CDSCO has initiated an immediate inquiry in collaboration with the Haryana drug regulator under whose jurisdiction the drug manufacturing unit is located.
“The Central Drugs Standard Control Ogranisation (CDSCO) has formed a committee to examine the facts pertaining to the cough syrups, the manufacturing license of the company etc. The committee has further investigate where the company has supplied these cough syrups across the globe," said the official aware of the matter.
“On 29 September, WHO had informed DCGI that it is currently providing technical assistance and advice to Gambia, where children have been suspected to have died with the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol. This has been confirmed in some of the samples by further analysis conducted by WHO," said the official.
According to the preliminary enquiry, it has been found that Maiden Pharmaceutical Limited based in Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for the products and holds manufacturing permission for cough syrups. As of now, the company has manufactured and exported these products only to Gambia only.
“CDSCO responded to WHO immediately and took up the matter very seriously along with the State Drug Regulator (Haryana government) to examine ascertain the facts/ details in the matter," said another official aware of the matter.
As per the tentative results received by WHO, out of the 23 samples tested, four have been found to contain diethylene glycol/ ethylene glycol as indicated. “The certificate of analysis will be made available to WHO in near future and WHO will share it with India soon," the officials said.
“At the same time, the exact one to one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity or source of the manufacturing of the products,“ said the official adding that it has been requested to WHO to share the report with CDSCO at the earliest.
Queries emailed to health ministry spokesperson did not respond immediately. Calls were made to Maiden pharmaceuticals remained unanswered.
Dr Tedros Adhanom Ghebreyesus, WHO DG, on Sunday issued an alert against four cough and cold syrups made by India-based Maiden Pharmaceuticals, saying that it might be linked to the deaths of 66 children in the Gambia.
“So far, the contaminated products have only been found in Gambia, the products have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients," Dr Tedros said.
