Centre to restrict cough syrup sales by unlicensed village pharmacists

Draft amendments propose removing "syrup" from Schedule K exemptions, tightening over-the-counter sales in small villages after Madhya Pradesh cough syrup deaths

Following the death of 22 children due to consumption of contaminated cough syrups in Madhya Pradesh three months ago, the Union Health Ministry has proposed amendments in the country’s drug rules to ensure a tougher criterion for their over-the-counter (OTC) sales in India. 

 

According to a draft notification, the ministry has proposed to drop the word ‘syrup’ from the Schedule K of the Drugs and Cosmetics Act, which exempts a segment of drugs from stringent manufacturing, distribution and sales related regulatory provisions of the Drugs Rules, 1940.

 

Under this category, an exemption was earlier given to a defined set of household remedies, which were allowed to be sold without a formal sales licence in villages with a population of not more than 1,000 people, provided there is no licensed dealer nearby.

 

 

This includes medicines such as anti-inflammatory tablets, including aspirin, paracetamol tablets, analgesic balms, antacid preparations, gripe water for use by infants and cough syrups.

 

People in the know told Business Standard that medications covered under Schedule K of the Drugs Rules are subjected to relaxed regulatory requirements, meaning they would face less strict licensing and monitoring.

 

“Some medicines in liquid form were listed simply as syrup, placing them in this category. Over the years, authorities observed that several medicinal syrups were being misused or illegally sold, especially cough and cold formulations,” an official with the regulatory authority said.

 

The move came after a similar recommendation to remove syrups from listing number 13 under the Schedule K was approved by the Drugs Consultative Committee (DCC) of India’s Central Drugs Standard Control Organisation (CDSCO). 

 

“The DCC was apprised about the recent incidences due to contaminated cough syrup and it was 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,” the minutes of the DCC meeting held on November 17, 2025 stated.

 

The draft notification proposes to remove the word syrup from the listing under the serial number 13, which currently reads “syrups, lozenges, pills and tablets for cough.”

 

“With only syrups removed, this indicates that pills, lozenges and tablets for cough and cold will remain available to be sold OTC from shops without a formal sales licence,” an industry executive said.

 

The enhanced monitoring and sales restriction come especially in face of the MP cough syrup death cases, which led to an alert by the World Health Organisation in October 2025.

 

The alert had indicated the presence of contaminants such as diethylene glycol in cough syrups consumed by children in MP.

 

The health ministry has sought comments on the proposed draft notification in 30 days, stating that the amendment is directly linked to public health and safety.

 

Industry experts suggested that the move may lead to a rural demand dip for cough syrups in the short term, as households may shift to home remedies or cheaper and available alternatives if syrup access becomes harder.

 

Rishi Agrawal, co-founder and chief executive officer at TeamLease RegTech, said that a big chunk of consumption for the cough/cold market is self-initiated for minor ailments and quick relief, and not planned clinical care. 

 

“Evidence from India shows self-medication contributes over 50 per cent, with cough, cold and fever being among the most common reasons,” he added.

 

So, when the rule changes, Agrawal said, “The need for relief (in coughs during winter and monsoon) would not disappear, but the demand can fall because access friction rises due to doctor visits, pharmacy compliance and higher prices.”