India Ends Over-the-Counter Sale of Syrups, Mandates Prescriptions Amid Safety Concerns
核心洞察
The Union Health Ministry (搜索) has amended the Drugs Rules, 1945, removing syrups from Schedule K exemptions and ending their over-the-counter sale effective immediately.
A doctor's prescription from a registered medical practitioner is now mandatory for purchasing cough syrups and other syrup-based formulations at licensed pharmacies.
The reform follows contamination-linked child deaths in India and abroad, including 22 children who died after consuming cough syrup containing toxic diethylene glycol (搜索) (DEG) at levels hundreds of times above permissible limits.
The Union Health Ministry (搜索) has notified the Drugs (Fifth Amendment) Rules, 2026, removing syrup-based formulations from Schedule K of the Drugs Rules, 1945, and effectively ending their over-the-counter (OTC) availability across India. The amendment, published in the official gazette, took effect immediately upon publication.
Under the revised regulations, popular cough syrups and other syrup-based medicines will now strictly require a prescription from a registered medical practitioner at licensed pharmacies. The term "syrups" has been deleted from item 7 under the "Class of Drugs" category in Schedule K, which previously exempted certain categories of medicines from specific requirements governing their manufacture, sale, and distribution under the Drugs and Cosmetics Act.
Regulatory Process and Stakeholder Consultation
The move follows a draft notification issued by the government in December of last year, which invited objections and suggestions from stakeholders. The ministry stated that comments received from the public were duly considered before finalizing the amendment. The decision was made after consultation with the Drugs Technical Advisory Board (搜索) (DTAB), the country's highest statutory body on technical matters related to drugs.
With the exemption withdrawn, syrup-based medicines will now be subject to stricter regulatory provisions governing their sale and distribution. The amendment is expected to enhance traceability and regulatory supervision by ensuring that manufacturers and sellers comply with more stringent licensing and quality-control requirements.
Safety Concerns Driving Reform
The regulatory overhaul comes against the backdrop of recurring safety concerns over cough syrups produced in India, with several contamination cases drawing scrutiny both domestically and internationally. In one of the most serious recent incidents, at least 22 children, most of them from Rajasthan, died after allegedly consuming contaminated cough syrup. Investigations revealed the presence of diethylene glycol (搜索) (DEG), a toxic industrial chemical commonly used in products such as brake fluid and antifreeze. Tests conducted on the syrup samples found DEG levels to be several hundred times above the permissible limit of 0.1 percent.
The decision also follows tragic incidents of child deaths linked to contaminated syrups reported in Gambia, Uzbekistan, Madhya Pradesh, and Rajasthan, which underscored the need for tighter regulatory oversight of liquid oral formulations.
Broader Regulatory Context
The Central Drugs Standard Control Organisation (搜索) (CDSCO) has been reviewing regulatory measures aimed at improving compliance and tightening monitoring mechanisms across the pharmaceutical sector. Health experts have welcomed the reform, emphasizing that routine cough medicines require stricter regulatory oversight given the widespread practice of self-medication and the potential risks posed by substandard or contaminated products.
The amendment represents one of the most significant drug safety reforms in recent years, shifting syrup-based medicines from a relatively liberal distribution framework to a prescription-mandated model designed to safeguard patient health and ensure greater accountability throughout the pharmaceutical supply chain.