Bracing for Regulatory Action in the Indian Pharma and Medical Device Industry
Post-BJP's election win in 2014, regulatory bodies such as the Securities and Exchange Board of India, Serious Fraud Investigation Office, and Competition Commission of India have closely enforced regulation violations. At the same time, companies have had to respond to the National Pharmaceutical Pricing Authority's price ceilings on essential drugs and medical devices, and may face new regulatory and marketing rules.
In this inaugural BRG Debate, speakers including Stuart Witchell, Abhijit Yadav, Savita Nair, Preeti Batham, and Marie-Alix von Meiningen examined potential threats facing pharmaceutical and medical device companies in India; and assessed how well equipped these organizations may be to respond to such potentially massive business disruptions. BRG's India office hosted the event. Leading law firms Ropes & Gray and Nishith Desai Associates lent their support as knowledge partners.
Ms. Nair began the debate with a brief recap of news headlines in the pharmaceutical and medical device spaces, highlighting the impact of extraterritorial actions. Mr. Yadav then moderated an informative session on global regulatory developments and enforcements with our panel of international experts: Mark Barnes, a partner at Ropes & Gray, Boston; Dr. Milind Antani, head of the Pharma and Healthcare practice at Nishith Desai Associates; Shantanu Mukherjee, Legal head, APAC and Japan at Lupin Limited; and Alexander Leslie of BRG London. The panelists provided an overview of changing regulations in clinical research, off-label promotions, anti-bribery and corruption, and marketing in various jurisdictions, including the United States and United Kingdom. The panel also touched on the impact of such regulations on Indian companies operating or supplying products in these markets.
In our second session, Ms. Nair and the panelists—Andrew Dale, a partner at Ropes & Gray, Hong Kong; Dr. Antani; and Ms. von Meiningen—discussed proactive ways to manage the maze of domestic and international laws governing the pharmaceutical and medical device industries. This session saw panelists commenting on how to be prepared for the unexpected. Shedding light on US DOJ’s and US FDA’s strict stance on regulatory violations and how leading pharmaceutical companies have been imposed with heavy penalties and fines in the recent past, Ms. von Meiningen noted that noncompliance is a far more expensive proposition.
Geoffrey Atkins, a partner at Ropes & Gray, Hong Kong, and Mr. Yadav led our last session, a free-flowing discussion with the audience. The session saw members of the audience sharing their perspectives on regulatory reforms and the need for robust implementation mechanism. The discussion also saw participants highlight their preferred jurisdictions for expansion, while industry veterans commented on how ways of doing business had changed over the years in response to external market and regulatory requirements. Mr. Yadav summed up the debate by stating that while the flux in India’s regulatory space and increased focus by foreign regulators is a pain point for pharmaceutical and medical device companies, the increased scrutiny indicates that India wants to be on a level-playing field with developed nations, and hence, drugs and devices of Indian companies or manufactured in India will be held to higher standards of quality and care.