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    CDSCO directs Veterinary manufacturers to submit Periodic Safety Reports every 6 months for first 2 years

    Farhat NasimWritten by Farhat Nasim Published On 2019-12-09T12:12:28+05:30  |  Updated On 9 Dec 2019 12:12 PM IST

    The direction to submit PSURs came after various stakeholders of Veterinary products raised a concern regarding the clarification with respect to Pharmacovigilance reporting for veterinary products in India.


    New Delhi: Through a recent notification, the Central Drugs Standard Control Organisation (CDSCO) directed the manufacturers to submit Periodic Safety Update Reports (PSURs) every six months for the first two years for veterinary products in India as part of the Pharmacovigilance Programme of India (PvPI).


    Periodic Safety Update Reports are pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product.


    The direction to submit PSURs came after various stakeholders of Veterinary products raised a concern regarding the clarification with respect to Pharmacovigilance reporting for veterinary products in India.


    Also Read: Government BANS the use of a decade-old antibiotic COLISTIN in animal feeding, fishing


    Taking note of the same, the government released a notice undersigned by Dr K Bangarurajan, Joint Drugs Controller of India that reads;




    "As per the conditions for grant of approval/permission in Form 45 and Form 46 of the Drugs and Cosmetics Act, 1940 and rules thereunder, the applicant shall submit Periodic Safety Update Reports every six months for the first two years. For the subsequent two years, the Periodic Safety Update Report shall be submitted annually."



    The Indian animal healthcare market is estimated to be around 42000 million INR (2014) and is projected to be around 60000 millions by 2018. There are nearly 50 major companies operating in the Animal health market in India. The regulation of the Animal health products in India is under the Department of Animal Husbandry under the Ministry of Agriculture (MOA). The Drug Controller General of India (DCGI) regulates and licenses, products for Veterinary use.


    Also Read: Health ministry releases Mobile APP for ADR reporting, Pharmacovigilance guidelines,

    CDCSOCentral Drugs Standard Control OrganisationDCGIIndiaPeriodic Safety Update ReportsPharmacovigilance Programme of IndiaPSURsveterinary manufacturersveterinary products

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    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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