Discuss how India's drug-regulatory architecture should evolve to ensure quality while easing trade in healthcare products.

In November 2026 the Union Health Ministry proposed 10 new import points for drugs, medical devices and cosmetics: 8 Inland Container Depots, the Bommasandra SEZ and Noida International Airport [1]. The aim is to make imports easier. But every new entry point is only as safe as the regulators who staff it. The system therefore has to grow its capacity as fast as it opens up trade.

Present gaps

• Too few staff: In 2008 a Rajya Sabha committee pointed to too few drug inspectors and testing facilities [3]. In 2026 the Health Standing Committee said vacancies among Drugs Controllers were still slowing CDSCO's daily work [2].
• Split enforcement: CDSCO clears goods at the port. After that, state drug controllers police the market, often with less capacity.
• Old law: The Drugs and Cosmetics Act, 1940 still governs a sector that now includes complex medical devices.

Ensuring quality

• Staff first, then ports: A port should start working only after its officers are in place. Recruitment should be time-bound and should create specialist scientific cadres [2].
• More testing capacity: Approve accredited public and private labs near the ICD clusters, and upgrade CDSCO labs in phases [2].
• Stronger institutions: Implement the Mashelkar Committee's proposal for a Central Drugs Authority and pass a modern law that covers drugs, devices and cosmetics [3].
• Risk-based checks: Inspect high-risk products closely and clear trusted importers faster, so that adding ports does not let in substandard drugs.

Easing trade

• Clearance near industry: Inland hubs near the NCR, Hyderabad and Bengaluru clusters cut the time and cost of moving goods [1].
• Digital single window: One online system for CDSCO, Customs and state regulators, so no consignment waits for paper approvals.
• Faster clearance means fewer shortages: This matters most for time-sensitive drugs arriving by air [1].

Balancing trade with self-reliance

• India imported about 90% of its medical devices when the PLI scheme began [4]. Easier imports should come with clear targets for domestic production, so that "temporary" dependence does not become permanent.

Easing trade and assuring quality can support each other if regulatory capacity grows before new ports open. A well-staffed, digital and risk-based CDSCO working closely with the states can deliver both. That would advance SDG 3.8 (access to safe, quality-assured medicines) and the Mashelkar Committee's goal of one strong regulator.