Drugs are classified under five categories in India based on their approval status. These classification forms the basis on which document requirement for DCGI BENOC application are being determined
Drugs are classified under five categories in India based on their approval status. These classification forms the basis on which document requirement for DCGI BENOC application are being determined.
Classification of drugs in India based on their approval status:
- Drugs approved in India for more than 4 years except for modified release dosage form [old drugs*]
- New Drugs approved in India for a period of more than 1 year but less than 4 years
- Drug products in modified release form irrespective of their approval status
- New drugs approved in India within a period of one year
- New molecule not approved in India but approved in other countries
*Drugs that are official in the Indian pharmacopeia are also considered as old drugs with the exception for modified release formulations.
It should be noted that one cannot perform bio study in India on Indian population for a drug not marketed/approved anywhere in the world.
Extensive documentation is required for DCGI BA / BE NOC application for new molecule not approved in India but approved in other countries. On the other hand comparatively less documentation is required for issuance of DCGI BA / BE NOC for drugs approved in India for more than 4 years. The degree of scrutiny of the BA / BE NOC application also follows the same scale i.e. ascending from A to E.
Sources to find approval status of a drug in India:
The latest updated list of drugs approved in India with month of approval, dosage form including strength can be found at http://cdsco.nic.in/listofdrugapprovedmain.html. Be informed that older approvals [prior to 1999] are without information on dosage form and strength. The respective dosage form and strength details for the approvals can be found in the respective years Indian Pharmacopeia.
Alternative sources to find if a drug was approved for over four years is to refer to MIMS or CIMS published four years prior to the current year. As such booklets portray drugs approved for marketing in Indian by DCGI, a drug published in such publications should have been approved by DCGI in that month/year.
Tags: CDSCO, DCGI, Regulatory