NEW DELHI : In order to come up with more clarity about provisions for drugs to be declared as over-the-counter (OTC), the centre has set a three months timeframe for an all doctor’s expert committee to provide with suggestion, according to officials aware of the matter.
The expert committee consists of eight members including doctors from LHMC, Safdarjung Hospital, PGIMER, SMS Medical College to examine matters regarding amendment of the Drugs Rules in line with recommendations from the Drugs Technical Advisory Board (DTAB). According to the apex drug regulatory body, all experts appointed to the subcommittee needs to adhere to the concept of confidentiality and cannot have any conflict of interest. The Directorate General of Health Services (DGHS) stated that various clinician committees have been formed on the OTC issue, and these committees will provide advice to the sub-committee for its consideration.
The Central Drugs Standard Control Organisation (CDSCO) has also suggested that the sub-committee may co-opt subject experts as and when required. According to the Drugs Controller General of India (DCGI), 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.
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CDSCO recommendation on sub-committee
Additionally, the CDSCO has recommended that the sub-committee can co-opt for experts on subject matters as needed. According to the DCGI, the development is in response to requests from a few companies for the OTC sale of specific drug formulations, such as the 200 mg transdermal patch of diclofenac diethylamine, the 500 mg effervescent tablets of acetylsalicylic acid, the 50 mg lozenges of dextromethorphan HBr, and the 50 mcg nasal spray of mometasone furoate.
Two years ago, the Ministry of Health and Family Welfare released a draft notification proposing changes to Schedule K of the Drugs Rules, 1945. These changes would include the necessary clauses allowing drugs to be sold over-the-counter (OTC) and exempting sales from the need for a prescription from a Registered Medical Practitioner (RMP). According to an official notice from Drugs Controller General (India), Dr. Rajeev Singh Raghuvanshi, the subcommittee will investigate the amendment request.
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 and Safdarjung Hospital, Delhi, Dr Bikash Medhi, Professor, Department of Pharmacology, Post Graduate Institute of Medical Education and 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.
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The decision to form the committee comes after a proposal was placed by the DTAB earlier this year on January, and the committee recommended to form a sub-committee to examine the matter with reference to various conditions based on which status of a drug as an OTC is decided and a detailed mechanism is to be developed for the drugs to be considered as OTC.
The Board further suggested a thorough revision of the draft notification, which might take into account global principles.
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Published: 17 May 2024, 05:53 PM IST
