Articles 18th Aug 2023

Quality controls standards and the EV charging ecosystem: All you need to know

Authors

Ashishchandra Rao Partner | Mumbai
Sharmin Kapadia Associate | Mumbai
Kareena Tahilramani Associate | Mumbai

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On August 2, 2023 the National Medical Commission (NMC), Ethics and Medical Registration Board (EMRB) issued the Registered Medical Practitioner (Professional Conduct) Regulations, 2023 (Regulations)[1] to regulate the practice and conduct of medical practitioners. The Regulations shall replace the (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (Code of 2002)[2] and certainly seem to be an attempt to give statutory backing to provisions of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP)[3]. The UCPMP is a voluntary code introduced in 2015 to prevent certain unethical practices employed in the pharmaceutical industry to promote and sale of drugs.  The UCPMP is well adopted by the pharmaceutical industry at large. However, since it was still a voluntary code, the enforcement of its provisions, was still a challenge for the concerned authorities.

  • Key highlights of the Regulations
    • Every Registered Medical Practitioner (RMP) is required to display their unique registration ID assigned to them by the EMRB in their prescriptions, certificate and money receipts given to patients.
    • The Regulations now make it mandatory for every RMP, irrespective of the state in which they practice, to re-new their license every 5 years. As a requirement for renewal of their license, every RMP is required to attend Continuing Professional Development (CPD) programs offered by recognized medical colleges and/or health institutions regularly every year. The Regulations require every RMP to obtain at least 3 credit points per year and a total of at least 30 credit points every 5 years, as a condition for renewal of their license. This is as opposed to the previous regime, wherein RMPs only practicing in certain states like Kerala were required to re-new their license every 5 years. The Regulations clarify the distinction between Continuing Medical Education (CME) and CPD. While CME largely addresses the needs of health professionals with regard to updating their knowledge and skills which may take the form of workshops, seminars, lectures etc., CPD is a more holistic approach and goes beyond knowledge and skill. CPD includes effective communication, evaluation of emerging evidence, application of law in healthcare, the understanding of the public health, health policy and health economics among others. CME is more speaker oriented whereas CPD is more learner oriented.
    • The Regulations place a complete prohibition on RMPs participating in any such third-party educational activities which involve direct or indirect sponsorships from pharmaceutical companies or the allied health sector. However, at the same time, the Regulations place importance on the RMPs duty to educate and spread awareness among the public at large by participating in CPD and CME programs, including seminars, workshops, symposiums, conferences, etc. This is a significant divergence from the previous regime, which allowed RMPs to participate in such educational activities sponsored by pharmaceutical companies, however, required the RMPs to do so at their own cost.
    • The Regulations continue to prohibit RMPs and their families from receiving 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.
    • There is now a requirement for RMPs to make his/her relationships with pharmaceutical companies and allied health sector industries (such as participation in clinical drug trials etc.), publicly available, clear, transparent, and open to scrutiny.
    • The Regulations now mandate that RMPs prescribe drugs using generic names only. RMPs can no longer prescribe medicines using their Brand names. However, the Regulations create an exception and allow this practice to be relaxed in the case of drugs with narrow therapeutic index, biosimilars and other similar exceptional cases. While this practice was included in the Code of 2002, it was not mandatory in nature and merely encouraged RMPs to use generic names as far as possible. The rationale behind mandating this practice seems to be an attempt on part of the authorities to improve access to and reduce the cost of health care, as generic medicines are priced approximately 30-80% lower than branded drugs (except price-controlled drugs). However, there is a widespread debate in the pharmaceutical industry as to the quality, standards and efficacy of generic medicines/drugs. The Regulations further clarify the difference between ‘generic names’ and ‘generic medicines’.[4]
    • The Regulations further prohibit RMPs from recommending, approving, endorsing, certifying, or issuing statements concerning any drug brand, medicine, nostrum remedy, surgical or therapeutic article, apparatus or appliance, or any commercial product or article with respect to any of its property or its quality, use thereof, demonstration or trial thereof. This provision will affect not only the pharmaceutical industry but also the Consumer Goods industry, which promote their products and services through doctor/dentist recommendations.
