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RIGHT DOSAGE: Need for predictable, transparent drug regulation
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India isn’t in need of better drug safety policies, rather it needs a smarter way to enforce existing ones. The recent ban on certain paediatric fixed-dose combination cough syrups is a case in point. While the ban was well-intentioned, its implementation exposed a serious flaw in how we manage regulatory transitions — we fail to pair public health decisions with industry-based implementation.
The decision to ban these formulations for children under four was based on sound scientific advice. Expert bodies had flagged concerns such as sedation, cardiovascular effects, and overall unsuitability for young children. Protecting this vulnerable segment of the population is non-negotiable. But the way the ban was communicated, enforced, and supported left manufacturers, pharmacists, and healthcare providers scrambling for clarity.
Too often, India’s regulatory playbook relies on advisories, followed by binding restrictions without adequate notice, infrastructure, or clarity. In this case, the advisory issued months earlier did not create any sense of urgency in the industry. When the ban came into force, manufacturers, distributors, pharmacists, and prescribers were unsure of their responsibilities. This signals a hostile regulatory environment stemming from lack of communication.
The fractured relationship between industry and regulatory authorities led to judicial intervention to partially clarify the rules. A court ruling exempted pre-ban stock but mandated disclosures and public notices by the manufacturers. This offered some breathing space but did little to address the confusion at the retail and distribution levels. The Indian Pharmaceutical Association had to step in to seek guidance from the Drugs Controller General of India. Such ambiguity in what is one of the world’s largest pharmaceutical ecosystems erodes compliance and trust.
This is not just a governance issue but also an economic one. Paediatric medicines represent a significant share of India’s cold and cough remedy market, pegged at over ₹13,000 crore. A disruption like this, without clear planning, risks inventory loss, compliance violations, and uneven access to safe alternatives, especially in semi-urban and rural markets, where combination formulations are preferred for affordability and convenience.
In high-risk issues that pose direct harm to health and life, regulators should act immediately. However, for non-critical matters, stakeholder consultation is essential to avoid ambiguity. A rigorous ‘regulatory impact assessment’ must precede announcements, addressing questions like stock produced, in transit, and at retail points. This helps in determining the appropriate timelines for enforcement. For higher-risk cases, a stock recall mechanism should be in place. Given India’s diverse rural-urban geography, robust digital infrastructure is crucial.
Effective point-of-sale systems should flash circulars, notifications, and advisories to resolve information asymmetry. Smoother information flow from the regulator to the implementing party ensures better enforcement. Regulatory technology platforms can convert policy into action, tracking notifications in real time, alerting supply chain stakeholders, supporting stock recall or segregation, and offering role-specific guidance to ensure no actor is left in the dark when rules change.
India has made major strides in drug regulation — from faster approvals to stronger pharmacovigilance. But implementation still suffers from opacity and fragmentation. We need to move from an era of surprise circulars to one of predictable, transparent enforcement. Scientific decisions must be paired with implementation timelines, inventory management guidelines, and consistent messaging to all stakeholders.
(The writer is Chief Executive Officer and co-founder, Teamlease Regtech. Views are personal)
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Published on June 1, 2025
This article first appeared on The Hindu Business Line
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