Kerala has become the first state in the country to temporarily stop the sale of drugs made by Haryana-based Maiden Pharmaceuticals after the World Health Organization (WHO) linked its cough syrups to the death of 66 children in The Gambia.
Though none of the four cough syrups flagged by the WHO are sold in India, several of the company's other products, many of which are used to treat children, are available in the country. The firm makes around 15 cough and cold products.
Also read: India vows action if cough syrup proved to be behind Gambia deaths
"We have ordered for a temporary halt of the sale of drugs manufactured by Maiden Pharmaceuticals," Kerala state drug controller PM Jayan told Moneycontrol on October 8.
The company, which has a manufacturing facility in Haryana's Sonepat, was yet to respond to Moneycontrol’s queries about the ban.
Jayan said the company would be allowed to sell drugs again only if the authorities get satisfactory results after running quality checks on the available stock of medicines.
Also read: Maiden Pharma’s factory wears a deserted look as its fate hangs in the balance
“Only after the government labs confirm the quality of the available drugs, the company would be permitted to continue the sale,” Jayan said.
Drug inspectors in Kerala have been instructed to draw samples from across the districts and send them for quality tests.
In 2021, the Kerala drug regulator reported substandard batches of medicine produced by Maiden Pharmaceuticals at least five times on India’s extended licensing, laboratory and legal node (XLN) database.
Even after they raised the issue, the drugs made by the pharma company continued to be substandard, the officials said. All the batches that failed the quality test were made in Haryana.
The Kerala health department officials drew samples of metformin, a drug used to treat type-2 diabetes, from a hospital in Palakkad in March 2022 and from a primary health centre in Ernakulam in September 2022.
Almost all the drugs reported on the XLN database either failed the dissolution test or were not compliant with IP standards.
The XLN database is used by state drug regulators for several functions including issuing licences, enforcement and laboratory management of drugs. The regulators can also flag substandard drugs on the portal for recall.
Repeat offender
On October 5, WHO Director-General Tedros Adhanom Ghebreyesus told the media, "WHO has today issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children. The loss of these young lives is beyond heartbreaking for their families. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India."
The findings followed tests on several syrups that were suspected of causing 66 child deaths in the West African country.
The four contaminated syrups identified by the WHO are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The firm produces syrups, capsules and tablets for both adults and children. Its website says it makes life-saving drugs, antibiotics and anti-allergics. It also makes drugs for cardiovascular diseases and diabetes.
Much before the death of children in The Gambia shone the spotlight on it, the company was banned in Vietnam in 2013.
Kerala, Bihar and Gujarat, too, had questioned the quality of the drugs manufactured by the firm. The company was blacklisted by Bihar government and barred from participating in tendering process in 2011 for supplying spurious drugs.
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