NMC Puts New Regulations On Docs In Abeyance; Directs To Follow Old Guidelines From 2002

In a new notification dated 23 August 2023, the National Medical Commission has set aside its earlier regulations released on 2nd of August which mandated doctors to prescribe generic drugs over branded medicines and barred the clinicians from receiving any gifts from pharmaceutical companies or endorsing any products. 

In a fresh order on Wednesday, NMC said, "National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect."

The NMC order further stated that the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, shall not be operative and effective till further notification on the subject is issued by the body. 

Moreover, the NMC order also directed the doctor's fraternity to follow the old guidelines, "The National Medical Commission hereby adopts and makes effective with immediate effect the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002," the NMC order stated. The NMC clarified that old regulations shall come into force with immediate effect.

Doctor's Body Up In Arms

The top doctor's body, the Indian Medical Association has been openly protesting against the new regulations ever since the rules became public knowledge. On Monday, a delegation of the IMA met with the Union Health Minister, Mansukh Mandaviya to record their concerns on regulations. 

IMA in the meeting highlighted its serious concerns over the regulation on doctors to prescribe generic drugs while avoiding branded drugs. Non-adherence to this regulation attracted suspension of the license for up to one month in the new rules which now are put on hold.  

The IMA in a letter addressed to the Union Health Minister had said that the regulation made it mandatory for doctors to prescribe only generic drugs. Calling it a is a matter of great concern affecting patient care and safety IMA said that it is believed that less than 1 per cent of the generic drugs manufactured in India are tested for quality. 

IMA had further said in the letter that India needs a comprehensively designed Quality Management System complying with cGMP standards as in India only a few categories of generic drugs need Bioequivalence (BE) and Bioavailability (BA) studies to the innovator product to prove their safety, clinical efficacy and equivalence. 

"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, and stability of the product are possible only through a comprehensively designed Quality Management System in a company complying with cGMP standards," IMA stated in the letter.

IMA added that the quality assurance mechanism in the country is very weak adding that, India has more than 3 lakh batches of 70,000 drug formulations, and the quality assurance mechanism can ascertain the quality control of only 15753 drugs annually.

"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," IMA stated.

Educational Conferences Need Balanced Approach

IMA had also opposed the regulation which restricted doctors from participating in seminars, workshops, symposia, and conferences sponsored by the pharmaceutical companies or the allied health sector.

"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," the doctor's body said.

Adding further it said that there are no Government or statutory funding of the CME activities in the country. "There is little doubt that the sponsors of CMEs i.e. the pharma companies, hospitals etc. plough back their earnings into society by providing opportunities to enrich knowledge and information," IMA protested in the letter to the Union Health Minister.