- Wednesday, April 30, 2025
By: Shubham Ghosh
Ever since India’s Maiden Pharmaceuticals has come under the World Health Organisation’s (WHO) scanner after being flagged for four cough syrups exported to The Gambia and blamed for the death of 66 children, it has been revealed that the company has been found flouting norms on several occasions but was allowed to function with impunity.
While statements from the Indian government said that the four cough syrups found to have alarming level of ethylene glycol and deithylene glycol that cause kidney injuries were only licensed by the state drug controller for export and sale in the west African nation, the pharmaceutical company has been flagged in a number of states in India over the years over medicines failing to meet the quality and safety parameter, India Today reported.
According to reports that came out previously, the company has been a serial offender when it comes to quality-control standards in the past since many state governments and authorities flagged it,
Dinesh Thakur, a public health activist based in St Petersburg, Florida, has come up with a long Twitter thread on the issue where he raised questions over the working of the Central Drugs Standard Control Organisation (CDSCO) and the pre-qualification procedure of the world health body.
“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,” he said in a tweet.
In 2011, the eastern state of Bihar blacklisted Maiden for supplying substandard drugs. One drug named Methylergometrine tablets that were provided to the civil surgeon in Munger area was found to be spurious. The quality of another batch of drugs — Erythromycin Sterate Syrup (125mg/5 ml) — was also found to be of unsatisfactory.
In states such as Kerala, a judicial first-class magistrate court in Kerala in 2017 had fined the company a small ransom of Rs 1,000 in a prosecution which was filed by a drug inspector in the state in 2005.
An alarm was also raised in Jammu and Kashmir over substandard products.
A central government drug inspector prosecuted the company in Sonipat in the northern Indian state of Haryana for quality violations under the Drugs & Cosmetics Act, the India Today report said, adding the company was charged for offences related to adulteration.
According to the extended licensing, Laboratory and Legal Node (XLN) database maintained by the Indian government, at least two states — Kerala and Gujarat — have warned of the company’s illegal practices repeatedly, the report added.
