Health Ministry Mulling New Drug Policy After Substandard Drugs Reports

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New Delhi: Following reports of substandard Indian drugs causing health concerns, and even deaths, in countries like the US, The Gambia, and Uzbekistan, the health ministry is seriously considering putting in place a new system for drug exports, top official sources said. Samples of all India-made drugs will be tested for quality before shipping out, they said.

The Union Health Ministry and the Department of Pharmaceuticals are deliberating this new policy, ministry sources said. Suggestions were sought from the Directorate General of Foreign Trade (DGFT) regarding this.

Medicines will be tested at the regional or central drug testing lab before sending them abroad.

So far, drug manufacturers used to directly export to foreign countries after obtaining export licences, without any quality check.

Last month, the top medical watchdog in the US raised concerns over the likelihood of a highly drug-resistant bacteria, linked to eye drops made by an Indian company, gaining a foothold in the US.

Three deaths, eight cases of blindness and dozens of infections were traced to eye drops made by Chennai-based Global Pharma Healthcare under the brand name EzriCare Artificial Tears, The New York Times reported, citing the Centres for Disease Control and Prevention (CDC). Though Tamil Nadu’s drug regulator later said it found “no contamination” in samples. Sources in the Union Health Ministry confirmed the same.

Earlier, in October last year, The Gambia in West Africa had reported the death of 70 children allegedly linked to India-made cough syrups. A joint probe by the Centers for Disease Control and Prevention (CDC) of the US and the Gambian health authorities in March this year suggested a strong link between the children’s death and the consumption of made-in-India cough syrups that were allegedly contaminated.

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