NMC puts on hold the regulation that made it mandatory for doctors to prescribe generic drugs

The IMA and the IPA had expressed concern over the regulation, saying this was not feasible because of the uncertainty about drug quality.

BySumit Jha

Published Aug 25, 2023 | 8:30 AM Updated Aug 25, 2023 | 8:30 AM

Medicine

Amid the row over doctors being mandated to prescribe generic drugs and being barred from accepting gifts from pharmaceutical companies or endorsing any drug brands, the National Medical Commission (NMC) on Thursday, 24 August, put on hold the regulations that prescribed this.

The Registered Medical Practitioner (Professional Conduct) Regulations of 2023, were published on 2 August.

The Indian Medical Association (IMA) and Indian Pharmaceutical Alliance (IPA) 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.

They said the regulation barring doctors from attending conferences sponsored by pharmaceutical companies warranted reconsideration, and also demanded that associations and organisations be exempted from the purview of NMC guidelines.

Members of the IMA and IPA met Union Health and Family Welfare Minister Mansukh Mandaviya on Monday and expressed their concerns over the regulations.

“Grand Victory for IMA against the 2023 Regulations Notified by NMC. The entire set of 2023 Regulations that were notified by the NMC has been held in abeyance. A heartfelt thanks to Health Minister Shri Mansukh Mandaviya for his receptive approach and for considering the concerns raised by IMA,” tweeted IMA after the regulation was put on hold.

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The regulation

On 2 August, the NMC released a comprehensive set of guidelines aimed at reshaping prescription practices.

The “Regulations relating to Professional Conduct of Registered Medical Practitioners” stated that all doctors must prescribe generic drugs, failing which they would be penalised and even their licence to practice might be suspended for a period. It also asked doctors to avoid prescribing branded generic drugs.

In a notification issued on Thursday, the NMC said, “…That National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect.”

It added: “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 adopted and made effective with immediate effect the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”, as if it had been made by the commission by virtue of the powers vested under the National Medical Commission Act of 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 Continuing Professional Development, seminars, workshops, symposia, and conferences, which involve direct or indirect sponsorships from pharmaceutical companies or the allied health sector.

Also read: Murky world of docs, hospitals, chemists, pharma-sector freebies

Trains without tracks: IMA

The NMC guidelines worried the IMA, the apex body of Indian medical professionals. It felt the decision would directly impact patient care and safety.

The IMA, while criticising the NMC’s “hasty” decision, termed the promotion of generic drugs “running trains without tracks”.

The association asserted that the ethical responsibility of prescription should remain with the medical practitioner rather than be shifted to pharmacists or chemists.

It warned against compromising patient care for the sake of cost-cutting and emphasised the importance of genuine promotion of generic drugs.

In a statement, the IMA highlighted the inconsistency of allowing branded drugs to be licensed while preventing doctors from prescribing them. It called for a quality-centric approach, suggesting that licences should solely cover generic drugs to ensure patient safety.

The association also called for a balance between making quality brands available and empowering doctors to make informed prescription choices.

Raising concerns over the uncertainty surrounding the quality of generic drugs due to weak quality control measures in the country, the association demanded transition to generic drugs be postponed until the government could guarantee the quality of all drugs in the market. “Patient care and safety are non-negotiable,” the IMA said.

In response to NMC’s insistence on generic prescriptions, the IMA proposed a unified approach where all pharmaceutical companies manufactured drugs without brand names, thereby eliminating the need for brand-specific prescriptions.

The association underscored that this shift should be accompanied by stringent quality checks on generic drugs, or else the responsibility should lie with the NMC and the government.

The IMA also called for the deferral of the regulation for wider consultations by the government of India, emphasising the need for a comprehensive and considered approach. The association demanded the urgent intervention of the Union government and NMC in this matter.

Also read: People demand pharma firms sell smaller quantities of medicines

Why the concern?

Doctors said they were concerned about drug quality, patient trust, accessibility, regulatory clarity, industry influence, and the need for additional education.

One significant concern stemmed from doctors’ apprehensions regarding the quality and efficacy of generic medicines.

While regulatory bodies have been striving to maintain standards, there was a certain degree of scepticism among medical practitioners about the consistency and reliability of these alternatives.

Doctors, holding the patient’s well-being as their utmost priority, expressed fear that prescribing medications with potential variances in effectiveness might compromise treatment outcomes.

Speaking to South First, nephrologist and transplant physician at the Bengaluru-based Trustwell Hospitals, Dr Arvind Canchi, offered a thought-provoking analysis of the NMC’s endorsement of generic medicines.

Emphasising the importance of maintaining consistent quality, Canchi acknowledged the potential benefits of generic drugs, but raised critical questions about their efficacy and reliability.

“The problem with the use of generic drugs is that the quality of these drugs should be equal in all respects,” explained Canchi, who is also the chairperson of the Indian Society of Nephrology Social Media Team.

He emphasised that the equivalence extended beyond mere cost considerations, encompassing factors such as absorption, drug content, and overall quality.

For generic drugs to be considered viable, they should meet rigorous standards across brands and remain comparable to their branded counterparts.