Pharma exporters body Pharmexcil has suspended the membership of Maiden Pharmaceuticals, the Delhi-based drugmaker facing a probe after the World Health Organization (WHO) red-flagged four products following the death of 66 children in the West African country The Gambia.
With the Council not receiving any input/report on the adverse events, from the company, the membership of Maiden Pharmaceuticals is being suspended with immediate effect, Pharmaceuticals Export Promotion Council of India Director General Ravi Udaya Bhaskar said.
Suspension of membership means the company will not be entitled to incentives made available by the government under its Market Access initiative. Under the scheme, incentives up to ₹2 crore are extended to a company registering their product with a drug/health regulator abroad. Another benefit the membership provide is a ₹25 lakh one time grant to the MSMEs for implementing the pharmaceutical drug track and trace system, he said.
Going forward, Pharmexcil may also recommend to the Directorate General of Foreign Trade to withdraw the import export code (IEC) of the company, thus making it ineligible to export, Mr. Bhaskar said.
On October 6, Pharmexcil had sought details of licensees and importers to whom the drugs were supplied as well as the manufacturing licence copies and product permissions of the products from Maiden. Failure to provide the information will result in the company’s registration cum membership certificate (RCMC) getting suspended without further notice, it had said setting October 7 deadline for the responses.
Additionally, the exporters body under the Union Commerce Ministry had advised the firm to investigate reasons of the serious adverse events and update with findings “at the earliest to take necessary further action.”
“From the preliminary enquiry of CDSCO, it has been made out that Maiden Pharmaceutical, 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,” Union Ministry of Health and Family Welfare said in a statement on October 6.
CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden is located. A detailed investigation was launched to ascertain facts/ details in the matter in collaboration with State Drugs Controller, Haryana, the Ministry had said.
The alert of WHO said the manufacturer has not provided guarantees to the global health body on the safety and quality of the 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,” WHO said.
There has been no update on the investigations by CDSCO since.