India’s top drug regulator has formed a panel to discuss making certain medicines like painkillers, nasal sprays and lozenges available without a doctor’s prescription, as certain drugs become available over-the-counter (OTC). It may soon be possible to do so. News18 has learned.
The Central Drugs Standard Control Organization (CDSCO) has received representation from several companies to sell certain drug formulations over the counter, according to a letter issued by the Drugs Regulatory Authority of India.
“For certain over-the-counter pharmaceutical formulations, namely diclofenac diethylamine transdermal patch 200 mg, acetylsalicylic acid effervescent tablets 500 tablets, dextromethorphan HBr lozenges 50 mg and mometasone furoate nasal spray 50 μg, some There have been separate representations from several companies,” the letter, accessed by News18, said.
Diclofenac diethylamine transdermal patch and acetylsalicylic acid are pain relievers, while dextromethorphan HBr lozenges are cough suppressants and mometasone furoate nasal spray can help treat allergies, nasal congestion, runny nose, itching, and sneezing.
The committee has been asked to submit its report within three months, i.e. by the first week of August.
New OTC policy
In 2022, the Ministry of Health and Family Welfare decided to allow the sale of certain medicines without the need for a prescription and developed a new OTC policy for medicines. The Drug Technical Advisory Committee, the largest advisory body on drugs, supported the new policy, but it never really took off. The government is now working again to implement this policy.
The proposal to add these drugs to OTC sales was floated at the 90th Drug Technical Advisory Board (DTAB) meeting held on January 25, according to a letter issued by CDSCO Director General Rajeev Singh Raghuvanshi. The Supreme Committee then deliberated on the issue.
The DTAB has decided to establish a subcommittee to consider issues based on how to determine the status of drugs as OTC and whether a detailed mechanism can be developed to sell them over the counter.
“The Board also recommended a comprehensive review of the draft notification, in which international guidelines may also be taken into account,” the letter reads.
Similarly, several panels have been established to provide input on new OTC policies.
“Various committees of clinicians have been constituted by the Directorate General of Health on OTC issues and will provide the necessary information for the subcommittee’s consideration.”
new panel
The committee will have eight members and will be chaired by Dr. Anupam Prakash, Dean and Professor of Medicine at the Delhi-based Lady Hardinge Medical College.
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The panel includes Dr. Umesh D. Suranagi, Directorate General of Health Services (DGHS); Dr. Ratan Kumar Gupta, Department of Pediatrics, Safdarjung Hospital. Dr. Bikash Mehdi, PGIMER Pharmacology, Chandigarh. Dr Abhishek Agrawal of SMS Medical College, Jaipur. Representative of Indian Council of Medical Research (ICMR) and drug controller of Jharkhand and Karnataka.
The committee may hire subject matter experts, according to the letter. “Experts appointed as members of this subcommittee must have no conflicts of interest,” the letter states.
First published: May 13, 2024, 09:37 IST
