Archive · 23 Aug 2026
India Extends Restrictions on Two-Ingredient Medicines for Under-Four Children
The Indian government has added new restrictions to certain children’s medicines.
These medicines contain Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The new rule applies to every fixed-dose combination containing both ingredients.
The medicines must not be used by children younger than four years old.
Companies must print this warning on the medicine label and inside the package.
They must also include it in advertisements and other promotional information.
The government said the combinations could be risky for very young children.
It also said safer alternatives are available.
Medical experts and the Drugs Technical Advisory Board recommended the decision.
The government restricted the manufacture, sale and distribution of all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The medicines must carry a warning that they should not be used in children below four years of age.
Manufacturers must display the warning on labels, package inserts and promotional literature.
The latest notification expands an April 15, 2025 restriction that covered only certain formulations containing the two ingredients.
The decision followed recommendations from an expert committee and the Drugs Technical Advisory Board, with the government citing potential risks and safer alternatives.
- Who
- The Government of India, the Ministry of Health and Family Welfare, medicine manufacturers, an expert committee and the Drugs Technical Advisory Board.
- What
- Restrictions were imposed on all fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, including a warning against use in children below four years of age.
- When
- The notification takes effect when published in the Official Gazette; an earlier restriction on certain formulations was issued on April 15, 2025.
- Where
- Across India.
- Why
- The government said the combinations may pose risks to children below four and that safer alternatives are available.
- Affected ingredients
- Chlorpheniramine Maleate and Phenylephrine Hydrochloride
- Affected products
- All fixed-dose combinations containing both ingredients
- Age warning
- “Fixed Dose Combination shall not be used in children below four years of age”
- Restricted activities
- Manufacture, sale and distribution
- Required warning locations
- Product labels, package inserts and promotional literature
- Legal basis
- Section 26A of the Drugs and Cosmetics Act, 1940
- Effective date
- The date of publication in the Official Gazette
Sources
Govt restricts fixed dose combinations containing 2 ingredients for kids below age 4
Under-4 Warning On Cold Drug FDCs
Govt Restricts Fixed Dose Combinations For Children Below Four Years
Govt Restricts Fixed Dose Combinations Containing 2 Chemical Compounds For Young Children
