EDITORIAL: The report that about one-fifth of generic medicines’ samples tested by researchers at the University of Notre Dame failed quality control tests is deeply troubling — all the more so given an increasing public reliance on generic drugs for affordable healthcare.
Adding a further layer of concern is the finding that 16 of the 17 manufactures investigated are based in India, which plays a dominant role in global pharmaceutical supply chain.
Often described as “pharmacy of the world” the country produces approximately 20 percent of the generic medicines, exporting them to more than 100 countries. A vast majority of them are low and middle income ones, including Pakistan, raising red flags about the quality of medications being consumed.
The drugs in questions, reveals the present report, form the backbone of treatment plans for numerous common cancers — including breast, ovarian and leukaemia. Some of them contained so little of their key ingredients that giving them to patients would be as good as doing nothing; other drugs in this category were composed of excessive active ingredients that put patients at risk of severe organ damage, even death.
These findings suggest cost-efficiency is prioritised at the expense of quality assurance and regulatory compliance, and call into question reliability of existing regulatory frameworks both in the exporting and importing countries. In India, while there are regulations in place under the Central Drugs Standard Control Organisation, enforcement has been inconsistent, if not shoddy.
Consequently, quality control lapses have plagued the sector for years. In 2023, Indian-made cough syrups made the news for causing death of at least 70 children in Gambia and many more in Cameroon and Uzbekistan. In August of last year, more than 50 drugs on the market, including some anti-acids and paracetamol, turned out to be substandard or fake.
Much before that in 2013, Indian manufacturer Ranbaxy paid a fine of US$ 500 million after its US subsidiary pleaded guilty to improper manufacturing, storing and testing of drugs. These examples plus the research findings of University of Notre Dame underscore the need for regulatory review and response from Pakistan.
Our health authorities, particularly the Drug Regulatory Authority of Pakistan (DRAP), must ramp up their quality assurance mechanisms, including more rigorous testing of imported drugs and reassessing licensing agreements with suspect companies.
As regards the broader issue of accountability and transparency, those involved in producing substandard medicines must be made to face meaningful consequences, such as bans, fines and blacklisting from markets. While affordable medicines are crucial, they must not come at the cost of safety and efficacy; patients everywhere deserve better than to be exposed to life-threatening risks from bad medications. Governments and regulators need to act decisively to certify that each medicine contains everything that is stated on its label.
Copyright Business Recorder, 2025
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