From UPSC perspective, the following things are important :
Prelims level : PVPI
Mains level : Pharmacovigilance initiatives in India
- The Central Drugs Standard Control Organisation (CDSCO) has now asked commonly-used antibiotics manufacturers to ensure its details be made available to the general public.
- This decision was taken considering directives from the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI).
Pharmacovigilance Programme of India (PvPI)
- Pharmacovigilance is defined as the science relating to the detection, assessment, understanding and prevention of adverse effects, principally long term and short term adverse effects of medicines.
- The CDSCO has a nation-wide Pharmacovigilance Programme for protecting the health of the patients by promising drug safety.
- The Programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC).
- The PvPI was started by the Government of India on 14th July 2010 with the AIIMS New Delhi as the National Coordination Centre for monitoring Adverse Drug Reactions (ADRs) in the country for safe-guarding Public Health.
CDSCO guidelines to manufacturers
- CDSCO has written to drug manufacturers, to mention in leaflets inserted into drug packets or on promotional literature, information about the adverse reactions of these medicines.
- All of the seven formulations have been instructed to warn patients of the “new” side effects.
Why such move?
- The Union Health Ministry was alerted about the adverse reactions of Antibiotic Cefixime last year in August.
- Antibiotic Cefixime is used to treat a wide variety of bacterial infections and is known to have adverse reactions, including pain, diarrhoea, nausea and headaches.