Probe begins after WHO issues alert for Made in India cough syrup

India's drug regulator, the Central Drugs Standard Control Organisation, has initiated a probe against Haryana-based Maiden Pharmaceutical Ltd. after the World Health Organization issued a 'global alert' over the deaths of 66 children in The Gambia due to India-made cough syrups.

The United Nations' public health agency had informed India's national drug regulator on September 29 that it is currently providing technical assistance and advice to Gambia, where children have died and where a contributing factor, is suspected to be the use of medicines which may have been contaminated with diethylene glycol or ethylene glycol.

"CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat is located," the Indian government says in a press note, adding that a detailed investigation was launched to ascertain the facts in the matter in collaboration with State Drugs Controller, Haryana.

From the preliminary enquiry of CDSCO, it has been made out that Maiden Pharmaceutical is a manufacturer licensed by the State Drug Controller for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup.

The drugmaker holds manufacturing permission for these products for export only, the government says, adding that these drugs are not sold domestically in India.

It is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country, the government further says.

As per the tentative results received by the WHO, out of the 23 samples of the products under reference which were tested, four samples have been found to contain diethylene glycol or ethylene glycol.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal .

"It has also been informed by WHO that the certificate of analysis will be made available to WHO in near future and WHO will share it with the Indian regulator which is yet to be done. The exact one to one causal relation of death has not yet been provided by WHO to CDSCO," the Centre says.

The drug regulator has requested the WHO to share the report on establishment of causal relation to death with the medical products in question at the earliest.

The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received from the WHO, the government adds.

While the pharma company has manufactured and exported these products only to the Gambia, the WHO warned that these four products may have been distributed, through informal markets, to other countries or regions as well.