Probe reasons for serious adverse events, Pharmexcil tells Maiden Pharma

The incident is a serious dent for Indian pharma industry and exports, says Director-General

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) on Thursday put on watch Maiden Pharmaceuticals, the drugmaker named in a medical product alert by the World Health Organization (WHO) following acute kidney injury and death of 66 children in the west African country the Gambia.

Citing the WHO communication that mentions the firm as manufacturer of four cold and cough syrup formulations potentially linked to the damage and deaths, the exporters body under the Union Commerce Ministry asked Maiden to share details of the licensees and importers to whom the drugs were supplied as well as manufacturing licence copies and product permissions.

“You are advised to investigate reasons for the serious adverse events and update us with your findings at the earliest to take necessary further action,” Pharmexcil said. Failure to provide the information sought by October 7 will result in the company’s registration-cum-membership certificate (RCMC) being suspended without further notice, it said. Maiden has its corporate office in Delhi and manufacturing facilities in Haryana.

“As far as WHO is concerned our manufacturer is involved... it is very serious,” Pharmexcil Director-General Ravi Udaya Bhaskar said, describing the incident as a serious dent for Indian pharma industry and exports. “CDSCO [Central Drugs Standard Control Organisation] and Haryana State Drugs Controller need to quicken the process of investigation... send a message to the world they are alert and working on it,” he said.

“Only their investigation can throw light on how much quantities the company manufactured and exported. Whether the products were exported to the Gambia or other countries too? Are the products also available in domestic market and if so in the same combination,” he said.

Stressing the need for a thorough investigation and punishing those guilty, Mr. Bhaskar said the government and the CDSCO need to develop confidence among international regulators by sending a strong message that we are very stringent in taking action against such people.

In its communication, the WHO said: “The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited [Haryana, India]. To date, the stated manufacturer has not provided guarantees to the WHO on the safety and quality of these products. Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”