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

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.

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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.

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