## Policy Analysis Report: Restriction on Fixed Dose Combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride
**1. Executive Summary:**
This report analyzes a new policy notification issued by the Ministry of Health and Family Welfare, Government of India, published on April 15, 2025. The policy restricts the manufacture, sale, and distribution of fixed-dose combinations (FDCs) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age. The core purpose is to mitigate potential risks to this age group, given the availability of safer alternatives. The key finding is that manufacturers must include a warning label regarding the restriction on product packaging, inserts, and promotional materials.
**2. Introduction:**
This report provides a detailed analysis of a policy notification regarding the regulation of Chlorpheniramine Maleate and Phenylephrine Hydrochloride FDCs. The analysis is based solely on the information contained within the provided policy text. The purpose of this report is to inform affected industry stakeholders about the key provisions, rationale, and expected impact of this policy.
**3. Policy Overview:**
This is a *new* policy.
* **Core Objective(s):** Based on the provided text, the primary objective is to protect children under four years of age from potential risks associated with the fixed-dose combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride. The objective is achieved by restricting the manufacture, sale, and distribution of these FDCs unless a specific warning label is prominently displayed.
**4. Background and Rationale:**
As this is a new policy, the provided text suggests the following rationale: The policy addresses concerns regarding the safety of Chlorpheniramine Maleate and Phenylephrine Hydrochloride FDCs for children under four years. The government is "satisfied that the use of the drug fixed dose combination…is likely to involve risk to children below four years of age" and acknowledges the existence of "safer alternatives." This suggests that scientific evidence and expert recommendations have led to the conclusion that the benefits of using these FDCs in young children do not outweigh the potential harm.
**5. Key Provisions / Changes:**
As a new policy, the following are the key provisions:
* **Restriction:** The policy restricts the manufacture, sale, and distribution of all formulations of the fixed-dose combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
* **Warning Label Requirement:** This restriction is conditional. Manufacturers *can* continue to manufacture, sell, and distribute these FDCs *if* they include a specific warning.
* **Warning Text:** The required warning is: "fixed dose combination shall not be used in children below four years of age."
* **Placement of Warning:** The warning must be prominently displayed on the label, package insert, and any promotional literature for the drug.
**6. Target Audience and Stakeholders:**
The primary target audience is:
* Manufacturers of Chlorpheniramine Maleate and Phenylephrine Hydrochloride fixed-dose combinations.
Other directly affected stakeholders include:
* Pharmacies and distributors of these medications.
* Healthcare professionals who prescribe or recommend these medications.
* Parents and caregivers of children under four years of age.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency:** The Ministry of Health and Family Welfare is responsible for implementing this policy, likely through the Central Drugs Standard Control Organization (CDSCO).
* **Timelines:** The policy came into force upon its publication in the Official Gazette (April 15, 2025, as per the document). Therefore, manufacturers are expected to comply with the warning label requirement immediately.
* **Enforcement:** Enforcement likely involves inspections and monitoring of drug labels and promotional materials by drug regulatory authorities.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this policy are:
* **Reduced use of Chlorpheniramine Maleate and Phenylephrine Hydrochloride FDCs in children under four years of age.** The warning label is intended to deter healthcare professionals and caregivers from using these drugs in this age group.
* **Increased awareness among healthcare professionals and caregivers about the potential risks of these FDCs in young children.**
* **Promotion of safer alternatives for treating cold and allergy symptoms in children under four.**
* **A decrease in adverse events associated with these FDCs in the target age group.**
**9. Conclusion:**
The policy notification regarding the restriction of Chlorpheniramine Maleate and Phenylephrine Hydrochloride fixed-dose combinations represents a significant step towards protecting the health of young children. By requiring warning labels, the government aims to reduce the use of these medications in children under four years and promote the use of safer alternatives. Compliance with the warning label requirement is crucial for manufacturers and distributors to ensure the safety and well-being of this vulnerable population.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: Legislation under which the Central Government restricts the manufacture, sale, or distribution of certain drug formulations.
section 26A: Section of the Drugs and Cosmetics Act, 1940, granting powers to the Central Government.
Central Government: The governing authority responsible for regulating drug manufacture, sale, and distribution.
Ministry of Health and Family Welfare: Government organization responsible for the Department of Health and Family Welfare.
Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare.
Chlorpheniramine Maleate Phenylephrine Hydrochloride: The specific fixed-dose combination drug being restricted for use in children below four years of age.
