Uzbek children’s deaths: Drug watchdog initiates process of cancelling Marion Biotech’s licence

(Representative Image)

Uttar Pradesh’s drug regulator has started the process of cancelling the manufacturing license of Noida-based Marion Biotech after cough syrups made by it were linked to the death of 18 children in Uzbekistan, officials said.

Twenty-two of 36 samples of syrups made by Marion Biotech, which allegedly manufactured adulterated and spurious drugs, failed drug contamination tests carried out by a central laboratory.

“The drug regulator is committed to take strict action against the firm for violations of norms. The production license is already suspended, so, there is no drug production taking place. We have initiated the process of cancellation of the manufacturing license,” Sandeep Kumar Chaurasia, Assistant Commissioner of Uttar Pradesh’s Food Safety and Drug Administration, told Moneycontrol.

Also read: Marion Biotech's licence to be cancelled after contamination confirmed

Marion’s manufacturing license was suspended by the state regulator on January 9 after the company failed to reply to a show-cause notice sent to it.

Chaurasia said the process of cancelling the licence will be speeded up after central government recommended revoking the licence of Marion Biotech. 

The state regulatory official, however, didn’t provide a timeline for the completion of the process.

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

Failure of drug contamination tests

The Central Drugs Standard Control Organization (CDSCO) last week complained to Noida police after 22 out of 36 samples of cough syrups collected by them were declared ‘Not of Standard Quality’ (Adulterated and Spurious) by the regional testing laboratory in Chandigarh.

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

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 First Information Report, accused the Noida-based company of disposing of materials and records related to drug manufacturing.

When contacted on the role of CDSCO in cancellation of the manufacturing licence of Marion Biotech, Kondal said the state regulators were the competent authority for the revocation.

Meanwhile, the state drug regulators too are preparing to file a case against the founders of Marion Biotech for manufacturing and selling adulterated drugs.

“We will also approach the Chief Judicial Magistrate court and file a case against the directors of this company for manufacturing ‘Not of Standard Quality’ drugs and violating the provisions of the Drugs and Cosmetics Act, 1940,” Chaurasia said.

Also read: Pharmexcil suspends membership of Marion Biotech

With violations of good manufacturing practices being detected at Marion Biotech, the state drug regulator said it has tightened vigil on the ground for tracing spurious cough syrups and other drugs.

“We have increased the sampling and surveillance of the cough syrups for testing for adulteration after the Marion Biotech incident,” Vaibhav Babbar, drug inspector, Noida, told Moneycontrol.

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.

The founders of Marion Biotech, Sachin Jain and Jaya Jain, are still at large and haven’t been arrested yet.

Marion Biotech came under the scanner in December after the allegations against it surfaced.