As Health Ministry issues diktat on cough syrups, questions arise over OTC enforcement

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When people in India are used to buying all sorts of medicines over the counter (OTC), the challenge is the enforcement of laws which make prescription mandatory, said Hyderabad-based paediatrician Sivaranjani Santosh even as she welcomed the Centre’s decision to make all syrups, including cough syrups, as prescription-only.

Many in the pharmaceutical trade as well are uncertain how effectively the new rules can be enforced among consumers accustomed to buying medicines over the counter (OTC).

On Tuesday (June 16) the Ministry of Health and Family Welfare notified amendments to the Drugs Rules, 1945, ending the OTC sale of syrups, including cough syrups. Following the amendment, cough lozenges, pills and tablets will continue to be available over the counter, but syrups will require a prescription.

Dr. Santosh welcomed the move, saying concerns over overdoses, incorrect dosing and indiscriminate use of cough-and-cold preparations justified tighter controls. Many formulations contain ingredients such as terbutaline, levosalbutamol, salbutamol, chlorpheniramine maleate and phenylephrine, which could add to complications if used inappropriately, she said.

Doubts over implementation were echoed by pharmacists. Uday Kumar of Mor Chemists and Druggists said consumers increasingly expected immediate relief and questioned whether a blanket prescription requirement would work in the long run. “Everyone wants to recover instantly. If they fall sick today, they want to become well tomorrow,” he said.

Mr. Kumar argued that counterfeit, adulterated and unbranded medicines posed a bigger challenge. He added that identifying genuine and fake products was difficult and laboratory testing often took months.

Neelesh Kanodia, who runs Yash Agencies, distinguished between codeine-based cough syrups and regular formulations. “I don’t think the blanket rule will continue in the long run. But restrictions on codeine-containing syrups will continue,” he said. According to Mr. Kanodia, codeine-cont