About Pharmaceutical Licence

Registration of drugs and other products/items are major regulatory functions executed through the Pharmaceutical & Regulatory Affairs Department. It involves an in-depth scientific evaluation of the technical documentation submitted in support of registration resulting in licensing of a drug or other related product. It is one of the primary mechanisms through which the quality, safety, and efficacy of drugs, and other products mentioned in the Food and Drugs Act and Regulations are ensured.

The process for Registration of Pharmaceutical Products involves broadly the following steps:

1. Application and payment
2. Application pre-screening and document verification
3. Scientific Assessment
4. Evaluation by the Product Registration Committee (PRC)
5. Approval/Rejection of the Application
6. If Approved – Registration of the Product(s).

You can submit these types of applications:

1. Application for Registration of a New Pharmaceutical Product
2. Application for Variation of a Pharmaceutical Product
3. Application for Cancellation of a Product
4. Application for Recall of a Product
5. Application to Appeal a Decision

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