Examine the regulatory mechanism for approval and restriction of Fixed Dose Combinations (FDCs) in India. Discuss recent measures taken to protect children from unsafe drug combinations.

Fixed Dose Combinations — two or more active ingredients in a single dosage form — are regulated as "new drugs" in India. Recent age-specific curbs on cough-and-cold FDCs show a maturing, though still largely reactive, safety architecture.

Approval mechanism

• Under the New Drugs and Clinical Trials Rules, 2019, an FDC is a new drug requiring CDSCO/DCGI permission on proof of therapeutic rationale, safety and efficacy [1].
• Subject Expert Committees (SECs) provide scientific evaluation; the Drugs Technical Advisory Board (DTAB), a statutory board under the Drugs and Cosmetics Act, 1940, advises the Centre [2].
• State licensing authorities grant manufacturing licences — a dual Centre-State structure that historically allowed unapproved FDCs to reach the market.

Restriction mechanism

• Section 26A, Drugs and Cosmetics Act, 1940 empowers the Centre to prohibit or restrict a drug in the public interest [2].
• March 2016: 344 FDCs prohibited; challenged by manufacturers. Following the Supreme Court judgment of 15 December 2017, DTAB re-examined the issue and 328 FDCs were banned by gazette notification of 7 September 2018 [3].
• The process continues — 16 FDCs were prohibited in a recent notification [4]. Judicial review remains a genuine check, several notifications having been stayed or quashed.

Recent child-protection measures

• The Health Ministry has restricted FDCs of Chlorpheniramine Maleate + Phenylephrine Hydrochloride for children below four years, mandating the warning "shall not be used in children below four years of age" on the label, package insert and promotional literature [5].
• Significantly, this is an age-calibrated restriction, not a blanket ban, reflecting risk-benefit reasoning after global cough-syrup child deaths.

Persisting gaps: thin post-market surveillance, limited state drug-inspector strength, and easy over-the-counter sale dilute enforcement.

Overall, India's FDC framework combines expert scrutiny with strong statutory prohibition powers, but acts mostly after harm surfaces. Strengthening paediatric pharmacovigilance, harmonising Centre-State enforcement and mandating dedicated paediatric data before approval would convert reactive bans into preventive protection — advancing the right to health under Article 21 and SDG-3.