Fragmented Centre–State drug licensing has hampered timely action against substandard medicines. Discuss with reference to recent amendments to the Drugs Rules, 1945.

Under the Drugs and Cosmetics Act, 1940, the power to license drug factories is split between State Licensing Authorities and the Central Licensing Approving Authority [1]. When a drug is declared Not of Standard Quality (NSQ), this split and a rule that requires a notice before any action slow the response. The draft amendments released in November 2026 try to close this gap.

How fragmentation delays action

• Jurisdiction mismatch: a drug is often sampled and tested in one State but made in another. The authority that licenses the factory may hear late, so action stalls [1].
• Notice before action: a licence can be suspended only after a show-cause notice, so NSQ batches stay on the market and recalls get harder [1].
• Uneven capacity: States do most of the enforcement, with 860+ actions after joint risk-based inspections since December 2022 [2]. The Parliamentary Standing Committee on Health flags persistent Drugs Controller vacancies at CDSCO [3].
• Scale: State/UT labs tested 1,16,323 samples in 2024-25, and 3,104 were NSQ [4].

How the draft amendments respond

• Immediate suspension: the Central or State authority can suspend a licence once a Government Analyst finds failure on five critical parameters: assay, dissolution, related substances, impurities and sterility [1].
• Amended Form 13: the test report goes at the same time to the DCGI, the licensing authority of the State where the factory is, the manufacturer and the marketer. This closes the information gap and makes third-party marketers answerable too [1].
• Conditional revocation: the suspension is lifted only after a verified Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) plan [1].
• Cooperative federalism: the proposal was discussed at the 65th DCC and recommended by the 92nd DTAB [1].

Gaps that remain

• Due process: under Section 25 of the Act, a firm can have the sample retested by the Central Drugs Laboratory, whose report is conclusive [5]. Under the draft, suspension comes before this retest.
• No deadline is set for verifying the CAPA [1]. With few inspectors, how fast a firm restarts may depend on the officer.

The draft replaces slow, step-by-step action with a single, simultaneous Centre–State response. To work well, it needs time-bound Central Drugs Laboratory retests and CAPA checks. Drugs Controller posts must also be filled and more testing labs empanelled, as the Standing Committee recommends [3]. Combined with revised Schedule M (good manufacturing rules) inside factories, this can protect the right to health under Article 21 and India's credibility as a supplier of quality generic drugs.