclinical studies and is currently being evaluated in a phase I/IIa trial for delayed-union fractures. In this pilot proof-of-concept study, 16 patients with symptomatic degenerative
lumbar disc disease that require interbody fusion will be treated with a single dose of Allob mixed with bioceramic granules to promote bone formation and fusion at the degenerative disc level. The use of a bioceramic scaffold mixed with Allob cells is intended to promote bone formation by (i) providing biologically active osteoblastic cells, (ii) restoring a healthy bone environment, and (iii) guiding growth in three-dimensions. Patients will be enrolled in four centres and safety and efficacy of the treatment will be monitored over 12 months by clinical (Oswestry Disability Index) and radiological (fusion progression) evaluation, with an additional 24-month post-study follow-up. Back pain is a widespread medical disorder in industrialised societies and several
pathologies require spinal surgery. Around 1.3 million spinal fusions are performed each year in Europe and the US, the majority of which are to address degenerative lumbar disc disease. Despite the frequency of this surgery, nonunion of bone and persistent pain following the intervention is still extremely common. Further improvements would thus be extremely beneficial to improve safety and efficacy. Enrico Bastianelli, Chief Executive Officer, Bone Therapeutics commented, “This new clinical trial clearance from the Competent Authorities in Belgium is an important milestone in the development of Allob and further validate Bone Therapeutics’ clinical, regulatory and manufacturing capabilities.” EP News Bureau-Mumbai
RESEARCH UPDATE
Sanofi,Regeneron drug may halve heart risk Targeting a protein known as PCSK9 could slash cardiovascular risks for millions of patients AN EXPERIMENTAL cholesterol-lowering drug from Sanofi and Regeneron Pharmaceuticals roughly halved the number of heart attacks and strokes in a clinical trial, researchers reported. The result is not conclusive, because the analysis was done retrospectively, but it provides the first evidence that targeting a protein known as PCSK9 could slash cardiovascular risks for millions of patients. The injectable drug, alirocumab, is from a new class of medicines, which are also being developed by Amgen and Pfizer. They lower 'bad' LDL cholesterol in a new way and
36 EXPRESS PHARMA October 1-15, 2014
are widely expected to reap multi-billion-dollar sales. The finding is likely to spur enthusiasm about the drugs, which could reach the market next year, although experts said it still needed to be confirmed in a much larger trial. Sanofi and Regeneron said in July that nine big studies showed consistent LDL reductions with alirocumab, but details from four of these trials have only now been unveiled at the European Society of Cardiology annual meeting in Barcelona. The encouraging cardiovascular data come from an interim safety analysis of one of
these studies showing patients on alirocumab were less prone to a combination of cardiovascular events, including cardiac death, heart attack, stroke and chest pain requiring hospitalisation. Both groups of patients got traditional anti-cholesterol statin pills in addition to alirocumab or a placebo. Among the alirocumab group, 1.4 per cent of patients suffered a major cardiovascular event against three per cent of those on placebo. The ongoing 2,341-patient study, called Odyssey Long Term, is expected to conclude early next year but researchers
said the early sign of efficacy was clearly positive. It is unclear if the rival PCSK9 drugs will prove to be very different from each other but Sanofi's research head Elias Zerhouni thinks alirocumab should enjoy an early advantage from the preliminary indication of improved cardiovascular results. That may help convince cost-conscious healthcare providers to pay up for an expensive new medicine before results from the large 18,000patient trial are available in 2017 or 2018. Reuters
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PHARMA ALLY I N T E R V I E W
‘Fujitsu aims to differentiate through its application knowledge’ Fujitsu enjoys a leadership position in High Performance Computing (HPC) services. Mehul Doshi, Country Manager-Enterprise Servers, Storage and Datacenter Solutions, Fujitsu, reveals more to Sachin Jagdale
Many big IT companies are operational in India and High Performance Computing (HPC) may not be the new concept in the Indian pharmaceutical market. What is the USP of your HPC services? At the high-end HPC market Fujitsu aims to differentiate through our application knowledge and service capability. Upstream, this translates into a higher quality and more thorough benchmarking process, and an endeavour to more clearly understand the client’s problems from a real application perspective. Taking this approach into the small to mid-size HPC market our USP translates into an approach for capturing and encoding this same global application knowledge and customer insight, combined with a mechanism to effortlessly disseminate such expertise on a broad scale. Explain the idea behind ‘Fujitsu HPC Simplicity’. HPC Simplicity provides the key by leveraging our own software stack – specifically the HPC Gateway web environment. We encode HPC methods and bestpractices that can then be
