Samples sent for testing; further action after results: Health Ministry on cough syrups

Central Drugs Standard Control Organisation (CDSCO) has sent the samples of the same batch of the four Maiden Pharmaceuticals Ltd-manufactured medicines, on which the WHO issued an alert, for testing and further course of action will be decided after the results are received, the Union Health Ministry said on Thursday.

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

The ministry said that the WHO informed the DCGI, the national drug regulator of India, that it is currently providing technical assistance and advice to The 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 (in some of the samples it was claimed to have been confirmed by further analysis conducted by WHO) on September 29.

The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical Ltd, Sonepat is located. Further, a detailed investigation was launched to ascertain the facts/details in the matter in collaboration with State Drugs Controller, Haryana, said the ministry.

It added that from the preliminary inquiry of the CDSCO, it has been made out that Maiden Pharmaceuticals is a manufacturer licensed by the State Drug Controller for products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to The Gambia.

“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 ministry said.

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 Diethylene Glycol/ Ethylene Glycol. It has also been informed the WHO that the certificate of analysis will be made available to the WHO in near future and it will share it with the Indian regulator. The exact one-to-one causal relation of death has not yet been provided by the WHO to the CDSCO, the ministry added.

However, the CDSCO has requested the WHO to share at the earliest report on the establishment of causal relation to death with the medical products in question, etc.

“The State Drug Controller had given licenses to the said company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup. Further, all these four drugs are manufactured only for exports by M/s. Maiden Pharmaceuticals Limited is not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India,” the ministry said.