Medical Associations do not fall under jurisdictions of NMC, says IMA, writes to Health Minister demanding exemption from new Ethics Regulations
New Delhi: Noting that an association registered under the Societies Act does not fall under the purview of the National Medical Commission (NMC), the Indian Medical Association (IMA) has now written to the Health Minister Mansukh Mandaviya demanding an exemption from the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023.
In the same letter, putting forward the demands of the medical fraternity, the association also asked the Union Health Minister to withdraw the mandatory nature of the regulations on the prescription of generic drugs and make digitalisation desirable yet optional.
IMA has also demanded to allow the professional associations to use pharma funding for CMEs and educational / research activities in a transparent and bonafide manner.
The letter comes a day after the association had a meeting with the Union Minister for Health and Family Welfare and Chemicals and Fertilisers yesterday at 4:30 PM.
Medical Dialogues had earlier reported that Minister Mandaviya had called the meeting to discuss the 'issues' with the new regulations, which were published in the official Gazette on August 2, 2023. The National Medical Commission, Union Health Secretary and the Director General of the Indian Pharmaceutical Alliance also participated in the meeting.
In the letter, IMA pointed out the objections and concerns of the association regarding some sections of the new regulations and put forward its demands to the Health Minister in this regard.
Objection to Mandatory Prescription of Generic Medicine:
Chapter 1 Section 8 of the NMC RMP Regulations 2023 states,
"Prescribing Generic Medicines: Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1 and/or L2)(Generic Drugs and Prescription guidelines)."
Further, Guidance to RMPs line 1 states "Prescribe drugs with “generic”/“non-proprietary”/“pharmacological” names only."
Referring to this, IMA mentioned in the letter, "It is a matter of great concern for IMA since this directly impacts patient care and safety. It is believed that less than 1 percent of the generic drugs manufactured in India are tested for quality. Patient care and safety are nonnegotiable for both, the Government and the medical profession."
The association also referred to Mashelkar Report of 2003 which noted,
“the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of data bank and nonavailability of accurate information.
• WHO and Schedule M of Drugs and Cosmetics Act, 1947 provides a comprehensive set of guidelines. The most important characteristics of any drug is its Bioequivalence (BE) and Bioavailability (BA) to the innovator product to prove its safety, clinical efficacy equivalence and cGMP compliance on continuous basis for sustainable supply. Currently only a few categories need BA/BE study. All generics may not be bioequivalent.
• It is worthwhile to mention here that testing some samples of a batch does not provide assurance of the product quality and safety. Batch to batch reproducibility, stability of the product is possible only through a comprehensively designed Quality Management System in a company complying to cGMP standards.
• The quality assurance mechanism in our country is very weak. India has more than 3 lakh batches of 70,000 drug formulations, the quality assurance mechanism in our country can ascertain the quality control of only 15753 drugs annually. In 2023 only around 12000 tests were conducted by CDCSO and State Drug Control Department together. If we consider one sample from each batch is tested, minimum required number of tests were around 3,00,000. India is not a signatory of the International Council for Harmonization (ICH). A new manufacturer is needed to take the approval of only the State Drug Authorities for 4 years.
• Time and again, major adverse events including death occur due to poor quality of drugs or contaminated drugs. e.g. one of the major reasons for number of deaths that had occurred in the sterilization camp held in Chhattisgarh in 2014 was due to generic drugs used. The Chhattisgarh High Court has found the deaths due to sub-standard generic drugs used during the operative course.
• The onus of exercising the choice shifts from the doctor to the medical shop. Market forces rather than the profession will determine the choice.
• The objective of NMC is to regulate and prescribe minimum standards in medical education and the yardstick of ethics cannot be applied on this matter of usage of generic drugs with or without a brand name.
In this context, the association also referred to Chapter 1 Section 10 of the Regulations which bar the doctors, individually or as a part of an organization, not to give any recommendations or approval regarding any drug brand, medicine, or any other commercial product etc.
Prohibition of endorsement of a product or person:
"RMP individually or as part of an organization/association/society etc. 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, certificate, report, or statement 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 or permit the publication of report thereof through any mode. (L3)," states the regulations.