38 EXPRESS PHARMA October 1-15, 2014
scaled to the largest number of individuals and teams, whether practiced users or HPC newcomers. Simplifying the HPC interface alone is not the complete answer. Without the expert-based means to drive applications and HPC workloads effectively, the range of users will always remain limited and narrow, regardless how easy the desktop interface appears. In fact our message combines simplicity and expertise. Again, expertise that can only be re-used by the expert or near-expert doesn’t widen the appeal and opportunity of HPC. These concepts only work in conjunction and Fujitsu is the only vendor today driving this discourse and engagement at the application level, rather than just at the infrastructure and system layer. What are the applications of this concept in the pharma industry? What are the revenue savings and how soon can the client see ROI? There are two areas where we target ROI. The first is the time to achieve near peak productivity. The combination of simplified user experience and optimal application
Without the expert-based means to drive applications and HPC workloads effectively, the range of users will always remain limited and narrow, regardless how easy the desktop interface appears
Expertise that can only be re-used by the expert or near-expert doesn’t widen the appeal and opportunity of HPC
methods aims helps to reduce this to a minimum. Sustaining maximum productivity then gives the bulk of the return. This is delivered through methods that are continually enriched by Fujitsu with learning acquired from its interactions with Independent Software Vendors (ISVs), endusers and other researchers, and by the additions of the customer themselves. This takes the form of further application self-on boarding and automation of standardised processes that are potentially unique to that organisation, that capture their own core competence, and which are spread more effectively across the widest set of their end-users. Ideally this gives the customer confidence and assurance to deploy HPC on more projects.
What implementation challenges do you foresee? The biggest challenge in the pharma industry is potentially the large range of applications that are regularly utilised across the different customers. More so than the CAE (Computer Aided Engineering) market, which is one of the other leading HPC segments which is dominated by a limited number of simulation codes from few ISVs (in CFD, structural mechanics, etc), the pharma industry has a wealth of choice and not only from commercial vendors but also trusted open source or academic codes. Ensuring adequate coverage of this application range is a major effort on the part of Fujitsu. sachin.jagdale@expressindia.com
INSIGHT
Drug recalls due to dissolution failures: What can be done? Priyanka Patil,Research Associate, pharmEDGE,shares insights on how to reduce drug recalls by improving the dissolution tests RECALL IS an action taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative or by FDA, MHRA request/order. Pharmaceuticals companies such as Sun Pharma, Wockhardt, Dr Reddy’s Laboratories to name a few, have faced such drug recalls from the US FDA recently, as few of their anti-depressant, anticancer, anti-diabetes and hypertension drugs did not meet the ‘drug release dissolution specifications’ during the long-term stability studies. Tablets and capsules taken orally remain one of the most commonly used means of providing treatment. Dissolution tests are commonly conducted to check the time taken for the active ingredient in a dosage form to release into the body and help predict how the drug performs inside the body. The effectiveness of these drugs relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the blood stream. The dissolution procedure is an important test both to evaluate safety , predict efficacy and stability with respect to manufacturing and storage conditions. Hence, carrying out dissolution studies on these dosage forms is crucial. Accelerated stability studies are conducted on tablets and capsules by storing them in extreme conditions over an extended period of time to help predict the behavior of medicines over their entire shelf life. The drugs are marketed prior to the completion of these long-term stability studies with an understanding
that the manufacturer will cooperate in recalling the medications if, they don’t meet specifications. Hence, it is important to understand the possible factors that can cause changes and failures in dissolution. “Dissolution testing is a delicate marriage of man, machine and method, where even if one variable is neglected, it can render your test results useless,” said Amit Marfatia, Managing Director, Electrolab, a leading dissolution equipment manufacturer. An increase in variability in dissolution testing makes it impossible to describe differences in product quality. Reducing variability in dissolution testing can help identify a batch not meeting specifications before it is marketed and may prevent a recall in the future. Variability in dissolution testing arises primarily from the human conducting the test (Man), the equipment used for the test (Machine), and the method undertaken for the test (Method).
