NEW DELHI : The Centre has set a three-month deadline for a doctors committee to come up with suggestions on what drugs can be sold over the counter, according to officials aware of the matter, in an attempt to stop random sale of non-prescription drugs.
The expert committee consists of eight members including doctors from LHMC, Safdarjung Hospital, PGIMER, and SMS Medical College. They will examine matters regarding amendment of the Drugs Rules in line with recommendations from the Drugs Technical Advisory Board (DTAB).
Over-the-counter (OTC) drug sales in India are a matter of global concern as they are seen to be a leading cause of anti-microbial resistance of medicines. Most chemists provide medicines, including antibiotics, without any prescriptions.
The amendment is expected to put a check on rampant misuse of the OTC system. Only certain drugs will be allowed to be sold without a prescription. The expert committee will be recommending which drugs can be sold over the counter without a prescription.
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 committees have been formed on the OTC issue, and these will provide advice to the sub-committee.
Also Read: India plans central online drugs registry to avoid medication errors
CDSCO recommendation on sub-committee
Additionally, the CDSCO has recommended that the sub-committee can co-opt experts.
According to the DCGI, the development is in response to requests from a few drug for the OTC sale of specific drug formulations including those used in pain relief balms and gels, aspirins, cough lozenges nasal sprays used for asthma, allergic rhinitis and congestion.
Two years ago, the health ministry released a draft notification proposing changes to Schedule K of the Drugs Rules, 1945. These changes would include clauses allowing drugs to be sold over-the-counter (OTC) and exempting sales from the need for a prescription from a registered doctor.
According to an official notice from Drugs Controller General (India), Dr. Rajeev Singh Raghuvanshi, the subcommittee will investigate the amendment request.
Also Read: New health insurance regulator may arrive faster than we thought
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
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