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    • CDSCO commitee warns...

    CDSCO commitee warns against repacking of Active Pharmaceutical Ingredients into smaller packs by Wholesalers

    Meghna A SinghaniaWritten by Meghna A Singhania Published On 2019-09-27T12:19:26+05:30  |  Updated On 16 Aug 2021 10:35 AM IST

    New Delhi : Taking into consideration, the proposal on measures need to be taken to address the issue of repacking of Active Pharmaceutical Ingredients into smaller packs by wholesalers for sale, the DCC committee of the CDSCO reiterated that the same cannot be allowed to protect the integrity and quality of the products


    Active Pharmaceutical Ingredients (Bulk drugs) can be manufactured and sold directly to the formulator or through the wholesaler in accordance with the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under.


    It has been observed that in some cases the wholesalers repack the Active Pharmaceutical Ingredients into smaller packs and sale the same to the formulators for manufacturing the finished formulation.


    The matter was recently brought up before the DCC committee of the CDSCO.


    After detailed deliberation, DCC recommended that repacking of Active Pharmaceutical Ingredients by wholesaler is as such not allowed under the Drugs and Cosmetics Rules, 1945 and it has a potential for breach of integrity and quality of the product.


    On the issue of measures that need to be taken to address the issue of repacking of Active Pharmaceutical Ingredients into smaller packs by wholesalers for sale, the committee further noted




    Therefore, it was opined that the authorities shall take the information from licensee in their jurisdiction about such activities by issuing letters/notices within 15 days and this compiled information along with executive summary shall be submitted to CDSCO within next 15 days i.e., 30 days after issue of the Notices and then hold national level stakeholders consultation with the representatives/ associations of these licensees by involving the states where such activities are happening, prominently to decide further course of action in consultative manner by understanding the views of stakeholders and spreading the awareness about the provisions of the Rules .



    Read Also: Make drugmakers upload data in SUGAM portal: CDSCO Committee recommends State Drug Authorities

    (DCC)active pharmaceutical ingredientsAPICDSCOcommiteerepackingwholesalers

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    Meghna A Singhania
    Meghna A Singhania

      Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

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