Central Drugs Standard Control Organisation (CDSCO) has asked manufacturers to inform general public on adverse reactions from some commonly-used antibiotics.
This comes after Union Health Ministry’s pharmaceutical watchdog-National Co-ordination Centre of Pharmacovigilance Programme of India (PvPI), raised alert on adverse reactions that were being reported from 7 commonly-used antibiotics. They are: Cefotaxime, Ofloxacin, Quetiapine, Cefixime, Tranexamic Acid, Sulfasalazine and Sodium Valproate.
CDSCO has written to drug manufacturers mandating them to mention in leaflets inserted into drug packets or on promotional literature, information about adverse reactions of these medicines.
Pharmacovigilance Program of India (PvPI)
It was launched in 2010 by Central Drugs Standard Control Organisation (CDSCO), New Delhi, under aegis of Ministry of Health & Family Welfare.
Its objective is to monitor adverse drug reactions (ADRs) among Indian population. It also helps regulatory authority of India viz. CDSCO in taking decision for safe use of medicines.
National Co-ordination Centre of Pharmacovigilance Programme of India (NCC-PvPI)
It is Union Health Ministry’s pharmaceutical watchdog. It had launched WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services in 2017.