(MENAFN- Live Mint)

New Delhi: India's top drug regulator is preparing to link its designated import ports with the country's digital customs gateway to strengthen oversight, and ensure that only safe medicines, devices, and cosmetics enter the domestic market, according to an official aware of the matter and documents reviewed by Mint.

The government has notified around 34 ports (sea, air, rail, road) for entry of medical products, and has launched the initiative to link these with the Indian Customs Electronic Gateway (ICEGATE) to ensure that drugs and devices don't enter through unapproved routes.

This plan is based on Rule 43-A of the Drugs Rules, 1945 that mandates that no drug can be imported into India except through designated points of entry. By mapping these ports on ICEGATE, the CDSCO (Central Drugs Standard Control Organization) aims to automate the referral of Bill of Entry (BOE)-a document declaring goods being brought in-to the right CDSCO port office.

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The directive, issued in a letter dated 7 October by the Drugs Controller General of India Rajeev Singh Raghuvanshi to the National Customs Targeting Centre (Cargo), is a crucial step to enforcing the Drugs and Cosmetics Act, 1940, which governs the import, manufacture, distribution, and sale of drugs and cosmetics. The National Customs Targeting Centre is a specialized unit under the Indian customs that tracks consignments using digital systems like ICEGATE and flags suspicious shipments.

“This regulatory move will enhance the oversight of foreign-sourced medical goods entering the country. By mandating imports through designated ports, the government can more effectively inspect and verify consignments, thereby preventing the entry of substandard or counterfeit products. The move is part of the government's ongoing efforts to improve ease of doing business while ensuring strong execution of regulations," the government official cited earlier said.

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Queries sent to the health ministry remained unanswered till press time.

The designated seaports include Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, Tuticorin, Kamarajar Port, Mormugao, Visakhapatnam, Krishnapatnam, Gangavaram, Hazira and Mundra.

Air imports are limited to Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru, Visakhapatnam, Cochin and Thiruvananthapuram.

In a nod to cross-border trade, specific railway stations and road points are also designated for imports from neighbouring countries like Pakistan, Bangladesh, and Nepal. Additionally, inland container depots in Delhi, Gujarat, and Madhya Pradesh are included as valid entry points.

The letter requests that the additional director general of the National Customs Targeting Centre ensure that all import entries or BOEs are referred to the corresponding CDSCO port office.

“This collaboration between CDSCO and customs is a key feature of the new system, ensuring a seamless and secure process for importers. The overall objective is to create a more transparent and robust regulatory environment that protects public health while supporting the growth of India's pharmaceutical and medical device sectors," the official added.

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Pharmaceutical imports rose 11% year-on-year to $8.6 billion in financial year 2024-25 (FY25). Key drivers for this growth include a surge in demand for advanced oncology and autoimmune biologics, with import volumes for these products rising 29%. Imports of bulk drugs and intermediates also saw a growth of 1.8% in value, reaching $4.65 billion in FY25.

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