The National Medical Commission on Thursday put on hold the controversial rules and regulations regarding the professional conduct of doctors, including prescription of generic medicines, as the country’s top medical body is likely to rework them. In a notification issued it stated: “That National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect.”
The medical fraternity was unhappy with the Registered Medical Practitioner (Professional Conduct) Regulations, 2023, issued on August 4. The move came two days after the Indian Medical Association (IMA) as well as Indian Pharmaceutical Association (IPA), which represents some of the country’s largest drugmakers, met health minister Mansukh Mandaviya.
The National Medical Commission (NMC), in a notification, had directed doctors to avoid prescribing branded medicines, and instead, prescribe generic drugs in majority of the cases. It had also warned that repeated violations could invite temporary suspension of licences.
The regulations had also asked doctors to avoid prescribing “branded” generic drugs and to encourage patients to purchase medicines from either Jan Aushadhi centres or from other generic pharmacies.
“The health ministry held an internal meeting with top officials, including the minister and health secretary Sudhansh Pant,” said a government official requesting anonymity, adding that the NMC was reworking the regulations.
The official added: “The new set of regulations will remove the stance on prescribing generic medicines. Rather, it will advise doctors to promote use of Jan Aushadhi or generic drugs in collaboration with the government instead of threatening to penalise them.”
Move triggered after meeting with health minister
The IMA was invited for a meeting with Mandaviya on August 21 to clarify its stand on the NMC regulations. The lobby of at least 4 lakh medical practitioners across India later issued a lengthy press release listing more than six reasons why it opposes the recommendations to prescribe generics.
“The quality assurance mechanism in our country is very weak,” the IMA said, while hinting that quality control over generic medicines could also be weak.
“India has more than 3 lakh batches of 70,000 drug formulations; the quality assurance mechanism in our country can ascertain the quality control of only 15,753 drugs annually. In 2023, only around 12,000 tests were conducted by CDSCO (Central Drugs Standard Control Organisation) and state drugs control department together. If we consider that one sample from each batch is tested, the minimum required number of tests were around 3,00,000.”
It also said 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”.
Other controversial issues
Another point of contention included the NMC’s mandate that “within three years from the date of publication of these regulations, the RMP (registered medical practioner) shall ensure fully digitised records, abiding by the provisions of the IT Act, data protection and privacy laws, or any other applicable laws, rules and regulations notified from time to time for protecting the privacy of the patient”.
The IMA cleared its stance saying: “Though the idea of digitalisation is welcome, mandating that this should be done in three years is unrealistic. The regulation should allow for gradual transition.”
Overall, the IMA has requested the central government to withdraw the mandatory nature of the regulation on prescription of generic drugs till the quality assurance of all drugs can be ensured. It has also asked to exempt associations or organisations from the purview of the NMC regulations, apart from allowing professional associations to use pharma funding for CMEs and educational or research activities in a transparent and bona fide manner.
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