Cough Syrup Now Requires Doctor's Prescription: Government Revises

The central government has introduced new regulations requiring a doctor's prescription for the purchase of cough syrups. As part of the revised drug rules, syrups have been removed from the list of medicines that could previously be purchased directly from stores without restrictions. The government stated that this move will enhance monitoring and quality control of syrup-based medicines. Manufacturers and sellers of syrups will now need to adhere to stricter licensing and quality control standards.

The decision follows incidents of contaminated cough syrups causing fatalities. In October 2025, 26 children in Madhya Pradesh's Chhindwara district died due to toxic cough syrup produced by Srisan Pharma. The company's director, Govindan Ranganathan, was arrested in connection with the case. Additionally, two doctors were arrested by SIT for prescribing the implicated syrup, which led to the deaths of five children.

The government had previously implemented measures to improve drug safety and quality. In 2022-23, concerns about the quality of Indian-made cough syrups arose internationally after reports of child fatalities in African countries and Uzbekistan. Following these incidents, mandatory testing of cough syrups in government labs before export was introduced, along with stricter Good Manufacturing Practices (GMP) standards for pharmaceutical units. Several companies faced license suspensions and production-related actions.

Under the new rules, Schedule K of the Drugs Rules, 1945, which previously granted exemptions for certain medicines, has been amended to exclude syrups. Experts have noted that even minor errors in the production or storage of syrup-based medicines can impact their quality, making stricter regulations essential.

Key Points

• Cough syrups now require a doctor's prescription for purchase under revised drug rules.
• Syrups removed from Schedule K of the Drugs Rules, 1945, which previously allowed exemptions.
• Stricter licensing and quality control measures introduced for syrup manufacturers and sellers.
• In October 2025, 26 children in Madhya Pradesh died due to contaminated cough syrup from Srisan Pharma.
• Government has implemented mandatory testing and stricter GMP standards for cough syrup production and export.