Govt's cough syrup move may shift rural demand towards Ayush remedies

The removal of cough syrups from Schedule K could make access more prescription-dependent in rural India, potentially shifting some demand towards Ayush products

The government’s move to tighten access to cough syrups by removing their ‘Schedule K exemption’ could shift some rural demand towards Ayurveda, Siddha and Unani (ASU) syrups.

 

By removing cough syrups from the Schedule K exemption list, the government has tightened their over-the-counter (OTC) availability in parts of rural India, where they have traditionally been sold through relaxed licensing channels.

 

The move could make access more dependent on prescriptions and licensed pharmacies, potentially reshaping purchasing behaviour in these markets.

 

Ayurvedic and Ayush medications generated ₹171 crore in sales during July 2025-June 2026.

 

The overall cough and cold market is estimated at around ₹6,700 crore, according to market research firm Pharmarack. It highlighted significant headroom for growth if demand shifts towards Ayush remedies.

 

The move follows the Union Health Ministry's decision to remove the word 'syrup' from Schedule K of the Drugs Rules. The provision had allowed certain household remedies to be sold without a formal sales licence in villages with a population below 1,000 if no licensed dealer was available nearby.

 

Prescriptions will now be required to buy cough syrups, with the government saying the amendment is intended to strengthen regulatory oversight and align the exemption framework with current public health and safety requirements.

 

“There may be some initial shift towards products that remain more readily accessible, including Ayush syrups, particularly in areas where access to healthcare professionals is limited,” an executive with a Delhi-based pharma company told Business Standard.

 

Sheetal Sapale, vice-president (commercial) at Pharmarack, said rural markets are major consumers of cough syrups, with Vidarbha, Madhya Pradesh, Chhattisgarh and Jharkhand among the key markets.

 

The change could pose challenges in rural areas, where up to 75 per cent of primary care is handled by rural medical practitioners (RMPs) or unqualified chemists. They often prescribe syrups for common coughs and colds without diagnostics.

 

“The effect will be uneven and will depend on whether the purchase is self-directed or doctor-directed,” said Rishi Agrawal, cofounder and chief executive officer (CEO) of Teamlease RegTech.

 

“While obtaining a prescription may be easy in metropolitan cities, access to qualified doctors can be limited in rural areas. If parents are dealing with a coughing child at night, they are likely to choose a low-friction solution off the shelf. That shelf still has Ayush syrups. ASU products are regulated separately under Chapter IVA and Schedule T of the Drugs Act, and the amendment does not affect them,” he said.

 

This could benefit popular Ayurvedic cough remedies such as Honitus (Dabur India), Koflet (Himalaya Wellness), Tulsi Cough Syrup (Zandu, part of Emami) and other regional brands sold through kirana stores, general stores and e-commerce platforms without a prescription.

 

Experts said fragmented rural distribution networks often push low-income families towards affordable, locally available remedies prescribed by neighbourhood practitioners.

 

Move comes after syrup deaths 

The move follows the Madhya Pradesh cough syrup deaths that triggered a WHO alert in October 2025. At least 22 children died in Chhindwara after consuming syrups contaminated with industrial chemicals ethylene glycol (EG) and diethylene glycol (DEG).

 

Senior health ministry officials told Business Standard the amendment had been under consideration for some time following recommendations by the Drugs Consultative Committee (DCC) of the 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,” minutes of the DCC meeting held on November 17, 2025 stated.

 

People familiar with the matter said drugs covered under Schedule K are subject to relaxed licensing and monitoring requirements.

 

"Over the years, authorities observed that several medicinal syrups, especially cough and cold formulations, were being misused or illegally sold," a regulatory official said.

 

The notification removes the word "syrup" from serial number 13 of Schedule K, which currently reads "syrups, lozenges, pills and tablets for cough."

 

"With only syrups removed, pills, lozenges and tablets for cough and cold will continue to be available OTC through shops without a formal sales licence," an industry executive said. 

The All India Organisation of Chemists and Druggists (AIOCD) has further asked for a detailed review of Schedule K regime. 

 

"In view of substantial increase in the number of licensed chemist shops across the country, there is an urgent need to rationalise and significantly restrict the stocking and dispensing of medicines under Schedule K by doctors and clinics," the chemists body said.

 

Doctors say Ayush syrups may also come under prescription lens 

While welcoming the move, doctors said Ayush syrups may eventually come under a prescription regime because of their therapeutic use.

 

"Such drugs also have a dosage and a time-dependent usage. This is something we need to be aware of as they will have to have a prescription requirement at some point," said Abhijit Ahuja, pulmonologist at Mumbai's Saifee Hospital.

 

Rajiv Uttam, director for paediatric pulmonology and paediatric care at Medanta Gurugram, said the larger objective was to discourage self-medication and encourage proper diagnosis.

 

"Simply switching from one syrup category to another does not address the underlying cause of a cough, which may range from a minor viral infection to asthma, tuberculosis, reflux disease or other significant illnesses," he said.

 

Doctors also said the move could improve traceability during investigations involving adverse events, contamination or product recalls.

 

"It creates a clearer documentation trail, making it easier for regulators to track distribution patterns, identify unusual spikes in consumption and conduct targeted audits," Uttam said.