CDSCO requests WHO for report that establishes link of medical products by Haryana-based company to deaths

New Delhi [India], October 6 : National Regulatory Authority, CDSCO has requested the World Health Organization (WHO) to share the report on the establishment of "causal relation to death" with the medical products manufactured by a Haryana-based company, Maiden Pharmaceutical Limited, a press release said.
This comes after the World Health Organization (WHO) issued an alert on four India-made cough and cold syrups used for paediatric groups. Central Drugs Standard Control Organisation (CDSCO) took up an urgent investigation in this regard.
WHO informed that the certificate of analysis will be made available to WHO in near future and it will be shared 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.
"As a robust National Regulatory Authority, CDSCO has requested WHO to share at the earliest with CDSCO the report on the establishment of causal relation to death with the medical products in question etc," it added.
CDSCO said that Maiden Pharmaceutical Limited holds manufacturing permission for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup for "export only."
"From the preliminary enquiry of CDSCO, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana 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 under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to The Gambia," the press release said.
The State Drug Controller had given licenses to the said Company only for exporting these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup.
Further, all these 4 drugs manufactured only for exports by Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of Maiden Pharmaceuticals is sold domestically in India, it added.
WHO on September 29 informed DCGI, the National Drug Regulator of India, that WHO is currently providing technical assistance and advice to The Gambia, where children have died.
World Health Organization expressed that 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), the press release added.
CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical Limited, Sonepat is located.
Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana.
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.
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.
The samples (controlled samples of the same batch manufactured by Maiden Pharmaceuticals Limited for all 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 a further course of action as well as bring clarity on the inputs received from WHO.