Prescription of drugs using generic names – Much ado about nothing?

The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 (Conduct Regulations) were introduced and withdrawn by the National Medical Commission (NMC) within 21 days. Very rarely does one see such an immediate reaction to industry pushback (compare this with the farm laws that took over a year to be withdrawn after long and sustained protests by the farmers). The hullaballoo surrounding the Conduct Regulations stemmed mostly from the requirement to “prescribe generic medicines”. Doctors and trade bodies expressed concern regarding the accessibility and pricing of generic drugs. But was that really what the Conduct Regulations said? And was this a new requirement in the law?

The requirement to prescribe drugs with generic names has existed since 2002 when the erstwhile Indian Medical Council issued the Professional Conduct, Etiquette and Ethics Regulations, 2002 (Ethics Regulations). With the rollback of the Conduct Regulations, the Ethics Regulations are back in force, and the legal requirement to prescribe generic names of drugs remains unchanged. While the industry viewed the rollback as a win, in effect there was no impact on the substance of a doctor’s obligations.

Both under the Ethics Regulations, as well under the revoked Conduct Regulations, the obligation on doctors has been to prescribe drugs using generic names – that is, the name of the chemical formulation – and not to prescribe generic drugs – that is, a drug that is comparable to the branded product in dosage, performance characteristics, and intended use. For instance, doctors must prescribe “ibuprofen” and not any specific brand thereof. At no point, however, has there been any restriction on the sale of branded drugs. If the doctor prescribes ibuprofen, pharmacies are allowed to sell branded ibuprofen and a patient may make an informed decision to purchase their preferred brand. 

There have been instances where doctors have been found to have tie-ups with a pharmacy or a pharmaceutical company. The requirement to prescribe drugs with generic names exists so that doctors are not influenced by pharmaceutical companies to promote one drug over another.

Some confusion may have been caused by the choice of words used while drafting this provision in the Conduct Regulations. The regulation heading reads “prescribing generic medicines” while the text of the regulation says that drugs should be prescribed using generic names. The rules of interpretation of statutes guide in this regard. While the heading of a section indicates the general purpose of that provision and can be used to assist in its interpretation, the title must only be considered a preamble, and more weightage should be given to the text of the section. The Supreme Court in 1989 had noted in the landmark case of Frick India Limited vs. Union of India, that headings may not even be referred to to construe the provision when the words used in the provision are clear and unambiguous. The Conduct Regulations must be read with a focus on the substance of the regulation, and not the heading. This makes it clear that doctors are required to prescribe medicine using generic names, as opposed to generic medicines.

Arguably, innovation and patenting is an exceptionally sticky area when it comes to prescribing drugs by their generic name. Undeniably, when a doctor prescribes a specific brand of drug, it helps build trust in the brand and increases its sales. On the other hand, prescribing a drug by its generic name may move some of the customer base towards more affordable brands or generic drugs, thereby decreasing the demand for specific brands and lowering the incentive for innovation. On precisely this issue, the OECD advocates for robust intellectual property rights for drug developers to sustain innovation in a market where generic drugs have been introduced. In a way, the prescription of drugs through their generic name is a step towards a free and competition-friendly market. While new pharmaceutical innovations may still be protected by patents for 20 years, allowing the creation of a strong customer base, the consumer will, at the end of the protected period, be free to buy either the known and familiar brand of drugs or the more affordable variety.

It is widely acknowledged that the present practices related to the prescription of drugs are not without faults and may sometimes result in a situation where unaffordable drugs are prescribed to the patient. While the Drugs (Price Control) Order prescribes a ceiling to essential medicines, many other lifesaving drugs continue to be highly-priced. At the same time, pharmacists often hand out substitute medicines if the prescribed drug is unavailable. Consumer needs to be aware of the medicines they have been prescribed – prescribing drugs by their generic names helps consumers check the formulation on the package of the medicine and make an informed choice at the time of purchase. However, the average patient in India may not have the prior information necessary to decide on an appropriate brand of medicine to consume. Doctors are widely held in a position of trust to make this decision for patients at the critical time of illness and prescribe a reliable and affordable brand of medicine, based on the patient’s circumstances. That said, implementing the provision to prescribe drugs with generic names is a long road and its efficiency rests significantly on the awareness of an average patient. This is ultimately a move in the interest of consumers and will require a structural change in the healthcare industry involving industry-wide consultations and awareness campaigns for consumers.