Display information on 7 common antibiotics: CDSCO
9th April, 2019Category: Health, National
In a move 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, the Central Drugs Standard Control Organisation (CDSCO) has asked manufacturers to ensure that this information be made available to the general public. CDSCO has written to drug manufacturers on April 9, to mention in leaflets inserted into drug packets or on promotional literature, information about the adverse reactions of these medicines so that it may be available to the general public.
All of the seven formulations — 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 — have been instructed to warn patients of the “new†side effects.
An antibiotic is a type of antimicrobial substance active against bacteria and is the most important type of antibacterial agent for fighting bacterial infections. Antibiotic medications are widely used in the treatment and prevention of such infections. 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.
The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India, having its headquarter at New Delhi. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Under the Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Read More: The Hindu