The Union Ministry of Health and Family Welfare recently notified an amendment to the Drugs Rules, 1945. It removed the word “syrups” from Schedule K under the heading ‘Class of Drugs’, thereby withdrawing the exemption for sale of cough syrups in small villages without requiring compliance with certain retail sale licensing provisions.

What does the amendment do?

The Ministry, in a press release, said that Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder for specified classes of drugs. Prior to the amendment, ‘Entry No. 13 of Schedule K’ permitted the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing provisions. With the omission of the word “syrup” from the entry, this exemption will no longer be available for cough syrups.

It said that consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder.

The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and is expected to promote responsible distribution of sale of cough syrups while ensuring greater compliance with regulatory standards across the country, the release said.

Concerns over adulteration

While the move is aimed at enhancing regulatory control over cough syrups, it has brought the spotlight back on concerns over the quality of cough syrups manufactured in India. The debate extends beyond access and misuse, to questions of manufacturing standards, ensuring quality and regulatory oversight, particularly in the wake of international scrutiny over contaminated Indian-made cough syrups linked to child deaths.

In October 2025, the deaths of at least 20 children in Madhya Pradesh were linked to a cough syrup, Coldrif, manufactured by Sresan Pharmaceuticals in Kancheepuram district, Tamil Nadu. Samples collected from the unit were declared “not of standard quality” and were found to be adulterated with Diethylene Glycol (DEG), a toxic substance harmful to health.

That month, the World Health Organization (WHO) issued a “WHO Medical Product Alert” referring to three substandard (contaminated) oral liquid medicines identified in India including Coldrif cough syrup. India’s Central Drugs Standard Control Organisation had reported to WHO the presence of DEG in specific batches of Coldrif, Respifresh TR and ReLife - manufactured by Rednex Pharmaceuticals, and Shape Pharma respectively.

This is one among the multiple alerts issued by WHO on contaminated medicines. In January 2023, WHO, in a statement said, that there were several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of DEG and ethylene glycol. The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries. Most are young children under the age of five. These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even when taken in small amounts and should never be found in medicines, its statement said.

Based on country reports, WHO had issued three global medical alerts addressing these incidents - on October 5, 2022 focused on the outbreak in the Gambia, on November 6, 2022 focused on Indonesia and on January 11, 2023 focused on Uzbekistan, it said.

What is the move’s impact?

S. A. Ramesh, president of the Tamil Nadu Chemists and Druggists Association, said this move (amendment) is unlikely to have a significant impact, as it would mainly reduce accessibility. “Already, cough syrups are being sold only on doctor’s prescription in licensed pharmacies. Under Schedule K, products such as syrup for cough, balm were allowed to be sold in non-pharmacies using 20A and 21A licenses. Now, with the removal of “syrup”, only licensed pharmacies in the small villages can sell cough syrups,” he said.

What is needed is stronger monitoring of drug quality, he added. “The government should monitor the manufacturing quality. The raw materials used in the cough syrup must be monitored. Before the product leaves the factory, every manufacturer should test samples for quality. The government should not only monitor but make the certificate of quality mandatory for every product before it hits the market,” he said.

Janani Sankar, medical director, Kanchi Kamakoti CHILDS Trust Hospital, said that most cough syrups are a combination of two to three drugs. “Doctors prescribe after looking at the composition, and the dosage is adjusted according to the weight and age of the child. When such syrups are purchased over-the-counter, parents may end up giving more than what is required, for instance, 5 ml when only 2 ml is required. Some of these combination drugs can act on the heart or respiratory system. It can cause drowsiness, respiratory depression, palpitations and also increase in heart rate. Sometimes, it can be serious,” she explained.

C.S. Rex Sargunam, president of Tamil Nadu Health Development Association, which had recently released a report on “Prevention of Adulterated and Spurious Drugs”called the amendment ‘superficial’. “Dispensing cough syrup on a doctor’s prescription is not the issue here. It is about the manufacturing quality of cough syrups,” he said.

Referring to the child deaths in Madhya Pradesh last year, he raised concerns on the lack of follow-up and lack of accountability. “The issue is no longer in the news and is forgotten,” Dr. Sargunam said adding: “What is needed is ensuring the quality of drugs. The laboratories of the Tamil Nadu’s Drugs Control Department must test and certify that a certain drug is of quality, is not adulterated or spurious. If a drug is supplied from other States, it is the duty of the State government to test and certify its quality even if it is tested and certified by the supplying State.”