Similar Biologics: Regulatory Prospective in India
A. Ramkishan 1*, Rajappan 2, Fahim Khan 3
Deputy Drugs Controller (India), Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
Abstract
No Abstract.
References
Drugs and Cosmetics Act, 1940 and Rules there under, 1945.
Guidelines in Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016.
Guidelines in Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012.