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PHARMA ALLY PERFORMANCE OF DISSOLUTION TESTING
PERFORMANCE OF DISSOLUTION TESTING
Man: An inexperienced or under qualified staff (analyst) may fail to understand the major difficulties occurring during dissolution studies. Regular training of all personnel (analysts and apparatus cleaning staff) may help raise awareness of the sensitivity of the process as a whole. A separate dissolution testing group with trained professionals is an optimal way to handle dissolution method development, routine testing and minimise the variability. Machine: Variability resulting due to the equipment can be controlled by increasing the number of parameters during the verification process and tightening the tolerances. The pharmacopeial specifications are very broad and many manufacturers provide tighter tolerances to reduce variability within a dissolution test and between multiple dissolution testers. The United States Pharmacopeia (USP) recommends performance verification testing (PVT) of all dissolution equipment prior to using the equipment. The accepted interval for the PVT is usually once in six months and equipment manufacturers offer third-party verification of the instrument as a service. Industry experts agree that third-party PVT testing is an excellent risk minimisation tool allowing analysts to focus on their core competency. Experts also believe that it’s more important to implement third-party PVT testing in quality control and quality assurance laboratories. Several research publications have revealed that factors like paddle height, rotation speed, tablet-sticking, level of de-aeration and vessel type attribute to variability and dissolution failure. Vessel type and level of deaeration are reported to be the major causes of variability. ◗ Vessel geometry: In a study conducted by USP, vessels were shown to be the single largest cause for standard deviation variability (37.7 per cent contribution) (Eaton J., et al., 2007). Vessel related failures are cor-
40 EXPRESS PHARMA October 1-15, 2014
Dissolution tests are commonly conducted to check the time taken for the active ingredient in a dosage form to release into the body and help predict how the drug performs inside the body.The effectiveness of these drugs relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the blood stream related to the use of different vessel types on a single system, deliberate use of poorly manufactured ‘economy’ vessels, misalignment within the system and scratched or dirty vessels. While the majority of vessels available in the market meet USP specifications, but the specifications for vessels are very wide, allowing different manufacturers to create ‘within-specification’ vessels having a wide range of dimensions and geometry. When these vessels with asymmetric geometry are mixed, they often have different inter-vessel hydrodynamics due to the relationship of height, diameter, and hemisphere resulting in variable results. Economy vessels may appear to be of good quality to the naked eye, however, they usually
do not have the same level of high quality found in vessels direct from the equipment manufacturers, and will show a wider percentage CV as well. Scratched and dirty vessels can also cause changes in the fluid flow pattern and hence change the dissolution results. Aditya Saraswat, Director, Analytical, Lupin, mentions “Over the time, dissolution regulations have crept closer and closer to dissolution science, but still there is a significant room for improvement, with regards to vibration and vessel hemisphere.”
Repeatability and Reproducibility) and variability well documented. However, sometimes as a time/cost saving exercise, some documented steps are not performed or changed without thorough evaluation. The methods are developed after careful consideration of a variety of variables and an omission/change of steps may have an adverse effect on the results of the dissolution test. As mentioned earlier, the level of deaeration of the dissolution medium is a critical method related factor contributing to variability of a dissolution test.
