Affiliations: Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai 400 012, India Tel.: +91 22 2413 3767; Fax: +91 22 2414 3435; E‐mail: dcpkem@vsnl.com
Abstract: Pharmacovigilance in India began in the mid eighties with an initiative by the drug regulatory authorities (DRAs) to set up centers for safety monitoring in India. Pharmacovigilance in India is hampered by the problems of a large population that is predominantly rural, extensive use of traditional medicines, poor spontaneous reporting, lack of physician and consumer awareness, rapid introduction of several new molecules, and inadequate post marketing surveillance. In recent times, the DRAs have taken significant steps to improve safety monitoring. In 1995, the Government of India created the Department of the Indian Systems of medicine and this department works towards standardization, enhancement of the availability, and quality of raw materials, research and development, information dissemination, communication and involvement of the practitioners of alternative systems of medicine into national health care. The release of good manufacturing guidelines (GMP) for non‐allopathic systems of medicine is yet another step in this direction. The DRAs are working towards the setting up of several regional centers that would cover the entire country and be linked with the national centre. They are also looking into modifying the existing regulations to improve drug safety and post marketing surveillance. The ADR monitoring centres are working towards improving patient and physician awareness. However, the ultimate responsibility of ADR monitoring rests with the physician whose good reporting practices will go a long way in improving safety monitoring in the country.
Keywords: Pharmacovigilance, Indian health care, post marketing surveillance, drug safety, non‐allopathic medicine, spontaneous reporting, safety regulations
