Centre To Amend Drugs Rules 1945 For Parallel Submission Of Marketing And Manufacturing Approvals

New Delhi : The Union ministry of health and family welfare is in the process of amending the Drugs 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 drug under rule 122B of the Drugs Rules.

A draft notification in this regard proposes to add 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 parenterals, 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 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 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 manufacturer for sale or distribution of the drugs shall be granted after approval of the drug as new drug.

The move comes as part of simplifying the process of application of new drugs, and reducing the timeline for approval for these applications.

The government has issued a notice 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 these draft rules are made available to the public. It has also invited objections and suggestions from the public within the period, which will be considered by the Central government.

It may be noted that the provisions for parallel submission of applications has 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), 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 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.

In this regard, the committee has recommended 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 [MA]) of new drugs with CDSCO. As per the current practices the application is disposed with in 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.

  • Related Posts

    • Pharma
    • December 23, 2024
    • 67 views
    Healthcare, pharma sectors raise Rs 14,811 crore via IPOs in 2024

    India’s healthcare and pharmaceutical sectors raised Rs 14,811 crore through initial public offerings (IPOs) in 2024, the largest since 2019, driven by strong domestic demand amid expanding global opportunities. According…

    • Pharma
    • December 23, 2024
    • 103 views
    NPPA sets retail prices for 65 drugs, revises ceiling for 20 formulations

    The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices for 65 new drug formulations and notified ceiling price fixation of 13 formulations. The regulatory body, under the Department of…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Healthcare, pharma sectors raise Rs 14,811 crore via IPOs in 2024

    Healthcare, pharma sectors raise Rs 14,811 crore via IPOs in 2024

    NPPA sets retail prices for 65 drugs, revises ceiling for 20 formulations

    NPPA sets retail prices for 65 drugs, revises ceiling for 20 formulations

    India-Latin America trade and collaboration prospects discussed at Kerala University conference

    India-Latin America trade and collaboration prospects discussed at Kerala University conference

    Karnataka Govt Files Criminal Cases Against Pharma Firm In Ballari Maternal Deaths Case

    Karnataka Govt Files Criminal Cases Against Pharma Firm In Ballari Maternal Deaths Case

    NPPA Notifies Ceiling Price Of 13 Formulations, Retail Price Of 65 New Drugs

    NPPA Notifies Ceiling Price Of 13 Formulations, Retail Price Of 65 New Drugs

    Over 14,000 PMBJK Centres Set Up To Provide Generic Medicines: Govt

    Over 14,000 PMBJK Centres Set Up To Provide Generic Medicines: Govt