Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-15042025-262456
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 1686]
NEW DELHI, TUESDAY, APRIL 15, 2025/CHAITRA 25, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 15th April, 2025
S.O. 1717(E). — Whereas, the Central Government is satisfied that the use of the drug fixed dose combination
of Chlorpheniramine Maleate + Phenylephrine Hydrochloride is likely to involve risk to children below four years
of age and whereas safer alternatives to the said drug are available.
And whereas, the matter was examined by Subject Expert Committee appointed by the Central Government
and the said Committee recommended that all formulations of fixed dose combination of Chlorpheniramine Maleate IP
+ Phenylephrine Hydrochloride should not be used in children below four years of age and accordingly manufacturers
should mention warning "fixed dose combination shall not be used in children below four years of age" on the label and
package insert or promotional literature of the drug.
And whereas, the Drugs Technical Advisory Board also examined the said fixed dose combination and
recommended that all formulations of the fixed dose combination of Chlorpheniramine Maleate + Phenylephrine
Hydrochloride should be prohibited for use in children below four years of age under section 26A of the Drugs and
Cosmetics Act, 1940 (23 of 1940) and for manufacture, sale and distribution of the said fixed dose combination subject
to the condition, that manufacturers shall mention a warning that "fixed dose combination shall not be used in children
below four years of age" on the label and package insert or the promotional literature of the drug.
And whereas, on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central
Government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction, the
manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940
(23 of 1940), the Central Government hereby restricts the manufacture, sale or distribution of all formulations of fixed
dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride subject to the following condition, that
the manufacturers shall mention the warning "fixed dose combination shall not be used in children below four years of
age" on the label and package insert or the promotional literature of the drug.
2. This notification shall come into force on the date of its publication in the Official Gazette.
[F. No. X.11035/132/2024-DR]
RAJIV WADHAWAN, Adviser (Cost)
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.