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India falls short of global norms for pharmacist-supervised OTC (over the counter) drug dispensing, as these medicines are frequently sold without the involvement of a qualified, registered pharmacist. In many developed and emerging healthcare systems, pharmacist supervision is a regulatory requirement to ensure appropriate medicine selection, prevent misuse, manage drug interactions, and enhance patient safety.
The absence of such structured oversight in India, not only increases the risk of irrational drug use and adverse events but also highlights a critical gap in aligning OTC drug dispensing practices with internationally accepted regulatory standards, said Dr Premnath Shenoy, former director, regulatory affairs & patient safety, AstraZeneca, and Central Council Member, Indian Pharmaceutical Association, Mumbai.
OTC drugs are a cornerstone of modern healthcare systems. They empower consumers to manage minor ailments such as headaches, allergies, coughs, and colds without the need for a doctor’s prescription. Globally, regulators like the US FDA and the EMA have established clear frameworks for OTC medicines, emphasizing safety, efficacy, and consumer education. Yet in India, policy makers, as reflected in the 92nd Drugs Technical Advisory Board (DTAB) meeting minutes, are considering defining OTC drugs simply as those that do not require the supervision of a registered pharmacist. This interpretation diverges sharply from international norms and raises important questions about accessibility, safety, and the future of pharmacy practice in India, he added.
Worldwide, OTC drugs are regulated under a few common principles. These are based on safety & efficacy and only medicines with a proven safety record are classified as OTC. Clear labelling on packaging must provide detailed instructions and warnings. In many countries, pharmacists act as gatekeepers, advising consumers and preventing misuse. However, in India, policy makers appear to be looking through a different lens, pointed out Dr Shenoy.
The DTAB discussions suggest defining OTC drugs as those not requiring pharmacist supervision. It is based on accessibility, expanding self-care options in rural areas with limited healthcare infrastructure. There is an element of cost saving by reducing dependence on pharmacists or doctors to lower healthcare costs. However, viewing OTC expansion it is a market growth opportunity for India’s pharmaceutical industry, he said.
By focusing only on the absence of pharmacist supervision, India overlooks the global emphasis on structured regulation, labelling, and consumer education. Without pharmacist guidance, misuse could lead to overdoses or harmful drug interactions. It unfolds safety risks and antibiotic misuse. A weak OTC framework could worsen the problem, Dr Shenoy told Pharmabiz.
In addition, literacy and health education levels vary widely, making reliance on label instructions alone problematic. Without clear categorization of between safe OTC drugs and prescription medicines, consumers may struggle to distinguish. Therefore, India’s policy makers need to correct their course of action and align with global best practices, said Dr Shenoy.
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