The Union Ministry of Health and Family Welfare created an advisory panel of four members on Wednesday to review the information it requested for from the World Health Organisation to find out whether there was evidence that the death of kids within Gambia were the result of cough syrups produced by Sonepat, a subsidiary of Maiden Pharmaceuticals.
The day before it was reported that earlier in the day, Haryana government had issued an order for the government to put a “complete end”on production by the company following the discovery of infractions to acceptable manufacturing practices as well as inadequacies regarding documentation in four Drug control authorities.
The move by the state government is just a week after the WHO issued an alert warning that four cough syrups produced through the Sonepat company could have killed 66 children from Gambia.
In confirming the news, Haryana Health Minister Anil Vij stated that 12 flaws were identified when conducting the checks at the pharmaceutical unit. Inspections took place on October 1 3,, and 11.
The committee created through Union MoH&FW comprises Vice-Chairperson of the Standing National Committee on Medicines Dr YK Gupta, Senior Scientist from the National Institute of Virology, Pune Dr Pragya Yadav Director of the Additional Director and Director of Epidemiology at the National Centre for Disease Control Dr Arti Bahl as well as Central Drugs Standards Control Organisation officer A K Pradhan.
“In consideration that the severity of violations discovered during the investigation, and the potential danger to the quality, safety and effectiveness of the drugs that are being manufactured and manufactured, all manufacturing activity of the company is being stopped immediately with effect…till another decision in the public interest, but without prejudicing further action in the issue,” the order by the state and Central Drug Control officers said.
“During these investigations…it was observed that the company has manufactured and tested drugs in defiance of and contrary to the numerous acceptable manufacturing methods … The company has not kept and maintained complete records of production and testing in accordance with the Drugs and Cosmetics Act,” the order noted.
Sources claimed that among the flaws discovered were the absence of batches numbers and dates of manufacture and expiry on statements for solvent propylene glycol.
Experts have pointed out that the using non-pharmaceutical grade propylene glycol can cause di-ethylene glycol as well as ethylene glycol contamination, both of which can be toxic for human beings. According to people familiar with the subject, the company did not test propylene glycol, the solvent for these contaminants.
In response to the WHO warning Following the WHO alert, the Haryana government sent samples of four cough syrups produced by this company to Central Drugs Laboratory (CDL), Kolkata. “The report is being waited for, and further action will be taken in line with the report. However, during the joint inspections conducted by teams from the state and central drugs department there 12 deficiencies were found. Therefore, we’ve determined that the pharmaceutical company’s production must be put on hold. A notice was issued for the business,” Vij said.
“A high-ranking Central Department of Pharmaceuticals official also spoke with Haryana’s Additional Chief Secretary (Health) about the issue. The cough syrups produced by the pharmaceutical company have been accepted to be exported. It’s not available to sell or market in the country. We will be able to decide once we receive the report from CDL,” the minister has stated.
(With data from ENS Chandigarh)