'Ill-advised': IMA files complaint with union health minister against NMC notification on generic medicine

IMA president Dr Sharad Kumar Agarwal told ETV Bharat making prescribing of generic medicine mandatory was just shifting the choice from a medical practitioner who is primarily concerned, trained and responsible for the patients’ health to a chemist or person sitting in a chemist shop. -- Reports ETV Bharat's Gautam Debroy.

New Delhi: The Indian Medical Association (IMA) on Monday lodged a formal complaint to Union Health Minister Mansukh Mandaviya against National Medical Commission’s (NMC) recent notification making it mandatory for registered medical practitioners (RMPs) to prescribe medicine with its generic names only.

“We have put our points in front of Health Minister Mansukh Mandaviya. In fact, all the parties put their points. The meeting took place in a cordial atmosphere,” IMA president Dr Sharad Kumar Agarwal told ETV Bharat after the meeting. Taking note of the controversy that has been raised over the use of generic medicine, the Health Ministry had convened a meeting with all stakeholders including IMA, National Medical Commission, and Indian Pharmaceutical Alliance (IPA) in New Delhi.

Agarwal said that they are now waiting for the central government's decision. "This measure (generic medicine) is just shifting the choice from a medical practitioner who is primarily concerned, trained and responsible for the patients’ health to a chemist or person sitting in a chemist shop, who is selling drugs. This naturally wouldn’t be in the best interest of the patient. If doctors are not allowed to prescribe branded drugs, then why should such drugs be licensed at all, given that modern medicine drugs can be dispensed only on the prescription of doctors of this system,” said Agarwal.

Terming the August 2 notification issued by NMC on generic drugs as an "ill-advised" step, the IMA president said that the regulation makes it mandatory for doctors to prescribe only generic drugs. “It is a matter of great concern for IMA since this directly impacts patients’ care and safety. Generic promotion needs to be genuine,” he said.

The NMC notification said that India’s out-of-pocket spending on medications accounts for a major proportion of public spending on health care. Further, generic medicines are 30 to 80 per cent cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care, the NMC said.

However, IMA said the government, if serious about implementing generic drugs, should give a license only to generics and not to any branded drugs while ensuring the quality of generic drugs. Making quality brands available in the market but disallowing doctors who are responsible for patients’ health, from prescribing them seems dubious, the IMA president said.

“The onus of exercising the choice shifts from the doctor to the medical shop. Now market forces rather than the profession will determine the choice. Will this assure that the patient gets a generic version of the drug? Or will the brand of pharmacy’s choice be dispensed?” he asked. Demanding a fool-proof system of quality assurance before switching over to generic drugs, the IMA said that the biggest impediment to generic drugs is the uncertainty about their quality.

“The quality control in the nation being very weak, there’s practically no guarantee of the quality of drugs and prescribing drugs without assured quality would be detrimental to patient health. Less than 0.1 percent of the drugs manufactured in India are tested for quality. This step should be deferred till the government can assure the quality of all the drugs released into the market,” Agarwal said.

A new regulation named “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 issued by the ethics and medical registration board of NMC, specifically highlighted the professional conduct of registered medical practitioners, duties of practitioners towards their patients, responsibilities of practitioners to each other, duties of practitioners towards the public and allied healthcare professionals, as well as professional misconduct.

The NMC regulation said that a branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies’ brand names. These drugs may be less costly than the branded patent version but costlier than the bulk-manufactured generic version of the drug. There is less regulatory control over the prices of these “branded” generic drugs.

According to the regulation, 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.

“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,” the regulation stated. It further said that an RMP shall not directly or indirectly participate in any act of division, transfer, assignment, subordination, rebating, splitting, or refunding of any fee for diagnostic, scanning, medical, surgical, or other treatment.

“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 and 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,” the regulation said.

It said that RMPs should avoid discussing the treatment of patients on public social media or prescribing medicine to patients on the public social media platform. If a patient approaches doctors through public social media, the doctor should guide the patient toward a telemedicine consultation or in-person consultation as the situation warrants, the regulation stated.

The NMC regulation also imposed a penalty if any of the rules were violated by any registered medical practitioner. The maximum action is a suspension of the license to practice for up to one month to 3 years.

“The last resort is to debar a member (RMP) permanently from practice (permanent suspension of license). This penalty may be awarded only after a detailed inquiry, carried out by an expert group constituted under the guidelines, finds that the treating doctor has committed a willful, or intentionally harm and unlawful, prohibited action. This will be taken as a ‘unique case’ and no precedent will need to be cited,” the NMC regulation stated.