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

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More than 50 cough syrup producers in India have failed quality tests mandated by the government due to concerns about the quality of medicines exported from the nation. According to a report provided by the state’s Central Drugs Standard Control Organisation (CDSCO), more than 120 of the 2,104 test reports produced by Indian pharmaceutical businesses failed to fulfil standard quality requirements, according to the Economic Times on Monday.

Extensive testing is underway after over 140 deaths in The Gambia, Uzbekistan, and Cameroon were connected to Indian-made cough syrups, jeopardising 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 implementation of the new rule.

Cough syrups made in India have come under scrutiny when the World Health Organisation (WHO) issued a notice in October 2022 regarding four brands of cough syrup made and sold by Indian drugmaker Maiden Pharmaceuticals to The Gambia in West Africa. At least 70 children have died from severe renal injury caused by cough and cold syrups.

According to the Economic Times, New Delhi raised the issue with the WHO, with the regulator, the Drug Controller General of India (DCGI), penning a “strongly worded letter” to the WHO, noting that all control samples of the items were determined to be in accordance with specifications.

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 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 which did not have a license to sell pharmaceutical products and only “dealt in industrial grade.”

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. Prior to that, the WHO had said that a sample picked up from Riemann-manufactured Naturcold syrup in Cameroon contained as much 28.6% of 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 have been issued notices after the reported deaths due to contaminated medicines. Out of them, 18 companies were asked to stop operations.