India’s drug detox: Digital update, regulator upgrade

On Nov 20, 2023

Express View: Use of IT-enabled solutions should be accompanied by enhancement of capacity of regulators

India has among the toughest laws against spurious drugs. However, a robust regulatory mechanism also requires an effective system for monitoring manufacturing and sales units.

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In recent years, adverse reports on Indian generics have led to questions being asked of the regulatory procedures governing the pharma industry. At least seven Indian-made cough syrups have been flagged as substandard by the WHO. The US FDA, too, has raised serious concerns. The country’s policymaking has been slow to respond to these charges. It has either resorted to piecemeal solutions or denied allegations of regulatory failure. In August, the government belatedly directed medicine manufacturers to follow WHO standards. It has now followed up this move by setting up a team to develop a portal that will enable tracking of drug-making processes. Medicine manufacturers will be required to feed in details of raw materials and distributors will need to upload their invoices on this platform. The site will also contain information about spurious and poor-quality drugs unearthed by inspectors — this could help tackle the problem posed by the movement of substandard medicines across state borders. The platform will also track court cases related to the pharma industry.

Studies have shown that pharma majors outsource production to small units which often escape the regulatory radar. State regulatory bodies find it difficult to track down supply chains of firms that comprise fly-by-night operators. While adulteration gets belated attention at times, experts believe that a more intractable problem is that of substandard drugs that delay or compromise treatment. By all accounts, a large section of physicians in the country do not seem to have faith in unbranded drugs. In August, a doctors’ protest forced the National Medical Commission to take back its directive on prescribing generic medicines. The use of IT-enabled procedures could make the pharma industry’s processes transparent and improve coordination between the country’s 36 regional regulators. But a single window for all drug regulation should be seen as only the first step towards restoring the credibility of generics.

India has among the toughest laws against spurious drugs. However, a robust regulatory mechanism also requires an effective system for monitoring manufacturing and sales units. That is still in the works. Most states haven’t found a way to adopt the 20-year-old formula of the Mashelkar committee which recommended one drug inspector for 50 production units and one inspector for every 200 retail units. In several states, there is no clear demarcation between the roles of drug testing and food regulatory agencies. Field officials are often tasked with administrative work related to the cancellation and renewal of licenses. Their primary responsibility of scrutinising the safety and efficacy of medicines suffers as a result. That’s why the creation of a portal for drug control should be accompanied by measures to enhance the capacity of regulatory bodies.

First published on: 20-11-2023 at 07:40 IST

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