Experts call for regulation of drug manufacturing process in India
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Experts call for regulation of drug manufacturing process in India

India’s experts have called for better regulation of the drug manufacturing process in the South Asian country.

This came after World Health Organisation (WHO) issued an alert earlier, this month, over four Indian-made cough syrups.

WHO said the syrups could be linked to acute kidney injuries and 66 deaths among children in The Gambia.

The flagging has brought into the limelight the menace of counterfeit drugs in India and calls for the regulation of the drug manufacturing process in the country.

The involved four cough syrups were manufactured by Maiden Pharmaceuticals Limited based in India’s northern Haryana state.

Immediately after the WHO warning over the four Indian cough syrups sold overseas, India’s federal government launched a probe.

Laboratory analysis has found the cough syrups to be contaminated with diethylene glycol and ethylene glycol, and India’s drug regulatory authority the Central Drugs Standard Control Organisation (CDSCO) has confirmed the exports were limited to The Gambia.

India is one of the leading manufacturers and exporters of affordable medicines to low and middle-income countries.

The CDSCO has been benchmarked as maturity level 3 for vaccines.

However, the regulation of medicines falls under the state governments.

“The absence of a centralised body to oversee the drug manufacturing process may result in certain cases of inconsistent regulatory control over pharmaceutical manufacturing activities leading to the production of substandard medicines, which may include medicines contaminated with toxic substances.

“India has been battling the challenge of substandard drugs for a while,” Gajendra Singh, a public health expert, wrote in an opinion piece in a local daily.

“The government must tighten its noose on quality and ensure that patient safety takes precedence over geography for medicines.

“The idea is to give patients the safest option available, whether it comes from the domestic market or overseas,” said the expert.

According to Singh, in 2018 the CDSCO identified about 4.5 per cent of all generic drugs in the Indian market as substandard.

“The Drugs Controller General of India should work closely with local drug control authorities and pharmaceutical companies to get to the root of the problem.”

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