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The crackdown follows concerns that unapproved medicines are entering India from neighbouring countries through unauthorised routes.
The advisory comes amid growing global concern over substandard, falsified and unlicensed medicines entering legitimate supply chains through illegal channels. (Representational image)
Amid concerns over the illegal entry of unapproved and unlicensed medicines into India, the country’s apex drug regulatory agency has directed all state and Union Territory drug controllers, along with its zonal, sub-zonal and port offices, to step up surveillance across the pharmaceutical supply chain, News18 has learnt.
In an advisory circular issued by the enforcement division of the Directorate General of Health Services on June 22, the national drug regulator, the Central Drugs Standard Control Organisation (CDSCO), said concerns had been raised over medicines entering the domestic supply chain through unauthorised channels from neighbouring countries.
The circular, seen by News18states: “The concerns have been raised regarding the illegal entry of certain unapproved and unlicensed drug products into the domestic supply chain through unauthorised channels from neighbouring countries.”
The CDSCO circular does not name any country or specific incident. However, it further notes: “The Ministry has highlighted the potential public health and patient safety risks arising from the import, distribution, storage, sale and marketing of such products without obtaining requisite approvals, permissions or licences under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder.”
To emphasise the urgency of the move, the circular, written by the Drug Controller General of India, Rajeev Singh Raghuvanshi, concludes that the matter may be “accorded utmost priority in the interest of safeguarding public health”.
The advisory comes amid growing global concern over substandard, falsified and unlicensed medicines entering legitimate supply chains through illegal channels. The World Health Organisation (WHO) estimates that at least one in 10 medicines in low- and middle-income countries is substandard or falsified, posing risks of treatment failure, toxicity and antimicrobial resistance.
Focus on border areas, warehouses and courier hubs
The regulator has instructed authorities to strengthen surveillance mechanisms in their jurisdictions, with particular attention to vulnerable locations.
Particular emphasis has been “placed on border regions, coastal areas, transit points, warehouses, courier facilities, logistics hubs and other vulnerable locations that may be susceptible to the illegal movement of unapproved and unlicensed drug products”.
It has also asked state regulators to intensify intelligence-gathering and coordinate with local law enforcement agencies to identify and curb unauthorised channels. “Intelligence gathering activities may be intensified, and close coordination may be maintained with local law enforcement agencies to identify and curb unauthorised channels involved in the entry and distribution of such products.”
The advisory directs authorities to carry out continuous surveillance across the pharmaceutical supply chain, including wholesalers, retailers, distributors, stockists, hospitals and clinics, to detect unapproved, unlicensed or illegally imported medicines. It has asked officials to strengthen market surveillance and inspections to verify the regulatory status, import authorisation and licensing compliance of medicines on the market.
Seizure, prosecution and coordination with Customs
The CDSCO has said that immediate enforcement action should be initiated wherever such products are detected. The circular noted: “Appropriate enforcement measures, including seizure, detention, sampling, investigation, prosecution and other legal actions, as warranted under law, may be undertaken against any individual or entity involved in the illegal import, unauthorized storage, distribution, sale or marketing of such products.”
The advisory also directs CDSCO port offices to ensure strict screening of imported consignments suspected of containing medicines lacking approvals, registrations, licences or import permissions. State regulators and CDSCO field formations have been asked to coordinate closely with Customs, border security forces, the police and other enforcement agencies for the timely sharing of intelligence and action against violations.
Finally, all state and UT drug controllers, along with CDSCO zonal, sub-zonal and port offices, have been asked to closely monitor the movement and availability of such products and promptly report any detection of unapproved, unlicensed or illegally imported drugs, along with the enforcement action taken, to CDSCO headquarters for further coordination and follow-up.
About the Author
Himani Chandna, Senior Associate Editor at CNN-News18, tracks healthcare, pharma and medical research, bringing clarity to complex science and policy.
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