National Medical Commission Enforces Mandatory Generic Drug Prescription: Stringent Penalties for Non-Compliance

The National Medical Commission (NMC) has introduced a series of stringent regulations aimed at revolutionizing the medical landscape in India. With a primary focus on affordability and accessibility to quality healthcare, the NMC now mandates doctors to prescribe only generic drugs. These regulations, outlined in the ‘Regulations relating to Professional Conduct of Registered Medical Practitioners’, carry penalties for non-compliance, including the potential suspension of medical licenses.

A notable departure from the previous norms, the new directives from the NMC not only emphasize the prescription of generic drugs but also actively discourage the use of branded generic medications. Notably, the earlier guidelines set by the Indian Medical Council in 2002 required the prescription of generic drugs, but failed to establish any punitive measures.

In a move to shed light on the broader healthcare scenario, a notification issued on August 2 elucidated how the substantial out-of-pocket expenditure on medications in India directly contributes to the high public spending on healthcare. The notification underscored that generic medicines, being significantly more affordable – often priced 30 to 80 percent lower than their branded counterparts – can play a pivotal role in alleviating the burden of healthcare costs while enhancing access to high-quality medical treatment.

A fundamental distinction drawn by the NMC was between generic medicines and branded generic drugs. Generic medicines, as clarified, stand as viable alternatives to the brand/reference listed products in key parameters such as dosage, quality, and intended use. Contrarily, branded generic drugs are formulated after the expiration of patents and are marketed under various company names. While they might be more economical than patented medications, they are typically more expensive than mass-produced generic drugs. The pricing of these branded generic medicines often suffers from a lack of rigorous regulatory oversight.

The new regulations leave no room for ambiguity, asserting that “Every Registered Medical Practitioner (RMP) should prescribe drugs using generic names clearly and should avoid unnecessary and irrational drug combinations.” Breaches of these regulations could result in a range of actions, including warnings, mandatory participation in workshops, or, in severe instances, the suspension of the practitioner’s license.

In a bid to further enhance clarity and precision, the NMC recommends that prescriptions be legible, preferably typed, and printed. Moreover, the commission has introduced a template for rational prescription writing to streamline this crucial process.

Going beyond prescription practices, doctors are urged to actively advocate for the availability of generic medicines, promote local pharmacies to stock these essential drugs, and encourage patients to procure medications from government-sanctioned sources such as Jan Aushadhi Kendras and similar outlets. The overarching objective remains to enlighten both the public and medical students about the comparable efficacy of generic drugs when weighed against their branded counterparts.

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