The Uttar Pradesh Food Safety and Drug Administration Department has suspended the production licence of Marion Biotech Pvt. Ltd, a Noida-based drug maker that manufactured a cough medicine linked to the deaths of 18 children in Uzbekistan.
“We have suspended the drug manufacturing license of Marion Biotech. The company hasn’t responded to the show-cause notice issued by us on the reason for manufacturing violations at the production plant in Noida,” an official at the department told Moneycontrol.
According to the official, Marion Biotech founders had two licenses -- Form 25 and Form 28 -- for manufacturing different types of drugs at the Noida based factory.
“The company possessed two types of licenses for production of biological and other-than-biological drugs and both have been suspended until further notice,” he added.
Also read: Uzbekistan cough syrup row: Marion Biotech asked to completely halt drug production at Noida plant
A show-cause notice was given to the directors of Marion Biotech on December 30, and they were told to reply by January 5.
When asked about the reason regulator delayed suspending licence after the company failed to respond by January 5, the official said the firm was given additional time to reply because results of tests done on the cough syrups were awaited from Chandigarh.
“We gave additional time, but the company didn’t respond and after assessing the violations observed at the plant during inspection, the suspension of production license was ordered yesterday,” the official said.
Also read: Exclusive | Uzbek Cough Syrup row: Drug regulators inspect Marion Biotech's manufacturing site
On being asked about further action on this matter, the official said the department would wait for the lab reports from Chandigarh.
“Once the lab findings indicate high presence of ethylene glycol in the cough syrups made by Marion Biotech, the company may also be prosecuted; the course of action will be decided basis the findings of report,” he added.
The drug regulator of Uttar Pradesh served a show-cause notice under Section 85(2) of The Drugs and Cosmetics Rules, 1945, to the founders of Marion Biotech.
Also read: Drug contamination reports hurt Indian pharma, government must find a way: Experts
According to Section 85(2), the licensing authority may cancel the licensee of a drug maker if it fails to reply to a show cause notice.
The notice was served on the company after a joint team of four officials from the central drug regulator and the Uttar Pradesh Drugs Controlling and Licensing Authority inspected the Noida plant twice on December 27 and 29, after the deaths of 18 children were reported in Samarkand, Uzbekistan.
The children reportedly consumed the cough syrup Doc-1Max (tablet and syrup) manufactured by Marion Biotech.
The company has been silent on queries related to the deaths.
"We regret the deaths; the government is conducting an enquiry. We'll take action as per report. Samples were collected. Manufacturing of that product has been halted as of now and other processes are underway," said Hasan Raza, legal head of Marion Biotech.
Marion Biotech has been suspended from the Pharmaceuticals Export Promotion Council of India (Pharmexcil) after the company didn’t reply to the council’s queries on the reported deaths of children in Uzbekistan.
Uday Bhaskar, Director General of Pharmexcil, said in a notice sent to Marion Biotech that the alleged supply of substandard medicines had brought ill repute to the Indian pharma industry, and is likely to have an impact on the trust reposed by international agencies in Indian pharma exports.
