India plans to restrict vaccine and biologics testing to government labs to maintain quality standards

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.