On 3rd August, National Medical Commission (NMC) issued new guidelines for Registered Medical Practitioners (doctors) via a gazette notification. The new guidelines, titled “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023”, talk about prescribing drugs, emphasis on generic drugs, social media guidelines for doctors, refusal of treatment, prohibition on receiving perks and gifts from pharmaceutical companies and more.
Notable, NMC is a commission constituted by the Ministry of Health and Family Welfare (MoHFW) of the Government of India in September 2020 to replace the Medical Council of India (MCI). The commission is affiliated with the MoHFW.
News agency Press Trust of India (PTI), Economic Times and The Indian Express published reports about the new guidelines suggesting that the NMC has made it ‘mandatory’ for doctors to prescribe generic medicines.
In its post on X (formerly Twitter), PTI wrote, “All doctors must prescribe generic drugs, failing which they will be penalized and even their license to practice may also be suspended for a period, say NMC new regulations.”
All doctors must prescribe generic drugs, failing which they will be penalised and even their license to practice may also be suspended for a period, say NMC new regulations
— Press Trust of India (@PTI_News) August 12, 2023
Other media houses, including NDTV, Economic Times, The Indian Express, The Print and others, used a similar language. Their reports read, “All doctors must prescribe generic drugs, failing which they will be penalized and even their license to practice may also be suspended for a period, according to the new regulations issued by the National Medical Commission.”
OpIndia accessed the gazette notification of NMC dated 3rd August. Section 8 under Chapter 1 (Professional Conduct of RMPs) of the guidelines discusses ‘Prescribing Generic Medicine’. The guideline reads, “Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.” Notably, the guidelines are not forcing doctors to prescribe only generic medicines but encouraging them to do so. PDF of the guidelines can be checked here.
Furthermore, under Section 12(B), the guidelines encouraged RMPs and pharmacies to state the drug’s generic name explicitly. Again, the guidelines used the phrase “should explicitly,” meaning the specific guidelines are not forced but suggested.
Why generic drugs?
In the guidelines, NMC said that the major portion of public health care spending is medication. Generic medicines being 30 per cent to 80 per cent cheaper than branded drugs, have the potential to bring down the overall healthcare cost.
Now coming to the specific guidelines under “Guidelines I” to RMPs on generic medicines and prescription guidelines. The guidelines point out that the RMPs should prescribe drugs with generic/nonproprietary/pharmacological names of the drugs. For example, if the doctor wants to prescribe Paracetamol/acetaminophen 650 mg, then rather than writing Dolo 650, the doctor should write Paracetamol 650mg on the prescription.
Regarding pricing, Paracetamol 650mg at a Jan Aushadi Kendra will cost Rs 15. On the other hand, Dolo 650 costs Rs 33, almost double the price. Similarly, Chlorzoxazone 500mg, Diclofenac 50mg and Paracetamol 325mg Tablets prescribed as painkillers and muscle relaxants cost around Rs 25 at Jan Aushadi Kendra. Still, depending on the pharmaceutical company, the branded strip may cost anywhere between Rs 45 to Rs 300. Glimepiride (2mg) + Metformin (500mg) + Pioglitazone (15mg) tablets prescribed for controlling blood sugar cost Rs 36 for 15 tablets at a generic medicine outlet. However, a branded strip of 15 tablets may cost Rs 250 or more. (Prices of the medicines as per 1mg.com and janaushadhi.gov.in)
The guidelines further recommend avoiding prescribing “branded” generic drugs. Notably, in the case of drugs with a narrow therapeutic index, biosimilars, and similar exceptional cases, the practice of prescribing generic drugs can be relaxed, NMC said in the guidelines.
No ‘highest level of commitment and obligation’ to prescribe generic medicines
The guidelines urged the RMPs to encourage patients to buy medicines from Jan Aushadi Kendras and generic pharmacy outlets. Furthermore, RMPs should educate medical students, patients and the general public regarding the equivalence of generic medicine with their branded counterparts, as per the NMC guidelines.
There is a specific note on the use of the words “must”, “shall/should “, and “may” in the notification. It reads, “The words ‘must’, ‘shall / should’ and ‘may’ are used purposefully in these guidelines and indicate the degree of obligation the doctor has to follow them. The word ‘must’ indicates a higher level of commitment and obligation required of the doctor, while in the case of ‘shall/should’, the level of obligation is less, and there could be room for individual judgment.”
Penalty for not following the guidelines
Under guideline-4, there is a mention of suspension of license for 30 days, three months and a maximum of three years and permanent suspension. However, it does not explicitly mention not prescribing generic medicines might attract such action. However, it categorically says that these penalties “may be awarded when the role of the doctor in causing direct harm was conclusively proved and the doctor was found to have breached relevant regulation.”
The guidelines recommend and urge doctors to prescribe generic medicines. However, “should” is used for prescribing generic medicines, it is NOT indicated as the highest level of commitment and obligation. The media reports on the guidelines are misleading.
