Pharmexcil sought details after WHO names firm in medical product alert
Pharmexcil sought details after WHO names firm in medical product alert
Pharma exporter body Pharmexcil has suspended the membership of Delhi-based drug maker Maiden Pharmaceuticals after four products were red-flagged by the World Health Organization (WHO). After the death of 66 children In the West African country of The Gambia.
Ravi Uday Bhaskar, Director General, Indian Pharmaceuticals Export Promotion Council of India said that due to non-receipt of any input/report on adverse events from the company to the Council, the membership of Maiden Pharmaceuticals is being suspended with immediate effect.
The suspension of membership means that the Company will not be entitled to incentives provided by the Government under its Market Access Initiative. Under this scheme, an incentive of up to ₹2 crore is given to a company that registers its product with a drug/health regulator abroad. He said that another benefit of providing membership is a one-time grant of ₹25 lakh to MSMEs to implement the Pharmaceutical Drug Track and Trace System.
Going forward, Pharmexcil may also recommend to the Directorate General of Foreign Trade to withdraw the Import Export Code (IEC) of the company, making it ineligible for exports, Mr. Bhaskar said.
On 6 October, Pharmexsil had sought details of the licensees and importers to whom the drugs were supplied as well as manufacturing license copies of the products and product permissions from Madden. Failure to provide the information will result in suspension of the company’s Certificate of Registration cum Membership (RCMC) without any notice, it said, setting October 7 as the deadline for responses.
Additionally, the exporting body under the Union commerce ministry had advised the firm to examine the causes of serious adverse events and update it with the findings “to take necessary action at the earliest.”
“From the initial investigation of CDSCO, it has been revealed that Maiden Pharmaceutical, Sonipat, Haryana is the manufacturer licensed by the State Drug Controller for Promethazine Oral Solution BP, Cofexalnein Baby Cough Syrup, Macoff Baby Cough Syrup and Magrip N Cold products. Syrup Reference and holds manufacturing permission for these products for export only. The company has manufactured and exported these products to The Gambia only,” the Union Ministry of Health and Family Welfare said in a statement on October 6.
CDSCO immediately took up the matter with the Haryana State Regulatory Authority under whose jurisdiction the pharmaceutical manufacturing unit of Maiden is located. The Ministry had said that a detailed inquiry was initiated to ascertain the facts/details in the matter in collaboration with the State Drug Controller, Haryana.
The WHO alert states that the manufacturer has not made any guarantees to the global health body on the safety and quality of the products. “Laboratory analysis of samples from each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol,” the WHO said.
There has been no update on the investigation by CDSCO since then.