Whalesbook
India's drug industry is facing increased regulatory pressure as the national authority targets about 90 unapproved fixed-dose combination (FDC) drugs. State regulators have been directed to take immediate and strict action against all companies involved in making, marketing, or distributing these unauthorized medicines.
The Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, stated this move reflects a commitment to zero tolerance for non-compliance. It follows an analysis of lab test data that found these unauthorized drug formulations. The flagged FDCs cover areas like diabetes, multivitamins, and iron supplements. The DCGI stressed that these drugs pose a "serious concern" to public health and safety, violating the Drugs and Cosmetics Act, 1940. State regulators must check for any incorrect local approvals and ensure manufacturers have central approval before getting manufacturing licenses, as required by Rule 83 of the NDCT Rules, 2019.
This crackdown is an escalation of ongoing regulatory concerns. A 2012 parliamentary committee report noted similar issues where state authorities issued licenses for FDCs without central approval, allowing untested combinations to spread. India has a long history of many FDCs, with estimates of over 6,000 unique combinations at one point. Past regulatory actions, such as bans on 328 irrational FDCs in 2018 and 156 in 2024, show a continuing problem with drug combinations that lack clear therapeutic benefit and may pose safety risks. Unapproved FDCs once made up over 60% of psychotropic drug sales in India in 2020. The Indian pharmaceutical market, valued at about $60.32 billion, is a major global player, especially in generics. This enforcement move signals a greater focus on quality and effectiveness across the industry.
For pharmaceutical companies, especially smaller and medium-sized ones (SMEs), this heightened scrutiny brings significant challenges. Firms with many unapproved or "irrational" FDCs might have to withdraw products, halt manufacturing, or face license cancellations. The expense of improving manufacturing to meet stricter Good Manufacturing Practices (GMP) and getting new approvals could be too high for some. This regulatory drive may speed up market consolidation, benefiting larger companies with the resources and compliance systems to adapt. Past issues with unapproved drugs remaining on the market despite regulations also raise questions about enforcement. Previous controversies involving poor manufacturing and impure products from Indian firms, leading to international alerts, highlight the need for strong oversight.
The Indian pharmaceutical industry is expected to grow 7-9% in FY2026, supported by domestic demand and exports. While this regulatory action may cause short-term disruption, it signals a maturing of the sector and better alignment with international quality and safety standards. India aims to strengthen its reputation as a reliable global supplier, reduce reliance on imported raw materials, and improve its regulatory framework. The industry's move towards more complex generics and specialty products, along with government initiatives like the Production Linked Incentive (PLI) scheme, points to a future focused on high-value, compliant manufacturing. Companies adapting to these stricter rules are likely to become stronger and more competitive globally.