HEADLINES around the world recently reported the deaths of at least 20 children under the age of six in India. Their young kidneys had failed after the children consumed cough syrup containing high levels of a toxic chemical. The images of parents carrying the limp bodies of their children, who were killed instead of healed by the medicine, were heartbreaking. These headlines and images could easily have come from Pakistan.

Pakistan has been fortunate to have avoided a healthcare-related tragedy of this scale in recent months, but the risks are real and persistent. We had a massive number of deaths — over 200 — from contaminated cardiac medicines in Punjab, and thousands of children have been infected with HIV in Sindh from contaminated syringes and drips.

The situation in India must propel us towards action on strengthening our drug regulatory system, as it demonstrates that the cost of inaction is high for everyone. We know that patients suffer when unsafe medicines reach the market. But weak regulation also hurts doctors, pharmaceutical companies and regulatory bodies.

In India, the doctor who prescribed the contaminated syrup has been arrested. This shows that doctors can easily get caught in a web of legal and ethical scrutiny, even if they are unaware of the quality issues with the medicines they are using. There is growing public awareness and concern about doctors prioritising kickbacks from pharmaceutical companies over medicine quality. A large study found that app­roximately 40 per cent of doctors in Karachi agreed to receive payments or other gifts in return for prescribing medicines from a fake pharmaceutical company without checking the company’s registration, manufacturing standards, or medicine quality.

Progress on strengthening our health regulators must be fast-tracked.

Pharmaceutical companies, too, have much to lose. News of harm to patients from a single poor quality product can tarnish the reputation of the entire industry. With the Pakistani industry looking to export medicines, a story of deaths from unsafe medicine would be a huge blow to the confidence that Pakistanis are safe.

Finally, we should learn from the impact on the global reputation of India’s drug regulator. The WHO has raised “deep concern” over gaps in India’s drug regulations. Previous issues in drug regulation in India have led to a book with a shaming title: The Truth Pill: The Myth of Drug Regulation in India. The Drug Regulatory Authority of Pakistan has been working to strengthen the regulation of medicine quality, with a series of recently reported actions. But small positive steps by Drap will quickly be forgotten if there is a similar cluster of deaths from unsafe medicines in Pakistan. We are sitting on a time bomb and we need to accelerate progress on strengthening our health regulators.

It is not a simple task, but it is an essential one. To start, there must be regular and transparent assessments of how well our health regulators — such as Drap, the Pakistan Medical and Dental Council and the provincial healthcare commissions — are functioning. What actions have they taken each year to protect patients? Are they adequately resourced to do so? How should they be supported to function better? We simply do not know. The WHO has provided a ‘Global Benchmarking Tool’ for drug regulators and Drap should use that to formulate an institutional development strategy rooted in identified stre­ngths and areas for improvement.

The unfortunate reality is that many of these institutions are often under-resourced and inappropriately staffed due to political appointments or interference. When technical expertise is rep­l­aced with patr­o­nage, the conseq­ue­n­c­­es are gr­­a­­ve. In­­suf­fic­ient hu­­m­­an and other resou­r­ces results in weak implem­entation. In Pak­istan and India, we know that inspections are irregular, and regulators tend to act only after a crisis occurs rather than con­­­duct regular compliance checks — whi­ch should be at the core of their mandate.

Compounding this is the near absence of reliable health data systems for regulators to use for monitoring. Pakistan urgently needs electronic prescription records and systems to monitor drug reactions. Without these, widespread unsafe prescribing practices and poor quality medicines will continue.

The problem is not only weak oversight of pharmaceutical products. Our entire system of health regulation needs to be strengthened to ensure the safety and quality of the care we receive. Regulators must be empowered to act independently, insulated from political and commercial pressures, and then held to account. The recent tragedy in India should serve as a wake-up call. If we do not act now, the next set of headlines about deaths from healthcare could be about Pakistan.

The writer is a health policy and systems-strengthening expert and professor at the London School of Hygiene and Tropical Medicine, UK.

Published in Dawn, November 6th, 2025