Against the backdrop of the much-awaited ‘Heal in India’ announcement, the new draft Drugs, Medical Devices, and Cosmetics Bill 2022, is insignificant. Indian pharma, healthcare, and allied sectors have been beset by a plethora of problems in the legal and regulatory domain. So, meaningful reform is a dire need.
As early as 1988, the government brought a set of rules for Indian pharma, and established a systematic framework. This could have been a viable blueprint of the overall regulatory aspects had it not lost direction and decisive implementation. On the other hand, aggressive and forward-looking markets worldwide have changed their compliance gears towards good manufacturing practices (GMPs) rather than adhering to mere manufacturing. This has ensured that drugs go through a progressive scan of quality checks and tests. Secondly, transparency in the drug inspectors’ publication of inspection reports in India is, sadly, lacking.
Please click here to read the full article by Sidharrth Shankar, published in The Financial Express.
Sidharrth is the Co-Chair of the Corporate Practice at JSA. He specializes in General Corporate Commercial, Mergers & Acquisitions and Private Equity.