Cough syrup deaths: Govt says drugs not permitted for sale in India

India’s health ministry issued a statement, on the issue involving cough syrups by a local manufacturer that have been linked with the deaths of 66 kids in African country Gambia, and said that the manufacturer, Maiden Pharmaceuticals, holds manufacturing permission for these products for export only.

The four drugs, so far, have been sold only in Gambia and none of the syrups is sold domestically in India, the ministry said in a statement on October 6.

It said that the World Health Organization, on September 29, had informed the Drug Controller General of India that the agency was providing technical assistance and advice to Gambia, where children died and a contributing factor, was suspected to be the use of medicines that may have been contaminated with Diethylene glycol or Ethylene glycol.

The Centre said that the WHO claims to confirm the contamination in some of the samples through further analysis.

As per the government, the Central Drugs Standards Control Organisation took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical, Sonepat is located.

Further, a detailed investigation was launched to ascertain the facts and details in the matter in collaboration with State Drugs Controller, Haryana, the government said.

From the preliminary inquiry of CDSCO, it has been made out that the company 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 and holds manufacturing permission for these products for export only.

The company has manufactured and exported these products only to Gambia, the Centre clarified.

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, said the ministry.

As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, 4 samples have been found to contain DEG or Ethylene Glycol.

Also read I Cough syrups that killed Gambian kids not sold in India but spark questions on quality check

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

As a robust National Regulatory Authority, CDSCO has requested the WHO to share at the earliest the report on the establishment of causal relation to death with the medical products in question.

Maiden is not licensed for manufacture and sale in India, Centre said, adding that none of the four drugs is sold domestically in India.

The controlled samples of the same batch manufactured by the firm have now been taken and sent for testing to the regional drug testing lab, Chandigarh by the CDSCO.

Its results will decide the further course of action and bring clarity on the inputs received from the United Nations health agency, said the government.