"KMSCL has not procured or distributed any batch of Rabies vaccine or Equine Anti-rabies Immunoglobulin without a batch release certificate from CDL," Nadda said.
For the manufacturing or import of new drugs, including vaccines, the manufacturers and importers are required to comply with the standards of quality, safety and efficacy as prescribed in the Drugs and Cosmetics Act, 1940 and Rules.
The mandatory quality requirements prescribed to ensure the quality of anti-rabies vaccines being manufactured in the country include a manufacturing licence and import licence issued under the Drugs and Cosmetics Act and Rules and that the anti-rabies vaccine must comply with the standards specified in the current edition of the Indian Pharmacopoeia.
Each batch must undergo complete in-house quality control testing at the manufacturer's facility according to validated procedures and IP standards.
Each batch or lot of vaccines manufactured or imported in the country is required to be released by the CDL at Kasauli in Himachal Pradesh before the release of vaccines for sale and distribution, Nadda explained.
According to PTI, he said that proper cold chain logistics, two degrees Celsius to eight degrees Celsius must be maintained throughout storage and transportation to preserve vaccine potency and vaccines must have a valid remaining shelf life at the time of supply and should be packaged to ensure protection during transit and storage.
According to Rule 2(w) of New Drugs and Clinical Trial Rules, 2019, vaccines are always deemed to be new drugs.
All manufacturers of vaccines have to comply with the conditions of mandatory quality tests apart from other conditions of licence as prescribed under Rules 78 and 78A of Drug Rules, 1945 and both the Central License Approving Authority (CLAA) and state licensing authorities are empowered to take stringent action against violation of provisions of the Act and Rules.
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