Doctors Should Only Prescribe Generic Drugs Instead Of Brand-Name Medicines : Plea In Supreme Court

The Supreme Court on Friday has issued notice in a public interest litigation (PIL) petition seeking action and guidelines against medical practitioners who prescribe branded medicines to patients instead of more affordable generic drugs with the same active ingredients. The petition argues that healthcare professionals prescribing generic drugs could help ease the financial burden on patients and improve access to essential medications.“Access to medicines plays a critical role in providing a lifeline to treatment for individuals in need. The affordability of medicines is vital factor that contributes to effective healthcare delivery and the realization of the ‘right to health’. Without access to necessary medications, individuals may face significant barriers in receiving proper medical treatment and achieving optimal health outcomes.” A bench of Chief Justice DY Chandrachud, and Justices JB Pardiwala and Manoj Misra heard the petition filed by transparency activist and environmentalist Kishan Chand Jain under Article 32 of the Constitution. By way of relief, the petitioner seeks strict disciplinary action against medical practitioners who do not adhere to the generic drug prescription mandate under the law, as well as suitable directions to fix maximum retail prices for non-scheduled and generic medicines, conducting surprise checks on prescriptions to ensure compliance, and prohibiting the use of trade names for off-patent drugs, requiring only the manufacturing entity’s name to be displayed. In this PIL, Jain underscores the economic benefits of generic drugs, which contain the same active ingredients as their branded counterparts but are not tied to a specific brand name, making them notably more affordable. Generic medicines, which have the same therapeutic effects, can cost 50 percent to 90 percent less than branded alternatives. The affordability of generic drugs also helps improve access to essential medications, the petitioner emphasises - “Cost is a crucial aspect when it comes to accessing medicines. Generic drugs, which have the same active ingredients as their branded counterparts but are not marketed under a specific brand name, are often significantly cheaper. The prices of generic medicines (off-patented) can be 50% to 90% lower than those of branded medicines. This price difference makes generic drugs more affordable and accessible to a broader section of the population.” In addition to the price factor, the PIL stresses the urgent need for effective enforcement mechanisms. The petitioner contends that the existing regulations, such as the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, emphasise the importance of prescribing drugs using their generic names. For example, Clause 1.5 of the regulations requires physicians to prescribe drugs using their generic names, preferably in capital letters. Similarly, to discourage doctors from pursuing profits, Clause 6.3 places a prohibition. A physician is not allowed to run an ‘open shop’ where medicines prescribed by other doctors are sold, or where medical equipment is sold. It is acceptable for a doctor to prescribe or supply medications, remedies, and appliances, as long as patients are not exploited. When a doctor prescribes or acquires medications for a patient, the medicine’s original formula and generic name must be clearly stated. Non-compliance with these regulations amounts to ‘professional or ethical misconduct’. But, the lack of a robust system to enforce these regulations through disciplinary proceedings, surprise checks of prescriptions, and regular prescription audits has hindered their practical implementation, leaving them confined to legal frameworks. The petitioner argues that the bodies responsible for enforcing these regulations, such as the Ethics and Medical Registration Board (EMRB) and state medical councils, have neglected their duty, leading to adverse consequences for marginalised sections of society and contributing to a healthcare crisis. Additionally, Jain points out the absence of provisions for setting maximum retail prices (MRP) for non-scheduled formulations, including generic versions of medicines. This absence allows manufacturers unchecked power to establish any MRP, potentially leading to arbitrary pricing regardless of the actual manufacturing cost of the medicine. The petitioner draws support from a Rajasthan High Court ruling that links the right to affordable medical treatment with Article 21 of the Indian Constitution, which states – “The right to obtain treatment is tacit of Article 21 of the Constitution of India, and right to obtain treatment at affordable prices of medicines is one of the concomitant of the same. Not prescribing the medicines in generic names may in given facts tantamount to violation of Article 21 of the Constitution of India.” The petitioner also cites a recent ...

Doctors Should Only Prescribe Generic Drugs Instead Of Brand-Name Medicines : Plea In Supreme Court

Awstika Das

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