Health Ministry ends OTC exemption for syrups in major drug safety reform

The Union Health Ministry has revised drug regulations to bar the over-the-counter sale of syrups, including cough syrups, amid concerns over medicine quality and patient safety.

Tighter controls on syrups

The decision is intended to place syrup-based medicines under tighter regulatory control and ensure greater oversight of their distribution, reported PTI quoting official sources.

Also Read: Tamil Nadu bans 'Coldrif' cough syrup after 11 child deaths in MP, Rajasthan

The change has been introduced through the Drugs (Fifth Amendment) Rules, 2026, which have been notified in the official gazette. The revised provisions took effect immediately upon publication.

Under the notification issued by the Ministry of Health and Family Welfare, the term "syrups" has been removed from item 7 under the "Class of Drugs" category in Schedule K of the Drugs Rules, 1945.

Exemption withdrawn

Schedule K lists certain categories of medicines that are exempt from specific requirements governing their manufacture, sale and distribution under the Drugs and Cosmetics Act and related rules, subject to prescribed conditions.

With the amendment, syrups will no longer be covered under those exemptions, bringing their sale under stricter regulatory provisions.

Also Read: Coldrif cough syrup deaths: ED attaches properties of Sresan Pharma in Chennai

The move follows a draft notification issued by the government in December last year seeking objections and suggestions from stakeholders.

The ministry said the comments received from the public had been considered before finalising the amendment after consultation with the Drugs Technical Advisory Board (DTAB), the country's highest statutory body on technical matters related to drugs.

Safety concerns behind move

The decision comes against the backdrop of increased regulatory scrutiny of cough syrups and other liquid oral formulations in recent years following reports of contamination-linked deaths of children in several countries.

Also Read: Cough syrup deaths: CAG report already flagged regulatory lapses in TN last year

The report further stated that the latest amendment is expected to enhance traceability and regulatory supervision of syrup-based medicines by ensuring that manufacturers and sellers comply with stricter licensing and quality-control requirements.

The decision comes against the backdrop of recurring concerns over the safety of cough syrups produced in India, with several contamination cases drawing scrutiny both within the country and abroad.

CDSCO review underway

The Central Drugs Standard Control Organisation (CDSCO) has been reviewing regulatory measures aimed at improving compliance and tightening monitoring mechanisms across the pharmaceutical sector.

Also Read: Cough syrup deaths: Noida pharma firm stops manufacturing, India begins probe

In one of the most serious recent incidents, at least 22 children, most of them from Rajasthan, died last year after allegedly consuming contaminated cough syrup.

Investigations revealed the presence of diethylene glycol (DEG), a toxic industrial chemical commonly used in products such as brake fluid and antifreeze.

Contamination cases

Tests conducted on the syrup samples found DEG levels to be several hundred times above the permissible limit of 0.1 per cent.

Similar contamination allegations were linked to child deaths in The Gambia and Uzbekistan, while another cough syrup contamination case was reported in Cameroon. (With agency inputs)