In India, regulatory oversight for pharmaceuticals needs to improve

In India, regulatory oversight for pharmaceuticals needs to improve

As part of an overarching attempt to restore confidence in India’s pharmaceutical supply chain after a series of deaths damaged the country’s reputation as a drug exporter, the government has required a doctor’s prescription for individuals to purchase syrup-based medicines. However, while it seems like a credible measure, it is also defensive rather than reformist. The Union Health Ministry has removed the term “syrup” from Schedule K of the Drugs Rules 1945, a change it had signalled when it issued the draft notification in December 2025, thus requiring cough syrups to be sold only with a prescription, through licensed pharmacies. These products were singled out after ethylene glycol (EG) and diethylene glycol (DEG) contamination in India-made cough syrups killed over 300 children across several countries since 2022. The WHO’s warnings in 2022 and 2023 also undermined assumptions that India’s export quality controls were effective and functioning independently. But beyond contamination, doctors have long raised concerns about how cough syrups are formulated and used. Many over-the-counter (OTC) cough syrups are ‘cocktails’ of bronchodilators, antihistamines, and decongestants, which can cause tremors and heart palpitations, extreme sedation or paradoxical agitation in infants, and blood pressure effects. The American Academy of Pediatrics has said that cough suppressants are quite ineffective for children under six years and may even be dangerous, as they can mask underlying conditions such as pneumonia or asthma. Yet, India’s entrenched OTC culture makes pharmacists de facto primary care providers in many rural and semi-urban areas.

Most importantly, however, the contamination was the result of failures in manufacturing quality control, testing of raw materials, and regulatory oversight rather than consumer access. Even now, requiring a prescription may reduce inappropriate use and push patients away from self-medication, but it could never prevent contaminated products from reaching the market in the first place. The fundamental issue is that the government continues to tolerate the pharmaceutical lobby’s argument that high-end testing requirements — for stronger quality control and ultimately better drugs — will bankrupt smaller manufacturers. Second, while the Indian Pharmacopoeia and the Pharmacopoeia Internationalis updated their analytical methods to detect EG/DEG following the deaths, failures in batch testing and enforcement persist. As a result, while India has around three dozen State drug controllers, they are chronically understaffed — so without a large increase in the inspectorate, the notification is likely to be ignored sans consequence in rural areas. In a globalised economy, subpar enforcement for medicines in even one country is dangerous; that is infinitely more so in a country aspiring to remain the world’s pharmacy.