NMC's generic-only prescription could be a health hazard
The government’s inconsistent stance, flipping between promoting branded and generic drugs, underscores a more extensive debate that transcends mere cost considerations.
The National Medical Commission’s (NMC) recent approval of generic-only prescriptions to promote affordability and prevent malpractices is a classic example of a remedy unwittingly increasing the problem even though its rationale is grounded in affordability and curbing malpractices.
According to the NMC’s August 2 statement, prescribing by generic names ensures rational drug usage and could significantly reduce medication costs, potentially enhancing access to quality care. Yet, the directive has spurred concerns, particularly when it threatens penalties like suspension of a doctor’s practice license for non-compliance.
The core issue revolves around the best judge for a patient’s medication needs. Transferring this crucial decision from doctors to chemists could compromise patient health, primarily because prescribing a medicine involves several factors ranging from how a particular individual reacts to a drug to certain diseases which needs a specific drug brand for its cure.
Dr Sharad Agarwal, the President of the Indian Medical Association (IMA), has aptly expressed concerns about this new approach. His core argument: if doctors, grounded in research and experience, can’t prescribe a specific, proven drug brand, how can we guarantee a chemist will provide a generic counterpart of equal quality?
Licensing: A double-edged sword
The government’s ambivalent approach towards branded drugs is evident. On the one hand, they approve pharmaceuticals to produce branded medicines, vouching for their efficacy. Conversely, the intensified push towards generics challenges the value of these very licensed drugs. The US, for instance, endorses a selective method, licensing only select firms for specific drugs after meticulous quality checks. This model, considering recent concerns about some Indian drugs’ quality, might serve India well. Given that less than 0.1 per cent of medicines produced in India undergo quality checks, it is essential to reconsider the directive.
India’s pharmaceutical categorisation system further complicates matters, allowing varied price points for drugs termed Branded and Generic. Addressing these policy ambiguities is urgent. The IMA has advocated a stringent quality assurance system before a complete shift to generic drugs and promotes a ‘single drug, single quality, single price’ policy. These guidelines risk overshadowing the medical community’s dedication to patient well-being. If the intent is for doctors to prescribe generics solely, the solution could be unbranded drug production. Yet, a policy overhaul of this magnitude demands significant time and effort.
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Pharmaceutical companies are now navigating uncertain terrains due to these directives. While big players might weather this storm, smaller firms could gain from increased demand for generics. But mid-sized companies, traditionally dependent on medical representatives, face potential upheaval.
The government’s inconsistent stance, flipping between promoting branded and generic drugs, underscores a more extensive debate that transcends mere cost considerations. It delves into quality, accountability, and overall patient health. IMA’s apprehensions resonate with a broader medical community, calling for clear, robust policies. Policymaking, especially in healthcare, requires holistic considerations. The NMC and government should prioritise dialogue to frame balanced policies that forefront patient health.
The drive for generics, though aimed at patient affordability, could have lasting economic ramifications for India’s pharma sector. This could significantly impact R&D investments for new drugs, deterring potential innovations. Furthermore, a doctor’s prescription carries trust derived from years of expertise. Challenging this trust by enforcing generic-only medications could leave patients questioning their care quality.
Towards a balanced approach
It is clear that the NMC’s decision, though rooted in keeping patients’ interests on the front, needs to strike the right balance between affordability and quality. Enhanced dialogue between policymakers, the pharma industry, and medical professionals can help refine and adapt policies. The debate between generic and branded medicine isn’t confined to India; it’s a global conundrum. But given India’s vast population and economic disparities, the impact of such decisions is magnified manifold. One must consider the inherent value of branded medicines, which often come with rigorous research, clinical trials, and an assurance of consistent quality. Their higher price often reflects pharmaceutical companies’ investments in R&D, ensuring cutting-edge, effective treatments.
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On the other hand, generics have a pivotal role in making medicines accessible to the wider population, especially among economically-challenged demographics. The ideal scenario would involve a seamless blend of both, wherein generics are available for those who cannot afford branded medicines while co-existing with branded medicines, pushing the envelope in medical innovation.
However, this decision also has geopolitical ramifications. India, one of the largest producers of generic medicines, is responsible not just to its citizens but to many countries, especially in Africa and South Asia, which depend on affordable medicines. India could further its stance as a global pharmaceutical powerhouse by emphasising generics. Yet, the key lies in ensuring that these generics match the quality of their branded counterparts.
The ball is in the court of NMC and the government: either assure top-quality generic drugs or take accountability when patients don't benefit from prescribed generics. Compromising patient safety and care isn’t an option.
