Doctors to be penalised for not prescribing generic drugs, says new NMC regulation

In a recent development, the National Medical Commission (NMC) has introduced a set of fresh regulations that mandate doctors to exclusively prescribe generic drugs. Failure to comply with this directive may lead to penalties and the potential suspension of their medical license for a specified period, as outlined by the NMC. 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. It’s noteworthy that although the current requirement for doctors is to prescribe generic drugs, the regulations issued in 2002 by the Indian Medical Council do not specify any punitive measures for non-compliance. These new regulations, officially notified on August 2, emphasize the significant role of India’s out-of-pocket expenses on medicines within the broader context of healthcare expenditure. “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 that is 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. There is less regulatory control over the prices of branded generic drugs. “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. On repeated violations, the doctor’s license to practice may be suspended for a particular period, the regulations said. The NMC said prescriptions should be legible and preferably written in all caps to avoid misinterpretation. As far as possible, prescriptions should be typed and printed to avoid errors, it said. A template has also been provided by the NMC that may be used for writing prescriptions rationally. Medical practitioners should prescribe only those generic medicines available in the market and accessible to patients. They should also advocate for hospitals and local pharmacies to stock generic drugs, the NMC regulation stated. They should encourage patients to purchase drugs from Jan Aushadhi Kendras and other generic pharmacy outlets, educate medical students and the public about the equivalence of generic medicine with their branded counterparts and should actively participate in programs related to promotion and access to generic medicines, it added.