    • The Regulations seek to promote the purchase of drugs from Jan Aushadi Kendras, established under the Pradhan Mantri Bharatiya Janaushadhi Pariyojana. The Regulations recommend that RMPs avoid prescribing “branded” generic drugs and actively participate in programs related to promotion of and access to generic medicines. “Branded generic drugs” are those which have come off patent, manufactured by drug companies and sold under different companies’ brand names. The Regulations further require RMPs to prescribe fixed-dose combinations drugs judiciously and avoid prescription of irrational fixed-dose combination medicines.
    • While RMPs were prohibited from using agents or touts for procuring patients under the Code of 2002, the Regulations now also explicitly prohibit a RMP from using online forums for procuring patients. This particular provision might have a significant impact on online aggregator websites that list RMPs according to their specializations, along with patient testimonials etc, and allow patients to book appointments with the RMPs through such websites or applications.
    • While the Code of 2002 and the Regulations both require that the RMP must make known to the patient, the consultation fees before examination or treatment of the patient, the Regulations now allow the RMP to refuse treatment to a patient in the event the fees are not paid. The only exceptions to this practice being emergency situations and/or RMPs working in government service. The Regulations further place an obligation on the RMPs to ensure that the patient is not abandoned and ensure that in the event treatment to a patient is refused, the patient is referred elsewhere for further treatment.
    • Except in life-threatening emergencies, RMPs are free to choose whom they will treat. RMPs may now under the provisions of the Regulations, refuse treatment to a patient who is abusive, unruly, and violent, or whose relatives are abusive, unruly and violent. In such cases, the RMP should document and report such behavior and refer the patient for further treatment elsewhere. This is a progressive effort on part of the Government for protection and well- being of RMPs, in the wake of various recent events of violence against the medical professionals and hospital staff.
    • In furtherance of the present Government’s push to promote and regulate use of digital information and documents, the Regulations require every self-employed RMP to maintain medical records (in the standard proforma laid down by the NMC) of their patients for 3 years from the date of last contact with the patient for treatment. Furthermore, the Regulations mandate that all medical records of patients are maintained in a digital format within 3 years from the date of publication of the Regulations, irrespective of the fact that they are maintained by a self-employed RMP or a hospital, nursing home, etc. In the event a request is made (either by the patient, authorized attendant or legal authority involved) for medical records to a RMP responsible for patient records in a hospital or healthcare institution, the request must be acknowledged and the required documents shall be provided within 5 working days. In case of medical emergencies, the records shall be provided at the earliest.
    • The Regulations provide for penalties for not adhering to the Regulations. The penalties are provided in varying degrees, depending on the seriousness of the misconduct/failure to adhere to the Regulations and bearing the principle of proportionality in mind. The penalty so awarded and confirmed to the RMP by the State Medical Council or EMRB/NMC is required to be publicized widely on its website and other platforms as they deem fit and communicated to the employer, the hospital/healthcare institution of the RMP and respective Medical Associations/Societies/Bodies.
    • While the Regulations have laid down certain requirements in addition to the Code of 2002 as seen above, the Regulations have retained various other provisions of the Code of 2002, such as the following:

    i. RMPs, corporate hospital, nursing home, private rehabilitation centre, or any type of medical training institution etc. are prohibited from advertising. They are however permitted to make announcements in print, electronic and social media which only contain the name of the institution, type of patients treated or admitted, kind of doctors and staff training, other facilities offered and the fees, and nothing else.
    ii. RMPs are prohibited from publishing photographs or case reports of patients in any medical or other journal, without first obtaining their informed consent.
    iii. Clinical drug trials or other research involving patients or volunteers must comply with ICMR guidelines and the New Drugs and Clinical Trials Rules, 2018. In the event the consent to participate in trial of drug/s or therapy is not taken from the patient in the manner as provided under the guidelines, such act shall be construed as misconduct.

