How do Vaccines get Government Approval?

The Serum Institute of India (SII) has developed the first indigenous vaccine against pneumonia – the Pneumococcal Polysaccharide Conjugate vaccine. The vaccine has got market approval from India’s drug regulator and will be launched by Union Health Minister Harsh Vardhan.

Before being approved for public use, any potential vaccine must go through several trial stages to ensure that the vaccine can be safely used without harmful effects on human health. This includes human clinical trials (phase-1), exploratory clinical trials (phase-2) and finally, confirmatory clinical trials (phase-3).

Skipping or shortening any of the vaccine trial phases could result in an ineffective or dangerous vaccine that people should not use.

Which law regulates vaccines?

In India, the Drugs and Cosmetics Act, 1940  regulates the manufacture and distribution of new drugs and vaccines. 

Which authority regulates vaccines?

Under the Act, the Central Drugs Standard Control Organization (CDSCO) is the main regulatory authority. The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in India. 

What is the procedure for getting approval for vaccines?

The Act lays out a detailed procedure that needs to be followed to get approval for producing vaccines that can be used by the public. This involves: 

• Application for approval to manufacture the vaccine – No vaccine can be manufactured for sale without approval from the Licensing Authority appointed by the Central Government. The manufacturer should apply to the Licensing Authority to allow manufacture of the vaccine.

• Application for permission to conduct clinical trials for the vaccine – Clinical trials need to be conducted for the vaccine with the permission of the Licensing Authority. 

• The Licensing Authority will give permission to conduct the clinical trials based on a few conditions. The clinical trial has to be conducted according to specified protocols and ‘Good Clinical Practice Guidelines’, and the approval of an Ethics Committee is needed before conducting the trial. Further, the clinical trial must be registered at the Clinical Trials Registry of India.

The Licensing Authority’s permission is required to import a vaccine from a foreign country. While applying for permission, the vaccine importer must submit data on the results of local clinical trials of the vaccine carried out according to the specified guidelines. However, this is not necessary if the drug is of such a nature that the Licensing Authority in public interest decides to grant permission on the basis of data available from other countries.

• Suspension or cancellation of permission – If the Licensing Authority feels that all the required conditions are not fulfilled, it can also cancel the permission for conducting trials after giving reasons for such cancellation. A person can approach the Central Government to appeal against any order of the Licensing Authority.