Prof Dr Debraj Shome, Clinical Scientist and Research Mentor, QR678® opines that when molecules with known biological action are presented under cosmetic frameworks, patients deserve clarity, not reassurance through semantics
Medicine has never progressed within neat boundaries.
Nearly every therapy we now consider standard once existed in an undefined space, where evidence was emerging, regulation had not yet caught up, and clinicians were making careful decisions based on science, judgment, and patient need. This grey zone is not a deviation from medicine’s principles. It is where progress has always occurred.
Yet contemporary discussions around medical practice often reduce this complexity to binaries. Approved or unapproved. Allowed or disallowed. Ethical or unethical. While such framing may feel reassuring, it does not reflect how medicine actually functions in the real world.
To understand why, we must first understand what regulation is designed to do, and what it is not.
What regulation is meant to protect, and what it cannot replace
Regulatory bodies exist to safeguard patients from harm, unsafe practices, exaggerated claims, and irresponsible experimentation. Their mandate is population-level safety and standardisation, assessed through structured data and defined endpoints.
What regulators do not do is practice medicine. They do not individualise care, interpret nuances in disease progression, or weigh patient-specific risk-benefit decisions. Regulatory approval is, by nature, retrospective. It evaluates evidence after it exists, not while it is being built. This conservatism is intentional and necessary. However, when regulatory labels are treated as the sole permission for clinical action, medicine risks becoming mechanical rather than a medical discipline.
Clinical practice has always required interpretation, accountability, and informed judgment, especially when science moves faster than formal approvals.
Off-label does not mean unethical
One of the most persistent misconceptions in healthcare discourse is that anything outside a formal approval is inherently unsafe or improper. In reality, off-label use is a recognised and legally permitted part of medical practice worldwide when supported by scientific rationale, emerging evidence, transparency, and documentation.
Many aspects of modern medicine require responsible clinical judgement, careful patient education, and appropriate use of medicines. As highlighted in the Indian Pharmaceutical Association’s “Responsible Use of Medicines” handbook, medicines can be highly beneficial when used correctly, but can also cause harm if used improperly. The handbook further emphasises that patients should receive the right medicines at the right time, use them appropriately, and benefit from them.
The document also highlights the importance of scientific justification, ethical responsibility, and accurate representation of medical products and claims. It notes that healthcare stakeholders, including manufacturers and healthcare professionals, share responsibility in ensuring safe and rational use of medicines. In areas where medical innovation, emerging therapies, and evolving evidence intersect, the ethical question is not merely whether a treatment exists within a regulatory label, but whether it is supported by scientific rationale, transparency, documentation, and responsible patient care.
At the same time, this does not justify irresponsible commercialisation, misleading claims, or the use of inadequately supported interventions under the guise of innovation. Responsible medicine requires both scientific progress and accountability.
They were used cautiously, observed closely, and eventually validated. Off-label practice is not a loophole. It is an acknowledgement that clinical innovation and regulation often evolve in parallel. The ethical question, therefore, is not whether a treatment sits inside a label, but whether it is used responsibly.
The reality of everyday medicine
Clinical medicine routinely operates beyond narrow regulatory definitions. From regenerative therapies to dermatologic interventions, from dosage modifications to alternate routes of administration, physicians adapt treatments based on evolving evidence and patient response.
This does not imply recklessness. It implies professional responsibility. The danger lies not in the grey zone itself, but in how it is navigated.
When compliance becomes performative
There is an increasing tendency to invoke regulatory language as a moral benchmark rather than a clinical framework. When regulatory compliance is used selectively, often in public narratives, while off-label practice continues quietly in daily clinics, the issue is no longer regulation. It is inconsistent.
True compliance is not performative. It lives in informed consent, detailed documentation, careful patient selection, and long-term follow-up. It does not require absolutes or grandstanding. It requires accountability.
Safety and efficacy operate on different timelines
Regulators prioritise safety across populations. Clinicians optimise efficacy for individuals. These goals are complementary but not synchronous.
If regulation moved as fast as clinical discovery, safety would be compromised. If clinical practice waited exclusively for regulation, innovation would stagnate. The ethical physician works between these realities, advancing care while remaining grounded in biology, evidence, and patient welfare.
Can something be regulatory undefined but medically sound?
Yes, and history confirms this repeatedly.
Biological plausibility, mechanism of action, dosage, route, and monitoring determine medical safety. Regulatory status reflects data submission, timelines, and permissible claims. These overlap, but they are not identical.
Responsibility cannot be outsourced entirely to a label.
The growing confusion between cosmetic and medical categories
Modern patients are increasingly exposed to products labelled as cosmetic yet containing biologically active compounds. These classifications are driven by regulatory thresholds and claim limitations, not necessarily by biological neutrality.
This creates confusion around what is medicinal, what is cosmetic, and what sits in between. When molecules with known biological action are presented under cosmetic frameworks, patients deserve clarity, not reassurance through semantics.
Regulatory categorisation explains what a product is allowed to claim. It does not explain everything it may biologically influence.
Where medicine must stand
Medicine cannot be practised in absolutes. The ethical standard is not rigid adherence to labels, but thoughtful navigation of grey zones, guided by evidence, transparency, patient education, and continuous evaluation. Innovation without responsibility is dangerous. Compliance without judgment is hollow. Medicine advances when clinicians acknowledge complexity rather than deny it.
And trust grows when we stop pretending that healthcare fits neatly into black-and-white boxes, when in truth, it never has.