The Legal Background: Prescribing Generic Names Isn’t New
The requirement for doctors to prescribe drugs by their generic names is not a recent development. Since 2002, the Indian Medical Council’s Professional Conduct, Etiquette, and Ethics Regulations (Ethics Regulations) have mandated that doctors use the chemical name of the drug, not a brand name, in their prescriptions. With the withdrawal of the 2023 Conduct Regulations, the Ethics Regulations remain in place, preserving the existing obligation to prescribe by generic name. Although the recent rollback was perceived by some as a “win” for the medical industry, it had no actual impact on the substance of doctors’ responsibilities.
Under both the Ethics Regulations and the rescinded Conduct Regulations, doctors are required to prescribe the chemical name of a drug (e.g., “ibuprofen”) rather than a branded version. This does not restrict pharmacists from selling branded drugs or prevent patients from choosing a brand based on preference.
Addressing Conflicts of Interest: The Purpose of Generic Naming
Prescribing by generic name is intended to reduce conflicts of interest by discouraging ties between doctors and pharmaceutical companies that could influence prescribing habits. When doctors use generic names, patients can more easily compare brands and prices, making the prescription process more transparent.
Confusion surrounding the Conduct Regulations might have been partly due to the terminology used. The section heading referred to “prescribing generic medicines,” whereas the text required “prescribing using generic names.” Legal interpretation standards emphasize that the content of the provision is more authoritative than the heading. As clarified by the Supreme Court in Frick India Limited vs. Union of India (1989), clear statutory language takes precedence over section titles.
Balancing Innovation with Affordability and Consumer Choice
Prescribing by generic name introduces a balance between promoting affordability and maintaining incentives for innovation. Prescribing a specific brand can build consumer trust in that brand and drive sales, encouraging pharmaceutical companies to innovate. However, prescribing generically shifts the focus toward affordability and competition, potentially reducing the demand for certain brands. Organizations like the OECD support strong intellectual property protections to sustain innovation in competitive markets. However, once patents expire, consumers can choose between established brands and more affordable alternatives, promoting a more diverse and cost-effective healthcare environment.
Patient Awareness and Implementation Challenges
Current prescription practices face several challenges, especially when it comes to the affordability of essential medicines. While the Drugs (Price Control) Order sets price limits on essential medicines, many lifesaving drugs remain unaffordable for some patients. Pharmacists often substitute prescribed drugs with available alternatives, making patient awareness crucial. By prescribing drugs by their generic names, doctors empower patients to make informed decisions by knowing the drug formulation. However, patients frequently lack the knowledge to select an appropriate brand, and thus rely on their doctors to prescribe affordable and effective medications.
Moving to a system where drugs are prescribed by their generic names is a step toward greater consumer empowerment. However, it requires substantial structural changes, collaboration across the healthcare industry, and increased consumer education. To fully realize the benefits of this policy, the healthcare sector will need to engage in sustained awareness efforts and consult widely with industry stakeholders.