Doctors Should Be Mandated To Prescribe Only Generic Medicines: Supreme Court

A Bench of Justice Vikram Nath, Justice Sanjay Karol, and Justice Sandeep Mehta observed, “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.”

Justice Sandeep Mehta added, “They cannot be prescribed by a company name. That direction was given in a PIL only.”

Justice Sandeep Mehta further said, "If this direction is made across the country, it will make a huge difference". The Judge referred to an order passed by the Rajasthan High Court in a PIL.

Senior Advocate Sanjay Parikh appearing for the Petitioners 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.”

The Counsel for the Union of India, referring to directions already issued under the Indian Medical Council Regulations, 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.”

However, it is to be noted that the National Medical Commission had issued a Gazette Notification to keep in abeyance the implementation of the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 which had initially placed restrictions on medical practitioners, preventing them from prescribing branded medicines to patients, instead of Generic drugs/medicines.

Background

The petition, filed by the Federation of Medical & Sales Representatives Associations of India and others, challenges the effectiveness of the current voluntary regulatory regime and seeks enforcement of the Right to Health under Article 21 of the Constitution.

The petitioners argue that the pharmaceutical industry continues to engage in unethical marketing practices. In the petition, it is stated, “The instant writ petition has been filed by the petitioners seeking a strict regulation in the marketing and promotion of drugs by pharmaceutical companies vis a vis health care professionals. The writ petition has highlighted that enormous money is spent on sales for promotion to influence doctors with a view to generate higher number of prescriptions and consequently higher number of sales… This has led to over prescription of drugs resulting in a serious infringement of right to life and right to health of the citizens.”

On the lack of binding law the petition further states, “No enforceable law exists which regulates the promotion of drugs by pharmaceutical companies vis-à-vis healthcare professionals, and therefore unethical practices continue unfettered… The pharma companies go scot-free.”

Criticizing the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) for being non-binding, the petition states, “The UCPMP is a voluntary code of marketing practices for the Indian pharmaceutical industry… Paragraphs 6 and 7 of UCPMP restrict supply of gifts, pecuniary advantages or benefits in any kind by pharmaceutical companies.”

The Union of India, in its counter affidavit, states, “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 adds.

On generic medicines, it is stated by the Union, “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.”

The Counter affidavit further goes on to state that the Government is considering recommendations of the Standing Committee on Health and Family Welfare in its 45th Report, which recommended making UCPMP mandatory by statutory enactment.

Pertinently, the Central Board of Direct Taxes(CBDT) had accused the makers of the Dolo-650 tablet of indulging in "unethical practices" and distributing freebies worth about Rs 1,000 crore to doctors and medical professionals in exchange for promoting products made by the pharmaceutical group. This has been highlighted in the petition as well as the Counter Affidavit of the Central Government.

The matter will be taken up for further hearing in July.

Cause Title: Federation of Medical and Sales Representatives Associations of India & Ors. v. Union of India & Ors. (W.P.(C) No. 323/2021)