Restriction of FDCs
Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare
Read or download the official PDF of this gazette notification issued by the Ministry of Health and Family Welfare on 19th August 2026. Classified under Extra Ordinary.
Executive Summary & Key Takeaways
Executive Summary The Ministry of Health and Family Welfare issued notification S.O. 4595(E) on August 18, 2026, restricting the manufacture, sale, and distribution of all fixed-dose combinations (FDC) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. Effective from its publication date of August 19, 2026, the order mandates that these drugs carry a specific warning against use in children under four years of age. This regulatory action follows recommendations from an Expert Committee and the Drugs Technical Advisory Board regarding safety risks to young children.
Key Points / Main Content
Regulatory Restrictions
- The Central Government has restricted the manufacture, sale, and distribution of all formulations of FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
- This restriction applies to all such formulations manufactured, imported, or marketed within India.
- The notification is issued under the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940.
Mandatory Labeling Requirements
- Manufacturers must strictly include the following warning on the drug label: “fixed dose combination shall not be used in children below four years of age.”
- This warning must also be clearly mentioned in the package insert and all promotional literature associated with the drug.
Safety and Expert Recommendations
- An Expert Committee and the Drugs Technical Advisory Board (DTAB) determined that these FDCs are likely to involve risks to children below four years of age.
- The government noted that safer alternatives to these drug combinations are currently available for the affected age group.
- The regulation is deemed necessary and expedient in the public interest to ensure human safety.
Impact Analysis
Drug Manufacturers Impact: Prohibited from the manufacture and distribution of these FDCs unless specific labeling conditions are met. Action Required: Immediately update all product labels, package inserts, and promotional materials to include the mandatory warning regarding children under four years of age.
Distributors and Retailers Impact: The sale and distribution of these specific drug combinations are now subject to the labeling restrictions defined in the notification. Action Required: Ensure that all stock of Chlorpheniramine Maleate and Phenylephrine Hydrochloride FDCs complies with the new warning requirements before sale or distribution.
Consumers and Healthcare Providers Impact: Notified of the potential risks and the availability of safer alternatives for pediatric use. Action Required: Observe the mandatory warnings on packaging and cease the use of these specific fixed-dose combinations for children under the age of four.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation, specifically Section 26A, providing the legal authority for the Central Government to restrict the manufacture, sale, or distribution of certain drug formulations.
Ministry of Health and Family Welfare: The central government ministry that issued the notification to regulate the usage of specific fixed-dose combinations for pediatric safety.
Drugs Technical Advisory Board (DTAB): The statutory advisory body that reviewed safety data and recommended restricting the use of these drug formulations in children under four years of age.
Expert Committee: A committee constituted by the Ministry that examined risks and recommended mandatory warning labels for all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
Official Gazette PDF Record
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-21082026-275640
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CG-DLxx-ExG-I2D1E0x8x2x0 26-275640
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 4415] नई दिल्ली, िुधवार, अगस्ट्त 19, 2026/श्रावण 28, 1948
No. 4415] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 18 अगस्ट् त, 2026
का.आ. 4595(अ) .— केंद्रीय सरकार न े का.आ. स.ं 1717 (अ), तारीख 15 अप्रैल, 2025 के माध्यम स े एक
अजधसूचना िारी दकया, िो भारत के रािपत्र, असाधारण, भाग 2, खण्ड 3, उप-खण्ड (ii) म ें प्रकाजित हुई थी, जिसम ें
क्लोरफेजनरामाइन मैजलएट + दफनाइलेफ्रीन हाइड्रोक्लोराइड के जनयत खुराक संयोिन कॉजबिनेिन (जनजित खुराक
संयोिन) के सभी जवजनर्मिजियो के जनमािण, जिक्री या जवतरण को इस िति के अधीन प्रजतिंजधत दकया गया था दक जनमािता
