Maiden Pharma, facing WHO ire for its cough syrups, flouted norms earlier too

Days after drawing ire from the World Health Organization (WHO) over four substandard cough syrups, India-based Maiden Pharmaceuticals LTD's METOMIN Tablets are now under the scanner.

As per the Xtended Licensing, Laboratory and Legal Node (XLN), "Maidens METOMIN Tablets (Metformin Tablets IP 1000 mg)", which were recovered in Kerala’s Ernakulam district, were not as per the standards. Metformin is used for treating diabetes.

"The sample does not conform to IP (Indian Pharmacopoeia) 2018. This particular batch of samples fails the test Dissolution. Hence, declared as Not of Standard, quality," XLS said in a note on its website.

The food and drugs laboratory (FDL) had found the drugs to be of substandard quality on September 28.

Indian Pharmacopoeia is recognised as the official book of standards for the drugs being manufactured and/or marketed in India. It is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health and Family Welfare "in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules 1945 there under".t

Earlier, the WHO sounded an alarm over four cough syrups made by Haryana-based pharma company. The global body had identified four paediatric cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — as substandard.

These were found in the Gambia, West Africa, "that have been potentially linked with acute kidney injuries and 66 deaths among children".

The Haryana Drug Regulatory authority has now sent samples of the four cough syrups for testing, and reports are expected in the next two days.

Maiden pharma is said to have flouted norms in four Indian states, India Today reported on Friday. It said that according to the XLN database, at least two state governments — Kerala and Gujarat — have repeatedly warned of the company’s illegal practices.

Meanwhile, the Bihar government had blacklisted two pharmaceutical companies, including Maiden Pharmaceuticals, for supplying sub-standard drugs in 2011, Money Control reported.

According to the Bihar government’s official order, the company was reportedly found to be supplying ‘spurious’ and ‘substandard’ medicines in the state several times.

The company has not responded on the matter yet.

As per the WHO, diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Their toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.

Diethylene glycol is a solvent present in numerous formulations like brake fluids, paints and chemical preparations. These solvents can cause renal failure and can even cause death when ingested.