Deemed approval for drug license if authorities fail to reply in 7 working days: MoHFW

New Delhi: Through a recent Gazette notification, the government has added a provision for deemed approval of a licence to manufacture drugs for examination, test or analysis, if the authority does not communicate it within seven working days from the date of receipt of the application.

This move came in order to ease the procedure of accessing manufacturing licences for the purposes of examination, testing, or analysis.

Earlier, the Medical Dialogues team had reported that the Ministry of Health and Family Welfare (MoHFW) had rolled out a draft notification to amend in the Drugs Rules, 1945, stating that the licensing authority may grant the license in Form 29 within 7 working days of receiving the duly completed application in Form 30, and that if the applicant does not receive communication from the licensing authority within that time frame, the license is deemed to have been granted.

Form 30 is an application for a license to manufacture drugs for the purpose of examination, test or analysis, while Form 29 is a license to manufacture drugs for the purpose of Examination Testing and Analysis. The application for the license is made in Form 30 and the certificate is valid for 1 year.

Earlier, it was said that said that the draft rules will be taken into consideration on or after the expiration of a thirty-day period from the date on which copies of the Gazette of India containing these draft rules are made available to the public for suggestions.

Now in continuation, the recent gazette notification said that objections and suggestions received from the public on the said rules have been considered by the Central Government.

After extensive deliberation, the Ministry of Health and Family welfare has rolled out the Gazette notification in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board.

The notification read,

In the Drugs Rules, 1945, in rule 90,—

(i) In sub-rule(2), for the words and figures "Form 29", the words and figures "Form 30" shall be substituted;

(ii) After sub-rule(2) so amended, the following sub-rule shall be inserted, namely:—

"(3) The license in Form 29 may be granted by the licensing authority within a period of seven working days from the date of receipt of the application duly completed in Form 30, and in case where no communication is received by the applicant from licensing authority within the said period of seven days, the licensing authority shall be deemed to have granted the license."