The cough and cold syrups manufactured by Haryana-based Maiden Pharmaceuticals, suspected to be the cause of deaths of 66 children in The Gambia, were not sold in India, the Union Health Ministry has clarified.
In a press release, the ministry said that the four syrups -- Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup -- were manufactured only for exports and not licensed for sale in India. The concerned drugs have been exported only to Gambia, it added.
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The government today sent samples of cough syrups for testing by the Drugs Controller General of India (DCGI) and said that its results will guide further course of action.
The World Health Organisation (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
India's drug regulator Drugs Controller General of India (DCGI) has already initiated a probe and sought further details from the WHO.
Haryana's Health Minister Anil Vij on Thursday said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination.
He said the cough syrups manufactured by the pharma company were approved for export. "It is not available for sale or marketing in the country."
The Union Health Ministry said the exact "one-to-one causal relation of death" has neither been provided by the UN health agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
The ministry in a statement said on September 29 that WHO informed DCGI 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 (in some of the samples it was claimed to have been confirmed by further analysis conducted by WHO).
The 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.
Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana, the statement said.
"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 Gambia," the statement said.
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, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol.
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 statement said.
As a robust National Regulatory Authority, CDSCO has requested WHO to share at the earliest with CDSCO the report on 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 04 drugs manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are 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 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/ to be received from WHO," the statement said.
(With inputs from agencies)
