New Delhi: The Union health ministry has proposed an amendment to remove cough syrups from Schedule K, to make its sales strictly under prescription of a medical practitioner.
The move comes in the backdrop of the recent death of over 20 children in Madhya Pradesh owing to contaminated cough syrup and taking into account the past incidences where death of children reported in other countries due to the contaminated cough syrups exported from the country.
The Ministry, in its draft amendment to the Drugs Rules, 1945, proposed to remove the word syrup from the entry number seven of serial number 13, under the Schedule K.
The Serial number 13 exempts house hold remedies such as aspirin tablets, paracetamol tablets, analgesic balms, among others from the requirement of prescription for purchase from retail stores. Entry number seven in this currently exempts “syrups, lozenges, pills and tablets for cough” from certain norms under the Drugs and Cosmetics Act, which in effect allows retailers to sell the drugs over-the-counter with required license.
The draft rules shall be taken into consideration on or after the expiry of thirty days from the date on which the draft it is published and circulated through the Official Gazette. Objections and suggestions received from any person within the period will be considered by the Central government.
It may be noted that the Ministry, while dealing with the deaths of children reported in Madhya Pradesh in October, has advised the medical practitioners across the country that cough and cold medicines should not be prescribed to children below 2 years and these are not recommended for children below the age of five. For children above this age, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing.
Removal of cough syrups from Schedule K would further ensure that these medicines are not accessible to the patients without the prescription of a medical practitioner.
As reported earlier, the recent meeting of the Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters that require uniform implementation across the country, has recommended removal of cough syrups from Schedule K list.
The Committee also directed the Central Drugs Standard Control Organisation (CDSCO) to hold consultations with the stakeholders regarding the concerns on the use of propylene glycol and its impurities such as the diethylene glycol (DEG) and Ethylene Glycol (EG) and the use of alternative excipients.
The DCC, in its meeting held on November 17, 2025, under the Chairmanship of Drugs Controller General (India), Dr Rajeev Singh Raghuvanshi, deliberated the recent incidents due to contaminated cough syrup and a proposal to delete the exemption provided under Entry no.13 of Schedule K of Drugs Rules, 1945 in respect of syrups for cough.
“DCC deliberated the matter and approved the proposal,” said the minutes of the meeting.
The Committee was also apprised that various cases regarding concerns on the use of propylene glycol and its related impurities i.e. DEG and EG in the Syrups for usage in the paediatric population for therapeutic use have been reported.
It observed that many oral liquid formulations are manufactured using high risk solvents including propylene glycol. Therefore, there is risk of contamination of these formulations with DEG/EG.
The DCC also discussed the possibility of using alternative excipients and formulations in the place of propylene glycol.
The Committee opined that the “CDSCO may initially have consultation with the stakeholders to take stock of the situation and to collate the details of the formulations that are manufactured using high risk solvents for taking further appropriate action”.
It may be noted that the presence of DEG or EG has been identified in cough syrup products following the recent incidence in Madhya Pradesh. The World Health Organisation (WHO), in 2022, alleged that the presence of DEG in cough syrups exported from India was the cause of death of several children in Gambia.
Following the death of children in Madhya Pradesh, Union health ministry has said that samples of Coldrif cough syrup tested by the state drug regulator from Sresan Pharma in Kanchipuram, Tamil Nadu, turned out to contain DEG beyond the permissible limit, according to the Union health ministry.
The Central drug regulator recommended cancellation of the manufacturing license of the manufacturer of cough syrup Coldrif, based on inspection findings. Criminal proceedings have also been initiated, said the authorities.
Following this, CDSCO has requested all drug controllers in the States and Union Territories (UTs) to ensure testing of raw materials and excipients before manufacturing and release of the batch to the market.
It also mentioned that as per Drugs Rules including Rule 74 (c) and rule 78 (c) (ii), the licensee shall either in his own laboratory or in any laboratory approved by the licensing authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U.
“All the state/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).
“Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only,” added the official.
