2022 seeks holistic revamping of pharma regulations

With the increasing relevance of the pharmaceutical industry, worldwide, as well as domestically, developments in regulation and policy pertaining to the industry are being keenly watched. We explore the expectations of a few opportunities and challenges that are projected for this industry in the coming year.

India's pharmaceutical industry is one of the largest in the world, as it currently ranks at No.3 worldwide for pharmaceutical production by volume and No. 14 by value. Notably, India is also stated to be the largest provider of generic drugs globally, which majorly attributes to the status that the country commands as the “Pharmacy of the World". Currently, the Indian pharmaceutical sector contributes to 1.72 per cent of the country's Gross Domestic Product (GDP).

Greater Focus on Domestic Production

In the backdrop of the pandemic highlighting the need for a robust Indian manufacturing base of pharmaceutical products, and finding its roots in the current government's “Atmanirbhar Bharat" and “Make-in-India" policies, the pharmaceutical industry (among others) has been a focus of multiple schemes relating to domestic production-linked incentives (PLI Schemes). PLI Schemes primarily focus on making the Indian pharmaceutical industry self-reliant and to reduce dependency on other countries for pharmaceutical manufacturing.

The first PLI Scheme, announced on July 21, 2020, focused on the promotion of domestic manufacturing of Key Starting Materials (KSMS) or Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs) and was initiated with a financial а outlay of Rs 6,940 crore. This was followed by a more extensive and broader PLI Scheme, announced on March 3, 2021, with a total sanctioned amount of Rs 15,000 crore, under which 55 of 278 applicants were recently selected by the government.