While applying for the grant of manufacturing licence, the drug producers may be required to submit more comprehensive information including the chemical and pharmaceutical data to the state licensing authorities (SLAs).

The regulatory authorities are planning to make necessary provisions in the Drugs and Cosmetic Rules, 1945 to make it mandatory for the manufacturers to submit comprehensive details along the application for grant of licence.

Under the Drugs and Cosmetics Rules applications are made to the SLAs for grant of manufacturing licenses. There is no provision which require the applicant to submit chemical/pharmaceutical data to the said authority with respect to the product applied for except for the patent and proprietary medicines as under 71(6), 71B, 76(7) and 76A of the Drugs and Cosmetics Rules, 1945, sources said.

In the case of new drugs, an applicant while making the application for grant of permission to import and / or manufacture a new drug already approved in the country is required to submit data as per appendix 1A of schedule Y of the said rules to the office of DCG(I).

“It is proposed that the SLAs should also obtain similar chemical/ pharmaceutical information about the products for which the permission to manufacture for sale in the country is being sought. This will help in ensuring that the product permitted by the State Licensing Authorities has the necessary stability data generated and other relevant information about the product before the grant of permission for manufacture of the product,” sources said.

A proposal is underway, cleared already by the Drug Consultative Committee (DCC), to amend  rules 71(6), 71B, 76(7) and 76A of the Drugs and Cosmetics Rules. Accordingly, the manufacturers will be asked to submit detailed chemical and pharmaceutical information (name, code name or number, if any; non-proprietary or generic name, if any, structure; physico-chemical properties), a brief description of the drug and therapeutic class, dosage form and its composition.

The manufacturers need to also forward data like test specifications, active ingredients, inactive ingredients, details of the tests for identification of the active ingredients and method of its assay, outline of the method of manufacturing, stability data, marketing information, proposed package inset, promotional literature, draft specimen of the label and carton, certificate of analysis of the products, the approval in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug as defined in Rule 122-E, from the licensing authority as defined in clause (b) of Rule 21.