Samples of four cough syrups manufactured by a Sonipat-based firm have been sent to the Central Drugs Laboratory in Kolkata for examination, Haryana's Health Minister Anil Vij said Thursday, a day after the WHO potentially linked them to the deaths of 66 children in The Gambia.
The World Health Organization (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Ltd based in Haryana's Sonepat could be the reason for the deaths of children in the West African nation.
A probe has already been initiated by India's drug regulator, the Drugs Controller General of India.
"The samples have been collected by a team of the DCGA and Haryana's Food and Drugs Administration Department and sent to the CDL, Kolkata for examination," Vij told PTI over phone on Thursday.
He said a senior official of Centre's Department of Pharmaceuticals spoke with Haryana's Additional Chief Secretary (Health). Vij said the cough syrups manufactured by the pharma company were approved for export. "It is not available for sale or marketing in the country."
"Whatever action has to be taken will be taken once the CDL report comes. Only after the report is in, we can arrive at any conclusion," Vij said.
When asked about the matter at a news conference here, Haryana Chief Minister Manohar Lal Khattar said the Centre was looking into this issue. “When an international issue in involved, the Government of India deals with it and they are dealing with it,” he said.
However, he added, "So far, we do not have information on whether the deaths happened actually because of these medicines or due to some other reasons.”
The sources said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/ Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.
A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Ltd is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.
"The company has manufactured and exported these products only to The Gambia so far," the source said. It is a practice that the importing country tests the products for quality before sanctioning their usage there.
As per the tentative results received by WHO, out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated.
It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.
