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2022-10-09

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Science & Technology
www.thehindu.com

Exporters’ body Pharmexcil 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.

As the Council did not receive any input/report on the adverse events, from the firm, the membership of Maiden Pharmaceuticals is being suspended with immediate effect, Pharmaceuticals Export Promotion Council of India Director General Ravi Udaya Bhaskar said.

This means the firm will not be entitled to incentives available under the Centre’s Market Access initiative. Under the scheme, incentives up to Rs. 2 crore are extended to a company registering its product with a drug/health regulator abroad. Another benefit that will not be available is a Rs. 25-lakh one-time grant to MSMEs for implementing the pharmaceutical drug track-and-trace system, he said

Withdrawal of IEC?

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, the Council 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 would result in the company’s registration-cum-membership certificate getting suspended without further notice, it had said then, setting October 7 as the deadline.

The exporters’ body, under the Commerce Ministry, had also advised the firm to investigate reasons for the serious adverse events and update with findings.

“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... 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 had said in a statement on October 6.

There has been no update on the investigations by CDSCO since.

The company will now not be entitled to incentives under the Centre’s Market Access initiative


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