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Firm linked to cough syrup deaths was penalised in India, blacklisted in Vietnam

WHO raised concern about Maiden Pharmaceutical's alleged involvement in the death of 66 children in Gambia with its toxic cough syrups. (PTI)Premium
WHO raised concern about Maiden Pharmaceutical's alleged involvement in the death of 66 children in Gambia with its toxic cough syrups. (PTI)

Indian company, Maiden Pharmaceuticals recently came under the WHO scanner for its connection with the death of 66 children in the Gambia. However, the three decade-old company was also blacklisted for its products in Indian states like Bihar, Jammu and Kashmir, Gujarat, etc

Days after WHO issued alert against the Indian company, Maiden Pharmaceuticals for the potential link of its cough syrups in the death of 66 children in the Gambia, Indian authorities have also begun their investigation into the matter.

However, the All India Organisation of Chemists and Druggists has clarified that Maiden Pharmaceuticals are only licensed to export products, but not to sell them in India.

Established in 1990, the company has a massive global presence, especially in Africa, South America, and the Middle East. WHO has also raised concerns that the controversial product could have been present in other parts of the world as well.

The involvement of an international organisation in the matter has raised several questions on how India-based Maiden Pharmaceuticals' products were able to get certified to export medicines abroad. But it is not the first time when the company has been called out for its substandard products. A thorough investigation of the company’s past track records will reveal how Maiden Pharmaceuticals was taken into court and was even blacklisted for its substandard products in India.

Public Health Activist, Dinesh S Thakur shared several government documents and legal orders that throw light upon the history of legal actions against Maiden Pharmaceuticals. Following are the states where the company has faced actions for its substandard products.

Haryana: The company was prosecuted by a central government drug inspector for quality violations under the Drugs and Cosmetics Act in 2017. According to the document, the next hearing of the case will be held in Sonepat District Court on 28 October.

Kerala: Maiden Pharmaceuticals was fined in Kerala in 2017 in a case filed by the Drugs Inspector office of the Drugs Controller.

Gujarat: According to the Department of Health and Family Welfare, the company was called out for supplying its substandard medicine products in Gujarat and Kerala.

Bihar: In 2011, the Bihar government blacklisted two pharmaceutical companies for supplying low-quality medicines. The first one was Man pharmaceuticals limited and the other one was none other than Maiden Pharmaceuticals Limited. That time too, the company was blacklisted because of supplying spurious and substandard syrups and tablets.

Jammu and Kashmir: The recent case of Maiden Pharma’s poor quality medicines is of Jammu and Kashmir, where the authority blacklisted its Cyproheptadine Hydrochloride Syrup IP for its substandard quality. The syrup is used to treat allergies generally in kids.

Vietnam blacklisted Maiden Pharmaceuticals in 2014

Apart from Indian states, many of its products are blacklisted in some countries across the world. In 2014, the company faced actions from the Vietnam government for violating the Quality Control Regulations and Drug Regulations.

Despite being fined and even blacklisted by some Indian states and countries for its substandard products, Maiden Pharmaceuticals got certification by the Central Drugs Standard Control Organisation through the COPP process. COPP certificate is considered to be one of the most important certificates for pharmaceutical companies and is also made mandatory by the WHO. The COPP certificate is issued on behalf of DGCI only after getting clearance from Central Drugs Standard Control Organisation. Issuance of the COPP certificate to a company whose certain products are blacklisted by nearly three states raises questions about the process.

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