The Central Drugs Standard Control Organisation (CDSCO) has formed a sub-committee to examine matters regarding amendment of the Drugs Rules to incorporate necessary provisions for drugs to be declared as over-the-counter (OTC).
According to a report by Pharmabiz, this decision has been taken in line with a recommendation of the Drugs Technical Advisory Board (DTAB) meeting.
In May 2022, the Department of Health and Family Welfare had issued a draft notification for amendment to incorporate necessary provisions for drugs to be sold OTC for providing exemptions from requirements of prescription from Registered Medical Practitioners (RMPs) for sales.
The sub-committee will look into the proposal for amendment, said Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi in an office memorandum, the report revealed.
The eight-member sub-committee will be headed by Dr Anupam Prakash, Director and Professor of Medicine, Lady Hardinge Medical College, Delhi, with Dr Umesh D Suranagi, Associate Professor of Medicine, Director General of Health Services (DGHS); Dr Ratan Kumar Gupta, Department of Paediatrics, Vardhman Mahavir Medical College & Safdarjung Hospital, Delhi, Dr Bikash Medhi, Professor, Department of Pharmacology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh; Dr Abhishek Agarwal, Professor, Department of Medicine, SMS Medical College, Jaipur; one representative from Indian Council of Medical Research (ICMR), and Drugs Controllers of Jharkhand and Karnataka, as members.
Reportedly, the sub-committee is expected to submit its report within a timeframe of three months and they may co-opt subject experts as and when required.
According to media reports, the DCGI said that the development follows representation from some companies for certain drugs formulations to be sold OTC, including diclofenac diethylamine transdermal patch 200 mg, acetylsalicylic acid effervescent 500 tablets, dextromethorphan HBr lozenges 50 mg and mometasone furoate nasal spray 50 mcg, among others.
In January this year, the proposal was placed in the DTAB’s 90th meeting and the committee recommended forming a sub-committee to examine the matter regarding various conditions based on which status of a drug as an OTC is decided. Moreover, a detailed mechanism is to be developed for the drugs to be considered as OTC.
The Board also recommended a comprehensive revisit of the draft notification for which international guidelines may also be considered.
