What Happened
- The Drug Controller General of India (DCGI) has launched a nationwide crackdown on unapproved Fixed Dose Combination (FDC) drugs, directing state and Union Territory Drug Controllers to examine 90 FDC drug samples and stop their manufacture and sale.
- The 90 FDCs flagged include commonly used products containing multivitamins, folic acid, paracetamol, clotrimazole with betamethasone cream, and diclofenac potassium with dicyclomine hydrochloride — many of them household names sold over the counter.
- The CDSCO directed immediate action against manufacture and sale of 35 unapproved FDCs that include combinations of antidiabetics, antibiotics, antihypertensives, painkillers, fertility drugs, and multivitamins — all marketed without central regulatory clearance.
- The root cause of the problem: State Licensing Authorities (SLAs) historically issued manufacturing licences to pharmaceutical companies for FDCs without obtaining no-objection certificates from CDSCO, creating a market for drugs whose safety and efficacy had never been evaluated.
- The regulatory crackdown raises broader questions about patient safety, irrational prescribing, and the porous boundary between central and state drug regulatory authority in India.
Static Topic Bridges
Fixed Dose Combinations (FDCs) — Definition and Regulatory Approval Process
A Fixed Dose Combination (FDC) is a pharmaceutical product containing two or more active drug ingredients combined in a single dosage form (tablet, capsule, syrup, injection) in fixed proportions. FDCs are treated as new drugs under Rule 122E of the Drugs and Cosmetics Rules, 1945, meaning each FDC requires independent evaluation of its safety, efficacy, and pharmacological rationale before central approval — it is not sufficient that its individual components are already approved. CDSCO evaluates FDCs for pharmacokinetic compatibility, potential drug interactions, whether the combination offers advantages over monotherapy, and whether the dose ratio is appropriate.
- Rule 122E: Defines a new drug to include a combination of two or more drugs, individually approved, in a new ratio or for a new indication — requires fresh clinical data and CDSCO approval
- FDC approval requires: Phase I–III clinical trial data (or bioequivalence data for generics of existing FDCs), pharmacokinetic compatibility studies, evidence of therapeutic advantage over monotherapy
- The approval gap: Many FDCs entered the Indian market between the 1960s–2000s when oversight was weaker; state regulators issued licences without central clearance — creating the "legacy FDC" problem
- WHO has advocated against irrational FDCs, particularly combinations where the individual components have different dosing requirements, different onset/duration profiles, or where combination offers no proven benefit
Connection to this news: The 90 FDCs currently under scanner entered the market through state-level licences without CDSCO approval — they lack the scientific validation that the central regulator requires, making their safety and efficacy genuinely uncertain.
Section 26A of the Drugs and Cosmetics Act, 1940 — Banning Powers
Section 26A of the Drugs and Cosmetics Act, 1940 is the primary legal instrument used by the Central Government to ban drugs. It empowers the Central Government — if satisfied that a drug or cosmetic is likely to involve risk to human beings or animals, or that it does not have the therapeutic value claimed for it, or that it contains ingredients beyond therapeutic justification — to prohibit by notification the manufacture, sale, or distribution of that drug.
- Section 26A: Central government power to prohibit drugs "in the public interest"
- Major uses of Section 26A in India:
- 2016: Health Ministry banned 349 FDCs (largest single FDC ban in India's history) under Section 26A; challenged in Delhi High Court and Supreme Court
- Supreme Court in Pfizer Ltd. v. Union of India (2018): Upheld the government's power to ban FDCs under Section 26A; directed fresh expert committee review of the 349 FDCs
- 2024: Health Ministry banned 156 FDCs (antidiabetics, pain medications, cough syrups)
- 2025: Additional 35 FDCs banned; now 2026 crackdown on 90 more
Connection to this news: The current enforcement action against 90 FDC samples follows the same legal pathway — DCGI identifying unapproved FDCs, directing state action, and setting the stage for potential Section 26A bans on those found unsafe or irrational.
Centre-State Regulatory Overlap in Pharmaceutical Regulation
Drug regulation in India is a concurrent subject (List III of the Seventh Schedule) and involves both central (CDSCO/DCGI) and state (State Drug Controllers, State Licensing Authorities) authorities. The Drugs and Cosmetics Act, 1940 designates certain approvals to the centre (new drugs, clinical trials, imports) and others to states (manufacturing licences for approved drugs, retail pharmacy licences). The structural flaw: historically, states could grant manufacturing licences for FDCs by treating them as combinations of individually approved drugs — without recognising that an FDC is itself a "new drug" requiring separate central approval.
- Seventh Schedule, List III (Concurrent List), Entry 19: "Prevention of the extension from one State to another of infectious or contagious diseases or pests affecting men, animals or plants" — health is primarily in the Concurrent List
- Entry 18 of Concurrent List: "Adulteration of foodstuffs and other goods"
- Entry 19 and 20: Drug regulations — both Centre and States can legislate, but Central law prevails in case of conflict (Article 254)
- Sheila Dikshit Committee (2012): Recommended restructuring FDC regulation to require mandatory CDSCO clearance before state licences — many of its recommendations remain incompletely implemented
- National Drug Authority (proposed): Multiple committees have proposed centralising drug regulation in a single national authority to eliminate the Centre-State gap; not yet implemented
Connection to this news: The unapproved FDCs in the current crackdown exist precisely because of this regulatory gap — state authorities licensed their manufacture without central evaluation. The DCGI's directive to state drug controllers is an attempt to use administrative coordination to close a structural regulatory flaw.
Key Facts & Data
- FDC samples currently under examination: 90 (including paracetamol combinations, multivitamins, clotrimazole-betamethasone cream, diclofenac-dicyclomine tablets)
- FDCs banned (2016): 349 (largest single ban); Supreme Court upheld in 2018
- FDCs banned (2024): 156; FDCs banned (2025): 35
- Legal basis for banning: Section 26A, Drugs and Cosmetics Act, 1940
- FDC regulatory rule: Rule 122E, Drugs and Cosmetics Rules, 1945 (FDCs = new drugs requiring fresh CDSCO approval)
- Nodal authority: CDSCO (Central Drugs Standard Control Organisation), headed by DCGI (Drugs Controller General of India)
- CDSCO under: Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare
- Drug regulation in Constitution: Concurrent List (List III), Seventh Schedule — both Centre and States can legislate