**Summary:**
This notice, issued by the Veterinary Division of the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, addresses stakeholder concerns regarding pharmacovigilance reporting for veterinary products in India. The notice clarifies the reporting requirements for Periodic Safety Update Reports (PSURs) as stipulated in Form 45 and Form 46 of the Drugs and Cosmetics Act, 1940, and its associated rules. Specifically, applicants/permit holders are required to submit PSURs every six months for the initial two years following approval/permission. Subsequently, PSURs are to be submitted annually for the following two years. Further inquiries can be directed to Dr. K. We, Joint Drugs Controller India, at the CDSCO Veterinary Division, FDA Bhawan, Kotla Road, New Delhi – 110002, India. The notice reference number is F. No. X11026712019VD.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India's Ministry of Health and Family Welfare.
Central Drugs Standard Control Organisation: National Regulatory Authority responsible for regulating pharmaceuticals and medical devices in India.
Veterinary Division: A division within the Central Drugs Standard Control Organisation, dealing with veterinary products.
FDA Bhawan, Kotla Road, New Delhi, Delhi: Address of the Central Drugs Standard Control Organisation office.
Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Drugs and Cosmetics Act, 4940: A law in India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Form 45: A form under the Drugs and Cosmetics Act related to grant of approval/permission.
Form 46: A form under the Drugs and Cosmetics Act related to grant of approval/permission.
F. No.
X-11026/71/2019-VD
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Veterinary Division)
FDA Bhawan, Kotla Road,
New Delhi-110002, India,
Notice
Various stakeholders of the Veterinary Products have raised concern
regarding the clarification with respect to Pharmacovigilance reporting for
veterinary products in India.
In this regard it is stated that as per the conditions for grant of
approval/permission in Form 45 and Form 46 of the Drugs and Cosmetics Act,
4940 and rules thereunder, the applicant shall submit Periodic Safety Update
Reports every six months for the first two years. For subsequent two years, the
Periodic Safety Update Reports shall be submitted annually.
(Dr. K. we
Joint Drugs Controller (India)