The Supreme Court on Friday issued a Notice of Public Interest Litigation (PIL) motion seeking action and guidelines against healthcare professionals prescribing branded drugs to patients instead of more affordable generic drugs containing the same active ingredients. The petition argues that medical professionals prescribing generic drugs could reduce the financial burden on patients and improve access to essential medicines.
the bench of Chief Justice DY Chandrachudand Judge JB Padiwala and Manoj Misra We heard the petition filed under Article 32 of the Constitution by Kishan Chand Jain, a transparency activist and environmental activist. As a remedy, the petitioner seeks strict disciplinary action against health care workers who fail to comply with their legal obligations to prescribe generic drugs and appropriate instructions to fix unscheduled generic drug maximum retail prices. We are conducting random inspections. It prohibits the use of prescriptions to ensure compliance and brand names of out-of-patent medicines, requiring only the name of the manufacturer.
In this PIL, Jain emphasizes the economic benefits of generic drugs. Generic drugs contain the same active ingredients as branded drugs, but are not tied to a specific brand name, making them significantly more affordable. Generic drugs with the same therapeutic effect cost him 50% to 90% cheaper than branded alternatives. Petitioners stress that the affordability of generic drugs also helps improve access to essential medicines.
“Cost is a very important factor when it comes to obtaining pharmaceuticals. Generic (off-patent) prices can be 50% to 90% lower than branded medicines.This price difference makes generic medicines more affordable and accessible to a wider audience. will be.”
In addition to the price factor, PIL emphasizes the urgent need for effective enforcement mechanisms. Petitioners allege that existing regulations, such as the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, emphasize the importance of prescribing medicines using generic names. are doing.
For example, Article 1.5 of the Regulation requires physicians to prescribe medicines using generic names, preferably in capital letters. Similarly, Section 6.3 provides prohibitions to discourage physicians from seeking profit. Physicians are not permitted to sell medicines prescribed by other physicians or operate “open shops” that sell medical devices. It is permissible for physicians to prescribe or supply drugs, treatments and devices as long as they are not abused by the patient. When a doctor prescribes or obtains a drug for a patient, the original prescription and generic name of the drug should be clearly stated. Failure to comply with these regulations constitutes “professional or ethical misconduct.”
However, the lack of robust systems to enforce these regulations through disciplinary procedures, spot checks of prescriptions, and regular prescription audits hinders practical implementation and remains confined to the legal framework. It is Petitioners allege that the bodies responsible for enforcing these regulations, such as the Ethics and Medical Registration Board (EMRB) and the State Medical Council, have failed in their duties, resulting in negative impacts on marginalized segments of society and the lack of access to healthcare. They claim it is part of the crisis.
In addition, Jain pointed out that no provision exists to set maximum retail prices (MRPs) for unscheduled formulations, including generic versions of drugs. This absence leaves the manufacturer with unchecked power to set his MRP, which could lead to arbitrary pricing regardless of the drug’s actual cost of manufacture.
The petitioner has received support from a Rajasthan High Court ruling linking the right to affordable health care to Article 21 of the Indian Constitution, stating:
“The right to treatment is an implicit provision of Article 21 of the Indian Constitution, which is accompanied by the right to affordable pharmaceutical treatment. It may violate Article 21 of the Constitution.”
Petitioners also refer to recent Supreme Court rulings that raise concerns about manipulating prescriptions for personal gain, including accepting gifts and bounties from pharmaceutical companies. Such practices could drive up drug costs and create a “perpetual cycle of pollution” that could adversely affect the public.
The petition was submitted through Defender of Record EC Agarwala.
The National Medical Commission (NMC) has issued new guidelines on professional conduct in its latest notice. One regulation requires doctors to avoid prescribing branded generic drugs. Violations may result in penalties and suspension of business license for a period of time. The regulation says –
“All registered physicians are required to prescribe medicines using legibly written nonproprietary names and to prescribe medicines rationally, avoiding the use of unnecessary medicines and unreasonable fixed-dose combination tablets. there is.”
Case details
Kishan Chand Jain v. Ethical Medical Registry Board and Ethics Committee.| 2023 Warrant Petition (Civil) No. 794
