Simplifying new drug approval process

In a move that will simplify the process of application of new drugs, and reducing the timeline for approvals, the Union Health Ministry has recently issued the final notification amending the Drugs and Cosmetics (D&C) Rules, 1945 to allow parallel submission of applications for grant of renewal of manufacturing and sales license for large volume parenteral, vaccines and recombinant DNA (r-DNA) derived drugs, and 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 D&C Rules.

The final notification 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, (NDCTR) 2019, or the application for manufacturing new drug under Rule 122 B of the Drugs 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 D&C Rules, 1945, the license to manufacturer for sale or distribution of the drugs shall be granted after approval of the drug as new drug. In fact, the provisions for parallel submission of applications have been under the consideration of the drug regulatory authorities for quite some time. In its meeting held in November 2021, the Drugs Technical Advisory Board (DTAB), the highest authority under the Union Health Ministry on technical matters, has given nod for necessary amendments in the Drugs and Cosmetics Rules for parallel submission of applications for import registration, marketing authorisation, and import licence for new drugs.

A similar amendment was recommended by the DTAB in the same meeting 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). The Union Health Ministry's action in this regard is significant 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. Taking this into consideration, the DTAB recommended to the Union Health Ministry 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 authorisation (MA) of new drugs with CDSCO. As per the current practices the application is disposed of 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. After obtaining the MA for the new drug, the applicant shall make an application to the state authority for grant of manufacturing licence in Form 28-D.

The application is processed by the State Licensing Authority in about 60 days without inspection. If inspection needs to be carried out the application is processed in 90 days. The state authority will forward the manufacturing licence in Form 28-D to the DCG (I) for approval. The application is processed at CDSCO within 30 days. Certainly, the Union Health Ministry has taken a well thought out decision as it will simplify the process of application of new drugs, and reducing the timeline for approval for these applications and will prove to be beneficial for the pharmaceutical industry in the county in the long run.