◗ Method: All marketed products have detailed and documented methods for dissolution testing. Most methods have their RRR’s (Robustness,
◗ Deaeration: It is the process which involves removal of air molecules from the dissolution medium. Several research articles have presented the ad-
verse effect of the presence of air molecules in the dissolution media. Bubbles formed on the dosage form may provide a barrier to wetting and reduce the dissolution results, or can cause the dosage form to become buoyant which may change the dispersion characteristics of particles and aggregates. In the USP study, not effectively deaerating the media was the single largest cause of variability in mean per cent prednisone dissolved (52.3 per cent contribution) (Eaton J., et al., 2007). Gururaj V, Senior Scientific Manager, Biocon, states “Some laboratories do deaerate the media in part volumes with conventional process, and this can cause significant inter-vessel variability in the level of dissolved air in the media. It would then be important to measure the level of deaeration even with surfactant media, in each of the vessels before starting the dissolution test.” Experimental studies revealed that, tests that used non-deaerated media experienced significantly higher failure rates than those that used deaeraeted media. Hence, the dissolution medium should be deaerated using a suitable deaeration technique and the level of deaeration should be recorded for each batch of dissolution media. Multiple recalls of generic medications can sway public perception to believe that generics are not safe, which could reduce the usage of generics and increase the cost of providing healthcare. In addition, drug recalls for India’s high quality manufacturers of pharma products may adversely impact the world view of the safety of Indian-made pharma products and may reduce our pharma exports. Recalls also have an adverse impact on the financial health of the pharma companies costing them millions of dollars in lost revenue and much higher in their brand value. Close attention to multiple factors in manufacturing and quality control of medicines may improve the quality of medications and reduce the frequency of recalls.
PHARMA ALLY INSIGHT
The shift from HPLC to UPLC: The industrial perspective
MANU GROVER Asst Product Manager, Waters Corp
Manu Grover,Asst Product Manager,Waters Corp gives an outlook about Waters contribution in the analytical industry THE INDIAN industry is at a turning point, with large enterprises beginning to recognise that the drivers for success are shifting away from conventional saving procedures onto concepts like productivity enhancement, faster decision making, shorter time to market, lowering the cost of analysis and manpower empowerment. With new opportunities in global market, new investments are being considered under an ‘future proof’ concept. In the late 90’s the technology vendors or the bio-suppliers were merely considered as general suppliers and now the enterprises considers these vendors as their partners in quality, compliance and research. The business model from product management and brand management is now being shifted to value management. As per the current trends, enterprises like to partner with those vendors or bio-suppliers who can not only give quality products but also can add value to their business and research through programmes like compliance education, application trainings, regulatory updates, technical works-shops etc. Waters has always been considered as an innovation leader and trustful partner in analytical industry. Waters revolutionised column technology and introduced columns with particle size from 10/5 μm to 3.5 μm and then to 1.7μm. To leverage upon these small particles, Waters introduced about 10 years ago Acquity UPLC system. These systems have higher pressure handling solvent management system and reduced sys-
FIGURE-1
tem volumes than the conventional LC systems. The column and instrument related innovations led to improvement of the chromatographic performance w.r.t. sensitivity, speed and resolution. The development in column chemistries continued at Waters and now Waters have more than 16 scalable UPLC-based column chemistries. The latest in portfolio is Cortecs columns featuring the ‘solid core technology.’ In-order to effectively utilise the power of smaller particles 1.7μm, we require a LC system that operates at higher pressures and is designed with lower dwell and dispersion volumes. Hence, in UPLC, the extra-column volumes were minimised. The retention time precision remains extremely important under UPLC running conditions such as high pressures and low flow rates. The Waters Acquity UPLC system uses an automatic and continuous compressibility
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FIGURE-2
compensation algorithm that does not require user intervention to cope with these demands, resulting in retention time reproducibility. Also, electronically controlled intelligent check valves in solvent management system ensure improved performance and priming reliability. Waters has introduced UPLC platforms in all areas of research and quality control Like Quaternary UPLC (H-Class), Binary UPLC (I-Class), two-dimensional chromatography (2DUPLC), Nano-chromatography
