CDSCO Directs to Display Information on 7 Common Antibiotics

After the alerts from the Pharmacovigilance Programme of India (PvPI) the Central Drugs Standard Control Organisation (CDSCO) has asked manufacturers of 7 common antibiotics to ensure that information related to symptoms/side effects is made available to the general public.

CDSCO Order

  • CDSCO has asked drug manufacturers, to mention in leaflets inserted into drug packets or on promotional literature, information about the adverse reactions of these medicines.
  • Manufacturers of antibiotics Cefotaxime, Ofloxacin and Cefixime; Tranexamic Acid ( used to control bleeding) antipsychotic drug Quetiapine; anti-rheumatoid drug Sulfasalazine and the anti-epileptic medicine Sodium Valproate are instructed to warn patients of the “new” side effects.

Pharmacovigilance Programme of India

Pharmacovigilance Program of India (PvPI) was launched in 2010 with a broad objective to safeguard the health of 1.27 billion people of India. Adverse drug Reactions (ADRs) are reported from all over the country to the National Coordination centre of PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs database.

The Indian Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.) hosts the coordination centre for PvPI. The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of the use of medicine outweighs the risks associated with its use.

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