Samples of cough syrup collected, sent for verification: Haryana government after WHO warning

Chandigarh: Haryana’s government confirmed on Thursday that it has taken samples of cough syrup from Maiden Pharmaceuticals’ Sonepat plant and sent them to the Central Drug Laboratory in Kolkata for analysis following a WHO manufacturing warning. Haryana’s Health Minister Anil Vij announced this. He said that if samples do not meet the standards, strict measures will be taken against the company and its owners.

The state government took action after the WHO raised the alarm saying cough syrups manufactured by an Indian company may be linked to the deaths of children in The Gambia. The World Health Organization (WHO) warned on Wednesday that four “contaminated” and “substandard” cough syrups reportedly produced by Maiden Pharmaceuticals Limited, based in Haryana’s Sonepat, could be the reason for the deaths in the West African nation.

The Indian drug regulator Drugs Controller General of India (DCGI) has already launched an investigation and has asked WHO for more information. Vi said a senior official from the Centre’s Department of Pharmaceuticals spoke to Haryana’s Additional Chief Secretary (Health). Vij said the cough syrups manufactured by the pharmaceutical company have been approved for export. “It is not available for sale or marketing in the country.”

“Whatever action needs to be taken as soon as the CDL report comes in. Only when the report is in can we come to a conclusion,” said Vij. The Union Ministry of Health said the exact “one-to-one causation of death” has not been provided by the UN health organization, nor that details of labels and products have been shared by it with the Central Drugs Standard Control Organization. (CDSCO), allowing it to confirm the identity or source of manufacture of the products.

The ministry said in a statement on Sept. 29 that the WHO has informed DCGI that it is currently providing technical assistance and advice to the Gambia, where children have died and are suspected of using drugs that may have been contaminated with diethylene. glycol or ethylene glycol (in some of the samples this would have been confirmed by further analysis by the WHO).

The CDSCO immediately took the matter to the 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 establish the facts/details in the case in conjunction with the state drug controller, Haryana, the statement said.

CDSCO’s preliminary investigation has revealed that Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer under license from 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 has permission to manufacture these products for export only. The company has only produced and exported these products to The Gambia,” the statement said.

It is common for the importing country to test these imported products for quality parameters and satisfy itself with the quality of the products before the importing country decides to release such products for use in the country. According to the preliminary results received by the WHO, of the 23 samples of the products tested, four samples were found to contain diethylene glycol/ethylene glycol.

WHO has also announced that the Certificate of Analysis will be made available to WHO in the near future and that WHO will share it with the Indian regulatory body, which is yet to be done.

The exact one-to-one causal relationship of death has not yet been provided to CDSCO by WHO, the statement said. As a robust national regulatory authority, CDSCO has requested WHO to share with CDSCO at the earliest the report on establishing a causal relationship to death with the affected medical products etc.

The State Drug Controller had granted the said company licenses only for the export of these four drugs, namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Furthermore, all these 04 drugs are manufactured for export by M/s only. Maiden Pharmaceuticals Limited is not licensed for manufacture and sale in India. In fact, none of these four drugs are from M/s. Maiden Pharmaceuticals is sold in India.

“The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all four drugs in question) have been taken and sent by CDSCO for examination to the Regional Drug Testing Lab, Chandigarh, the results of which will serve as guidance take further steps and clarify the input received/received from WHO,” the statement said.

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