National Medical Commission Puts New Drug Prescription Regulations on Hold

August 25, 2023

The National Medical Commission (NMC) has decided to halt the implementation of its recent regulations, which mandated doctors to prescribe generic drugs or face penalties, including potential suspension of their medical licenses. The Indian Medical Association (IMA) criticized the regulation and called for its withdrawal until quality assurance for all drugs could be guaranteed.

The NMC’s directive, titled “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023,” has been temporarily suspended due to concerns over its impact on patient care. The Union health minister urged the NMC to reconsider and make changes in the best interest of all stakeholders. The IMA expressed apprehensions about patient safety due to the lack of comprehensive quality testing for generic drugs and advocated for transparent funding sources for medical education and research. It also sought exemptions from NMC regulations for medical associations and recommended reevaluation of the prohibition on third-party educational sponsorships by pharmaceutical companies.

What was the focus of the National Medical Commission’s recently proposed regulations?

The NMC’s new regulations aimed to make it mandatory for doctors to prescribe generic drugs, under threat of penalties and potential suspension of their medical licenses. This move was intended to promote the use of cost-effective medication and increase accessibility.

Why did the Indian Medical Association (IMA) oppose the new regulations?

The IMA raised concerns about patient safety and drug quality. It called for the withdrawal of the regulations until comprehensive quality assurance for all drugs could be guaranteed. The IMA argued that the prescription of only generic drugs could adversely affect patient care.

How does the IMA view the impact of prescribing only generic drugs?

The IMA believes that prescribing only generic drugs could compromise patient care and safety. It expressed worries about the lack of quality testing for generic drugs and the potential risks associated with their widespread prescription.

What were the key recommendations made by the IMA in its letter to the health minister?

The IMA urged the government to permit professional associations to use pharma funding for medical education and research transparently. It also called for the reconsideration of the prohibition on third-party educational activities sponsored by pharmaceutical companies and emphasized the need for unbiased and transparent presentations.

How does the IMA’s stance tie into the larger issues of drug regulation and healthcare infrastructure?

The IMA referenced the Mashelkar Report of 2003, highlighting the shortcomings in the country’s regulatory system, including inadequate drug control infrastructure, testing facilities, and enforcement. The IMA’s concerns reflect the broader challenges in ensuring drug quality and patient safety.

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