INDIA – The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has cautioned Maiden Pharmaceuticals of suspension of its certificate that validates it as an exporter authorized by the Indian government.

The drugmaker was named in a medical product alert by the World Health Organization following the death of 66 children in the Gambia.

In the wake of the ongoing WHO investigations into the alleged deaths caused by the syrup, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has suspended Maiden Pharma’s membership.

The suspension means that the company’s exports will become ineligible for incentives under the Market Access Initiative Scheme.

The suspension came after the council warned the firm of suspension of its authorization certificate if it failed to share details of its licensees and importers with Pharmexcil by October 7.

The council is not in receipt of any inputs/report on the adverse events and hereby state that the membership of Maiden Pharmaceuticals with Pharmexcil… is suspended with immediate effect,” the council said in a letter dated October 7, to the company.

According to sources, the Directorate General of Foreign Trade (DGFT) may withdraw the company’s import-export code (IEC) in the future.

Meanwhile, the Medicines Control Agency of Gambia has issued a notification to complete the recall of Maiden Pharma’s ‘contaminated and substandard’ products and quarantine all of the company’s products.

Implications of Pharmexcil membership suspension

For the time being, the suspension of Pharmexcil membership implies that Maiden Pharmaceuticals will not be eligible for any government incentives under the Market Access Initiative, according to Pharmexcil Director General Ravi Uday Bhaskar.

He also stated that a company can receive up to Rs 2 crore (US$0.24 million) in incentives for registering their product with a health regulator in another country, and MSMEs can receive a Rs 25 lakh (US$ 0.3 million) one-time grant for implementing the pharmaceutical drug track and trace system.

Pharmexcil had requested information on drug importers (cough syrups that are linked to deaths). It had set an October 7 deadline for receiving information, after which the company’s registration cum membership certificate (RCMC) would be suspended.

Bhaskar also stated that in the future, the export promotion council may recommend the withdrawal of the IEC to the DGFT, which could halt all of this firm’s exports.

Multiple government sources from various departments stated that India is taking this seriously and that if proven, exemplary action would be taken against the company, which could include revoking its export license or penal action against the promoters.

Business Standard reports that the Health Ministry is awaiting the results of the laboratory tests on the samples before deciding on the next course of action.

According to Maiden Pharma, government officials visited the facility last week.

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 the Gambia on October 5.

Goyal said that government officials from the Central Drugs Standards Control Organization (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 the company directors.

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

From the preliminary inquiry 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.

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