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Prescribe Generic Drugs Or Lose Licence, Mandates National Medical Commission

Now, the prescription of generic drugs by all registered medical practitioners has been made mandatory by an NMC directive. And, for the first time, for violators, punitive measures are - finally - put in place, writes Gajanan Khergamker

A revolutionary shift is underway as the National Medical Commission (NMC) introduces groundbreaking regulations, aiming to divert doctors from endorsing branded generic drugs. This momentous step promises significant relief for patients contending with exorbitant medical expenses.

The move, not just holds the potential to alleviate healthcare expenses for patients, but underscores the pivotal role of
medical practitioners in shaping a healthcare system in India that is both cost-effective and accessible

A Paradigm Shift to Generic Drugs

In a moment of pivotal change, the NMC mandates the prescription of generic drugs by all registered medical practitioners, underlining potential consequences for non-compliance. These repercussions encompass financial penalties and, in more serious cases, the suspension of medical licenses. This directive is embedded within the comprehensive 'Regulations Relating to Professional Conduct of Registered Medical Practitioners' by the NMC. 

While the expectation for doctors to advocate for generic drugs has existed previously, the regulations proposed by the Indian Medical Council in 2002 lacked punitive measures for non-adherence.

Embracing the Transition to Generic Medications

The endorsement of generic medicines by the NMC is rooted in the stark reality of India's out-of-pocket expenses for medications, constituting a substantial portion of public healthcare expenditure. Generic drugs typically offer a cost reduction of 30 to 80 percent compared to their branded counterparts. This cost disparity holds the potential to substantially alleviate healthcare expenses while simultaneously expanding access to top-tier medical care. 

The regulations, unveiled on August 2, accentuate the indispensable role of generic drugs in mitigating the financial burden experienced by patients

Defining Generic Medicines by Regulation Laid Down

As per the regulations laid out by the NMC, a generic medicine is defined as a drug product closely mirroring the characteristics of the brand/reference listed product. These attributes encompass factors such as dosage form, strength, route of administration, quality, performance characteristics, and intended use. 

On the contrary, a branded generic drug emerges as a product that transitions from patent protection, produced by diverse drug companies and marketed under distinct brand names. 

While these branded generics may carry a lower price tag than the patented version, they often prove more expensive than their bulk-manufactured generic counterparts. The regulatory oversight concerning the pricing of branded generic drugs is limited, potentially resulting in augmented costs for patients.

Responsibility of Medical Practitioners

The regulations set forth by the NMC mandate that every Registered Medical Practitioner (RMP) adopts legible prescriptions employing generic drug names. 

Additionally, doctors are strongly encouraged to prescribe medication judiciously, avoiding unnecessary prescriptions and irrational combinations of fixed-dose tablets. In cases of non-compliance, doctors may receive a warning, advising them to adhere to the regulations. 

Alternatively, they could be directed to engage in workshops or academic programmes focusing on ethics, personal and social conduct, and professional training. For repeated violations, the regulations empower the suspension of a doctor's medical license for a specified duration.

Elevating Prescription Clarity, Providing a Template too

The NMC places a notable emphasis on the clarity of prescriptions, advocating for doctors to employ capital letters to enhance legibility and prevent misinterpretation. Whenever feasible, prescriptions should be typed and printed to minimize errors. 

The NMC provides a template to facilitate practitioners in the thoughtful drafting of prescriptions. 

The regulations underscore that medical professionals should exclusively recommend generic drugs readily accessible in the market. Furthermore, doctors are encouraged to champion the inclusion of generic medications within hospital and local pharmacy inventories.

Fostering Broader Adoption of Generic Medicines

To invigorate the widespread embrace of generic medicines, the NMC's regulations beckon medical practitioners to adopt an active role. 

Doctors are encouraged to guide patients towards procuring drugs from Jan Aushadhi Kendras and other generic pharmacy outlets. Moreover, medical professionals are expected to enlighten both medical students and the general public about the parity between generic medicines and their branded counterparts. 

Active participation in initiatives that endorse and amplify access to generic medications is also fervently recommended.

The directives from the National Medical Commission epitomise a monumental transition towards prioritising generic medicines above their branded counterparts. 

This shift, not just holds the potential to alleviate healthcare expenses for patients, but also underscores the pivotal role of medical practitioners in shaping a healthcare system in India that is both cost-effective and accessible to the stakeholder.

Members of the medical fraternity and students of medicine and law, interested in participating in a workshop on the issue may write in to legal@draftcraft.in


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