Gambia deaths case: Four cough syrups made by Maiden Pharmaceuticals are of standard quality, declares Centre

New Delhi: The Centre on Thursday declared that four cough syrups, which allegedly led to the death of 66 children in Gambia, were of "standard quality". The government's response came in reply to a question in Rajya Sabha.
Bhagwant Khuba, Union Minister of State for Chemical and Fertiliser in a written reply in Rajya Sabha said, "As per the report of the Government Analyst, the samples have been declared to be of standard quality. The said samples were also found negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG)."
"Based on investigations conducted, State Drugs Controller, Haryana issued show cause notice to M/s Maiden Pharma on 7.10.2022 under Rule 85(2) of the Drugs Rules, 1945. Further, an order under section 22(1)(d) of the Drugs and Cosmetics Act, 1940 issued to M/s Maiden Pharmaceuticals Limited, Sonepat, Haryana on September 11, 2022, stopping all the manufacturing activities of M/s Maiden Pharmaceuticals at Sonepat with immediate effect in the public interest," the reply mentioned further.

According to the mail written by DCGI on December 13, 2022, to Dr Rogerio Gaspar, Director, Regulation and Prequalification, WHO, in reply to the letter dated December 6, 2022, received through e-mail, "WHO had been informed that the samples of these 4 products in question were drawn and sent for testing to Government Laboratory as per extant rules. As per the test reports received from the Government laboratory, all the control samples of the 4 products have been found to be complying with specifications. Further, DEG and EG were not found to be detected in these products and the products have been found not to have been contaminated with DEG or EG as per the test reports. These reports have been made available to the aforesaid Technical Committee which is examining them."

"As regards the use of excipients specifically the propylene glycol, it was sourced 7. from Goel Pharma Chem, Delhi which is recorded to have been imported from SKC, 255, Yongjam-ro, Nam-gu, Ulsan, South Korea as per COA. Further Glycerine was recorded to be sourced from M/s Goel Pharma Chem, Delhi which was sourced from M/s Adani Wilmar, India. Excipients specifically propylene glycol available at the manufacturing site at the time of inspection were also sampled and tested at Government Laboratory as per rules and were found to be complying with USP (wherein DEG and EG were complying with USP test 2(b), and propylene glycol was not found contaminated with DEG and EG. Further, for testing at a Government laboratory. It has also been found to be complying with IP specifications (wherein content of DEG was found 0.0119% and content of EG was not detected)." the letter further stated. (ANI)