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    • CDSCO releases updated...

    CDSCO releases updated list of 2006 WHO GMP certified drug manufacturers; Details

    Farhat NasimWritten by Farhat Nasim Published On 2019-06-06T12:11:50+05:30  |  Updated On 17 Aug 2021 12:52 PM IST

    New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has recently released an updated list of WHO GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (COPP) across the various States of India.


    Every country has its own system and requirements for registering a pharmaceutical product to ensure that the product being registered meet their standards for efficacy, safety and quality.


    The Indian pharma regulator has been issuing the Certificate of Pharmaceutical Products (COPP) which is valid for a period of only two years. The COPP is the legal document that declares a certain manufacturing company is legally allowed to sell their pharmaceutical product in the country they are producing. When registering a pharmaceutical product overseas, the government body in charge of approving the application will usually require a COPP to ensure that the product is being sold as a commercial finished product in the country that is producing it


    The COPP is on par with the WHO-GMP certificates.


    WHO-GMP certifications of a Group's manufacturing facilities are a testimony to its compliance with the World Health Organization's (WHO) international norms. It is a system (and part of the quality assurance programme) to ensure that the pharmaceutical products are consistently produced and controlled according to the quality standard. It is designed to minimize the risk involved in any pharmaceutical production that cannot be eliminated through testing the finished product.


    Recently, CDSCO has released a list of manufacturing units that fall under WHO GMP certification. The notification reads a total of 2006 WHO GMP Certified Manufacturers in different states of India. A large number of manufacturers are in the state of Gujarat with 684 manufacturers, followed by 229 manufacturers in Maharashtra.


    Few of the major pharma companies mentioned in the list include Sun Pharma, Aurobindo Pharma, Dr Reddy's Labs, Indoco Remedies, Cadila healthcare, Unichem Labs, Cipla, Glenmark, Merck and others.


    In India, the GMP was given statutory status much later in 1988 and were incorporated as Schedule M under Drugs and Cosmetics rules 1945. This was again revised in 2001 but implemented only in 2005 after stiff resistance from many small-scale manufacturers.


    Also Read: Biocon up 5 per cent as Malaysia arm gets GMP compliance certificate

    Aurobindo PharmaCadila HealthcareCDSCOCiplaDr Reddy's Labsdrug manufacturerDrugs and Cosmetics RulesGlenmarkGMPGMP CertificateIndiaIndian drugmakerIndoco RemediesMerckSun PharmaUnichem LabsWHOWHO-GMP

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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