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Not prescribing generic drugs can cost docs licence: NMC regulation

The National Medical Commission (NMC) in its ‘Regulations relating to Professional Conduct of Registered Medical Practitioners” also asked doctors to avoid prescribing branded generic drugs.

Not prescribing generic drugs can cost docs licence: NMC regulation
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NEW DELHI: All doctors must prescribe generic drugs, failing which they will be penalised and even their licence to practice may also be suspended for a period, according to new regulations issued by the National Medical Commission.

The National Medical Commission (NMC) in its ‘Regulations relating to Professional Conduct of Registered Medical Practitioners” also asked doctors to avoid prescribing branded generic drugs.

Even though doctors are currently required to prescribe generic drugs only, there are no penal provisions mentioned in the regulations issued in 2002 by the Indian Medical Council.

The NMC regulations notified on August 2, stated that India’s out-of-pocket spending on medications accounts for a major proportion of public spending on healthcare. “Generic medicines are 30 to 80 per cent cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care,” it said.

Under the generic medicine and prescription guidelines of the regulations, the NMC defined generic medicines as a “drug product comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use”. On the other hand, a branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies’ brand names.

These drugs may be less costly than the branded patent version but costlier than the bulk-manufactured generic version of the drug.

“Every RMP (registered medical practitioner) should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets,” the regulation stated.

In case of violations, a doctor may be given a warning to be more careful about the regulations or instructed to attend a workshop or academic programme on ethics, personal and social relations and/or professional training, it said adding prescriptions should be legible and preferably written in all caps to avoid misinterpretation.

List out on ‘drugs sans prescription’

The National Medical Commission, 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.

It includes antiseptics, analgesics, decongestants, aspirin, vasodilators, antacids, expectorants, anti-histamines, anti-flatulence agents, smoking cessation, and anti-fungal 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 over-the-counter medicines in the Drugs and Cosmetics Act and the Rules thereunder. However, schedule H of the Drugs Rules mentions a list of drugs which are required to be dispensed only through prescription, the source said.

DTNEXT Bureau
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