Noting that NMC does not have a jurisdiction over an Association registered under Societies Act, IMA mentioned in the letter, "IMA and many professional organisations are registered under Societies Act or similar Acts. IMA has clearly stated objects in its Memorandum, Rules and Bye Laws regarding medical education and public health. Its capacity to conduct Continuing Medical Education and Health awareness campaigns flows directly from its objects. It is legally eligible and empowered to raise funds for such activities. So long as the funds are raised transparently in a bonafide manner and are used for the objects of the Association IMA is within its legal rights. This right was upheld by the Appellate order U/S 250(6) of the Commissioner of Income Tax on 30 05 2016. That the National Medical Commission does not have a jurisdiction over an Association registered under Societies Act is clear."
The association also referred to The Finance Act, 2021, which has made retrospective amendment w.e.f. 1st July 2017 by inserting sub clause (aa) to sub section 1 of section 7 because of which any services or activities or transactions given by a trust or association or society to its member or vice versa shall be considered as Supply.
"This amendment makes concept of mutuality redundant in the case of transactions between association with its members or vice versa. The relationship between the members and the association was previously treated as mutual benefit transactions and there was no tax in the pre-GST era. Now any transaction between an association and its members will be between distinct person i.e., association on one hand as person and members on the other side. If this transaction is supply it will be taxable under GST," IMA noted in the letter.
The association pointed out that the Government cannot have two different principles for the GST Act and the NMC Regulations and it cannot treat the association and its members as different persons under the GST and one and the same under NMC.
IMA demands to allow professional Associations to use pharma funding for CMEs and educational/research activities:
Section 35 of the NMC RMP (Professional Conduct) Regulations 2023 states, "RMPs 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 RMPs may receive as employees of these organizations. 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. RMP should be aware of the conflict-of-interest situations that may arise. The nature of these relationships should be in the public domain such as clinical drug trials and should not be in contravention of any law, rule, or regulation in force. RMP himself or as part of any society, organization, association, trust, etc. make regarding the relationship with the pharmaceutical and allied health sector industry clear and transparent open to scrutiny. (L3)"
While NMC has even barred the doctors to use pharma sponsorship in respect of seminar, workshop etc., IMA argued in the realm of modern medicine, the pursuit of excellence is synonymous with an ongoing commitment to learning, collaboration, innovation and Conferences and CME events stand 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. 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," the association further pointed out in the letter.
"Across the globe, regulatory bodies and medical associations have crafted frameworks that enable RMPs to participate in educational activities while upholding ethical standards. Adapting such models can preserve the integrity of educational activities. RMPs are highly trained professionals capable of discerning valuable information from promotional content. Rather than limiting their exposure to industry insights, the emphasis should be on empowering them to critically evaluate the information presented. The integration of pharmaceutical sponsorships into medical educational activities is a topic that necessitates a balanced approach, one that acknowledges the potential for conflicts of interest while preserving the invaluable role these partnerships play in advancing medical knowledge," it added.
The association referred to the fact that there are no Government or statutory funding of the CME activities in the country and mentioned that there is little doubt that the sponsors of CMEs i.e. the pharma companies, hospitals etc. plough back their earnings into the society by providing opportunities to enrich knowledge and information.
So long as individual personal gains are not allowed the professional Associations are the best bet to handle this responsibility on behalf of the patients. That this should be done transparently in a bonafide manner is not disputed. The best way to spend part of pharma profit for patients is to allow them to sponsor CME activities of professional associations. Updating the knowledge of doctors will ensure better patient care, argued the association.
Objection to mandatory digitalisation of medical records:
While specifying the Professional Conduct of RMPs, NMC in Section 13, Sub-section D of the regulations mentioned, "
Responsibility of RMP regarding the Medical Records:
"D. Efforts shall be made to computerize patient’s medical records for quick retrieval and security. Within 3 years from the date of publication of these Regulations, the RMP shall ensure fully digitized records, abiding by the provisions of the IT Act, data protection and privacy laws, or any other applicable laws, rules, and regulations notified from time to time for protecting the privacy of the patient. (L1, L2)"
Objecting to the mandatory digitalisation of medical records of the patients within 3 years, IMA argued that even though the idea of digitalisation is welcome, mandating that this should be done in 3 years is "unrealistic".
The regulation should allow for gradual transition. Moreover, there are valid counter arguments against EMR like loss of quality patient time, eye contact etc the medium and platform of documentation should be left to the doctor, demanded IMA.
Therefore, IMA requested the Government to withdraw the mandatory nature of the regulation on prescription of Generic drugs till the quality assurance of the all drugs could be ensured, exempt Associations / Organisations from the purview of NMC Regulations, allow professional Associations to use pharma funding for CMEs and educational / research activities in a transparent and bonafide manner, and make digitalisation desirable yet optional.
