According to a study conducted in the UK, millions of antibiotics currently being sold in Indian markets haven’t been approved by the regulator.
64 percent antibiotic medicines that can be found at pharmacies around the country haven’t been regulated, the study said.
Despite pledging to tackle the rising problem of antibiotic resistance, multinational companies continued to manufacture many unapproved formulations, it was found.
Antibiotic resistance is slowly gaining momentum as a global crisis. It occurs when bacteria change in a way that reduces the effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections.
As it becomes increasingly prevalent, it also threatens to undermine healthcare systems across the globe.
These findings, therefore, underline grave obstacles to bring antimicrobial resistance under control in India – a country which has one of the highest antibiotic consumption rates and sales in the world.
Parliamentary investigations into failures of the country’s drug regulatory system have also been previously carried out.
For the study published in the British Journal of Clinical Pharmacology, researchers analyzed figures for fixed dose combination (FDC) antibiotics (formulations composed of two or more drugs in a single pill) and single drug formulation (SDF) antibiotics (composed of a single drug) on the market in India.
Despite the sale of unapproved new medicines being illegal in India, it was found that of 118 different formulations of FDCs being sold in the country between 2007 and 2012, 64 percent (75) were not approved by the national drugs regulator, the Central Drugs Standard Control Organisation (CDSCO). Only five of the formulations were approved in the UK or US.
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