(M-Class), Super critical fluid based chromatography (UPC2) and PAT-based UPLC for on-line analysis (PATROL) Acquity H-Class and H-Class Bio are the UPLC’s with quaternary solvent management system for small molecules and large molecules analysis respectively. With in-built feature to assist in solvent, pH/salt blending and method transfers, Acquity UPLC are most reliable instrument in their class. UPLC HClass, has capabilities of performing both UPLC and HPLC
applications. This flexibility has translated UPLC H-Class technology in-to a best example of ‘Future-proof’' investment in pharmaceutical industry. UPLC usage has increased significantly in both API and Formulation industries. The savings (time and cost) associated while performing the typical tests such as reaction monitoring, assay, dissolution and related substances during the release and In-process testing by UPLC is significantly high. The saving in time in R&D leads to faster product development hence 'early to market.' In quality control labs, saving in time during analysis leads to decrease in quarantine time of intermediates, reduced shifts, faster release of batches for In-process testing and hence 'faster to market.' Acquity UPLC I-Class is the current choice of analysts for LC as an MS inlet. It has lower dispersion and dwell volumes and also higher pressure limit of 18000 psi. This system can be used to run gradient programmes of one minute and below. This leads to faster analysis and higher throughput. This advancement has lead to increased implementation of Acquity UPLC I-Class as an MS inlet. The QbD approach as emphasised by US-FDA during analytical method development process in their recently issued draft guidance on 'Analytical Procedures' dated February 2014 is an important reason for UPLC implementation in pharmaceutical R&D’s. QbD recommend to perform multivariate experiments by screening and scouting of different variables
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PHARMA ALLY using DOE approach. screeningn-scouting can be done by using multiple buffers, solvents and column chemistries. UPLC HClass with its additional method development modules like nine solvent selection valve and six column manager with independent column temperatures zones can lead to faster screening-nscouting of the analytical methods than the conventional HPLC. (See Figure1) Any LC system in the pharmaceutical industry or research should be flexible w.r.t capability of handling multiple detectors and Acquity UPLC comes with wide range of detectors developed by Waters like UV, PDA, RI, ELSD, fluorescence and mass detectors. Historically, UV/PDA detection has been favoured in many laboratories for its ease of use, robustness, and reliability. However, some of the inherent challenges with UV/PDA during development include analysis of analytes that are non-chromophoric, confirmation of coelutions, Mass balance studies etc. The challenges in UV-based developments can be resolved
FIGURE-3 VARIABLE
ALLOWABLE ADJUSTMENT AS PER USP CHAPTER 621 USP36-NF31 (previous)
After Aug 1, 2014 (USP37-NF32 S1)
Isocratic & Gradient
Isocratic
Gradient
Per constant L / dp or N: -25% to +50%
No changes allowed
Particle size
-50%
Column length
±70%
Flow rate
±50%
Based on particle size and ±50%
No changes allowed
Column ID
Flexible
Flexible
No changes allowed
Injection Volume
Flexible
Flexible
Flexible
Column Temperature
±10%
±10%
±10%
Mobile phase pH
±0.2 unit
±0.2 unit
±0.2 unit
using orthogonal detectors like mass detectors. Waters introduced recently Acquity QDa Mass Detector, which have been purposefully designed to enable analysts to readily incorporate mass detection within a UV/PDA chromatographic workflow. The simplicity of this Single Quadrapole Mass detector is such that it can be handled easily by the chromatographers who have no MS trainings and
are only UV/PDA users. QDa, the mass detector has the quickest start time, once switched on, the detector is ready to use in less than 25 minutes. QDa through Empower CDS software can enable scientists to do tasks like peak tracking, identify impurities/peaks, analyze nonchromophoric impurities, understand mass-balance related issues, perform MS finger printing, confirm peak purity data,
etc. (See figure 2) The adoption of UPLC methods for various tests by different regulators like US-FDA, EMEA as release methods or alternative methods and adoption of UPLC by EP and USP in their monographs (NF and MC) clearly reflects the reason for the increase in trend w.r.t its implementation. Here are some of the products having official UPLC methods in USP- Glycopyrro-
late, Tramadol HCl extended release tablets, Ganoderma Lucidum, Sulindac, Aminolevulinic acid, Schisandra Fruit, Almotriptan tablets. Reference UPLC methods official in EP are Quetiapine fumarate and Nevirapine. The recent revision of USP Chapter <621> (See figure-3) allows the conversion of HPLC methods to UPLC without the need of complete validation.
