Over 50 Indian cough-syrup makers fail quality test – report

New Delhi has ordered testing of medicines destined for export after a link to a spate of child deaths in Central Asia and Africa

More than 50 cough syrup manufacturers in India have failed quality tests that were made mandatory by the government due to concerns over the quality of medicines the country exports. According to a report released by the state’s Central Drugs Standard Control Organisation (CDSCO), out of 2,104 test reports filed by Indian pharmaceutical companies, over 120 failed to meet standard quality requirements, as the Economic Times reported on Monday.

Extensive testing is being carried out after over 140 deaths in The Gambia, Uzbekistan, and Cameroon came to be linked to Indian-made cough syrups, hindering the reputation of the country’s $41-billion pharmaceutical industry. 

In response, the Indian government in May made it mandatory for cough syrup manufacturers to get their products tested at government labs before export. The Ministry of Health and Family Welfare is collaborating with state governments and exporters to ensure the implementation of the new rule.

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Cough syrups manufactured in India have been under scrutiny after the  World Health Organization (WHO) issued an alert in October 2022 over four brands of cough syrup manufactured and exported by Indian drug maker Maiden Pharmaceuticals to The Gambia in West Africa. At least 70 children have died there from acute kidney injury that could be linked to cough and cold syrups.

New Delhi took up the issue with the WHO, with the regulator, the Drug Controller General of India (DCGI), writing a “strongly worded letter” to the WHO, stating that all control samples of the products have been found to be in compliance with specifications, Economic Times reported. The report claimed the statement issued by the WHO on The Gambia case was based on “an assumption that has yet not been substantiated by the WHO or its partners on [the]ground.” 

Meanwhile, The Gambia recalled multiple cough and cold medications and banned all Maiden Pharmaceuticals’ products. In October, the country’s high court opened legal proceedings over the deaths, and about $230,000 per child is being sought in compensation.

A similar case came to light in December last year in Uzbekistan, where the health ministry linked the death of dozens of children to the consumption of cough syrup manufactured by Marion Biotech of Noida in the northern state of Uttar Pradesh. Earlier this year, Reuters reported that Marion had allegedly bought a chemical for its syrup – propylene glycol – from a Delhi-based trader that did not have a license to sell pharmaceutical products and only “dealt in industrial grade.”

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In August, New Delhi ordered Riemann Labs in Madhya Pradesh state to cease operations following allegations that its cough syrup was linked to the death of at least six children in Cameroon in March 2023. Before that, the WHO had said that a sample picked up from Riemann-manufactured Naturcold syrup in Cameroon contained as much as 28.6% toxic diethylene glycol, compared with an acceptable limit of no more than 0.10%.

India is the largest supplier of generic drugs in the world, with an estimated 3,000 drug companies and around 10,500 manufacturing units, exporting cough syrups worth $17.6 billion in 2022-23 alone, according to news agency PTI. In June this year, Health Minister Mansukh Mandaviya told the agency that 71 companies had been issued notices after the reported deaths due to contaminated medicines. Out of them, 18 companies were asked to stop operations.

The minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country. “We are the pharmacy of the world and we want to assure everyone that we are the ‘quality pharmacy of the world,’” Mandaviya explained.