Indian Pharmacopeia Commission, an autonomous body of the Ministry of Health & Family Welfare, functioning as National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI), collects, collates, analyses & monitors the data of Adverse Drug Reactions (ADRs) received from its 202 Adverse Drug Reaction Monitoring Centres (AMCs) across the country.
It has been stipulated in the Drugs & Cosmetics Rules, 1945 that prescribing information should be submitted as part of the application for marketing a new drug. It has also been laid down that prescribing information (package insert) should include information regarding indications and contra-indications; use in special populations (such as pregnant women, lactating women, paediatric patients, geriatric patients, patients with renal impairment, patients with hepatic impairment, etc.); warnings; precautions; drug interactions; overdose, etc.