औषजध के लेिल और पैकेि इंसटि या प्रचार साजहत्य पर यह चेतावनी अंदकत करेंगे दक "जनयत खुराक संयोिन का उपयोग
चार वषि स े कम आय ुके िालकों म ें नहीं दकया िाना चाजहए";
और केंद्रीय सरकार का यह समाधान ह ै दक क्लोरफेजनरामाइन मैजलएट और दफनाइलेफ्रीन हाइड्रोक्लोराइड यक्तु
अन्य िवा जनयत खुराक संयोिन का उपयोग चार वषि स े कम आय ु के िालकों के जलए िोजखम उत्पन्न कर सकता ह ै और
अतः ऐसी औषजधयों के सुरजित जवकल्प उपलब्ध ह;ैं
और स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार द्वारा गरित जविेषज्ञ सजमजत ने क्लोरफेजनरामाइन
मैजलएट और दफनाइलेफ्रीन हाइड्रोक्लोराइड यक्तु अन्य औषजधयों के जनयत खुराक संयोिन की िांच की, और उक्त जविेषज्ञ
सजमजत न े आगे यह जसफाररि की दक यही चेतावनी भारत म ें जनर्मित या आयाजतत और जवपणन दकए िान े वाल े
क्लोरफेजनरामाइन मैजलएट और दफनाइलफ्रे ीन हाइड्रोक्लोराइड युक्त जनयत खरु ाक संयोिन के सभी फॉमूिलिे न पर लाग ू
होनी चाजहए;
6411 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
और औषजध तकनीकी सलाहकार िोडि ने भी 16 फरवरी, 2026 को आयोजित अपनी िैिक म ें उक्त अजधसूचना
का.आ. स.ं 1717 (अ), तारीख 15 अप्रलै , 2025 के अजतररक्त, क्लोरफेजनरामाइन मजै लएट और दफनाइलेफ्रीन
हाइड्रोक्लोराइड यक्तु जनयत खरु ाक संयोिन के सभी जवजनर्मिजियो के जिक्री या जवतरण के जलए जनमािण को प्रजतिंजधत
करने के प्रस्ट्ताव की िांच की, और जवस्ट्तृत जवचार-जवमिि के िाि, औषजध तकनीकी सलाहकार िोडि इस िात पर सहमत
हुआ दक ऐस े जवजनर्मिजियो का उपयोग चार वषि स े कम आय ु के िालकों म ेंनहीं दकया िाना चाजहए;
और औषजध तकनीकी सलाहकार िोडि की उक्त जसफाररिों के आधार पर, केंद्रीय सरकार का यह समाधान ह ै दक
िनजहत म ें ििे म ें मानव उपयोग के जलए ऐसी औषजधयों के जनमािण, जिक्री या जवतरण को प्रजतिंध के माध्यम स े
जवजनयजमत करना आवश्यक और समीचीन ह।ै
अतः, अि, केंद्रीय सरकार औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 26क द्वारा
प्रिि िजक्तयों का प्रयोग करत े हुए, क्लोरफेजनरामाइन मैजलएट और दफनाइलफ्रे ीन हाइड्रोक्लोराइड युक्त जनयत खुराक
संयोिन के सभी जवजनर्मिजियो के जनमािण, जिक्री या जवतरण को इस ित ि के अधीन प्रजतिंजधत करती ह ै दक ऐसी औषजधयों
के जनमािता औषजध के लेिल और पैकेि इंसटि या प्रचार साजहत्य पर यह चते ावनी अंदकत करेंगे दक " जनयत खरु ाक संयोिन
का उपयोग चार वषि स ेकम आय ु के िालकों म ेंनहीं दकया िाना चाजहए"।
2. यह अजधसूचना रािपत्र म ेंइसके प्रकािन की तारीख स ेप्रवृि होगी।
[फा. स.ं X.11035/132/2024-DR]
हष ि मंगला, संयुक्त सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th August, 2026
S.O. 4595(E).— Whereas, the Central Government has issued a notification vide S.O. No. 1717 (E), dated
the 15th April, 2025, which was published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section(ii),
restricting the manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine
Maleate + Phenylephrine Hydrochloride, subject to the 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
promotional literature of the drug;
And whereas, the Central Government is satisfied that the use of other drug fixed dose combinations
containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride is likely to involve risk to children below
four years of age and whereas safer alternatives to such drugs are available;
And whereas, the Expert Committee constituted by the Ministry of Health and Family Welfare, Government
of India examined the fixed dose combinations of other drugs containing Chlorpheniramine Maleate and
Phenylephrine Hydrochloride, and the said Expert Committee further recommended that the same warning should be
applicable on all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine
Hydrochloride manufactured or imported and marketed in India;
And whereas, the Drugs Technical Advisory Board also examined the proposal in its meeting held on the 16th
February, 2026 to restrict the manufacture for sale or for distribution of all formulations of fixed dose combinations
containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, in addition to the said notification S.O. No.
1717 (E), dated the 15th April, 2025, and after detailed deliberation, the Drugs Technical Advisory Board agreed that
such formulations shall not be used in children below four years of age;
And whereas, on the basis of the said recommendations of the 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 or for distribution for human use of such drug in the country.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
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 combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, subject to the condition
that the manufacturers of such drugs 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]
HARSH MANGLA, Jt. Secy.
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and Published by the Controller of Publications, Delhi-110054.