The Supreme Court on Friday issued a notice in a public interest litigation (PIL) petition seeking action and guidance against medical practitioners prescribing brand-name drugs to patients instead of more affordable generic drugs with the same active ingredients. The petition argues that healthcare professionals prescribing generic drugs can help ease the financial burden on patients and improve access to essential medicines.
A bench Chief Justice DY ChandrachudAnd Judge JB Pardiwala And Misha’s hand heard the petition filed by transparency activist and environmental activist Kishan Chand Jain under Article 32 of the Constitution. As a relief, the applicant seeks strict disciplinary action against medical practitioners who do not comply with statutory prescription generic drug mandates, as well as appropriate directives to set maximum retail prices for unscheduled and generic drugs, carry out unannounced checks on prescriptions to ensure compliance, and prohibiting the use of trade names for unpatented drugs, which only require the name of the manufacturer to be displayed.
In this PIL, Jain underscores the economic benefits of generic drugs, which contain the same active ingredients as brand-name drugs but are not tied to a specific brand name, making them more affordable. Generic drugs, which have the same therapeutic effect, can cost 50 percent to 90 percent less than brand-name alternatives. The affordability of generic drugs also helps increase access to essential drugs, the applicant emphasizes –
“Cost is an important aspect of accessing medicines. Generic drugs, which have the same active ingredients as brand-name drugs but are not marketed under a specific brand name, are often much cheaper. Prices for generic drugs (non-patented) can be 50% to 90% lower than brand-name drugs. This price difference makes generic drugs more affordable and accessible to a wider audience.”
In addition to the price factor, PIL emphasizes the need for an effective law enforcement mechanism. The Petitioner argues that existing regulations, such as the Medical Council of India (Professional Conduct, Etiquette and Ethics) Regulations, 2002, emphasize the importance of prescribing drugs using their generic names.
For example, Clause 1.5 of the regulation requires doctors to prescribe drugs using their generic names, preferably in capital letters. Similarly, to prevent doctors from pursuing profits, Clause 6.3 places a ban. A doctor 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 provide drugs, medications, and equipment, as long as the patient is not being exploited. When a doctor prescribes or obtains a drug for a patient, the original drug formula and generic name must be clearly stated. Non-compliance with these rules amounts to a ‘professional or ethical misconduct’.
However, the lack of a robust system for enforcing this regulation through disciplinary proceedings, spot checks on prescriptions, and regular prescription audits has hindered its practical application, limiting it to legal frameworks. The petitioner argues that the agencies responsible for enforcing these regulations, such as the Ethics and Medical Registry (EMRB) and state medical boards, have neglected their duties, leading to detrimental consequences for marginalized sections of society and contributing to a health care crisis. .
In addition, Jain pointed out that there is no provision to set a maximum retail price (MRP) for non-scheduled formulations, including generic versions of the drug. This absence allows manufacturers to exert uncontrollable power to set any MRP, potentially leading to arbitrary pricing regardless of the actual cost of manufacturing the drug.
The petitioner found support from the ruling of the Rajasthan High Court linking the right to affordable medical care to Article 21 of the Indian Constitution, which states –
“The right to get treatment is not written in Article 21 of the Indian Constitution, and the right to get treatment at affordable drug prices are one of the things that go together. Not prescribing drugs with generic names may in fact amount to a violation of Article 21 of the Indian Constitution.”
The petitioner also cited a recent Supreme Court ruling raising concerns about manipulation of prescriptions for personal gain, such as accepting gifts and incentives from pharmaceutical companies. Such practices can increase the cost of medicines, affecting society negatively by creating a ‘perpetual cycle of harming society’.
The petition has been filed via Advocate-on-Record EC Agarwala.
In its most recent notification, the National Medical Commission (NMC), has issued new guidelines on professional conduct. One of its provisions requires doctors not to prescribe brand-name generic drugs. Non-compliance can result in punishment or even suspension of their license to practice for a certain period of time. The regulation states –
“Every registered medical practitioner should prescribe drugs using clearly written generic names and prescribe drugs rationally, avoiding unnecessary drugs and irrational fixed-dose combination tablets.”
Kishan Chand Jain v. Agency for Ethics and Medical Registration and Ors.| Write Application (Civil) No. 794 Year 2023
Click here to read the order
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