Indian Drug Regulator Issues Alert After Adulteration Found in Marion Biotech’s Samples

The Central Drugs Standard Control Organization, India’s apex drug regulatory agency, has issued an alert to states and union territories after adulteration was discovered in drug samples from Marion Biotech in Uttar Pradesh. The alert, issued by India’s drug controller general Rajeev Singh Raghuvanshi, states that the samples failed quality tests.

The pharmaceutical company is at the centre of a controversy in Uzbekistan over the deaths of children. Uzbekistan’s health ministry shared information about the problem with India’s health ministry in December of last year.

Marion manufactured Dok-1 Max syrup contained ethylene glycol, a deadly chemical found to be responsible for deaths in Gambia, according to studies conducted by Uzbekistan’s primary laboratory.

An investigation was conducted by the Central Drugs Standard Control Organisation (CDSCO), an arm of the Ministry of Health and Family Welfare, in collaboration with state drug regulatory officers. According to the alert, the investigation discovered that the drug samples had failed quality tests. 24 of the 33 samples drawn are of poor quality, and 22 are adulterated or spurious.

“This is in relation to Marion Biotech investigations… in connection with the deaths of children in Samarkand, Uzbekistan,” stated the alert sent to licencing authorities in all states and UTs on Tuesday.

“During the course of the investigation, a total of 33 samples were drawn by drug inspectors of CDSCO NZ RTDL, Chandigarh has now forwarded the test reports of 30 drug samples, wherein 24 samples were declared as not of standard quality and 22 samples fall under the category of adulterated/spurious under Section 17A and 17B of the Drugs and Cosmetics Act (sic),” according to the alert.

It was first reported on the investigation report prepared by the food safety and drug administration in Lucknow on January 13. Marion was portrayed “very poorly” in the report, which revealed numerous flaws in the manufacturing process.

The drug controller general of India (DCGI) has directed officials to prohibit the use of raw materials manufactured by Maya Chemtech, a Delhi-based drugmaker, and has directed all manufacturers to stop procuring from the company.

“It is also stated that Maya Chemtech was primarily the supplier of propylene glycol, which was used in the impugned batches,” according to the alert. “In light of the foregoing, you are requested to issue instructions to all manufacturers in your jurisdiction not to use Maya Chemtech propylene glycol.”

The DCGI further asked states and UTs to act in “public interest” by keeping a “strict vigil on the matter” and taking “stringent action against offenders”. He concludes the letter by stating that the matter has been referred for “strict scrutiny.”