**Executive Summary**
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, to withdraw the licensing exemption for selling cough syrups in villages with populations under 1,000. Notified via Gazette Notification G.S.R. 927 (E) on December 30, 2025, the amendment mandates that cough syrups be dispensed exclusively through licensed pharmacies. This measure aims to strengthen regulatory oversight and ensure that syrup formulations align with contemporary public health and safety standards.
**Key Points / Main Content**
* **Regulatory Amendment**
* The word “Syrup” has been omitted from Schedule K, Serial No. 13, Entry 7 of the Drugs Rules, 1945.
* This change effectively cancels the previous exemption that allowed the sale of cough syrups in small villages without retail sale licensing.
* **Licensing and Dispensing Requirements**
* The sale and dispensing of cough syrups in villages with a population of less than 1,000 must now comply with the retail sale licensing provisions of the Drugs and Cosmetics Act, 1940.
* Cough syrups can now only be sold through pharmacies that are duly licensed under the established regulatory framework.
* **Objectives of the Measure**
* To enhance regulatory control and oversight over the distribution of syrup formulations.
* To align the exemption framework with modern public health requirements and promote responsible sales practices.
* To ensure uniform compliance with regulatory standards for drugs across all regions of the country.
**Impact Analysis**
**Retailers in Small Villages (Population < 1,000)**
**Impact**
These entities are no longer exempt from retail licensing requirements for the sale of cough syrups.
**Action Required**
They must obtain necessary retail sale licenses and ensure cough syrups are dispensed only through licensed pharmacies as per the Drugs and Cosmetics Act, 1940.
**Manufacturers and Distributors**
**Impact**
These stakeholders are now responsible for ensuring their supply chain complies with the tightened regulatory oversight for syrup formulations.
**Action Required**
They must ensure strict adherence to all applicable licensing and regulatory requirements when dealing with cough syrups.
**Ministry of Health and Family Welfare / Regulatory Authorities**
**Impact**
The amendment provides a stronger legal basis for monitoring the distribution of cough syrups in previously exempt areas.
**Action Required**
Authorities must monitor and enforce compliance with the new licensing requirements to ensure public health safety.
Key Entities Referenced
Drugs Rules, 1945: The primary regulatory framework being amended to withdraw exemptions for the sale of cough syrups in small villages.
Schedule K: A specific schedule within the Drugs Rules that provides exemptions for certain classes of drugs from retail sale licensing requirements.
Drugs and Cosmetics Act, 1940: The parent legislation governing the import, manufacture, distribution, and sale of drugs in India.
Villages with population less than 1,000: The specific geographic locations central to the policy change where unlicensed sale of cough syrups is no longer permitted.
Ministry of Health and Family Welfare: The primary Union Ministry responsible for notifying and implementing these regulatory amendments to enhance drug safety.
Ministry of Health and Family Welfare
Union Ministry of Health and Family Welfare
Amends Drugs Rules, 1945; Exemption for Sale
of Cough Syrups in Small Villages Withdrawn
Key Amendment to Drugs Rules to Enhance Regulatory
Control Over Cough Syrups notified
प्रव तथ: 16 JUN 2026 11:41AM by PIB Delhi
The Ministry of Health and Family Welfare has notified an amendment to the Drugs Rules, 1945, vide
Gazette Notification G.S.R. 927 (E) dated 29th December 2025, published in the Gazette of India
Extraordinary on , Part II, section 3, sub-section (i), dated the 30th December, 2025, omitting the word
“Syrup” from Schedule K, Serial No. 13, Entry 7 under the heading “Class of Drugs”.
Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and
Cosmetics Act, 1940 and the Rules made thereunder for specified classes of drugs. Prior to this
amendment, Entry No. 13 of Schedule K permitted the sale of cough syrups in villages with a population
of less than 1,000 without requiring compliance with certain retail sale licensing provisions.
With the omission of the word “Syrup” from the said entry, this exemption will no longer be available for
cough syrups. Consequently, the sale and dispensing of cough syrups in smaller villages will now be
required to take place only through duly licensed pharmacies in accordance with the provisions of the
Drugs and Cosmetics Act, 1940 and the Rules framed thereunder.
The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align
the exemption framework with contemporary public health and safety requirements. The measure is
expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance
with regulatory standards across the country.
Manufacturers, distributors and retailers dealing with cough syrups are advised to ensure strict adherence
to the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the
Drugs Rules, 1945.
The e-Gazette notification can be accessed at https://egazette.gov.in/WriteReadData/2026/273467.pdf
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SR
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