The National Medical Commission (NMC), in its newly notified regulations, has for the first time provided a list of therapeutic categories of drugs which can be dispensed over the counter without any prescription. However, the list does not provide names of specific drugs.
In its 'Regulations relating to Professional Conduct of Registered Medical Practitioners" issued on August 2, the NMC stated that over-the-counter (OTC) drugs are legally allowed to be sold without a doctor's prescription.
The list of OTC therapeutic categories that have been mentioned by the NMC regulation include anti-hemorrhoid drugs, topical antibiotics, cough-suppressants, anti-acne drugs and non-steroidal anti-inflammatory medicines.
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It also includes antiseptics, analgesics, decongestants, aspirin, vasodilators, antacids, expectorants, anti-fungal drugs, anti-histamines, anti-flatulence agents and smoking cessation drugs.
The NMC defined OTC drugs as medicines for common ailments that are available over the counter and are safe and effective for use by the public without seeking treatment from a health professional. All drugs that are not included in the list of 'prescription drugs' are considered non-prescription or OTC drugs, the NMC said.
There is no definition of OTC medicines in the Drugs and Cosmetics Act and the Rules thereunder. Also, there are no specific provisions to regulate OTC drugs, an official source said.
However, schedule H of the Drugs Rules mentions a list of drugs that are required to be dispensed only through prescription, the source said. This list is updated from time to time and the last time it was done was in 2019. "Due to the lack of clearly defined regulations for OTC medicines, these drugs are not easily available. But the NMC in its latest regulations prescribed a wide range of therapeutic categories of drugs without mentioning or specifying any drug name which may lead to misuse of habit-forming drugs such cough suppressant Codeine," a source explained.
Also, self-medication of some of these drugs may lead to toxicity. Also, when available as OTC, there is no medical advice regarding the number of doses, how to take the medicine, the contraindications and what precautions should be taken, the source said.
The Drugs Consultative Committee under the Drugs and Cosmetics Act constituted a sub-committee to define OTC drugs and identify a list of such medicine a few years ago. The panel submitted its report to the Central Drugs Standard Control Organisation in 2019.
The government is yet to accept the recommendations of the sub-committee.
