Indian drugmaker's license suspended over fake antibiotic

Indian flag, hand and tabletsAn Indian pharma company has had its manufacturing license suspended after an antibiotic product it supplied hospitals in Jammu and Kashmir state was found to be spurious.

Jammu-based Life Line Pharmaco Surgicals was found to have supplied around 200,000 tablets of the spurious product - called Maximizin-625 (amoxicillin and potassium clavulanate) - over the course of 2012, according to local news reports.

The plot has thickened now that another drugmaker - Affy Parenterals - has claimed the Maximizin-625 brand as its own but insisted it has never supplied the product to Jammu and Kashmir hospitals and that the offending product is packaged differently to its own.

An article in the Business Standard suggested a senior official in the Kashmir state government had also been suspended while an investigation into the incident is carried out. Meanwhile local medical groups, including the Doctors Association of Kashmir (DAK), have filed a legal petition to put the authorities' actions in the case under scrutiny.

Analysis of the spurious product has revealed zero amoxicillin content, raising questions about the possible need for routine screening of potentially life-saving medicines in India's hospitals.

Trying to identify how many spurious medicines (i.e. those with little or no active ingredient as a result of counterfeiting or substandard production) are on the market in India is a massively-difficult task, not least because of the dissociation between central and state governments.

The official line of India's Central Drugs Standard Control Organisation (CDSCO) - from a report published in 2010 - is that the rate stands at around 0.04 per cent, although that claim is contentious and other research has suggested rates of 3-10 per cent, depending on the region of India surveyed.

In 2011, the Federation of Indian Chambers of Commerce and Industry (FICCI) set up a committee to tackle smuggling and counterfeiting, suggesting at the time that illicit trade in medicines is around 15 to 20 per cent of the total market.

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