Government to amend Drugs Rules 1945

The Union ministry of health and family welfare is currently in the process of amending the Drugs Rules 1945 to allow for the parallel submission of applications for the grants of renewal of manufacturing and sales licenses for large volume parenteral, vaccines and various recombinant DNA (rDNA) derived drugs, along with applications for grants of manufacturing permission for new pharma drugs under the New Drugs and Clinical Trials Rules, 2019 and for application for approval to manufacture new drug under rule 122B of these Drugs Rules.

A draft notification issued in this regard proposes to add a sub-rule under Rule 75 (3). This sub-rule will stipulate submitting an application with the licensing authority in Form 27D to grant or renew a license for manufacturing, selling, or distributing medicinal drugs in a large volume of parenteral, sera and vaccine, and r-DNA derived drugs.

The new sub-rule, (3A), will further add that the application, as referred to in the sub-rule (3) or for grant of permission to manufacture the new drug for selling or distributing under the 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 also be made simultaneously.

The sub-rule (6) of Rule 75 – makes it mandatory that an application under this rule is for the manufacturing of pharma drug formulations falling under the purview of new drugs as defined in Rule 122-E and that such an application shall also be accompanied by approval, in writing, in favor of the respective applicant, from the licensing authority as defined in clause (b) of Rule 21 is also going to be substituted with a new sub-rule, as per the draft amendment.

The substituted sub-rule will mandate that if the application is made under the Rule 80 of the NDCTR 2019 or the Rule 122B of the Drugs Rules, 1945, the license to the manufacturer for sale or distribution of the drugs shall be granted after approval of the drug as a new drug.

The move comes as part of the union government’s measures to simplify the application process of new medicinal drugs and reduce the timeline for approval for such applications.

The union government of India has also issued a notice that the said draft rules will be taken into consideration only on or after the expiry of a period of thirty days from the date on which the copies of the new draft rules are made available to the public. It has also invited objections and suggestions from the various stakeholders in the people within the period, which will be considered by the union government of India.

The reader must note that the provisions for parallel submission of such applications have already been under consideration by the union drug regulatory and policy-making bodies in the past. In the last meeting of the Drug Technical Advisory Board (DTAB) earlier in November 2021, the advisory board gave the nod for a necessary amendment in the Drugs Rules for parallel submission of import registration, import license, and marketing authorization and new drugs.

In the same meeting, the board also recommended a similar amendment related to marketing authorization and grant of manufacturing license of new drugs under Form 28-D of the regulation with the Central Drugs Standard Control Organisation (CDSCO).

The entire process of obtaining new drug permissions, import registration, and an import license is sequential, and filing one following the other leads to severe delays in placing the product on the market.

In this regard, the committee has recommended making new provisions for parallel submission of applications in such a way that the authorities shall then process the application for grant of the registration certificate and import license simultaneously instead of the current practice of sequential processing for the application for grant of permission of new drug. The process can reduce the processing duration significantly – by about 3-6 months.