Discuss the regulatory architecture governing drug imports in India. How does the proposed 2026 amendment to Drugs Rules, 1945 reflect the tension between ease of doing business and drug safety?

Q. Discuss the regulatory architecture governing drug imports in India. How does the proposed 2026 amendment to Drugs Rules, 1945 reflect the tension between ease of doing business and drug safety? (15 marks, 250-350 words)

India's drug import regime rests on the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, which balance two goals — protecting patients from substandard drugs and enabling a globally competitive pharmaceutical industry [3]. The June 2026 draft amendment simplifying Form 11 imports illustrates how that balance is being recalibrated [1].

Regulatory architecture governing drug imports - Statutory base: The 1940 Act and the 1945 Rules regulate import, manufacture and sale; drug import is a central subject, unlike sale and distribution which States enforce [3]. - Apex regulator: The CDSCO, headed by the Drug Controller General of India (DCGI), grants import licences and permissions; it also runs port-level testing and market surveillance [1]. - Purpose-based permissions: Commercial import requires registration and a licence; import for examination, test or analysis uses Form 11; clinical-trial imports follow the New Drugs and Clinical Trials Rules, 2019 [3]. - Special-category controls: Narcotic and psychotropic substances additionally attract the NDPS Act, 1985, reflecting India's UN drug-convention obligations.

The 2026 amendment: easing business without abandoning safety - Deregulation: Prior licensing is replaced by an acknowledgement-based system — the importer files a prior intimation and may import small quantities for analytical and non-clinical testing on the auto-generated acknowledgement [1]. - Ease-of-business gain: It cuts approval delays for start-ups, CROs and academic labs importing reference standards, aiding R&D deregulation [1]. - Safety safeguard: The relaxation is risk-tiered, excluding sex hormones, cytotoxic drugs, beta-lactams and biologics containing live microorganisms [1]. - Residual concern: Self-declaration shifts the burden to post-market oversight, demanding stronger CDSCO inspection capacity to prevent diversion of "test" consignments. - Wider trend: It mirrors the Jan Vishwas (Amendment of Provisions) Bill, 2026, which decriminalised 717 provisions, including under the 1940 Act [2].

The amendment shows that ease of doing business and drug safety are complementary when regulation is proportionate to risk. Reserving strict scrutiny for high-risk drugs while trusting low-risk research imports, backed by robust post-market surveillance, can make India both an easier and a safer place to innovate.

(~320 words)

Sources: 1. Government Simplifies Procedure for Import of Drugs for Examination, Test or Analysis under Drugs Rules, 1945 — PIB, MoHFW, 26 June 2026 — Form 11 acknowledgement-based system, prior intimation, small-quantity scope, excluded drug categories, CDSCO/DCGI role 2. Jan Vishwas (Amendment of Provisions) Bill, 2026: Rationalizing Compliance and Decriminalizing Minor Offences in the Health Sector — PIB — 717 provisions decriminalised; amendments to the Drugs and Cosmetics Act, 1940 3. The Drugs Rules, 1945 (as amended) — CDSCO, Ministry of Health and Family Welfare — statutory framework for import licensing, purpose-based permissions and Form 11