As the Department of Health issues a diktat on cough syrups, questions are being raised about OTC enforcement

Many in the pharmaceutical trade are also unsure how effectively the new rules can be enforced among consumers accustomed to buying over-the-counter (OTC) drugs. Image is for representational purposes only | Photo credit: REUTERS

When people in India are used to buying all kinds of over-the-counter (OTC) medicines, it is a challenge to enforce laws that make prescriptions mandatory, Hyderabad-based pediatrician Sivaranjani Santosh said, though she welcomed the Centre’s decision to make all syrups, including cough syrups, prescription-only.

Many in the pharmaceutical trade are also unsure how effectively the new rules can be enforced among consumers accustomed to buying over-the-counter (OTC) drugs.

On Tuesday (June 16), the Department of Health and Welfare announced changes to the 1945 drug rules, ending the sale of over-the-counter syrups, including cough syrups. After the amendment, over-the-counter cough lozenges, pills and tablets will continue to be available, but syrups will be available on prescription.

Dr. Santosh welcomed the move, saying concerns over overdose, wrong dosage and indiscriminate use of cough and cold products warranted tighter controls. Many products contain ingredients such as terbutaline, levosalbutamol, salbutamol, chlorpheniramine maleate and phenylephrine that could worsen complications if used inappropriately, she said.

Doubts about implementation were repeated by pharmacists. Uday Kumar of Mor Chemists and Druggists said consumers increasingly expect immediate relief and doubt whether a blanket prescription requirement would work in the long term. “Everybody wants to get well immediately. If they get sick today, they want to get well tomorrow,” he said.

Counterfeit, falsified and off-brand drugs pose a bigger challenge, Mr. Kumar argued. He added that identifying genuine and counterfeit products was difficult and laboratory testing often took months.

Neelesh Kanodia, who heads Yash Agencies, differentiates between codeine-based cough syrups and conventional formulations. “I don’t think the blanket rule will continue in the long term. But the restrictions on syrups containing codeine will continue,” he said. According to Mr Kanodia, cough syrups containing codeine were already largely prescription-only, while commonly used preparations were traditionally available over the counter.

Meanwhile, the Telangana Chemists and Druggists Association (TCDA) was quick to inform retailers about the new rules. Krishna Kumar, treasurer of the association, said broadcast messages were sent to pharmacies across the state immediately after the notification was issued. “We also circulated these messages in Telugu so that they reached even the remote corners of the state,” he said.

Mr. Kumar said that Telangana has around 39,000 pharmacies, of which nearly 18,000 are located in Hyderabad.

A Hyderabad-based pharmacist who runs a prominent shop in Panjagutta, requesting anonymity, said the implementation is likely to vary across regions. “Large and reputable pharmacies in metropolitan cities and affluent areas would comply with the rules, but enforcement in smaller localities and towns could prove more difficult,” he said.

He added that consumer behavior is a big obstacle. Patients often reuse old prescriptions rather than return to doctors, while consultation fees, travel costs and waiting times discourage repeat visits.

Published – 16 Jun 2026 20:53 IST