Doctors Dodge Penalty Bullet...For Now!
Supreme Court issues notices to Centre, All State governments, Ethics and Medical Registration Board and others on PIL pressing for consequences against doctors refusing to prescribe generic medicines, writes Anushka Singh
The National Medical Commission has, on 24 August 2023, put on hold the regulations that make it mandatory for doctors to prescribe generic drugs and bar them from accepting gifts from pharma companies or endorsing any drug brands.
The Registered Medical Practitioner (Professional Conduct) Regulations, 2023, were published on August 2.
However, the Indian Medical Association and Indian Pharmaceutical Alliance had expressed concern over the NMC making it mandatory to prescribe generic medicines saying this was not feasible because of the uncertainty about their quality. They also suggested that registered medical practitioners should be allowed to attend conferences sponsored by pharmaceutical companies or the allied health sector.
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They said the regulation barring doctors from attending conferences sponsored by pharma companies warrants reconsideration and also demanded that associations and organisations should be exempted from the purview of NMC guidelines.
Members of the IMA and IPA had met Mansukh Mandaviya on 21 August 2023 and expressed their concerns over the regulations.
The NMC in its 'Regulations relating to Professional Conduct of Registered Medical Practitioners" stated that all doctors must prescribe generic drugs, failing which they will be penalised and even their licence to practice may also be suspended for a period. It also asked doctors to avoid prescribing branded generic drugs.
In a notification issued, the NMC said, "... That National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect.
"That for removal of doubts, it is clarified that the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, shall not be operative and effective till further Gazette Notification on the subject by the National Medical Commission."
The Commission also said that it adopts and makes effective with immediate effect the "Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002," as if the same have been made by the Commission by virtue of the powers vested under the National Medical Commission Act, 2019.
"That for removal of doubts, it is clarified that Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, shall come into force with immediate effect," the notification by NMC said.
According to the regulations, registered medical practitioners and their families "must not receive any gifts, travel facilities, hospitality, cash or monetary grants, consultancy fee or honorariums, or access to entertainment or recreation from pharmaceutical companies or their representatives, commercial healthcare establishments, medical device companies, or corporate hospitals under any pretext."
However, this does not include salaries and benefits that registered medical practitioners may receive as employees of these organisations, the regulations stated.
Also, these practitioners should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector.
FROM THE EDITOR'S DESK - Any law on the issue of reaching public health to the masses in an affordable manner is welcome. In this context, the Regulations Relating to Professional Conduct of Registered Medical Practitioner that provide for penalisations even withdrawal of license to practice for a period, if legislated through democratic means, seem reasonable considering that the intent is to further the reach of cheap and affordable medication to one and all and not penalise. The National Medical Practitioner (Professional Conduct) Regulations 2023 has been rendered inoperative till further Gazette Notification on the subject by the National Medical Commission. A demand made for associations and organisations to be exempted from the purview of NMC guidelines and regulations barring doctors from attending conferences sponsored by pharma companies be struck down, seems ultra vires as the request defeats the very purpose of the Rule Of Law that mandates the same for all. It is also in contravention of Article 14 of the Constitution of India that guarantees equal protection of law to all within the territory of India, Article 15 that guarantees that the State does not discriminate against any citizens. Why, even in the plain reading of the anomaly, a doctor’s insistence on prescribing a branded drug or procedure instead of a generic, cheaper one can be perceived as a deficiency in service and warrant action in a Consumer Forum. IMA said less than 0.1 per cent of the drugs manufactured in India are tested for quality, the Medico Legal society warned that concerns arise due to potential compromise in quality control of generic drugs, leading to uncertain efficacy and liability for doctors. Now, these issues seem argumentative, open to conjecture and patently irrelevant to the issue in question which is of providing the option of cheaper generic drugs to the individual - Gajanan Khergamker
A registered medical practitioner "individually or as part of an organisation/ association shall not give to any person or to any companies or to any products or to software/platforms, whether for compensation or otherwise, any approval, recommendation, endorsement... concerning any drug brand, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or appliance or any commercial product or article with respect of any property, quality or use thereof or any test, demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode nor shall he boast of cases, operations, cures or remedies...", the regulations said.
The practitioners who attend to the patient will be fully accountable for his actions and entitled to the appropriate fees.
"In case of abusive, unruly, and violent patients or relatives, the registered medical practitioners can document and report the behaviour and refuse to treat the patient. Such patients should be referred for further treatment elsewhere," the regulations said.
Also, for the first time, the term emergency has been defined as 'life and limb saving procedure. Previously, the term emergency was not clearly defined.
According to the regulations, any request for medical records to a registered medical practitioner responsible for patient records in a hospital either by the patients or authorised attendant has to be duly acknowledged and documents has to be supplied within 5 working days instead of the existing provision of 72 days.
In case of medical emergencies, efforts should be made to make the medical records available at the earliest.
PIL In Supreme Court, Notices Issued To Parties
It may be recalled that Advocate Kishan Chand Jain has concurrently filed a Public Interest Litigation (PIL) in the Supreme Court of India, pressing for consequences against doctors refusing to prescribe generic medications.
The Supreme Court bench, comprising Chief Justice of India D.Y. Chandrachud, Justices J.B. Pardiwala and Manoj Misra, sought a response from the Centre, all state governments, the Ethics and Medical Registration Board (erstwhile Medical Council of India), and others in the matter.
Advocate K.C. Jain, the petitioner, apprised the bench that regulations emphasising the importance of prescribing generic medicines, which were notified back in 2002, remain largely unimplemented in practice.
He said the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, which highlight the significance of prescribing drugs by their generic names, exist solely within legal frameworks. The plea stated that affordability of medicines is a vital factor that contributes to effective healthcare delivery and the realisation of the 'right to health’.
Generic drugs, which have the same active ingredients as their branded counterparts but are not marketed under a specific brand name, are significantly cheaper. The prices of generic medicines (off-patented) can be 50 percent to 90 percent lower than those of branded medicines.
The petition sought directions to the National Pharmaceuticals Pricing Authority to fix the Maximum Retail Price (MRP) of Non Scheduled formulations and off-patented generic medicines.
By prescribing generic drugs, healthcare professionals can help alleviate the financial burden on patients and facilitate their access to vital medications. Advocate Jain’s PIL highlights the importance of generic medicines in reducing financial stress on patients and enhancing access to crucial medications.
This PIL can bring about positive changes in the healthcare system by promoting the use of affordable generic drugs.
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