Apex Court Issues Notice On PIL Seeking Action Against Doctors Prescribing Medicine Brands Instead Of Generic Drugs

The Supreme Court, today, issued notice in a Public Interest Litigation seeking action and guidelines against the medical practitioners/doctors prescribing branded medicines to patients instead of Generic drugs/medicines which have the same active ingredients as their branded counterparts but are not marketed under a specific brand name and are often significantly cheaper.

Initially, the Bench of Chief Justice D.Y. Chandrachud, Justice J.B. Pardiwala and Justice Manoj Misra indicated hesitation in entertaining the case and advised the Petitioner, who was appearing in person, to submit his concerns to the Indian Medical Council in the form of a representation. However, upon being told that regulations emphasizing the importance of prescribing drugs using their generic names had been established since 2002, the Court changed its stance and formally issued a notice.

"Okay, we will consider it. Issue Notice", said the CJI.

In the PIL filed under Article 32 of the Constitution by the RTI Activist and Environmentalist, Kishan Chand Jain, it is submitted that by prescribing generic drugs, healthcare professionals can help alleviate the financial burden on patients and facilitate their access to vital medications. The petitioner says that it is unfortunate that due to the lack of a robust system in place to enforce these regulations through the initiation of disciplinary proceedings, surprise checks of prescriptions, and regular prescription audits, the regulations remain largely unimplemented in practice, existing solely within legal frameworks.

"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", reads the PIL.

Jain has highlighted that to enhance the affordability and accessibility of medications, India has implemented regulations aimed at ensuring the use of generic names in prescriptions. "The Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002 (as amended), highlight the significance of prescribing drugs by their generic names", states the PIL.

Further, Jain submits that the EMRB and/or the State Medical Councils have grossly neglected their mandatory duty to enforce adherence to the above Regulations. This has resulted in significant hardship for the underprivileged and economically weaker sections of society, leading to a ‘health crisis’.

Also, it is pleaded that "the glaring absence of provisions for fixing maximum retail prices (MRPs) for non-scheduled formulations, including generic versions of medicines, is arbitrary and grants manufacturers unrestricted and unchecked authority to set any MRP, regardless of the actual manufacturing cost of the medicine."

The Petitioner also relies upon the Judgment of the Rajasthan High Court, in the case of Vijay Mehta 2011 SCC Online Raj 2984, where the following observation was made: "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."

It has been stated that Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002 (as amended), mandates that physicians should clearly prescribe drugs using their generic names, preferably in capital letters while ensuring rational prescription and use of drugs while non-compliance with Regulation No. 1.5 and 6.3 of the Regulations amounts to "professional or ethical misconduct".

In addition to that, Jain relied on the recent Judgement of the Apex Court in M/s Apex Laboratories Pvt. Ltd. v. Deputy Commissioner of Income Tax (2022) 7 SCC 98 where it was stated that "Therefore, it is a matter of great public importance and concern, when it is demonstrated that a doctor’s prescription can be manipulated, and driven by the motive to avail the freebies offered to them by pharmaceutical companies, ranging from gifts such as gold coins, fridges and LCD TVs to funding international trips for vacations or to attend medical conferences. These freebies are technically not ‘free’ – the cost of supplying such freebies is usually factored into the drug, driving prices up, thus creating a perpetual publicly injurious cycle".

The Petitioner seeks the following relief: strict disciplinary actions against medical practitioners who fail to prescribe drugs with generic names, as mandated by the Indian Medical Council Regulations; to fix the Maximum Retail Price (MRP) of Non Scheduled formulations and off-patented generic medicines; surprise checks on prescriptions to ensure compliance with generic drug regulations; to prohibit the use of trade names/brand names for off-patent drugs, mandating the display of only the manufacturing entity's name and such similar reliefs.

Cause Title: Kishan Chand Jain v. Ethics And Medical Registration Board (Emrb) (Erstwhile Medical Council Of India) and Ors. [W.P.(C) No. 794/2023]