New Delhi: In the midst of an uproar over the National Medical Commission’s (NMC) new professional conduct norms, it has emerged that the Union health ministry had expressed reservations about a clause that barred doctors from attending continuing professional development (CPD) programmes sponsored by pharmaceutical firms.
The norms, issued on 2 August, were put on hold Thursday following strong objections from doctors and drugmakers, particularly regarding a stipulation that doctors must prescribe only generic medicines — or else face a penalty.
Now, it is learnt that an internal note prepared by the health ministry had raised the issue of CPD programmes. ThePrint has seen the document. According to the note, a committee formed under NITI Aayog member (health) Dr V.K. Paul had suggested allowing pharmaceutical companies to sponsor such events.
This committee was formed in 2022 to review the Uniform Code of Pharmaceutical Marketing Practices — a voluntary set of guidelines introduced in 2015 to govern the conduct of drugmakers and their relationship with healthcare professionals.
According to the note, the committee has said that CPD programmes sponsored by pharmaceutical companies can be permitted as long as they are organised within India and doctors’ family members are not invited on such trips.
“The committee is yet to submit its final report but from the discussions so far, it has emerged that conditional permission can be given to pharma companies to organise CPDs for doctors and these suggestions were to be incorporated in the conduct norms for doctors but the NMC suddenly issued the guidelines without proper consultations,” reads the note.
The note also says that the “world over, CPDs are organised by pharmaceutical companies,” adding that the programmes are essential for doctors, and that banning them would impact their continuous training and learning, bringing down the quality of their services.
ThePrint reached health secretary Sudhansh Pant for comment but the calls went unanswered. This report will be updated if and when a response is received.
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Bone of contention
The NMC Registered Medical Practitioner (Professional Conduct) Regulations, 2023, now put in abeyance, had said that every registered medical practitioner (RMP) should attend continuing professional development programs regularly each year, totalling at least 30 credit hours every five years.
“Only recognised medical colleges and health institutions or medical societies accredited or authorised by the Ethics & Medical Registration Board under NMC/State Medical Councils can offer training and credit hours for this purpose,” the NMC notification said.
It added that RMPs should not be involved in any third-party educational activity — including CPD, seminars, workshops, symposia and conferences — that involves direct or indirect sponsorship from pharmaceutical companies or the allied health sector.
RMPs, it said, should be aware of conflict-of-interest situations that may arise, adding that the nature of these relationships, such as clinical drug trials, should be in the public domain and should not be in contravention of any law, rule, or regulation in force.
The regulations also said that an RMP — whether acting as an individual or as part of any society, organisation, association or trust — should make public his/her relationship with the pharmaceutical and allied health sector industry. Further, the notification added that any violations in this regard could lead to the practitioner’s licence being suspended for up to three months.
The health ministry’s internal note also pointed out that the NMC notification said credit scores accumulated through CPD programmes organised by pharmaceutical companies would not be recognised, which in effect means that such CPDs are “banned”.
‘Many organisations opposing’
The note said organisations opposed to the professional conduct norms for doctors include the Indian Medical Association (IMA), the National Medicos Organisation, the Indian Pharmaceutical Alliance, the Central Drugs Standard Control Organization (CDSCO), the Organisation of Pharmaceutical Producers of India (OPPI) and the Indian Academy of Pediatrics (IAP).
In its written representation to Union Health Minister Mansukh Mandaviya Monday, the IMA said that in the realm of modern medicine, the pursuit of excellence is synonymous with an ongoing commitment to learning, collaborating and innovating, and that conferences and CME (continued medical education) events serve as crucibles of knowledge enrichment.
“While the intention to ensure ethical conduct and unbiased learning environments is valid, an outright prohibition on third-party educational activities sponsored by pharmaceutical companies or the allied health sector warrants thoughtful reconsideration,” it had said.
The IMA had also said that “rather than assuming that sponsorships affect the educational process, the focus should be on ensuring transparent and unbiased presentations, enabling healthcare professionals to make informed judgments”.
“Across the globe, regulatory bodies and medical associations have crafted frameworks that enable RMPs to participate in educational activities while upholding ethical standards,” the IMA submitted.
The doctor’s body had also stressed that there is no government or statutory funding of CME activities in the country.
“There is little doubt that the sponsors of CMEs i.e. the pharma companies and hospitals, plough back their earnings into the society by providing opportunities to enrich knowledge and information,” it said.
‘Violation of NMC act’
The health ministry has also taken an exception to a provision in the regulations that said the NMC and state medical councils would have the powers of a civil court when they receive a complaint against a doctor and in such cases, would function as “Civil Procedure Courts”.
“In reality, there is no such provision in the NMC Act, 2019,” the ministry said.
The ministry’s note also says that while the regulations had suggested that drugs under 14 therapeutic categories are sold as over-the-counter or OTC drugs (medicines that can be sold without doctor’s prescription) in India, the CDSCO has expressed reservations over the country not having an OTC drug policy in place yet.
(Edited by Amrtansh Arora)
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