Drugs Technical Advisory Board: Advisory board that examined the fixed dose combination and made recommendations.
Subject Expert Committee: Committee appointed by the Central Government to examine the matter.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-15042025-262456
CG-DxLx-xEG-I1D5H0x4x2x0 25-262456
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 1686] नई दिल्ली, मगं लवार, अप्रलै 15, 2025/चत्रै 25, 1947
No. 1686] NEW DELHI, TUESDAY, APRIL 15, 2025/CHAITRA 25, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 15 अप्रलै , 2025
का.आ. 1717(अ).—केन्द्रीय सरकार इस बात स े संतष्टु ह ै कक क्लोरफेननरामाइन मलै टे + कफनाइलफ्रे ीन
हाइड्रोक्लोराइड की नननित खरु ाक संयोजन ओषनि के प्रयोग स ेचार वषष स ेकम आय ुके बच् चों को खतरा होने की संभावना
ह ै और उक्त ओषनि के सुरनित नवकल्प उपलब्ि ह।ैं
और, इस मामल े की जांच केंरीय सरकार द्वारा ननयक्तु नवषय नवशेषज्ञ सनमनत द्वारा की गई थी और उक्त सनमनत न े
नसफाररश की थी कक क्लोरफेननरामाइन मलै ेट आईपी + फेननलफ्रीन हाइड्रोक्लोराइड के नननित खरु ाक संयोजन के सभी
फॉममषलेशन का उपयोग चार वषष स े कम उम्र के बच् चों म ें नहीं ककया जाना चानहए और तदनसु ार ननमाषताओं को ओषनि के
लेबल और पैकेज इंसटष या प्रचार सानहत्य पर इस चेतावनी का उल्लेख करना चानहए कक "नननित खुराक संयोजन का उपयोग
चार वषष स े कम उम्र के बच् चों म ें नहीं ककया जाएगा।"
और, ओषनि तकनीकी सलाहकार बोड ष न े भी उक्त नननित खरु ाक संयोजन की जांच की और यह नसफाररश की कक
क्लोरफेननरामाइन मलै टे + कफनाइलफ्रीन हाइड्रोक्लोराइड के नननित खुराक संयोजन के सभी फॉममषलेशन को ओषनि और
प्रसािन सामग्री अनिननयम, 1940 (1940 का 23) की िारा 26क के अिीन चार वष ष स े कम उम्र के बच् चों म ें उपयोग के
नलए और उक्त नननित खरु ाक संयोजन के नवननमाषण, नबक्री और नवतरण के नलए इस शत ष के अिीन प्रनतबंनित ककया जाना
2522 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
चानहए कक ननमाषता दवा के लेबल और पैकेज इंसटष या प्रचार सानहत्य पर एक चेतावनी का उल्लेख करेंगे कक "नननित खरु ाक
संयोजन का उपयोग चार वष षस े कम उम्र के बच्चों म ेंनहीं ककया जाएगा"।
और, उक्त ओषनि तकनीकी सलाहकार बोडष की नसफाररशों के आिार पर, केन्द्रीय सरकार का यह समािान हो गया
ह ै कक दशे म ें उक्त ओषनि के मानव उपयोग के नलए नवननमाषण, नबक्री और नवतरण को प्रनतबंि के माध्यम स े नवननयनमत
करना लोकनहत म ेंआवश्यक और समीचीन ह;ै
अतः, अब, केंरीय सरकार ओषनि और प्रसािन सामग्री अनिननयम, 1940 (1940 का 23) की िारा 26क द्वारा
प्रदत्त शनक्तयों का प्रयोग करते हुए, क्लोरफेननरामाइन मलै ेट + कफनाइलफ्रीन हाइड्रोक्लोराइड के नननित खुराक संयोजन के
सभी युग्म कों के नवननमाषण, नबक्री या नवतरण को ननम्ननलनखत शत षके अिीन एततद्वारा प्रनतबंनित करती ह,ै कक ननमाषता दवा
के लेबल और पैकेज इंसटष या प्रचार सानहत्य पर चेतावनी "नननित खुराक संयोजन का उपयोग चार वषष स े कम उम्र के बच्चों
में नहीं ककया जाएगा" का उल्लखे करेंगे।
2. यह अनिसमचना राजपत्र म ेंअपन े प्रकाशन की तारीख को प्रवृत्त होगी।
[फा. सं. एक्स.11035/132/2024-डीआर]
रािीव वधावन, सलाहकार (लागत)
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.