The National Medical Commission (NMC) Registered Medical Practitioner (Professional Conduct) Regulations, 2023 were notified in the Gazette of India on August 2, 2023.
Key highlights of the Regulations include the mandate for prescription of drugs only by their generic names, rather than by brand. The Regulations also place an embargo on sponsorship of doctors for medical conferences, workshops and seminars by pharmaceutical and health-allied companies.
The Regulations, which have far-reaching ramifications for the medical profession and the marketing of pharmaceutical products, received severe backlash from physicians’ organisations such as the Indian Medical Association and the Association of Physicians of India, as well as from pharmaceutical companies for lack of consultation and speculation over the quality of generic drugs in India. Following multiple post-facto consultations, the Regulations were kept in abeyance on August 23, 2023.
In relation to the sponsorship of seminars and workshops, Regulation 35 states:
“…Also, RMPs 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.”
This provision leads to an interpretation conundrum – does the embargo apply to doctors (registered medical practitioners) for attending conferences or is it a prohibition for pharmaceutical companies to sponsor such events? The Association of Physicians of India took the approach that the embargo applies to the sponsorship of individual doctors for participation in such events, but does not preclude societies/associations from receiving sponsorship for the events.
In any event, without the necessary clarity from the NMC, several medical conferences nation-wide were cancelled during the period when the Regulations were in effect. These seminars form the backbone of continuing medical education and research, and without adequate funding, they would have been in jeopardy, hampering research, innovation, and the dissemination of information.
Amongst the positives of the Regulations, in line with addressing the inherent conflict of interest, they make the prohibition relating to pharma sponsorships, gifts, hospitality and commissions for referrals or endorsements even more stringent. Further, the Regulations set out social media guidelines that restrict the circulation of patient testimonials, images, videos and prohibiting any solicitation through social media. The Regulations also settle the debate between the Hippocratic Oath and the Charaka Shapath by adopting instead the World Medical Association’s Declaration of Geneva, popularly called the ‘Physician’s Pledge’.
The most perilous mandate of the Regulations concerns the prescription of generic medicines; not following the diktat would attract a penalty of suspension of licence of the registered medical practicioner (RMP) for up to one month. This was heavily criticised primarily on account of quality concerns. A generic drug, by its very nature, does not carry a brand name or other trade mark and only lists the ingredients. While manufacturers of branded drugs usually spend on research and often follow USFDA-level processes, on the other hand, many smaller firms making non-branded generic medicines manage by complying simply with the more relaxed requirements of ‘Schedule M’ of the Drugs and Cosmetics Act, 1940 that lists ‘Good manufacturing practices’ for manufacturing drugs.
Another related issue was the absence of any standards of quality for combination drugs which could result in different results if only generic versions are taken. The absence of regulatory rules for certification and testing of drugs in India is evident as generic India-exported cough syrups and eye drops, which were found to be contaminated with industrial solvents, caused several deaths and blindness in Africa. This led to a major embarrassment for India, which is seen as the global hub for the manufacturing of generic drugs, and the World Health Organisation (WHO) asked that the cough medicines be removed from the market.
Therefore, while the objective of the statute may have been to improve access to medicines for the masses, it falls short by creating an information barrier, where the patient is unsure of the quality of drug purchased, leaving her at the mercy of the chemist.
It may be pertinent for industry observers to note that the Regulations did not apply to veterinary practitioners or drugs by virtue of the definition of “medicine” in its in its parent act, the National Medical Commission Act, 2019. The Act excludes “veterinary medicine and surgery”, thereby saving the animal pharmaceutical industry from such confusion.
It is surprising that even in the backdrop of intervention by the WHO, India is lacking a law on drug recall, which would ensure withdrawal of flawed or contaminated medicines from the market immediately after they have been detected. Further, the focus should be on mandating quality testing and certification for all drugs that are released in the market. Moreover, it is suggested that the Central Drugs Standard Control Organisation (the national regulator of pharmaceutical products) should publish reviews of new drugs and its applications in a manner similar to the US Food and Drug Administration.
In the recent past, the NMC Graduate Medical Education Regulations, 2023 also met with similar fate, being withdrawn merely 17 days after their notification. Amongst the controversial provisions in these guidelines were the introduction of a family adoption programme for medical students from the very beginning of their course, and the provision making students on wheelchairs and crutches ineligible for pursuing a medical degree. Both sets of regulations were released in quick succession and withdrawn subsequently, thereby highlighting the lack of adequate consultation with stakeholders, while seeking to upend the pre-existing processes.
Shouryendu Ray is a Partner and Vatsala Poddar is an Associate at Nora Chambers.