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New Delhi: After Indian-made cough syrups killed 66 children in the West African nation of Gambia last week, the Haryana government has ordered the Sonipat-based manufacturer of the medicines, Maiden Pharmaceuticals Limited, to stop production, news agency ANI reported.
As The Wire had reported on October 5, World Health Organisation (WHO) director-general Tedros Adhanom Ghebreyesus, while addressing a press conference, had linked the cough syrups to the deaths of the children and had said that the international health body would be conducting inquiries into both the manufacturer and Indian drug regulators.
The WHO issued a medical product alert and advised all countries to remove these products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – from their markets, pitching for increased surveillance within the supply chains of countries and regions likely to be affected by these products.
According to the ANI report, Haryana health minister Anil Vij said that a joint inspection by Haryana’s Food and Drug Administration (FDA) and the Union government’s drug regulator, the Central Drug Standard Control Organisation (CDSCO), found 12 violations at Maiden Pharmaceuticals’s manufacturing facility and as such, issued a notice to the company to shut down operations.
The state health minister also said that samples of the drugs from Maiden Pharmaceuticals’s facility have been sent to the Central Drug Laboratory in Kolkata for testing and the results of the same are still awaited.
The order, which led to the suspension of activities at the plant of Maiden Pharmaceuticals, says that the firm was grossly violating the rules prescribed under the Drugs and Cosmetics Act. “It is observed that the firm has been manufacturing and testing drugs without adhering to and in contravention to the various GMP (good manufacturing practises) requirement,” the order read.
It also said that Maiden had not maintained complete records of manufacturing and testing. “Various documents were examined by the investigating team which clearly indicates that the firm is not meeting the requirements of Drug Rules, 1945 across its manufacturing and testing activities,” the order said.
Meanwhile, India’s health ministry on Wednesday constituted a four-member committee to look into the matter. It includes two scientists from the Indian Council of Medical Research (ICMR) – one from the National Institute of Virology and the other the head of the epidemiology division of ICMR, a joint drug controller from the Central Drugs Standards Control Organisation and the vice chairperson of the standing national committee on medicines.
A statement from the ministry said, “The committee will, after examining and analysing adverse events reports, causal relationship and all related details shared by/to be shared by the WHO, suitably advise the drugs controller general of India about future course of action.”
The statement also said the WHO has already shared the ‘certificate of analysis’ of the products the latter had tested and the summary of adverse events. However, the statement did not provide any details and repeated that the ministry was waiting for documents from the WHO that would establish a causal relationship with deaths.
Meanwhile, the Gambian police force has said that out of 50,000 bottles supplied to the country of the four cough syrups, 8,538 bottles still remain unaccounted for. The statement, which was shared via the agency’s Facebook page, said that a firm named Atlantic Pharmaceuticals Company Limited had imported the said products. The statement has not specified anything more about the company.
“Investigations so far revealed that Atlantic Pharmaceuticals Company Limited ordered a quantity of 15,000 bottles of Makoff Baby Cough syrups of 100ml, 15,000 bottles of Magrip and Cold Syrups of 100ml, 10,000 bottles of Promethazine Baby Syrups of 100ml and 10,000 Kofexmalin baby cough syrups of 125ml,” the statement read.
What did Haryana report say?
The four products were reported to the WHO by the Gambian authorities in September 2022 and subsequent laboratory analysis found the products contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.
While polyethylene glycol is a food additive used in cough syrups, diethylene glycol and ethylene glycol are chemicals which, when metabolised by the human body, can cause severe kidney and liver damage and can prove fatal.
The two potentially fatal compounds are sometimes mixed with polyethylene glycol to cut costs, which raises two concerns – that Maiden Pharmaceuticals did not conduct adequate testing of its products and that it sourced raw materials for them from unlicensed vendors.
These concerns are in line with what Haryana’s drug regulator found during inspections of the manufacturing plant which, according to the ANI report, found that Maiden Pharmaceuticals “failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question”.
“The firm has not produced process validation and analytical method validation for the drug products in question,” the state regulator had reportedly written in a show-cause notice. It also said that it did not test for diethylene glycol and ethylene glycol.
Additionally, the notice stated that the manufacturer did not provide the batch numbers of three raw materials used in the products – propylene glycol, sorbitol solution and sodium methyl paraben.
The Wire had also reported on the chequered history of Maiden Pharmaceuticals, which includes having lied about having a ‘WHO-certified’ manufacturing facility in Haryana’s Kundli as well as having two other facilities which comply with the UN health body’s ‘Good Manufacturing Practices’ (GMP).
Note: This article was first published at 2:53 pm on October 12, 2022 and was updated at 9:40 pm on the same day.