NEW DELHI: India plans to restrict the testing of vaccines and specialized biological products exclusively to government-controlled laboratories to maintain quality standards, according to two government officials and documents reviewed by Mint. This new approach will affect private laboratory operators and the pharmaceutical manufacturers that rely on them for faster testing turnaround times.
Under the existing rules, private labs are allowed to test specified drugs including vaccines and biologicals. However, after criticism for lax oversight, the Central Drugs Standard Control Organization (CDSCO) is now planning a major policy shift by restricting the use of private facilities for testing vital pharmaceutical products. The proposal was discussed during the 68th Drugs Consultative Committee meeting of India’s apex drugs regulator last month.
“The CDSCO believes that the specialized nature of vaccines warrants a more restrictive testing environment. Another objective is also to bring uniformity across all testing platforms,” one government official said, requesting anonymity. “The new policy in the works would mandate that manufacturers of biological products route their batch testing through authorized government institutions like the National Institute of Biologicals based in Noida, effectively de-authorizing private labs for this specific category of medicines.”
Currently, the Drugs and Cosmetic Rules, 1945, has provisions for the approval of standalone private laboratories to test the identity, purity, quality and strength of drugs and raw materials on behalf of licensed manufacturers.
There are seven Central Drug Testing Laboratories and 36 state drug testing laboratories across India. In the private sector, there are 350 to 400 standalone laboratories approved to test drugs and raw materials, according to the CDSCO "Sugam" portal. However, only a small, specialized fraction has the high-level biosafety certification required to test vaccines and biologics.
In FY25, a total of 116,323 drug samples were tested, of which 3,104 samples were declared Not of Standard Quality (NSQ), and 245 were found to be spurious and adulterated, government data showed.
Consistent quality
According to the document reviewed by Mint, the quality of biological products has a direct impact on public health and immunization programmes. Consequently, it is essential to assure the consistent quality of each lot before it is released in the market.
Biologics including monoclonal antibodies (lab-made proteins that act like human antibodies) and hormones are tested at the National Institute of Biologicals in Noida. Biologics are medicines that are made from living systems such as microorganisms and plant or animal cells and not chemically synthesized.
“Keeping in view the nature of these specialized products, the PTL (private testing labs) may be restricted for testing of non-biological products only on behalf of the licensed manufacturer as per rules,” according to the government document.
The policy change will have a significant impact on India's $50 billion pharmaceutical market, which is ranked third globally by volume and supplies 20% of the world's generic medicines and 60% of its vaccines to over 200 countries. The Indian biopharmaceutical market is valued at $12 billion, with the vaccine market valued at $5.19 billion and monoclonal antibodies at $8.2 billion, according to Invest India and market research reports.
The Serum Institute of India is the world’s largest vaccine manufacturer by number of doses produced and sold. Other major vaccine producers include Bharat Biotech, Biological E and Zydus Lifesciences. In the biopharma and biosimilars segment, Biocon Biologics, Dr. Reddy’s Laboratories and Lupin are the key producers of complex monoclonal antibodies and therapeutic proteins.
Public health experts said a balanced, well-regulated system that leverages both public and private sector capabilities may be better suited to India’s growing needs, ensuring both the rigour and responsiveness in the testing of biologicals.
Rigorous testing
Dr. Rajeev Jayadevan, a public health expert, said unlike common medications like paracetamol, biological products are increasingly used in the prevention and treatment of diseases including cancer, heart disease, stroke, arthritis and infections and their testing needs to be extremely rigorous.
“Biologicals are much larger molecules that frequently require living cells in highly controlled environments to produce,” Jayadevan said. “Any variation in their quality can potentially lead to major consequences. So, their testing has to be stringent. India’s position as the ‘pharmacy of the world’ brings with it not just opportunity, but responsibility—particularly in the production and testing of increasingly complex biological products.”
Upgrading government labs and enhancing the number of trained personnel will help standardize the testing of biologicals and reduce potential variability from using different private labs, he said. However, eliminating private labs from the process can create bottlenecks.
“This could lead to delays in approvals, thus ultimately impacting patient care, limiting their access to critical treatments. In a field where time is often as important as precision, such delays carry real consequences,” Jayadevan said.
Queries emailed to the spokespersons of the health and family welfare ministry, the Drugs Controller General of India, Dr. Reddy’s and Zydus Lifesciences remained unanswered till press time. Serum Institute of India, Biocon, Bharat Biotech and Lupin declined to comment.
Dr. Vikram Paradkar, executive vice president – vaccines at Biological E, said in an email that every single batch of the company’s vaccines is tested at its own quality control facilities and submitted to the National Control Laboratory at Kasauli for testing and release.
“Thus, there is no change to existing practice and Biological E. Limited manufacturing sites possess necessary internal infrastructure to conduct all the required testing,” he said.