PRODUCT
Laboratory scale spray drying solutions by BUCHI FOR MORE than 30 years BUCHI has been the global market leader for laboratory scale spray drying solutions. Spray drying is a fast and continuous one-step drying process to transform solutions, emulsions, slurries or melts into a dry powder, and is well established at laboratory as well as industrial scale. The application of microencapsulation generates more and more interest within academy and industry. Whether you wish to encapsulate your product for protection, to control or target the release, or improve handling or organoleptic properties, BUCHI has it covered. BUCHI offers instruments to produce particles from nano- to millime-
42 EXPRESS PHARMA October 1-15, 2014
ter in size. The Mini Spray Dryer B-290 is upgradable with the new ultrasonic package or is part of a complete system the new Spray Drying System B-290 Large and allows users to significantly increase their application possibil-
ities. The new ultrasonic nozzle produces larger particles (10 - 60 μm) for better flowability for easier dosing of final product. The diameters of the produced particles are at least double the size compared to a standard nozzle system, with a narrow standard
size distribution.
Advantages Improve powder handling: Improve dosing and handling due to better flowability Highly preformat: Larger particles (10 – 60 μm) with narrow
size distribution. Easy operation: Easy installation and operation of the Ultrasonic Package and the Spray Dryer System B-290 Large. Contact details: www.buchi.com/ ultrasonic_package
PHARMA ALLY VENDOR NEWS
Ashland Pharmaceutical Centre of Excellence conducts training programmes Training will help the channel partners from India and other parts of Asia to understand the technology ASHLAND PHARMACEUTICAL Centre of Excellence located at the Alexandria Knowledge Park, near Hyderabad, recently conducted training programmes for distributors from India and from rest of Asia. The training will help the channel partners to understand the technology and its effective application. The research centre is gearing up to be the nerve centre for pharma research in India. Launched in April this year, the research centre is catering to some of the top names in the pharma industry in India, working on to improve the efficacy of poorly soluble drugs and increasing use of controlled-release technology. The new pharmaceutical centre of excellence in Hyderabad, is a
Participants from Asia during the training programme
state-of-the-art facility specialising in oral solid-dosage form research. In addition to developing innovative and need-based solutions for the customers, Ashland team at Hyderabad also provides customised training on product applications and technical assistance as per specific
requests from customers. Superior technical service forms an important part of the offering and distinguishes Ashland from others. ‘Training to distributors is an initiative to reach out to the very crucial community that actually drives the market activity. Recently, the Centre con-
ducted two training programmes for pharma industry distributors. One for Indian distributors and another for rest of Asia channel partners. The training, as an educational seminar, highlighted pharma core application areas - tablet binders, disintegrants, controlled release solubilisation
and film coating. The distributors toured around the centre of excellence and were also given opportunities for handson laboratory training. The training demonstrated ASI’s commitment to expand its presence in Asia. Tom Durig, Senior Director, Global pharmaceutical R&D, Ashland Speciality Ingredients said, “Our ability to drive meaningful innovation- from creation of new chemistries to enhanced formulations for existing products allows us to deliver highly tailored customer solutions.” Research taking place at Ashland today will form the basis of new technical solutions that further address formulation and manufacturing challenges. EP News Bureau-Chennai
Sanner introduces AdPack desiccant pillow pack family It is efficient, economical and safe solution for the protection of moisture-sensitive pharmaceuticals SANNER, MANUFACTURER of high-quality plastic packaging for pharmaceutical, medical and healthcare products, is expanding its portfolio with the new AdPack desiccant pillow packs, an efficient, economical and safe solution for the protection of moisture-sensitive pharmaceuticals such as tablets and capsules inside the packaging. Following the market launch of the Brilliance Tubes for decorated packaging, the company has introduced yet another new product at CPhI Worldwide. “With the AdPack desiccant pillow packs, we have developed a new drop-in solution for moisture protection inside the pack-
