The Central Drugs Standard Control Organisation (CDSCO, the apex drug regulator, has asked drug manufacturers to inform consumers about known side effects/ adverse reactions after intake of certain popular antibiotics. These antibiotics include Cefotaxime, Ofloxacin Cefixime, Tranexamic Acid, Quetiapine, Sulfasalazine and Sodium Valproate.
CDSCO’s move has come after the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI) had alerted the Union Health Ministry about adverse side-effects of these antibiotics.
In 2010, the Pharmacovigilance Programme of India (PvPI) was started by the Indian government with All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordination Centre. The aim is to monitor Adverse Drug Reactions (ADRs) in India for safe-guarding public health. In 2011, the National Coordination Centre was shifted from AIIMS, New Delhi to the Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh.
The Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare which is responsible to set standards of drugs manufactured, sold and consumed in India.