A move that will save time & money of pharma companies

In what can be termed as a positive move by the government for the pharmaceutical industry in India, the central government has recently issued the final notification amending the Drugs & Cosmetics Rules 1945 to allow parallel submission of applications for grant of renewal of manufacturing and sales license for large volume parenterals, vaccines and recombinant DNA (r-DNA) derived drugs, 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 drugs under Rule 122B of the Drugs & Cosmetics Rules 1945.

The final notification, issued by the Union Ministry of Health and Family Welfare (MoHFW) on August 24, adds a sub-rule under the Rule 75 (3), which stipulates submission of an application with the licensing authority in Form 27D for grant or renewal of license to manufacture for sale or for distribution of drugs in large volume parenteral, sera and vaccine and r-DNA derived drugs. The new sub-rule, (3A), will add that the application, referred in the sub-rule (3) or 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 & Cosmetics Rules, 1945, may be made simultaneously.

The sub-rule (6) of Rule 75 - which mandates that an application under this rule is for the manufacturing of drug formulations falling under the purview of new drugs as defined in Rule 122-E, such application shall also be accompanied with approval, in writing, in favour of the applicant, from the licensing authority as defined in clause (b) of Rule 21 - will also be substituted with a new sub-rule, as per the draft amendment. The substituted sub-rule now mandates that if the application is made under the Rule 80 of the NDCTR 2019 or the Rule 122B of the Drugs & Cosmetics Rules, 1945, the license to manufacturer for sale or distribution of the drugs shall be granted after approval of the drug as new drug.

For the pharmaceutical industry in the country, the move comes as part of simplifying the process of application of new drugs, and reducing the timeline for approval for these applications. The health ministry had received several objections and suggestions from industry and the public for its draft amendment, which were considered by the central government before issuing the final notification. The provisions for parallel submission of applications have been under consideration of the drug regulatory and policy making bodies in the past too. In the last meeting of Drug Technical Advisory Board (DTAB), the highest decision making body of the Union Health Ministry on the technical issues, in November 2021, it has given nod for necessary amendment in the Drugs Rules for parallel submission of applications for import registration, marketing authorisation, and import licence for new drugs.

A similar amendment was recommended related to marketing authorisation and grant of manufacturing licence of new drugs under Form 28-D of the regulation, with the Central Drugs Standard Control Organisation (CDSCO), in the same meeting. The government's move in this regard is a laudable one as the entire process of obtaining new drug permission, import registration and import licence is sequential, and filing one following the other is leading to serious delay in placing the product in the market.

After detailed deliberations, the DTAB had recommended for making provisions for parallel submission of application in such a way that the application for grant of registration certificate and import licence shall be processed simultaneously instead of present practice of sequential processing, with the application for grant of permission of new drug. This will reduce the processing duration by about 3-6 months. In case of manufacture of new drugs, the applicant initially files an application for grant of permission for manufacture and marketing (Marketing Authorisation) of new drugs with CDSCO. As per the current practices the application is disposed within a period of 90 days.

However, if clinical data is required to be submitted along with the application, the applicant will conduct a clinical trial which may take from 1-3 years depending upon the phase of clinical trial and data required. Overall, the Union Health Ministry's action in this regard is a laudable one as it will save a lot of time and money for the pharmaceutical industry.

(The author is freelance journalist with varied experience in different fields)