The Pharmaceutical Exports Promotion Council (Pharmexcil) has suspended Maiden Pharmaceuticals' membership in light of the controversy surrounding the connection between the cough syrups made in India and the deaths of 66 children in the Gambia. Maiden Pharmaceuticals is based in Delhi.
According to sources, the Directorate General of Foreign Trade (DGFT) may eventually withdraw the company's import-export code (IEC). To complete the recall of Maiden Pharma's "contaminated and substandard" products and place all of the company's products under quarantine, the Medicines Control Agency of Gambia has issued a notification.
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According to Pharmexcil director general Ravi Uday Bhaskar, the suspension of membership implies that Maiden Pharmaceuticals will not be eligible to receive any incentives under the government's Market Access Initiative for the time being. He added that companies can receive incentives of up to Rs 2 crore for registering their products with foreign health regulators, and MSMEs can also receive a one-time grant of Rs 25 lakh for putting the pharmaceutical drug track and trace system in place.
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 continued by saying that going forward, the export promotion council might also advise the DGFT to revoke the IEC, which would halt all exports from this company.
A number of government sources from various departments claimed that India is indeed taking this seriously and that, if it is, the company will face stiff penalties, including the revocation of its export licence.
The laboratory test results of the samples, according to sources in the Health Ministry, are required before they can decide on the best course of action.
Authorities reportedly visited the facility last week, according to Maiden Pharma.
In a statement, Maiden Pharma's director Vivek Goyal stated that the company was "shocked to hear media reports regarding the deaths" and that on October 5, their agent in the Gambia provided them with official information.
The company has posted a notice from the Medicines Control Agency of Gambia asking that all products be quarantined and Maiden Pharma's faulty and contaminated products be fully recalled.
On their website, Maiden Pharma asserts that they have an ISO 9001:2000 and WHO GMP certificate and that they "At any cost don't compromise on Quality." The company's factory space is currently not operational.
“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 claimed that on October 1, October 3, October 6, and October 7, government representatives from the Central Drugs Standards Control Organisation (CDSCO) visited their facilities. In the presence of the company directors, the CDSCO took samples and all pertinent documents.
The WHO notified the DCGI on September 29 about the deaths in the Gambia and any potential associations 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.
