Mumbai, September 28, 2013: Lex Witness, India’s first Magazine on Legal and Corporate Affairs today hosted a well-conceptualized The 2nd Annual Edition of Pharma Legal & Compliance Summit in Mumbai. The summit provided an ideal platform to all business experts and stakeholders from the country’s top 20 Pharma Companies to come together and discuss the recent regulation, grey areas, business impact and implementation solutions.
Globally, India is one amongst the leading five pharmaceutical emerging markets and it leads the range of specialties involving drugs’ manufacture, development, and technology. The Pharmaceutical industry in the country is witnessing steady growth and is a major player in the Indian economy and is expected to touch US$ 35.9 billion by 2016.
However, the pharma companies in India are facing the challenge of an increasing complex, demanding and fast changing logistics and regulatory environment. Traditional approaches are being challenged by shorter market cycles, outsourced production, and increasing government regulations. Multinational Pharma companies are increasing efforts to strengthen their presence in India through research investment, licensing deals, co-marketing arrangements, acquisitions, or other partnerships. 25% of proposal received by FIPB 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 strategizing current and future response to legal, regulatory and compliance challenges.
With the Competition Commission of India starting a study on the domestic pharmaceutical industry, there exists an urgent need for Pharma companies to understand and analyse the implication of competition act on their business practise and processes. The layout and agenda of the power packed summit included panel discussions on Practical Strategies for driving Compliance and Contracts, Agreements and Dispute Management, Q&A rounds and networking sessions of over 100 proficient industry veterans.
Speaking on the occasion, 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.”
The day long discussion focussed on how to use compliance and ethical business practices as competitive business advantage, key elements of a compliance program, analysis of Legal and Regulatory Updates, Section 3d of Indian Patent Act, Patent Litigations: Recent Case Updates and Analysis, grey areas of Competition Law, Uniform Code of Pharmaceutical Marketing Practices (UCPMP), Contracts, Agreements and Dispute Management and Pharma Industry occupying 25% of FIPB.
Commenting on the significance of PLCS 2013, Shyam Grover, Group Editor & CEO, Lex Witness said “The structural growth drivers of Indian pharmaceutical industry continue to remain impervious and its future development demand that all the rules and regulations which guide, monitor and control the conducts of the contributors of the country’s healthcare system and also examine the means to bring them at par with international standards. I am delighted that we took one step further towards progress by bringing together so many professionals of pharma sphere under one roof who made us see where we stand as of now and where we have to reach.”
Chaired by A. S. Kumar, General Counsel, Dr. Reddy’s Laboratories Ltd., the summit’s proficient speakers’ panel included Abhishek Malhotra, Partner, TMT Law Practice | Ajay Thomas, Registrar, LCIA India | Amitava Chakraborty, Associate Partner, TMT Law Practice | Arjun Vaidyanathan, Partner & COO, Forensic KPMG | Darshini Bhatt, AGM IPR, Troikaa Pharmaceuticals Limited | Debolina Partap, Associate Vice President & Head Legal, Wockhardt Group, India | Dr. Nanda Kumar, Member, Advisory Board, Lex Witness | Dr. Milind Antani, Head – Pharma & 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 Ltd | 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 Limited | Vivekananda N., Deputy Registrar & Head (South Asia), SIAC.
The PLCS 2013 initiative was conceived by Lex Witness as part of a knowledge series and was supported by KPMG as Knowledge Partner, TMT Law Practice as Gold Partner, Nishith Desai Associates as Legal Partner, Capital Novus as Technology Partner, Echo Solutions as Legal Services Partner, Vaish Associates Advocates as Associate Partner, Society of Indian Law Firms (SILF), ICCA, LCIA India & SIAC as Fraternity Partners and DSA as Kit Partner. — PR Newswire