Drug manufacturers to get deemed approval for license if authorities fail to reply in 7 working days
New Delhi: Through a recent Gazette notification, the Government has notified a draft amendment in the Drugs Rules, 1945, to add a provision for deemed approval of license to manufacture drugs for examination, test or analysis, if the authority does not communicate it in seven working days from the date of receipt of application.
With an aim to ease the procedure of accessing manufacturing licenses for the purposes of examination, test, or analysis, the Ministry of Health and Family Welfare (MoHFW) has rolled out a draft amendment 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.
The Gazette dated August 3, 2021 came in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board.
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.
As per the amendment rules, the Ministry has replaced Form 29 with Form 30 under Rule 90, sub-rule 2 of the Drugs Rules, 1945, which states that Form 30 must be submitted along with a cost of Rs 250 in order to get a manufacturing license for the purposes of examination, test, or analysis.
Furthermore, the draft rules stated that the licensing authority may grant the license in Form 29 within seven working days of receiving the duly completed application in Form 30, and that if the applicant does not receive communication from the licencing authority within that time frame, the licence is deemed to have been granted. 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 in Form 30 duly completed, and in case where no communication is received by the applicant within the such stipulated period from licensing authority, such license shall be deemed to have been granted."
The Gazette has been published for the information of all persons likely to be affected by it.
Further, it has been said that the above-mentioned 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. Objections and suggestions which may be received from any person within the period will be considered by the Central Government.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi-110011 or emailed at drugsdiv-mohfw@gov.in," added the Gazette.
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