New Delhi, Oct 6 (UiTV/IANS) – After World Health Organization (WHO) on Wednesday issued an alert on four India-made cough and cold syrups ‘potentially linked with acute kidney injuries and 66 deaths among children in Gambia’, the Central Drugs Standard Control Organisation (CDSCO) has launched a probe to find out the fact with the products in the question.
“WHO has today issued a medical product alert for four contaminated medicines identified in Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children,” said WHO on Wednesday.
“The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is conducting further investigation with the company and regulatory authorities in India,” WHO had added further.
“The CDSCO has taken up the matter and ordered a detailed investigation against the cough and cold syrups produced and exported to The Gambia by Maiden Pharmaceuticals Limited,” said a source.
According to the source, the global health body has been requested to share at the earliest with CDSCO the report on the establishment of causal relation to death with the medical products in question.
Maiden Pharmaceuticals Limited is based in Haryana’s Sonepat and the CDSCO has launched detailed investigation to find out the fact about the products in the question in collaboration with State Drugs Controller, Haryana.
However, the preliminary enquiry has revealed that Maiden Pharmaceutical Limited is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products.
The WHO said that while the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommended all countries detect and remove these products from circulation to prevent further harm to patients.
CDSCO, DCGI and Haryana State Drugs Controller collect sample:
A team of the Central Drugs Standard Control Organisation (CDSCO), the Drug Controller General of India (DCGI) and Haryana State Drugs Controller have collected samples of four cough syrups manufactured by Sonepat-based Maiden Pharmaceuticals over their alleged links to the deaths of dozens of children in west Africa.
The government agencies sprung into action after the World Health Organisation (WHO) issued an alert regarding the cough syrups manufactured by Maiden Pharmaceuticals for their potential links to the deaths of 66 children in The Gambia.
Assistant State Drug Controller Manmohan Taneja told IANS that “a team of the CDSCO, the DCGI, and the State Drugs Controller, Haryana have collected the samples of the four cough syrups exported to The Gambia for investigation”.
The four products are Promethazine Oral Solution BP, Chlorphenamine Maleate, Phenylephrine HCI, Dextromethorphan HBR Syrup (Makoff Baby Cough Syrup), Pheniramine Maleate, Ammonium Chloride, Menthol Syrup (Kofexmalin Baby Cough Syrup), and Paracetamol Phenylephrine HCL & Chlorphenamine Maleate Syrup (MaGrip n Cold Syrup).
The samples have been sent to a Kolkata-based lab and the result of the tests is expected in the next few days, he said.
Meanwhile, sources said Maiden Pharmaceuticals has recalled its products for further investigation and waiting for the government’s directions to proceed further.
Sources also said during the preliminary enquiry revealed that Maiden Pharmaceutical is a manufacturer licensed by the state drug controller for the products under reference, and exported these products only to The Gambia.
The company has two directors — Naresh Kumar Goyal and Vivek Goyal – and two manufacturing plants, one based in Sonepat and the other in Panipat. Its corporate office is at Netaji Subhash Place, Pitampura, Delhi.