Govt to allow parallel submission of marketing and manufacturing approvals
New Delhi: Through a recent Gazette Notification, the Ministry of Health and Family Welfare (MoHFW) has issued a draft of certain rule to amend the Drug Rules 1945 allowing parallel submission of application for grant of renewal of manufacturing and sales license serum, hormones, vaccines ,toxins, anti-toxins and other biological and special products, applications for grant of manufacturing permission for new drugs under the New Drugs and Clinical Trials Rules, 2019 and application for approval to manufacture new drug under rule 122B of the Drugs Rules.
The move is intended to streamline the process of applying for new pharmaceuticals and shorten the time it takes for these applications to be approved.
In this regard, a draught notification proposes to add a sub-rule under Rule 75 (3) that requires the licencing authority to submit an application in Form 27D for the grant or renewal of a licence to manufacture, sell, or distribute drugs in large volume parenterals, sera, vaccines, and r-DNA derived drugs.
The new sub-rule (3A) adds that the application referred to in sub-rule (3), or the application for grant of permission to manufacture new drug for sale or distribution under rule 80 of the New Drugs and Clinical Trials Rules, 2019, or the application for manufacturing new drug under Rule 122 B of the Drugs Rules, 1945, may be made at the same time.
Furthermore, according to the draught amendment, Rule 75 sub-rule (6), which states that an application under this rule must be for the manufacturing of drug formulations falling under the purview of new drugs as defined in Rule 122-E, and that such application must also be accompanied by approval, in writing, in favour of the applicant, from the licencing authority as defined in clause (b) of Rule 21, will be replaced with a new sub-rule.
In addition, if the application is made under Rule 80 of the NDCTR 2019 or Rule 122B of the Drug Rules, 1945, the licence to manufacture for sale or distribution of the drugs will be issued once the drug is approved as a new drug, according to the substituted sub-rule.
Through the recent gazette notification, the Central Government, in exercise of the powers conferred by sections 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
The gazette also added," 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. 437, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in" the notice further added
As per the proposed amendment;
"1. (1) These rules may be called the Drugs (... Amendment) Rules, 2022.(2) They shall come into force on the date of their final publication in the Official Gazette.2. In the Drugs Rules 1945, in rule 75,—"(i) after sub-rule (3), the following sub-rule shall be inserted, namely:―"(3A) The application,—(a) referred in sub-rule (3) of rule 75 of these rules, or(b) for grant of permission to manufacture new drug for sale or distribution under rule 80 of the New Drugs and Clinical Trials Rules, 2019, or(c) rule 122B of these rules, as the case may be made simultaneously."(ii) for sub-rule (6), the following sub-rule shall be substituted, namely:―"Where an application under these rules is for the manufacture of drug formulation falling under the purview of new drug under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule 122B of the Drugs Rules, 1945, as the case may be, the license to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug." "
To view the Gazette Notification, click on the link below: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODQ4OA==