aging,” explains Holger Frank, CEO, Sanner. “This offers our customers a cost-efficient solution that unites all the advantages of GMP-compliant production, professional risk management, 100 per cent traceability and outstanding Sanner quality.” The AdPack product family consists of desiccant pillow packs that are filled into the packaging along with the drugs, thus protecting them against moisture. Designed for pharma applications worldwide, AdPack complies with all relevant European and FDA (Food and Drug Administration) regulations for contact with food and drugs.
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The products are also listed in a Type III Drug Master File (DMF). The pillow packs are available as single strips or on reel, and are made of industryleading, extremely durable, and tear-resistant Tyvek material.
AdPack is highly permeable and ensures long-term adsorption of moisture and odours. Due to the flexible non-dusting, lint-free Tyvek material, the packaged pharmaceuticals remain intact at all times. The low-profile Ad-
Pack desiccant pillow packs take up little space within a package. Their distinct shape eliminates potential confusion with capsules or tablets, and prevents accidental ingestion. To maximise flexibility for customers, AdPack is compatible with standard semi- and fully-automated dispensing equipment and filling lines. Depending on the type of machine, AdPack is available as single pillow packs or as strips on reel. Thanks to a punch hole in the sealing seam, AdPack on reel ensures a clean pack separation during the dispensing process. EP News Bureau – Mumbai
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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.
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KLEPTOSE速 HPB KLEPTOSE速 HPB and HP comprise a range of accessible hydroxypropyl cyclodextrins used increasingly as formulation aids to solve difficulties with aqueous solubility, stability or taste. KLEPTOSE速 HPB and HP are available as compliant cGMP grades that are particularly useful for parenteral solutions, syrups and oral suspensions, as well as for dry formulations.
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58
October 1-15, 2014
EXPRESS PHARMA
BUSINESS AVENUES
EXPRESS PHARMA
EXPRESS PHARMA
October 1-15, 2014 59
BUSINESS AVENUES
60
October 1-15, 2014
EXPRESS PHARMA
EXPRESS PHARMA
BUSINESS AVENUES
EXPRESS PHARMA
EXPRESS PHARMA
October 1-15, 2014 61
PHARMA LIFE INITIATIVES
Piramal Foundation supports J&K’s disaster relief operations Piramal Sarvajal, Piramal Foundation’s philanthropic safe drinking water initiative to set up 10 water purification plants across Srinagar PIRAMAL FOUNDATION has partnered with the Central Government, State Government of Jammu & Kashmir and Indian Air Force to provide relief support to the flood ravaged state of Jammu and Kashmir. In order to provide clean and safe drinking water, Piramal Sarvajal, Piramal Foundation’s philanthropic safe drinking water initiative, is in the process of sending and setting up 10 Sarvajal water purification plants across Srinagar. Four plants have been sent via the Indian Air Force, of which one has been installed at the Srinagar Air Force station. Another six Sarvajal plants will be sent over the course of the
The joint relief exercise is being helped and coordinated via the Prime Minister’s Office, Cabinet Secretariat, Home Secretary, Air Force, the J&K Government through its Resident Commissioner, ISKCON and Akal Takht (Golden Temple) for volunteer force and manpower week. More plants are being organised and will be provided as per the needs of the state. The Piramal Sarvajal team of engineers and technicians has been stationed there to install, run and maintain the machines. The joint relief exercise is be-
ing helped and coordinated via the Prime Minister’s Office, Cabinet Secretariat, Home Secretary, Air Force, the J&K Government through its Resident Commissioner, ISKCON and Akal Takht (Golden Temple) for volunteer force and manpower.
