AIOCD Welcomes Government Decision to Bring Cough Syrups Under Stricter Control

New Delhi: Welcoming the amendment that the Central Government has removed cough syrups from the list of exempted household remedies under Schedule K of the Drugs Rules, 1945, bringing their sale under stricter regulatory oversight, the All India Organisation of Chemists & Druggists (AIOCD) said the move would help prevent misuse of medicines, strengthen patient safety, and enhance compliance with drug regulations.

In a press note issued on June 16, 2026, AIOCD praised the notification G.S.R. 477(E) dated June 9, 2026, issued by the Ministry of Health and Family Welfare, through which the word "Syrups" has been omitted from Item (7) under Serial No. 13 of Schedule K of the Drugs Rules, 1945.

The amendment was notified by the Ministry of Health and Family Welfare under the Drugs (Fifth Amendment) Rules, 2026. The notification was issued after considering objections and suggestions received from the public regarding draft rules published on December 30, 2025.

Under the amendment, in Schedule K, under the heading "Class of Drugs", against Serial Number 13, Item Number (7) has been modified by deleting the word "Syrups."

Before the amendment, Item (7) under Serial No. 13 listed: "Syrups, lozenges, pills and tablets for cough."

With the deletion of the word "Syrups," only lozenges, pills and tablets for cough continue to enjoy the exemption available under Schedule K.

Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 and related rules for specified categories of products under defined conditions.

Serial No. 13 of Schedule K covers certain household remedies that may be sold in villages with populations not exceeding one thousand persons and where no licensed dealer exists, subject to specific conditions. These conditions include that:

• The drugs should not contain substances specified in Schedules G, H, or X.
• The drugs should be sold in the original containers of licensed manufacturers.
• Other licensing-related conditions prescribed under the Drugs Rules must be complied with.

AIOCD has consistently been raising concerns before the Government regarding the misuse of Schedule K provisions by certain entities, including online pharmacies and others, for the sale and supply of medicines without adhering to the safeguards envisaged under the Drugs and Cosmetics Act and Rules. The organisation has repeatedly demanded a comprehensive review of Schedule K to prevent misuse and to strengthen patient safety.

As per the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder, as amended from time to time, the pharmaceutical retail sector in India has witnessed exceptional growth over the years.

In view of the substantial increase in the number of licensed chemist shops across the country, there is an urgent need to rationalise and significantly restrict the stocking and dispensing of medicines under the provisions of Schedule K by doctors and clinics. Therefore, a comprehensive review and immediate amendment of Schedule K is required to prevent misuse, ensure a level playing field, and safeguard public health.

Welcoming the amendment, AIOCD President J. S. Shinde and General Secretary Rajiv Singhal stated that this decision is a positive and significant step towards ensuring responsible distribution of medicines and curbing regulatory loopholes that have been exploited in recent years.

The leaders further stated that while this amendment is a good beginning, there is still an urgent need for a detailed review of Schedule K. They urged the Ministry of Health and Family Welfare to undertake a comprehensive revision of Schedule K in consultation with all stakeholders, including regulators, healthcare professionals, pharmacists, chemists and druggists, patient groups, and industry representatives.

AIOCD believes that any exemption under the Drugs Rules must be aligned with the paramount objective of patient safety and public health. The organisation remains committed to working with the government to ensure that medicines are dispensed through proper channels and in compliance with applicable laws and regulations.

In view of the latest amendment, AIOCD has also issued an advisory to all its member associations across the country to ensure strict compliance with statutory provisions governing the sale of medicines and to exercise utmost caution while dispensing cough syrups and other prescription medicines.

To view the official document, click the link below: