Uzbek children deaths: DCGI alerts states against firm that supplied raw material to Marion Biotech

Days after adulteration in cough syrups samples drawn from Noida-based Marion Biotech was confirmed, the Drug Controller General of India (DCGI) issued an alert to all states against the use of raw materials manufactured by Delhi-based Maya Chemtech, which supplied the ingredients for the drugs.

DCGI Rajeev Kumar Raghuvanshi in a letter to all state and Union territory licensing authorities said that 24 samples drawn by the inspectors of the Central Drugs Standards Control Organisation (CDSCO) were "not of standard quality".

“Out of these samples, 22 samples fall under the category of adulterated/spurious under Section 17A and 178 of the D&C (Drugs and Cosmetics) Act, 1940,” he said.

The samples were collected by a joint team of state and central regulators after Marion Biotech’s cough syrups were linked with the death of 18 children in Uzbekistan.

Raghuvanshi apprised state regulators that Maya Chemtech was the main supplier of propylene glycol, which was used in the impugned batches. The DCGI in the alert, seen by Moneycontrol, urged the licensing authorities of states to issue directions to all manufacturers not to use propylene glycol supplied by the company.

Also read: Marion Biotech used untested ingredients procured from unapproved vendors

“Accordingly, you are requested to instruct your enforcement officials to keep a strict vigil on the matter and take stringent action as per the provisions of the said Act and Rules against the offenders in public interest,” he added.

Raghuvanshi has called for strict implementation of the alert.

Licence cancellation

A senior official of Uttar Pradesh’s drug regulator told Moneycontrol that Marion Biotech’s manufacturing licence is being cancelled.

“We have initiated the process of cancellation of the manufacturing licence of Marion Biotech. We are going to take strict action against the company for adulteration,” Sandeep Kumar Chaurasia, assistant commissioner of Uttar Pradesh’s Food Safety and Drug Administration, told Moneycontrol.

Marion Biotech, a registered business entity in Uzbekistan since 2012, exported Ambronol syrup and Dok-1 Max cough syrups to the central Asain country.

The company’s licence was suspended on January 9 after it failed to reply to the state drug regulator’s notice on violations of manufacturing practices at its production unit.

FIR registered, owners absconding

Ashish Kondal, drug inspector, CDSCO, North Zone, Ghaziabad, filed a complaint for registering a First Information Report (FIR) against five officials of Marion Biotech for manufacturing and selling adulterated and spurious drugs. Kondal in the complaint accused the Noida-based company of disposing of materials and records related to drug manufacturing.

Three officials from Marion Biotech have been arrested by Noida Police for selling adulterated medicine. They are Tuhin Bhattacharya, head of operations; Atul Rawat, manufacturing chemist; and Mool Singh, analytical chemist, under different sections of Indian Penal Code.

Also read: WHO issues alert for 'substandard' Marion Biotech drugs linked to Uzbekistan tragedy

The founders of Marion Biotech, Sachin Jain and Jaya Jain, are still at large.

The state regulator is also preparing to file a case against the founders of Marion Biotech for manufacturing and selling adulterated drugs.