*Centre Moves to End Over-the-Counter Sale of Cough Syrups; Prescription Now Mandatory, Says Health Ministry.

Draft rules propose removing cough syrups from Schedule K exemptions after child deaths linked to contaminated formulations; Nimesulide above 100 mg also banned.

New Delhi,:- The Central Government has proposed a major change in how cough syrups are sold across India. As per a draft notification from the Ministry of Health and Family Welfare, cough syrups will no longer be available over-the-counter and can only be purchased with a doctor’s prescription. 

 What’s the New Rule?

The Health Ministry has proposed removing the word “syrup” from Entry 13 of Schedule K of the Drugs Rules, 

Currently, Schedule K allows certain household remedies  including aspirin, paracetamol, antacids, gripe water, and cough syrups — to be sold without a formal sales licence in villages with populations under 1,000, provided no licensed dealer is nearby. 

The draft amendment will delete cough syrups from this exemption list. Lozenges, pills or tablets for cough will continue to remain available 

 Why the Change?

The move follows the deaths of at least 22 children in Madhya Pradesh after consuming contaminated cough syrups. The WHO had issued a global alert in October 2025 over toxic levels of diethylene glycol (DEG) found in Coldrif cough syrup made by Tamil Nadu-based Sresan Pharmaceuticals. 

An expert committee under the drug regulator noted: “In view of the recent incidences due to contaminated cough syrup, it is proposed that the exemption provided under entry number 13 of Schedule K of Drugs Rules, 1945 in respect of syrups for cough may be deleted”. 

 Other Key Changes.

-Nimesulide ban: The government has banned the manufacture, sale and distribution of all oral formulations containing Nimesulide above 100 mg in immediate-release form, citing health risks.

Age restrictions: The Centre is separately tightening rules for paediatric use. Cough and cold medications should not be prescribed or dispensed to children under 2 years. Select fixed-dose combinations of chlorpheniramine maleate + phenylephrine are already banned for children below 4 years. 

Impact on Rural Sales.

The Drugs Consultative Committee said the change aims to stop unlicensed village pharmacists from selling cough syrups without oversight. Without a licence, tracing contaminated drugs back to manufacturers becomes “nearly impossible”. 

Industry experts said rural demand may dip short-term as households shift to home remedies if syrup access becomes harder. 

What Happens Next?

The draft rules are open for public comments for 30 days from publication in the Official Gazette. After considering objections and suggestions, the Central Government will issue a final notification. 

The Indian Pharmacists Association has also advised pharmacies not to dispense cough syrups to children below 2 years, even with a prescription. 

The rule change applies specifically to cough syrups Tablets, lozenges and pills for cough will still be available OTC.