Usha Sharma – Mumbai
Lex Witness recently hosted the 2nd Annual Edition of Pharma Legal and Compliance Summit (PLCS) in Mumbai with an aim to gain better understanding of the recent regulatory reforms in the Indian pharmaceutical sector. The summit provided an ideal platform for business experts and stakeholders from the country’s top 20 pharma companies to come together and discuss the recent regulations, grey areas, business impact and implementation solutions.
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During the summit, experts discussed about the challenges which the Indian pharma companies are facing in an increasingly complex, demanding and fast changing logistics and regulatory environment. Traditional approaches are being challenged by shorter market cycles, outsourced production, and increasing government regulations.
The day-long event also presented how multinational pharma companies are increasing efforts to strengthen their presence in India through research investment, licensing deals, co-marketing arrangements, acquisitions, or other partnerships.
Today, nearly 25 per cent of proposals received by Foreign Investment Promotion Board are for pharma. On the other hand approval timelines and over restrictive regulations are giving thoughts for India- centric pharma organisation for establishing base in countries offering transparent regulations. Therefore, with increasing management expectations on business strategy formulation, especially in a complex regulatory environment, the 2nd Edition of Pharma Legal and Compliance Summit witnessed veteran speakers analysing, interpreting and strategising current and future response to legal, regulatory and compliance challenges.
The summit was chaired by AS Kumar, General Counsel, Dr Reddy’s Laboratories, and the speakers’ panel included Abhishek Malhotra, Partner, TMT Law Practice; Ajay Thomas, Registrar, LCIA India; Amitava Chakraborty, Associate Partner, TMT Law Practice; Arjun Vaidyanathan, Partner and Chief Operating Officer, Forensic KPMG; Darshini Bhatt, AGM IPR, Troikaa Pharmaceuticals; Debolina Partap, Associate Vice President and Head Legal, Wockhardt Group, India; Dr Nanda Kumar, Member, Advisory Board, Lex Witness; Dr Milind Antani, Head – Pharma and Life Sciences; Nishith Desai Associates; Gowree Gokhale, Partner, Nishith Desai Associates; KP Pradeep, Healthcare Compliance Officer, Johnson & Johnson, South Asia; Marshall Mendonza, Independent Legal Professional; MM Sharma, Head-Competition Law and Policy, Vaish Associates Advocates; Mukundan Bharathan, Senior Legal Counsel, GlaxoSmithKline Pharmaceuticals; Sanjay Sharma, CFE, CPP, Regional Security Manager, Asia Pacific – Japan, Global Security Group, MSD – Merck, Sharp & Dohme Corp; Sanjay Singh, Director, Corporate Finance KPMG India; Sofi Joseph, Head, Regulatory Operations, Pfizer; Vivekananda N, Deputy Registrar and Head (South Asia), SIAC.
Revealing the motive behind the holding the Summit, PBA Srinivasan, Editor-in-Chief, Lex Witness said, “Non-compliance related issues can cause irreparable reputational damage which can engulf the entire Indian pharma sector with loss of credibility in global markets. There are apprehensions of increased scrutiny following recent news of dodgy compliance, hence right now is the time to revise the legal and compliance strategies concerned so as to ensure sustenance and future growth.”
During the panel discussion, Sharma briefed about the different competition challenges which are prevalent in the Indian pharma sector and how these competition issues are really affecting the pharma sector on a bigger scale to the Indian economy.
Joseph predicted that in the near future we will be able to see much more such regulation reforms in the system.
Antani informed, “The Drugs and Cosmetics (Amendment) Act, 2013 Bill, tabled in the Upper House of India’s Parliament, has proposed criminal prosecution and fine for violation of any requirement specified under the Act or Rules or for violation of any condition prescribed in the permission to conduct clinical trials in India.”
Before concluding the event the panelists also discussed hot topics like cost-based and market-based price mechanism in the DPCO 2013, FDI in the pharma, clinical trial regulations, competitive competition and many more topics.
Sharing the feedback of the summit, Partap said, “The Pharma Legal and Compliance Summit 2013 has been an excellent platform for all pharma legal, compliance and regulatory personnel to share their views and also the common challenges the industry is currently facing in India as well as globally. It also addressed very effectively the solutions, the do’s and don’ts which the pharma companies should ideally adopt to achieve the winning space in world scene. The summit further very illustriously deliberated upon the emerging trends and law in the patent and biologics spectrum. Overall it has been a very successful event.”
EP News Bureau – Mumbai
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