Health Ministry asks NMC to reconsider its RMP regulations over Generic Medicines issue: Report
Generic Medicine
The regulations are facing backlash from many in the medical fraternity and beyond for imposing harsh penalties for not prescribing generic medicines.
New Delhi: Prescribing generic clause is likely to lose its teeth as the Union Health Ministry has now written to the National Medical Commission (NMC) to modify the recent National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, a recent media report by The Print has stated.
Sources in the Union Health Ministry informed The Print that the Apex Medical Commission has been asked to make changes in the regulations on various issues, including the clause involving generic drugs and the Ministry has reportedly asked the Commission to allow the doctors to at least prescribe branded medicines.
This comes after the Indian Medical Association (IMA) recently met with the Union Health Minister Mansukh Mandaviya, who had called the meeting to discuss the 'issues' with the new regulations, which were published in the official Gazette on August 2, 2023. The National Medical Commission, Union Health Secretary, and the Director General of the Indian Pharmaceutical Alliance also participated in the meeting.
Medical Dialogues had earlier reported that doctors were objecting to the new NMC regulations which made it mandatory for the doctors to prescribe generic/pharmacological names of the medicines only.
Chapter 1 Section 8 of the NMC RMP Regulations 2023 states,
"Prescribing Generic Medicines: Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1 and/or L2)(Generic Drugs and Prescription guidelines)."
According to section 12 (b) of the said regulations state: "RMP can prescribe or supply drugs, remedies, or appliances as long as there is no exploitation of the patients. Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug. (L2)"
Further, Guidance to RMPs line 1 states "Prescribe drugs with “generic”/“non-proprietary”/“pharmacological” names only."
More importantly, the new code of Conduct laid stress on generic prescriptions by doctors only, making violation of the same a punishable offence where punishment can lead to suspension of licence for up to 30 days.
However, these regulations were opposed by the medical fraternity and IMA had earlier demanded deferring the implementation of the NMC regulations that make it mandatory for doctors to prescribe generic drugs, stating the biggest impediment to such medicines is the uncertainty about their quality. Stating that less than 0.1 per cent of the drugs manufactured in India are tested for quality, the association mentioned in a statement, “This step should be deferred till the government can assure the quality of all the drugs released into the market. Patient care and safety are not negotiable.”
Recently after the meeting with the Health Minister on Monday, the association wrote to the Health Minister again and demanded an exemption from the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023.
In the same letter, putting forward the demands of the medical fraternity, the association also asked the Union Health Minister to withdraw the mandatory nature of the regulations on the prescription of generic drugs and make digitalisation desirable yet optional.
Now, a recent media report by The Print has stated that the Union Health Ministry has asked NMC to modify the NMC RMP Regulations, 2023, which introduced a provision to penalise doctors for failing to prescribe generic drugs.
Commenting on this, a senior Union Health Ministry official told the Daily, “We heard the issues raised by doctors and drugmakers in this regard and concur that it may not be practical to only prescribe generic medicine in all cases mandatorily.”
“In some cases, for instance, a drug may have multiple ingredients and it is not practical for doctors to write lengthy prescriptions,” the official further added.
Speaking to the Daily, a second official in the Ministry added, “The NMC has been asked to make changes in the regulations on various issues, including the clause involving generic drugs, and we have asked them to allow doctors to at least prescribe branded generics.”
Meanwhile, sources in the Indian Drug Manufacturers Association (IDMA), a network of generic drugmakers, supported the demand of IMA and termed the new regulations as "immature".
Commenting on the matter, a senior IDMA member told The Print on the condition of anonymity, “Given the current landscape of marketing and regulatory practices, it may not be possible for doctors to solely prescribe generics.”
