Synopsis

India should examine trade margins across medicines, medical devices and consumables using a common, scientifically credible method - not a one-size-fits-all formula - to identify where and how intervention is needed. Meaningful stakeholder consultation must form part of this exercise to help design a framework that is both effective and workable. It can ensure that unjustified margins are addressed while recognising legitimate differences in clinical settings, infrastructure, safety requirements, geographical reach and the cost of delivering quality care.

Need just the right dose

C K Mishra

C K Mishra

The author is former health secretary, GoI

GoI's decision to regulate trade margins on non-scheduled anti-cancer medicines is welcome. It has a responsibility to ensure that healthcare is both accessible and affordable, while creating an environment in which quality care can be delivered sustainably. But a good first step should not be mistaken for a complete solution.

The present debate raises 3 questions:

Is the exercise comprehensive enough?


Is it based on adequate evidence?

Can it be implemented effectively across a healthcare market as large and varied as India's?

GoI has informed Supreme Court that trade margins on specified anti-cancer medicines will be capped at 30%. An expert committee will identify the medicines to be covered, after which NPPA will examine its recommendations. The top court has also asked why similar scrutiny should not extend to other medicines and medical products.

That's a legitimate question. If excessive trade margins are the problem, India should examine the issue comprehensively rather than regulate one category at a time. A fragmented approach can shift distortions from one part of the market to another, create uncertainty and make enforcement needlessly difficult.

Price controls should be there wherever they are legitimate. When credible evidence establishes that margins are unreasonable and patients are carrying an unfair burden, intervention is justified. But evidence must come before the prescription.

The same medicine or medical product can cost different amounts to administer at hospitals in the same city. Differences may reflect the patient's condition, treatment complexity, clinical expertise, infrastructure, infection control, monitoring and emergency support. A routine outpatient dose is not equivalent to a complex therapy requiring specialist supervision.

Procurement price of a med or device tells only part of the story. A robust framework must distinguish trade margins from legitimate costs of storing, handling and safely administering products, while accounting for the infrastructure needed to maintain quality and patient safety. It must also weigh the impact on availability and access. Without this distinction, curbs on excessive margins could inadvertently compromise care.

GoI's experience supports this approach. The 2019 trade-margin rationalisation pilot covered 42 selected non-scheduled anti-cancer medicines. Since then, consultations have raised concerns about production costs, viability of smaller manufacturers, and cost of maintaining supplies in remote areas.

These concerns underline the need to evaluate the earlier intervention before widening its scope. Did price cuts reach patients consistently? Were medicines readily available? Did outcomes vary across metros, smaller cities and remote areas? Could smaller manufacturers and distributors remain viable?

The answers should shape future policy. India should examine trade margins across medicines, medical devices and consumables using a common, scientifically credible method - not a one-size-fits-all formula - to identify where and how intervention is needed. Meaningful stakeholder consultation must form part of this exercise to help design a framework that is both effective and workable. It can ensure that unjustified margins are addressed while recognising legitimate differences in clinical settings, infrastructure, safety requirements, geographical reach and the cost of delivering quality care.

The healthcare industry should be a constructive partner in this process. Hospitals can provide evidence on the clinical and operational costs of administering treatments in different settings. Manufacturers and distributors can contribute data on production, storage, logistics and supply. Clinicians can help assess implications for treatment decisions, availability and patient safety.

The success of any policy will ultimately depend on whether it can be implemented consistently across India's diverse healthcare market. Success cannot be measured merely by the number of products brought under control. The more meaningful test is whether patients pay fairer prices without experiencing shortages, reduced access or any compromise in the quality and safety of care.

Blanket controls that don't recognise legitimate differences in cost and complexity could discourage precisely this investment. They could also make it harder for hospitals to maintain quality and safety standards or adopt medical advances that can improve patient outcomes.

India should regulate wherever credible evidence establishes a legitimate need. The larger argument is for a more transparent, accountable and evidence-based approach that protects patients and addresses unjustified pricing, without compromising access, quality, innovation or the long-term sustainability of healthcare delivery. Good regulation must protect the patient today without weakening India's healthcare capacity for tomorrow.
(Disclaimer: The opinions expressed in this column are that of the writer. The facts and opinions expressed here do not reflect the views of www.economictimes.com.)

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