Cough syrup test report awaited; Marion Biotech gets breather to respond on GMP violations

With the laboratory test reports of cough syrup samples awaited, the Uttar Pradesh drug regulator has given Noida-based Marion Biotech additional time to respond to the show cause notice issued to the company for violation of good manufacturing practices, government sources told Moneycontrol.

“As we await an update on the results of cough syrups taken from this manufacturing site for testing, we have given additional time to the company to reply on the violation of norms observed at the Noida plant,” an officer of the Uttar Pradesh drug regulator told Moneycontrol.

Also Read: Exclusive | Uzbek Cough Syrup row: Drug regulators inspect Marion Biotech's manufacturing site

The official in the know of the development said the firm will be asked to respond to the show cause notice basis the findings of Regional Drugs Testing Laboratory (RDTL), Chandigarh. A Health Ministry official said the firm may be served another notice for violation of norms after the results of the test by the Central Drug Laboratory, Chandigarh, come in.

A show cause notice was given to the directors of Marion Biotech on December 30, and they were told to reply by January 5.

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.

According to Section 85(2) of The Drugs and Cosmetics Rules, 1945, the licensing authority may cancel the issued license if the licensee fails to reply to the show cause notice.

Also read: Uzbekistan cough syrup row: Marion Biotech asked to completely halt drug production at Noida plant

“The notice was issued after violation of Schedule M of current Good Manufacturing Practice (cGMP) was found in the plant where drug manufacturing was taking place,” an official of the Uttar Pradesh drug regulator, said.

The notice was served on the company after a joint team of four officials from the central drug regulator and 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, on consuming cough syrup Doc-1Max (tablet and syrup) manufactured by Marion Biotech.

The company has been silent on queries related to the deaths in Uzbekistan.

"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 Pharma Company, on the syrup deaths in Uzbekistan.

Pharmexcil suspends membership

The Pharmaceuticals Export Promotion Council of India (Pharmexcil), on December 30, suspended the membership of Marion Biotech after the company didn’t reply to the council’s query on the reported deaths of children in Uzbekistan, on alleged consumption the cough syrups produced by Marion Biotech.

Uday Bhaskar, Director General, Pharmexcil, in a notice sent to Marion Biotech, said the alleged supply of substandard medicines by the firm led to the deaths of 18 children; it brought ill repute to the Indian pharma industry, and is likely to have an impact on the trust of international agencies on Indian pharma exports.

Bhaskar asked Sachin Jain, Chairman and Managing Director, Marion Biotech, to reply within 24 hours with details of the cough syrups exported to Uzbekistan.