Pharma Practice Group
Corporate Law Group represents the interests of many multinational pharmaceutical companies in India in policy and Intellectual Property matters. Over the years of practice CLG has emerged as one of the few firms in the country that have institutional knowledge in every aspect of the research based foreign pharmaceutical industry business, straddling IP rights (Patents, Trademarks, Trade Secrets), Regulatory, Pricing, Foreign Direct Investment (FDI), Government Policy and Advocacy.
At corporate Law Group, all our industry practices have a multi-disciplinary structure – with lawyers and professionals with experience in the industry vertical. Our Pharmaceutical Practice Group is the best example of this approach – a blend of IP Lawyers; Regulatory Professionals; Scientists and Litigators, all specializing in the pharmaceutical industry.
We are routinely engaged by pharmaceutical and biotech clients for legal counsel in product development processes – including clinical trial design, informed consent, and good clinical practices – as well as advice on obtaining DCGI / DBT approval of drugs, biologic products, especially those that have encountered difficulties in the development or approval process. CLG also provides advise and opinions regarding distribution, promotion, and marketing of innovative drugs, biologics, and medical devices. The team has a clear understanding of the best ways in which to leverage science as well as laws and regulations to meet business objectives.
Further, with the advent of new price control regime through Drug Price Control Order (DPCO) 2013 pursuant to the National Pharmaceutical Pricing Policy (NPPP) 2012, the industry was faced with new challenges thrown in by new set of Rules that are often ambiguous and susceptible to multiple interpretations. CLG has worked closely with the Government of India while formulation of NPPP 2012 as well as Drafting of DPCO 2013. CLG has provided advice and assistance to clients for making submissions before the Government Ministries and lead advocacy activities by representing the industry before Government agencies. CLG has also been representing OPPI in the drug Pricing PIL in the Supreme Court of India (WP (C) 423/2003) and in the process has garnered rich experience in the nuances of the present Drug Pricing Policy. CLG continues to advise and represent clients before the Government in their efforts to seek clarification on ambiguous aspects of DPCO 2013 and provides strategic advice to clients in developing their submissions/representations to the Government