Last Updated on June 17, 2026 by The Health Master
Over-the-Counter Cough Syrups
The Union Ministry of Health has officially ended the sales of over-the-counter cough syrups in the nation.
As a result of a new amendment to the Drugs Rules of 1945, all cough syrups will require a doctor’s prescription to be legally sold.
The government has issued a notification No. GSR 477(E) dt 09-06-2026.
Download the notification No. GSR 477(E) dt 09-06-2026
This new ruling was implemented following several incidents across different nations of the contaminated nature of these types of drugs.
For the owners of retail pharmacies, doctors, and the public, it is critical that each individual be made aware of these new regulations.
Understanding the Schedule K Amendment
To understand the reason for this regulation, it is first important to understand how the drugs have been classified within India for several decades.
Under the Drugs and Cosmetics Act, Schedule K includes a list of drugs that are to be exempted from the requirements for prescription of those drugs.
These items include items like aspirin, paracetamol tablets, and balms with analgesic properties.
Entry Number 7 within Schedule K has long permitted the sale of syrups, lozenges, pills, and tablets that are prescribed for the relief of coughs.
The new amendment to the Drugs Rules of 1945, however, deletes the inclusion of the word “syrup” within this entry.
Timeline of the Amendment
The steps that the health ministry took to create this amendment between 2025 and 2026 are as follows:
Late December 2025: The Ministry of Health announced the creation of a draft amendment to Schedule K, with a 30-day period to receive feedback from the individuals impacted by such an amendment.
Early 2026: The Ministry of Health received and reviewed the suggestions for and objections to the proposed amendment.
June 9, 2026: The amendment was officially signed by the Ministry of Health and Health Department Director General and will go into effect upon publication in the Official Gazette of India.
Why the Health Ministry Cracked Down on Cough Formulations
The major reason for the Health Ministry of India’s creation of this regulation was due to the dangers of several types of cough syrups that were manufactured for sale within the nation’s pharmacies.
The Drugs Consultative Committee (DCC), a group of experts within the health and regulatory policy of India, led by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, recommended the amendment to Schedule K after discovering that many of the cough syrups that were manufactured contained harmful solvents.
The Contamination Risk: DEG and EG
Many of the ingredients required to be included within cough syrups to enable the active ingredients to remain in liquid form and soluble are the solvents Propylene Glycol and Glycerol.
However, it has been found that many of the batches of Propylene Glycol that are manufactured at lower cost often contain lethal amounts of two other chemicals:
- Diethylene Glycol (DEG)
- Ethylene Glycol (EG)
Both chemicals are often associated with the development of kidney failure, neurological damage, and the failure of multiple organs within the body.
Therefore, the government desires to reduce the distribution of these medications to the general public.
Furthermore, the Central Drugs Standard Control Organisation (CDSCO) has announced their intention to work with the pharmaceutical manufacturing companies that produce these medications to find an alternative to Propylene Glycol that can be used in place of it.
New Paediatric Dosing Guidelines: A Strict Warning for Parents
Beyond the general restrictions on these medications being sold to the public without a prescription, the Health Ministry has also published guidelines for doctors on how to treat young children with cough syrups.
| Age Group | Regulatory & Clinical Guidance |
| Under 2 Years Old | Strictly Prohibited. Cold and cough medicines must not be prescribed under any circumstances. |
| Under 5 Years Old | Not Recommended. Healthcare providers are advised to avoid these formulations for toddlers. |
| Above 5 Years Old | Allowed with Caution. Requires thorough clinical evaluation, tight medical supervision, and meticulous dose tracking. |
Key Changes for Stakeholders
Consumers:
Previously, consumers were able to purchase cough syrups from chemists without the need for a prescription.
Now, individuals will have to obtain a prescription from a doctor to purchase these medications.
Retail Chemists:
Chemists are prohibited from selling over-the-counter cough syrups without a prescription and could be punished for such distribution of the medications.
Manufacturers:
The manufacturers of these medications will be required to adhere to new quality control standards for their medicines and will have to participate in consultations between themselves and the regulators about the replacement of Propylene Glycol with an alternative soluble ingredient.
FAQs
Q. What is Schedule K under the Drugs Rules of 1945?
Ans: Schedule K is a list of drugs that are to be exempted from the requirements for the prescription of those drugs. These exemptions allow many medicines to be sold to the public over the counter at various retail outlets.
Q. Can I still buy cough lozenges and tablets without a prescription?
Yes. While cough syrups will be subject to a prescription requirement, lozenges and tablets that are used to treat the same symptoms are not yet included in the new regulations.
