Cough syrups require doctor's prescription for purchase, to not fall under OTC, says Health Ministry

The Ministry of Health and Family Welfare has notified the Drugs (Fifth Amendment) Rules, 2026, removing “syrups” from the list of medicines exempted under Schedule K of the Drugs Rules, 1945. With this amendment, syrup-based formulations, including cough syrups, will no longer qualify for Over-The-Counter (OTC) sale and can be dispensed only on a doctor's prescription.

The notification states that the central government invoked its powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, to introduce amendments to the Drugs Rules, 1945.

It notes that "these rules may be called the Drugs (Fifth Amendment) Rules, 2026" and further specifies that they "shall come into force on the date of their publication in the Official Gazette". The amendment provides that the word "Syrups" will be removed from item number seven under the "Class of Drugs" section in Schedule K of the Drugs Rules, 1945.

Schedule K of the Drugs Rules, 1945, outlines classes of medicines that are exempt from certain regulations related to their manufacture, sale and distribution, provided they meet prescribed conditions.

The Centre's draft National Formulary of India (NFI) 2026 proposed that cough and cold medications should neither be prescribed nor dispensed to children below the age of two, Mint reported earlier. It further stated that such medicines are generally not advised for children under five years unless there is a clear clinical need and their use is closely monitored by a healthcare professional.

NHRC's notices to state govts after cough syrup deaths

The development comes after the National Human Rights Commission (NHRC) issued notices to the governments of Madhya Pradesh, Rajasthan and Uttar Pradesh last year in October over reports that contaminated cough syrup may have caused the deaths of several children.

The Commission also asked the Union Ministry of Health and Family Welfare, along with relevant regulatory authorities, to investigate the issue and implement urgent safeguards. Taking cognisance of a complaint alleging that 12 children died in Madhya Pradesh and several others in Rajasthan after consuming the syrup, the NHRC mentioned that the claims indicate serious lapses in drug safety, regulation and oversight, raising concerns about potential violations of the right to life and health.

Acting under the provisions of the Protection of Human Rights Act, 1993, a Bench headed by NHRC Member Priyank Kanoongo directed the Principal Secretaries of the Health and Family Welfare Departments in Rajasthan, Madhya Pradesh and Uttar Pradesh to conduct an immediate inquiry. The Commission also ordered the collection and testing of samples of the suspected cough syrup and called for prompt action to curb the sale of counterfeit or substandard medicines.

WHO's alert last year

The World Health Organisation (WHO) issued a medical product alert last year concerning three cough syrups manufactured in India — Coldrif, Respifresh TR and ReLife — after identifying them as "substandard". The global health body urged regulators across countries to immediately notify authorities if any of these products are detected in their markets. The warning came in the wake of the deaths of children in Madhya Pradesh, most of them below five years of age, who reportedly suffered suspected kidney failure after being administered Coldrif.

The WHO called for intensified monitoring of pharmaceutical supply chains in regions that could be exposed to the affected products. It also advised authorities to strengthen oversight of informal and unregulated markets. According to a PTI report, the organisation said, “Increased surveillance of the informal/unregulated market is also advised.”

The alert noted that India's Central Drugs Standard Control Organisation (CDSCO) informed the WHO on 8 October about the detection of Diethylene Glycol (DEG) in at least three oral liquid medicines. The notification followed WHO's identification on 30 September of localised clusters of acute illness and child deaths in India.

The CDSCO said the children affected in the incidents had reportedly consumed the contaminated medicines. It added that state authorities had responded by stopping production at the facilities linked to the products and suspending their manufacturing and marketing approvals.