  • Analysis
    • The new Regulations seem to promote transparency in the medical profession, while prescribing various degrees of penalties for contravention of its provisions. However, in our opinion certain provisions of the Regulations put unreasonable and arbitrary restrictions on the medical professionals which may fall foul of the principles of right to profession under the Constitution of India.
    • The Regulations restrict the participation of RMPs to only the CMEs and CPDs of either the Government, non-profit organizations, or Healthcare institutions or industry associations, which are not related to or funded by pharmaceutical companies. These restrictions may affect the organization of these essential CMEs and CPDs due to budgetary constraints and/or other considerations like geographical limitations etc. While the Regulations are a beneficial social welfare legislation, it may in fact affect various campaigns and Corporate Social Responsibility (CSR) activities carried out by listed pharmaceutical companies, which engage with specialist RMPs, even though, on a non- endorsement or non-remuneration basis.
    • The prohibition on the use of online media/fora by RMPs is another example of an unreasonable and arbitrary restriction. There can be potential misuse of this provision by the concerned authority to reprimand a RMP, for listing their services on online aggregating platforms. This provision may also impact/contradict the various regulations framed with regards to telemedicine, leading to unnecessary prosecution.
  • Conclusion

    In conclusion, the Regulations mark a significant shift towards promoting ethical practices and transparency within the medical profession. They aim to address several key aspects of medical practices, including professional conduct, engagement with pharmaceutical companies, prescription practices, patient interactions, and the maintenance of medical records. While these reforms are commendable in their attempt to enhance accountability and safeguard both practitioners and patients, there are points of concern. Some provisions, though well-intentioned, may appear overly restrictive. Striking a balance between the needs of the medical community and the interests of public health is crucial and may be achieved by other means, such as requiring higher level of disclosures by RMPs and/or pharmaceutical companies while participating in or conducting (as the case may be) workshops, seminars, lectures etc. that may be sponsored by pharmaceutical companies. As the healthcare landscape evolves, ongoing dialogue and adjustments will likely be necessary to ensure that the Regulations effectively serve their purpose without hindering the practice of medicine or stifling innovation in the field.

  • References

    [1] National Medical Commission, Ethics and Medical Registration Board, Notification No. R-12013/01/2022/Ethics, dated 02 August 2023
    [2] Indian Medical Council, Notification No. MCI-211(2)/2001/Registration dated 11 March 2002, published in Part III, Section 4 of the Gazette of India, dated 6th April 2002.
    [3] Government of India, Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals, F. No. 5/3/2009-PI-I/PI-II (Vol. III), accessible here: https://pharmaceuticals.gov.in/sites/default/files/Uniform%20Code%20of%20Pharmaceuticals.pdf
    [4] Guidelines – 1 of the Regulations define the term ‘generic name’ as the “non-proprietary or approved name of the drug”. Whereas, ‘generic drug/medicine’ is defined as “drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use”.

Disclaimer: The information contained in this document is intended for informational purposes only and does not constitute legal opinion or advice. This document is not intended to address the circumstances of any individual or corporate body. Readers should not act on the information provided herein without appropriate professional advice after a thorough examination of the facts and circumstances of a situation. There can be no assurance that the judicial/quasi-judicial authorities may not take a position contrary to the views mentioned herein We trust you will find this an interesting read. For any queries or comments on this update, please feel free to contact us at insights@elp-in.com or write to our authors: Ashishchandra Rao, Partner – Email – AshishchandraRao@elp-in.com Sharmin Kapadia, Associate – Email – Sharminkapadia@elp-in.com Kareena Tahilramani, Associate – Email – KareenaTahilramani@elp-in.com