Law and statutory body
Drugs and Cosmetics Act, 1940 (Section 26A) and FDC restrictions
GS2 HealthGS3 Science and TechnologyPrelims and Mains
- Why in news
- On 22 August 2026, the Health Ministry announced restrictions on all Fixed Dose Combinations of Chlorpheniramine Maleate and Phenylephrine Hydrochloride, with a warning against use in children below four years.
- What it is
- The Drugs and Cosmetics Act, 1940 regulates the import, manufacture, sale and distribution of drugs and cosmetics in India. Section 26A lets the Central Government prohibit or restrict a drug in the public interest. A Fixed Dose Combination (FDC) puts two or more active drug ingredients in one fixed ratio in a single dosage form.
- Legal provision used
- The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health.
- Advisory process
- The decision followed recommendations of an Expert Committee and the Drugs Technical Advisory Board (DTAB).
- Labelling requirement
- The warning must appear on the label, package insert and promotional literature.
- DTAB
- DTAB is the statutory technical body under the Drugs and Cosmetics Act that advises the Central and State Governments on technical matters.
Don’t confuse with DTAB vs DCC: DTAB advises on technical matters; the Drugs Consultative Committee (DCC) promotes uniform administration of the Act across States.
Laws, judgments and statutory bodies: 30 Prelims questions since 2013 (what the law says, who chairs, legal basis). In Mains, 44 news-triggered questions, most in GS2, asking for provisions and challenges.
Why it matters
- Protects young children from risks of unsafe combination drugs.
- Shows the Centre using Section 26A to regulate irrational FDCs.
Problems
- Weak State-level enforcement allows continued sale of banned or restricted products.
- Over-the-counter sale and self-medication make age warnings hard to enforce.
Way forward
- Strengthen State drug regulators and post-market surveillance.
- Run public awareness on paediatric cough and cold medicines.
Put in your answer
Section 26A action: The 15 April 2025 notification S.O. 1717(E) first restricted certain FDCs of these ingredients, now extended to all.
- 2013Mains GS3 · Q14What are Fixed Dose Drug Combinations, and their merits and demerits?
- 2014Mains GS3 · Q11Whether free antibiotic availability without prescription causes drug resistance; monitoring and control mechanisms.
UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
Prelims practice · Statements
Ours, not from a UPSC paper
Consider the following statements:
- 1.The restriction on Fixed Dose Combinations of Chlorpheniramine Maleate and Phenylephrine Hydrochloride has been notified under Section 26A of the Drugs and Cosmetics Act, 1940.
- 2.The latest notification applies only to certain FDCs of the two ingredients, as the April 2025 notification did.
- 3.The Drugs Technical Advisory Board, whose recommendation preceded the decision, is a statutory body constituted under the Drugs and Cosmetics Act, 1940.
Which of the statements given above is/are correct?
True or false?
1 of 6
Statements the way Prelims prints them. Say first, then see the fact.
1.The restriction has been notified under Section 26A of the Drugs and Cosmetics Act, 1940.
True. Section 26A empowers the Centre to restrict or prohibit drugs in public interest.
2.The decision was taken following recommendations of an Expert Committee and the Drugs Technical Advisory Board.
True. An Expert Committee and DTAB recommended it.
3.The warning says the medicines must not be used in children below four years of age.
True. The age threshold is four years.
4.The warning is required only on the outer label and not on the package insert or promotional literature.
False. It is required on the label, package insert and promotional literature.
5.The Drugs Technical Advisory Board is a statutory body constituted under the Drugs and Cosmetics Act, 1940.
True. DTAB is constituted under the Act (Section 5) as the highest statutory technical advisory body.
6.The notification takes effect six months after its publication in the Official Gazette.
False. It is effective from the date of its publication in the Official Gazette.
Written by us from the release, not by UPSC; checked by a second model.
Worth revising until Prelims 2028: most news questions come within two years of the event.