Maiden pharma, under WHO scanner for Gambia kids' deaths, flouted norms in 4 states

The Central Drugs Standard Control Organisation (CDSCO) has not yet barred the company from operations in India even as many of its medical products made for Indian use have also been found to be of substandard quality, often flagged by authorities.

Ever since Maiden Pharmaceuticals has come under the scanner of the World Health Organisation (WHO) after being flagged for the four cough syrups manufactured in India and exported to Gambia that led to the death of 66 children, it has come to light that the company has in the past flouted countless norms but was allowed to operate with impunity.

While the statements from the Indian government state that the four cough syrups found to have dangerously high levels of ethylene glycol and deithylene glycol that led to kidney injuries were only licensed by the state drug controller for export and sale in Gambia, the company has been flagged in many Indian states over the years for their medicines failing the quality and safety parameters.

Previous reports suggest that the company has been a serial offender on quality control standards in the past as many state governments, and authorities have flagged it. Dinesh thakur, a public health activist based in St Petersburg has published a long Tweet thread on the matter and has also raised questions over the functioning of the Central Drugs Standard Control Organisation (CDSCO) in India as well as the pre-qualification process of the WHO.

#longthreadThe @WHO issued a Medical Product Alert a couple of days back about DEG poisoning and death of over 60 children in Gambia. https://t.co/vPgriIIJuOThis thread documents the persistent, callous, unaccountable and nonchalant attitude of every #publichealth1/n pic.twitter.com/IrCMuqKUlm

“Usually the CDSCO simply passes the buck in these cases to the state drug controller who issues the manufacturing licence. Except in this case Maiden Pharmaceuticals was certified by the CDSCO through the CoPP process. The national drug regulator, CDSCO provides assurance via the CoPP (Certificate of Pharmaceutical Product) to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards. A pharma manufacturer has to provide this certificate (and the certification is not worth the paper it is written on) to the buyer overseas. Given the wonderful track record above of this company, does it not beg the question on what basis does the CDSCO issue this piece of paper,” Dinesh Thakur tweeted.