Maiden Pharma may lose import-export code over cough syrup deaths in Gambia

As the controversy surrounding the deaths of 66 children in Gambia being linked to India manufactured cough syrups by Delhi-based Maiden Pharmaceuticals, the Pharmaceutical Exports Promotion Council (Pharmexcil) has suspended the membership of the firm.

Going forward, the import-export code (IEC) of the company may also be withdrawn by the Directorate General of Foreign Trade (DGFT), sources said. Meanwhile, the Medicines Control Agency of Gambia has issued a notification to complete the recall of the ‘contaminated and substandard’ products of Maiden Pharma and quarantine all products of the company.

For now, the suspension of membership of Pharmexcil implies that Maiden Pharmaceuticals will not be entitled to receive any incentives under the Market Access Initiative of the government, Pharmexcil director general Ravi Uday Bhaskar said. He added that incentives up to Rs two crore are extended to a company registering their product with a health regulator abroad, and a Rs 25 lakh one-time grant is also given to MSMEs for implementing the pharmaceutical drug track and trace system.

Pharmexcil had sought information about importers to whom the drugs (cough syrups that are linked to deaths). It had set a deadline of October 7, beyond which failure to receive information would lead to the company’s registration cum membership certificate (RCMC) getting suspended. Bhaskar added that going forward; the export promotion council may also recommend withdrawal of the IEC to the DGFT, which can stop all exports of this firm.

Multiple government sources across departments indicated that India is indeed looking at this seriously, and if proven, exemplary action would be taken against the company, that could include revoking its exports license or penal action against the promoters.

Sources in the Health Ministry indicated that they are awaiting the laboratory test reports of the samples, before they can decide on the future course of action.

Maiden Pharma says govt officials visited facility last week.

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In a statement, Vivek Goyal, director of Maiden Pharma said that they were ‘shocked to hear media reports regarding the deaths’, and that they received official information from their agent in Gambia on October 5.

The company has posted a notification by the Medicines Control Agency of Gambia which has asked to complete the recall of substandard and contaminated products of Maiden Pharma and quarantine all products.

Claiming that they have an ISO 9001:2000 and WHO GMP certificate, Maiden Pharma website says that “At any cost don’t compromise on Quality”. The company’s factory premises are non functional at the moment.

“All products manufactured in our plants are equivalent to International Quality Standards & GMP norms are followed at each manufacturing step. Production is done under a highly controlled, fully air-conditioned in a hygienic environment,” the company website claims.

Goyal said that government officials from the Central Drugs Standards Control Organisation (CDSCO) visited their facilities on October 1, October 3, October 6 and October 7 and samples were withdrawn by the CDSCO along with all relevant documents in the presence of company directors.

On September 29, the WHO informed the DCGI about the deaths in Gambia and suspected links with Maiden Pharma.

“The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical, Sonepat, is located,” the Union Health Ministry said on Thursday.

From the preliminary enquiry by the CDSCO, it had been found that Maiden Pharma is a manufacturer licensed by the state drug controller for products such as Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup, it said.