Where are the rules for doctors to prescribe generic medicines: HC asks NMC, seeks response
Gujarat High Court
Ahmedabad: The National Medical Commission (NMC) has been issued a notice by the Gujarat High Court, which was considering a Public Interest Litigation (PIL) seeking framing of rules for doctors to prescribe generic names of drugs in the prescription.
During the course of the PIL, which was initially filed back in 2016, the HC bench had earlier issued notice to the erstwhile Medical Council of India. However, since MCI has now been replaced by NMC, the bench on Thursday asked the petitioner to serve a notice to NMC, the apex medical body in the country.
Initially, while considering the matter, the HC bench of Chief Justice Aravind Kumar and Justice Ashutosh J. Shastri had noted that the matter lied in the domain of the executive.
As per the latest media report by Economic Times, the PIL had been filed by four consumer activists in the city and they sought direction upon the concerned authorities for framing rules to ensure that the doctors prescribe generic drugs to patients and do not insist on using branded medicines. It was stated in the PIL that the health sector should not engage in exploiting people and force them to buy branded drugs costing several times more than the generic drugs, available at affordable rates.
Arguing that the patients must have the option for choosing from different brands manufacturing the prescribed medicine having the same composition but different names, the counsel for the petitioner submitted, "The public at large is affected because of the doctors writing the brand name rather than writing the generic name."
Responding to this, Chief Justice Aravind Kumar was quoted saying by Live Law, "If it is a case of paracetamol, it can be agreed but there are certain drugs which we can not even spell. If the doctors start writing the composition (of the drugs)... neither you will understand, nor the person who sells it will understand."
At this outset, the counsel for the petitioner argued, "In European Countries, there is a practice that the doctors prescribe the composition of the medicine, and the pharmacist will give me the options of the brands he has."
CJ Aravind Kumar responded to this by saying "We are not Europe. India is considered to be the best as far as healthy industry is considered. So don't compare Mr. Counsel...This is an area that the executive will look into." To this, Counsel added that he wasn't comparing India with Europe."
However, later, when the Court inquired if the MCI had filed a reply in this regard, the counsel for the petitioner submitted that even though earlier MCI was a respondent in the case, now NMC has replaced MCI and its name has been added as the proposed respondent in the PIL plea. However, it has not been notified, submitted the counsel for the petitioner.
Taking note of this fact, the HC bench asked the counsel for the petitioner for serving notice to the NMC and listed the matter for further hearing on January 30, 2023.
Live Law adds that previously while considering this matter back on June 17, 2019, the HC bench of Justice SR Brahmbhatt and Justice AP Thaker had issued notice to MCI and had directed it for filing its reply and clarify what steps have been taken by it for encouraging and implementing its policy regarding generic medicines.
A generic drug has been defined by NMC as a "drug product that is comparable to brand/reference listed product in dosage in dosage form, strength, route of administration, quality and performance characteristics, and intended use".
Medical Dialogues had earlier reported that recently the National Medical Commission (NMC) issued the draft Registered Medical Practitioner (Professional Conduct) Regulations, 2022, and clarified that doctors should prescribe medicines with "generic"/"non-proprietary"/"pharmacological" names only.
Section 8 of the Regulations Stated, "Prescribing Generic Medicine: Every RMP is expected to prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1, L2)."
Since the Apex Medical Body has recommended Level 1 (L1) and Level 2 (L2) disciplinary action for the violation of this rule of prescribing generic medicines, the doctors might get warnings and instructions or advisories that can be issued in this regard. However, if charged under Level 2 violation, their license can be suspended for up to one month, as specified in the Regulations.
