No prescription by company brand names: SC calls for statutory mandate for doctors to prescribe generic
Doctor-Pharma Bribery row
New Delhi: While hearing a Public Interest Litigation that sought enforcement of a statutory code to regulate unethical marketing practices by pharma companies, the Supreme Court has recently observed that doctors across India should be directed to mandatorily prescribe only generic medicines to patients, instead of the brand names of medicines.
The top court bench orally remarked that if there was a statutory mandate for doctors to prescribe generic medicines, the issue of pharmaceutical companies allegedly bribing doctors to prescribe excessive or irrational drugs and push for high-cost, overpriced brands would be resolved, Live Law has reported.
Observing that Rajasthan, where such a direction has been issued to medical professionals, could be considered as an example, the Apex Court bench comprising Justices Vikram Nath, Sanjay Karol, and Sandeep Mehta noted,
"We believe that the doctors should be mandated only to prescribe generic medicines. That will fall in line with what you are praying… In Rajasthan, there is now an executive instruction that every medical professional will have to prescribe only generic medicines."
Verdictum has reported that referring to an order passed by the Rajasthan High Court in a PIL, Justice Sandeep Mehta observed, "They cannot be prescribed by a company name. That direction was given in a PIL only." "If this direction is made across the country, it will make a huge difference," Justice Mehta further added.
The Plea:
The Supreme Court made these observations while considering a plea that contended that pharmaceutical companies were bribing doctors to bring business and to prescribe excessive and/or irrational drugs and a push for high-cost and/or overpriced brands. The plea was filed by the Federation of Medical & Sales Representatives Association of India (FMRAI), a national-level Trade Union with local units in 300 cities and towns of the country, registered in 1963 under the Trade Unions Act, 1926.
Filing the plea, FMRAI sought a direction stating that till the Uniform Code of Pharmaceutical Marketing was given the colour of a legislation, the Court may lay down the guidelines to control and regulate unethical marketing practices by pharmaceutical companies.
As an alternative, the plea also implored the Court to make the existing code binding with such modifications/additions as the Court may find proper and reasonable, which should be followed by all the authorities/courts under Articles 32, 141, 142 and 144 of the Constitution.
Medical Dialogues had earlier reported that the plea by FMRAI added that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 prescribe a Code of conduct for doctors in their relationship with the pharmaceutical and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from Pharmaceutical companies.
"This Code is enforceable against doctors, however, does not apply to drug companies, leading to anomalous situations where doctors' licenses are cancelled for misconduct which is actuated, encouraged, aided, and abetted by pharma companies. The pharma companies go scot-free," it added.
The plea said that though termed as 'sales promotion,' in fact, direct or indirect advantages are offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits) in exchange for an increase in drug sales.
It said that unethical drug promotion can adversely influence doctors' prescription attitudes and harm human health by over-use/ over-prescription of drugs, prescription of higher doses of drugs than necessary, prescription of drugs for a longer period than necessary, prescription of a higher number of drugs than necessary and prescription of an irrational combination of drugs.
It said that pharmaceutical companies use high-pressure promotion practices to lure physicians to prescribe irrational combination drugs to generate massive sales.
Union Government's Stand:
Earlier, while considering the matter, the Supreme Court had issued notice in this regard to the Union in March 2022. Verdictim has reported that in its counter affidavit, the Union Government submitted, "The Department of Pharmaceuticals has issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), which is applicable to Pharmaceutical Companies, medical representatives and agents… The UCPMP clearly prohibits pharmaceutical companies from offering gifts, travel facilities, hospitality, cash or monetary grants to physicians or their family members."
"This Code is currently being implemented voluntarily by the pharmaceutical industry associations and their members," it further added.
Addressing the issue of generic medicines, the Union submitted before the Court that "Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 were amended to mandate that every physician should prescribe drugs with generic names and ensure rational use of drugs."
Further, the counter affidavit mentioned that the Government was considering recommendations of the Standing Committee on Health and Family Welfare in its 45th Report, which recommended making UCPMP mandatory by statutory enactment.
Hearing before the Supreme Court:
During the hearing of the case, the counsel for the petitioners, Senior Advocate Sanjay Parikh submitted, "…as far as the bribe givers are concerned, that is the pharmaceutical companies, there is nothing against them because there is some kind of voluntary code. The takers, that is the Doctors... there is a law which takes care of it…So this Hon’ble Court looked into both the aspects, looked into what is the law which is really prohibiting the pharmaceutical companies to act in this way…If this direction is across the country, it will be a huge difference. It will be wonderful."
Referring to the counter-affidavit that stated that a High Powered Committee was appointed, the counsel for the petitioner remarked that there was nothing on record as to what the Committee had suggested as a recommendation, Live Law has reported.
At this outset, Justice Mehta questioned if there was any statutory mandate stating that the doctors must prescribe generic drugs only and not those of some specific company or brand. "This will follow in line with what you are praying. In Rajasthan, there is now an executive instruction that every medical professional with have to prescribe generic medicine. They can't prescribe by any company name. That should take care of the things," Justice Mehta observed, further adding that this was through a direction passed in a PIL in the case of Vijay Mehta.
In response, the counsel submitted that there was no statutory code but only a "voluntary code" that existed in place stating that the doctors should prescribe generic drugs. He also stated that there was a matter before the Supreme Court related to this issue.
Taking note of this, Justice Mehta asked the counsel to look into the matter, observing, "Just think of this in this line, if this direction is given across the country. Then all these things will be taken care of." He further added that Rajasthan could be looked at as an example.
At this outset, the counsel for the Union Government informed the court that there actually was a direction in place by the Indian Medical Council for all doctors to prescribe generic medicines only.
Referring to the NMC RMP Regulations 2023, which were later put on hold, the counsel for the Union Government submitted, "Actually, a notification has been issued by the Indian Medical Council giving a direction to all the doctors that they have to prescribe new medicines… We have mentioned that in the counter itself. And that is a mandate."
NMC RMP Regulations 2023:
NMC, on August 3, 2023 had released the National Medical Commission Registered Medical Practitioners Regulations 2023, through which, NMC encouraged doctors to prescribe generic medicines.
As per Section 8 of the NMC RMP Regulations 2023, "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)."
Similarly, Section 12(b) states, "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, in the guidance to RMPs, the doctors were asked to prescribe drugs with "generic" names only. More importantly, the code of conduct had laid stress on generic prescription by doctors, adding that violation of the rules may result in punishment leading to suspension of the doctor's license for up to 30 days.
However, these regulations were opposed by the medical fraternity, and the 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. After facing severe opposition regarding the regulations, the Health Ministry intervened and NMC put these regulations on hold.
Observations by Court:
Taking note of the plea and the submissions by the parties, the Court observed that since the matter would take some time, it would keep it for further hearing after the vacation. Accordingly, it listed the plea for a further hearing on July 24.