Piramal has offered to help set up an automated kitchen, as and when required, with ISKCON and which is being led by Dr Radhakrishna Das. Akal Takht has offered its volunteer network to provide disaster relief.
Piramal has also offered to help with healthcare solutions through Piramal Swasthya, which runs 104 healthcare helpline across six states, mobile health units and telemedicine centres. The entire exercise draws from Piramal’s experience in disaster relief in Uttrakhand, where a team has been set up to help bring back normalcy and train women in vocational jobs. Piramal’s initiatives in Srinagar are being personally overseen by former Lieutenant Commander from the Indian Navy, Harinder Sikka. EP News Bureau-Mumbai
Himalaya signs MoU with Andhra Pradesh Prisons Department To expand the Prisoners’ Rehabilitation Programme to Central Prison, Visakhapatnam THE HIMALAYA Drug Company has extended its existing Memorandum of Understanding (MoU) with the Department of Prison Rehabilitation, Government of Andhra Pradesh to expand its Prisoner’s Rehabilitation Programme to Central Prison, Visakhapatnam. Under this programme Himalaya imparts Inmate Skills Development (ISD) training to the prison inmates’ to help them to join the mainstream society once they complete their jail term. The MoU addendum was signed by B Sunil Kumar, Inspector General of Prisons, Government of Andhra Pradesh and Dr Babu, Head – Phytochemistry – R&D, The Himalaya Drug
62 EXPRESS PHARMA October 1-15, 2014
Company. As per the provisions of the MoU, Himalaya along with the jail authorities will give training to the prisoners for cultivating medicinal plants. Subsequent to the training, they will undertake the project of cultivation of medicinal plants for Himalaya at the Visakhapatnam semi open prison. Inmates of the prison will be earning a regular monthly income and acquiring essential skills in the process. Apart from training the prisoners, Himalaya will also supply seeds and provide technical assistance. To begin, the inmates will cultivate Kalmegh (Andrographis paniculata) and drum stick (Moringa Oleifera). The plants were selected based on their suitability
Himalaya along with jail authorities will give training to the prisoners for cultivating medicinal plants to the nature, climatic conditions and soil characters. Government authorities will provide the infrastructure-irrigation facilities, electricity supply, as well as
farming implements. Speaking on the occasion, Babu said, “We have received tremendous response from our Prison Farm in Prisoners’ Agricultural Colony, Anantapur and we are glad to extend this programme to Central Prison, Visakhapatnam. I would also like to thank Andhra Pradesh prison department for allowing us to contribute towards their Prison Rehabilitation Programme. Today, such programmes are quite imperative for the overall growth of the society and we are proud to be a part of one. In future we are looking at expansion of such programmes to other parts of the state and the country for a more holistic growth.” Currently, a similar project is
underway in Anantapur open prison farm, Andhra Pradesh and has achieved a huge success. The positive acceptance of this project and the success achieved, has paved way to replicate this model in Visakhapatnam prison as well. Sunil Kumar said, “We believe everyone should a get second chance in their life. This initiative in collaboration with The Himalaya Drug Company will offer the inmates a second chance to rebuild their social lives. Under this programme, we will be equipping the prisoners with basic skills that will open up avenues for employment, once they have served their sentences.” EP News Bureau-Mumbai
REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.