CDSCO requests WHO for report linking medical products by Haryana-based firm to deaths
New Delhi, October 6: National Regulatory Authority, Central Drugs Standard Control Organisation (CDSCO) has requested the World Health Organization (WHO) to share the report that established the "causal relation to death" with the medical products manufactured by a Haryana-based company, Maiden Pharmaceutical Limited, according to the press release.
This comes after WHO issued an alert about four cough and cold syrups developed in India that are used in paediatric patients. The Central Drugs Standard Control Organization (CDSCO) launched an immediate investigation into this matter. The certificate of analysis will be made available to WHO in the near future, and it will be shared with the Indian regulator, which is yet to be done. WHO has yet to provide CDSCO with the exact one-to-one causal relation of death.
"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 stated.
According to CDSCO, Maiden Pharmaceutical Limited is authorised to manufacture 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 added.
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The State Drug Controller had only granted the company licences to export four drugs: Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup.
Furthermore, Maiden Pharmaceuticals Limited does not have a licence to manufacture or sell any of these four drugs in India. In effect, none of Maiden Pharmaceuticals' four medications is sold in India, it claimed.
WHO informed DCGI, India's National Drug Regulator, on September 29 that WHO is now providing technical assistance and advice to The Gambia, where children have died.
CDSCO immediately notified the Haryana State Regulatory Authority, which has jurisdiction over Maiden Pharmaceutical Limited's Sonepat drug manufacturing unit.
In addition, a thorough investigation was conducted in collaboration with the State Drugs Controller of Haryana to ascertain the facts/details of the case.
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-PTC News
