Highlights:
The newest planned restrictions requiring all doctors to prescribe generic drugs have been put on hold by the National Medical Commission (NMC). The NMC's regulation issued earlier in August 2023 that required doctors to prescribe generic drugs, failing which they will be penalized and their license to practice may be suspended for some time, has not gone down well with the Indian Medical Association (IMA). This has urged the government to withdraw it until the quality of all drugs can be ensured.
- The National Medical Commission (NMC) suspends regulations requiring doctors to prescribe only generic drugs
- The Indian Medical Association (IMA) raises concerns on the quality and testing of generic drugs produced in India
- The IMA seeks flexibility in pharma funding for educational sessions and a more optional approach to digitalization
India Takes Legal Advice on European Union’s 700 Generic Drugs Ban
The largest suspension of sales and distribution of generic drugs ordered by EU, has already come into effect and will be applicable to all 28 member nations.
The largest suspension of sales and distribution of generic drugs ordered by EU, has already come into effect and will be applicable to all 28 member nations.
‘Facing concerns from the IMA, the NMC reevaluates its mandate on generic drug prescriptions. The question remains: Can quality assurance keep pace with policy? #GenericDrugDebate #NMCvsIMA’
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Suspension of New Medical Practitioner Regulations
“National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect,” the new notification said. “For the 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,” it added. Mansukh Mandaviya, the Union Health Minister, called a meeting earlier this week and requested the NMC to make suitable reforms and make the decision "in the interest of all.""The NMC has held internal meetings on the same," said a person in the know of the matter. He said that one view is to put in abeyance certain regulations till more discussions are held," said the same person.
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European Union Suspends the Sale of 700 Generic Drugs Made in India
There is no evidence of harm or lack of effectiveness in the medicines. They were taken off to ensure patient safety and to retain confidence in EU system.
There is no evidence of harm or lack of effectiveness in the medicines. They were taken off to ensure patient safety and to retain confidence in EU system.
IMA Raises Concerns on Generic Drug Quality
The IMA had requested the government to revoke this law until the quality of all pharmaceuticals could be ensured. According to the IMA, it is a "matter of great concern" for them because prescribing exclusively generic pharmaceuticals has a direct influence on patient care and safety. Even more so, "it is estimated that less than 1% of generic drugs manufactured in India are tested for quality." "Both the government and the medical profession believe that patient care and safety are non-negotiable," it wrote in a letter to the health minister.It also mentioned the Mashelkar Report of 2003, which highlighted problems in the country's regulatory system, primarily due to (1✔ ✔Trusted Source
A Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs
Go to source):
- Inadequate or weak drug control infrastructure at the state and central levels
- Inadequate testing facilities
- Shortage of drug inspectors
- Non-uniformity of enforcement
- Lack of specially trained cadres for specific regulatory areas
- Absence of a data bank
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Variation in Appearance of Generic Drugs may Disrupt Use
Generic versions of the same prescription drug are clinically interchangeable but depending on the manufacturer, they often look different.
Generic versions of the same prescription drug are clinically interchangeable but depending on the manufacturer, they often look different.
IMA Advocates for Transparent Pharma Funding and Flexibility in Digitalization
The IMA also asked the government in a letter to the health minister to allow professional associations to use pharma funding for continuing medical education (CME) sessions (CMEs) and educational/research activities transparently and legitimately and to make digitalization desirable but optional.The IMA also encouraged the government to exclude associations and organizations from NMC regulations. It also criticized an outright ban on third-party educational initiatives supported by pharmaceutical corporations or the allied health industry, saying it deserved careful "consideration."
"Rather than assuming that sponsorships affect the educational process, the focus should be on ensuring transparent and unbiased presentations, enabling healthcare professionals to make informed judgments," it said.
Reference:
- A Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs - (https://pharmaceuticals.gov.in/sites/default/files/MashelkarCommitteeReport.pdf)
India Moving from Generic Drugs to New Drug Molecules: Russian Pharma Expert
India is famous for its affordable healthcare system, due to which, in less than a decade, the winners are going to be innovative pharmaceutical companies.
India is famous for its affordable healthcare system, due to which, in less than a decade, the winners are going to be innovative pharmaceutical companies.
