India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), is considering a major policy change that would restrict the testing of vaccines and other biological products to government-run laboratories, effectively excluding private testing facilities from this segment.
Currently, private laboratories are permitted under the Drugs and Cosmetics Rules, 1945, to test drugs including vaccines for quality parameters such as identity, purity, and strength. However, following concerns over regulatory oversight, the CDSCO is now proposing tighter control over the testing of complex biological products.
The proposal was discussed during the 68th Drugs Consultative Committee meeting. According to officials, vaccines and biologics require highly specialized testing environments, and shifting testing to government labs would help ensure uniformity and stricter quality control. Under the new plan, manufacturers would be required to send their products to authorized public institutions such as the National Institute of Biologicals for batch testing and approval.
India currently has seven central and 36 state drug testing laboratories, alongside 350-400 approved private labs. However, only a limited number of private facilities have the advanced biosafety capabilities needed to test vaccines and biologics.
Government data shows that in FY25, over 116,000 drug samples were tested, with more than 3,100 failing quality standards and 245 identified as spurious or adulterated highlighting the need for stringent oversight.
Biological products, including monoclonal antibodies and hormone-based therapies, are derived from living cells and are far more complex than conventional chemical drugs. Their quality directly impacts public health, particularly in immunization programmes, making consistent and rigorous testing essential.
The proposed move could significantly impact India’s $50 billion pharmaceutical sector, which supplies 20% of the world’s generic medicines and 60% of global vaccine demand. Major players include the Serum Institute of India, Bharat Biotech, and Zydus Lifesciences, among others.
While experts agree that stricter testing is necessary due to the complexity of biologics, some have raised concerns. Public health specialists warn that removing private labs entirely could create bottlenecks, delay approvals, and potentially limit patient access to critical treatments.
They suggest a balanced approach leveraging both public and private sector capabilities may better serve India’s growing pharmaceutical needs while maintaining high standards and efficiency.