India orders nationwide crackdown on smuggled, unapproved medicines

INDIA'S drug regulator has ordered a nationwide crackdown on smuggled and unapproved medicines, escalating enforcement across borders, logistics hubs and the domestic pharmaceutical supply chain, according to two government officials and a communication to state-level drug controllers, Central Drugs Standard Control Organization (CDSCO) zonal offices, sub-zonal offices and port offices.

The directive, dated 22 June, from the Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, follows what the officials describe as a rise in illegal entry, distribution and sale of unapproved and unlicensed medicines from neighbouring countries, including Bangladesh, through unauthorised channels. It signals a sharper enforcement posture extending beyond customs checkpoints into wholesale networks, retail pharmacies, hospitals, clinics and digital supply chains.

The officials said India’s $50 billion pharmaceutical market is facing a major challenge from the illegal entry, distribution and sale of unapproved and unlicensed medicines through unauthorized channels from neighbouring countries, including Bangladesh.

The DCGI has directed increased intelligence gathering and closer coordination with law enforcement agencies to protect patient safety and secure the domestic pharmaceutical supply chain, with a focus on entry and transit points. The communication calls for tightened scrutiny across border regions, coastal areas, transit points, warehouses, courier facilities and logistics hubs, alongside customs authorities, the Border Security Force and police agencies.

It also expands surveillance across the pharmaceutical supply chain, including wholesale and retail drug establishments, distributors, stockists, hospitals and clinics, to detect unapproved, unlicensed and illegally imported drugs and medicines, according to the officials and the communication.

The enforcement push comes as authorities flag broader concerns over regulatory compliance in the domestic market. The CDSCO has flagged 90 unapproved fixed-dose combination (FDC) drugs being sold without FDA clearance, including certain diabetes pills, paracetamol combinations and multi-vitamins.

Last week, the health ministry imposed a strict ban on 16 irrational FDC drugs—single tablets, capsules or syrups that combine two or more active ingredients—including antibiotic combinations such as amoxicillin and serratiopeptidase, and aloe vera-based products, citing a lack of therapeutic justification.

The legal framework already prohibits such activity. Manufacture, sale and distribution of prohibited, banned and unapproved drugs is a punishable offence under Section 18 of the Drugs and Cosmetics Act, carrying imprisonment and a fine of ₹1 lakh.

“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 DCGI letter said, adding, “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.”

“Any information relating to suspicious consignments, unauthorized imports or regulatory breaches may be shared expeditiously with the concerned authorities for necessary intervention,” the communication said.

Queries emailed to the spokespersons of ministries of health and family welfare, home, external affairs, DCGI office on 23 June and finance ministry and Bangladesh High Commission on 24 June remained unanswered.

Patient safety risk

Health experts say unapproved drugs are already affecting clinical outcomes and patient safety.

Dr. Aashish Chaudhry, managing director, Aakash Healthcare said, “Medicines lacking evaluation and approval by India’s regulatory authorities may fail safety, quality, and efficacy standards. Their use can pose significant health risks to patients, including treatment failure, adverse reactions, or life-threatening complications.”

Industry bodies have backed the crackdown, arguing that illicit trade is both a health risk and an economic distortion.

“This is a regulatory enforcement matter. If unauthorized cross-border medicine movement is occurring via vulnerable land routes, it must be restricted immediately through stronger customs and port-level checks…This is a highly dangerous trade that must be stopped. Unapproved drugs entering outside standard channels lack verified stability or bio-evaluation data, which severely compromises patient safety while inflicting direct injury on our domestic pharmaceutical economy and legitimate businesses,” said Namit Joshi, chairman, Pharmexcil, pharma export promotion council under the ministry of commerce.

Viranchi Shah, national spokesperson of Indian Drugs Manufacturers Association (IDMA) representing 1,200 member companies, added, “This directive is a welcome step to protect patient safety…Historically, these illegal operations target highly valued or patented medications. It is a shared responsibility of regulators, trade, industry and all members of the supply chain to eliminate these unscrupulous activities.”

Digital health platforms and distributors said they operate within authorized supply chains and rely on traceability systems to ensure compliance.

Rajeev Sharma, vice president of medical affairs, Tata 1mg over a telephone said, “We take patient safety and regulatory compliance very seriously and these are embedded across our sourcing, onboarding, and listing processes. The majority of our inventory is procured directly from manufacturers or their authorized distributors, which helps us enhance control, authenticity, and traceability across the supply chain.”

Madhivanan Balakrishnan, chief executive, Apollo HealthCo, and chief digital and technology officer at Apollo Group, said Apollo 24/7 is built around patient safety and regulatory compliance, with medicines dispensed only through licensed Apollo Pharmacy stores sourced via verified and authorised channels.