New Delhi: The Ministry of Health in India Thursday said that the cough syrups linked by the World Health Organization (WHO) to the deaths of dozens of children in The Gambia were not sold in India and were only for exports.
The Health Ministry also said that the 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 alert, for testing and further course of action will be decided after the results are received.
"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 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 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 enquiry 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", the ministry 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," 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 by 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 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", the ministry said.
"Further all these four 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," it added.
The WHO had on Wednesday said while the four products in question have been identified in The Gambia, it apprehended that they may have been distributed, through informal markets, to other countries or regions, and it "is important to detect and remove these substandard products from circulation to prevent harm to patients".
WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised, the alert said.
It underlined that all medical products must be approved and obtained from authorised/licensed suppliers, the products' authenticity and physical condition should be carefully checked, and advice taken from a healthcare professional when in doubt.
"If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre," the alert said.
"National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country," it added.
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