In India, the Drugs and Cosmetics Act, 1940 regulates the manufacture and distribution of drugs and vaccines.
Authority regulating vaccines
The Central Drugs Standard Control Organization (CDSCO) is the main regulatory authority. The Drugs Controller General of India (DCGI) is an official member of the CDSCO who is the final regulatory authority for the approval of clinical trials in India.
Procedure for approval for vaccines
The detailed procedure that needs to be followed to get approval for producing vaccines that can be used by the public 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 must apply to the Licensing Authority to allow manufacture of the vaccine.1
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.2
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.30
- Section 122B, Drugs and Cosmetics Act, 1940.
- Section 122DA, Drugs and Cosmetics Act, 1940.
- Section 122DB, Drugs and Cosmetics Act, 1940.