Pharmaceutical firm linked to children’s death in Gambia a repeat offender

Maiden Pharmaceuticals Limited, which has been in the eye of a storm after the World Health Organisation stated that four cough syrups made by it contained toxic chemicals, is a repeat offender. Both Kerala and Gujarat governments have repeatedly warned about the company’s substandard products since 2017.

The Haryana-based pharmaceutical company had manufactured and exported products to Gambia which have been held responsible for the death of 66 children in the West African country.

The WHO had said earlier this week that four of its products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – had unacceptable limits of diethylene glycol and ethylene glycol, which are toxic and lead to kidney injury.

“To date, these four products have been identified in Gambia, but may have been distributed, through informal markets, to other countries or regions. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” said Tedros Adhanom Ghebreyesus, WHO director-general.

The US Code of Federal Regulations state that there can just be 0.2 per cent of diethylene glycol in polyethylene glycol, when the latter is used as a food additive, but most countries do not allow for its use in food or drugs.  Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids, manufacture of polyester resins and polyurethanes, but are also used as a cheaper substitute in certain pharmaceutical products.

According to the eXtended Licensing, Laboratory and Legal Node (XLN) database maintained by the Government of India, Kerala drug authorities had found certain tablets manufactured by Maiden Pharmaceuticals Ltd (Metomin, Easpirin, Maical-D, Metoformin) to be of substandard quality five times in 2021 and 2022 and once in 2015.

In 2015, Gujarat drug authorities had reported that samples of Macipro were of substandard quality.

Metformin is used to treat type-2 diabetes, Maical D for vitamin D and calcium deficiency and Macipro for urinary tract infections and conjunctivitis.

In 2017, a judicial first class magistrate court in Kerala fined this company Rs 1,000 in a prosecution filed by a Drug Inspector in Kerala in 2005. Since 2018, there is a case in the court of the additional sessions judge in Sonipat, Haryana, between the Union government and Maiden Pharmaceuticals Ltd for offences relating to spurious drugs. The next hearing of this case is on October 18, 2022.

In 2011, Bihar government had blacklisted Maiden Pharmaceuticals Limited for the supply of substandard drugs.

Vietnam had blacklisted the company in 2014 for violation of Quality Control Regulation and Drug Regulation.

Activist T Prashant Reddy had obtained the list of all the 45 blacklisted companies through a Right to Information request and it was found that Maiden Pharmaceutical Limited was one of them.

Currently, the website of the company is not accessible. According to a report published by The Wire, it had claimed on its website that its manufacturing facility in Haryana’s Kundli district had been certified by the WHO as complying with ‘good manufacturing practices’ (GMP).

The company had also claimed that its plants in Panipat in Haryana and Solan in Himachal Pradesh were “WHO-GMP compliant”. However, WHO has refuted this claim.

There has been an advisory released from India’s Central Drugs Standard Control Organisation (CDSCO) or its parent organisation, the Drugs Controller General of India (DCGI). The Ministry of Health and Family Welfare, in a press release, stated that DCGI was informed on September 29, 2022 that WHO was currently providing technical assistance and advice to Gambia, where children have died as a result of the use of medicines manufactured by Maiden Pharmaceuticals Ltd.

“CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat is located. Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana,” said the Union Health ministry.

The State Drug Controller had given licenses to the company only for export of these four drugs – Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. “Further, all these four drugs manufactured only for exports by Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of Maiden Pharmaceuticals Ltd is sold domestically in India,” stated the Health Ministry.

Haryana state drug controller Manmohan Taneja said that they were currently only investigating the four cough syrups and the other violations may come up during investigations. CDSCO has taken samples of the syrups and of polypropylene glycol on October 3 for tests. They were taken from the same batch that WHO reported about.

National Herald reached out to DCGI chief VG Somani to check about the status of the investigation, but got no response. This article will be updated if and when he responds.