The Ministry of Health and Family Welfare has removed the word "Syrup" from Schedule K, Serial No. 13, Entry 7 under the category "Class of Drugs." The amendment has been notified through Gazette Notification G.S.R. 927(E) dated December 29, 2025 and published in the Gazette of India Extraordinary, Part II, section 3, sub-section (i), dated the 30th December, 2025.

Under this amendment, cough syrups can no longer be sold without prescription. Entry No.13 of Schedule K of Drugs Rules, 1945, permitted the sale of cough syrups in villages with a population of less than 1,000 people without needing a strict, formal retail drug license or a registered pharmacist on site to help people in rural areas access basic medicine. However, cough syrups are no longer exempt from regulation due to the removal of the word "Syrup" from the exemption. Now, cough syrups can only be sold and dispensed in smaller villages through licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and its related regulations.

According to the Ministry, the amendment has been introduced to strengthen oversight of syrup-based formulations and align the regulatory framework with contemporary public health and safety requirements.

Which syrup medicine will now require a prescription?

By deleting the word "Syrup" from Entry 7 of Serial No. 13 in Schedule K, all oral liquid syrup formulations that were previously categorised as Over-The-Counter (OTC) "household remedies" now strictly require a doctor's prescription.

1. All cough and cold syrups

Cough syrups are the main category targeted by the amendment. Any liquid formulation used to treat respiratory symptoms is no longer OTC:

  • Expectorants and Mucolytics: Syrups used to thin and loosen mucus in a wet cough containing ingredients like Ambroxol, Guaifenesin, or Bromhexine.
  • Antitussives or Cough suppressants: Syrups used to quiet dry coughs, containing ingredients like Dextromethorphan.
  • Decongestant and antihistamine combos: Common cold and flu syrups that mix allergy and congestion relievers.

2. Pediatric oral liquid formulations

Pediatric cold/flu syrups and suspensions: Paracetamol and Ibuprofen tablets remain on the exempt list as simple household remedies, but liquid oral suspensions and syrups used for pediatric pain, fever, or cold symptoms will now require a prescription.

3. Other medicated liquid

Serial No. 13 of Schedule K was explicitly designed for common household remedies that people regularly bought without seeing a doctor. While lozenges for coughs remain exempted, any medicinal formulation in liquid "Syrup" form has been entirely stripped of its OTC status.

What can you still buy without a prescription?

The notification only targets the liquid Syrup format. You can still buy the following over the counter:

  • Cough lozenges and throat tablets
  • Standard paracetamol or aspirin tablets/pills
  • Antacids
  • Analgesic balms
  • Topical antiseptics like Povidone-iodine
  • ORS powders

Chemists are now legally required to check for a valid prescription from a Registered Medical Practitioner (RMP) before dispensing any medicinal cough or cold syrup.

This amendment comes months after series of child deaths linked to consumption of toxic cough syrups. These events sparked demands for enhanced oversight and more stringent inspections on the production and distribution of syrup formulations.



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