The National Regulatory Authority, CDSCO - Central Drugs Standard Control Organisation - has requested World Health Organisation (WHO) to share at the earliest with it the report on the establishment of causal relation to death with the medical products -- India made cough syrups -- in question, etc, the government said.
Enquiry of CDSCO said that Maiden Pharma, Haryana, a manufacturer licensed by the State Drug Controller for products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup & MaGrip n Cold Syrup and has manufacturing permission of these products for export only, the government said.
As per the tentative results received by WHO, out of the 23 samples of these products which were tested, 4 samples were found to contain Diethylene Glycol/ Ethylene Glycol. The exact one-to-one causal relation of death has not yet been provided by WHO to CDSCO, it said.
The samples (controlled samples of the same batch manufactured by Maiden Pharma for all the four drugs in question) have also been sent for testing to the Regional Drug Testing Lab, Chandigarh, the government mentioned.
"We express deep pain and anguish on the tragic death of 66 children in Africa's Gambia. These deaths were attributed to the consumption of some cough syrups having an unacceptable amount of toxic elements," Dr Upendra Kinjawadekar President-elect, Indian Academy of Pediatrics (IAP) said.
"While the investigative agencies will look into the matter, we strongly feel that the safety & quality standards of the drugs can never be compromised & we offer our complete assistance to the drug licencing authorities in India in this regard," Kinjawadekar mentioned.
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