On May 1, 2025, the Supreme Court of India, led by a Bench of Justice Vikram Nath, Justice Sanjay Karol, and Justice Sandeep Mehta, made an important observation in a case addressing unethical practices by pharmaceutical companies. While hearing a Public Interest Litigation (PIL) filed by the Federation of Medical & Sales Representatives Associations of India (FMSRAI), the Court remarked that doctors across the country should be mandated to prescribe only generic medicines, not branded ones. The case brings to light how pharmaceutical companies often offer freebies and incentives to doctors to boost sales of branded drugs like Dolo-650, raising serious concerns over public health, healthcare costs, and the Right to Health under Article 21 of the Constitution. This blog breaks down the Court’s observations, the legal issues involved, and the possible national impact if generic prescriptions become mandatory.
Background of the Case: Generic Medicine
The petition by FMSRAI aims to end unethical marketing by pharmaceutical companies. It claims that many companies are offering large amounts of money, gifts, or other benefits to doctors in exchange for prescribing their branded medicines instead of cheaper generic alternatives. As a striking example of unethical conduct, the Central Board of Direct Taxes (CBDT) had accused the makers of Dolo-650 of distributing freebies worth ₹1,000 crore to doctors to promote the drug. This was cited both in the petition and the government’s response as evidence of unchecked unethical practices.
The petitioners argue that these practices harm patients, promote unnecessary prescriptions, and violate their Right to Health. They also criticized the existing Uniform Code of Pharmaceutical Marketing Practices (UCPMP), calling it weak because it is voluntary, not enforceable by law.
Court’s Reasoning
The Supreme Court appeared supportive of the demand for stricter rules. During the hearing, Justice Vikram Nath said:
“We believe that doctors should be mandated only to prescribe generic medicines. That will fall in line with what you are praying…”
Justice Sandeep Mehta mentioned that in Rajasthan, a similar order was passed through a PIL, and doctors there are already instructed to prescribe only generic medicines. He emphasized:
“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.”
The Bench clearly sees a need for national-level action to curb pharma ethics violations and make medicines more affordable.
What the Petitioners Argued in Court on Generic Medicine
Appearing for the petitioners, Senior Advocate Sanjay Parikh drew attention to a critical gap in current regulation. He pointed out that while doctors can be held accountable under existing laws, there is no legal punishment for pharmaceutical companies that offer bribes or freebies.
He told the Court:
“…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.”
They also criticized the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) for being non-binding:
“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.”
They pointed out the serious gap in law:
“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.”
This statement highlights the uneven enforcement and doctors may face action for accepting freebies, but companies offering them often escape punishment due to the non-binding nature of the UCPMP. His remarks underline the urgent need for statutory reforms to hold both parties accountable and ensure that prescriptions are driven by patient needs, not profits.
The petitioners argue that such practices infringe upon the Right to Life and Right to Health under Article 21 of the Constitution and demand that ethical and enforceable regulations be put in place.
Government’s Position in Court on Generic Medicine
The Counsel for the Union of India informed the Supreme Court that guidelines already exist which mandate the use of generic medicines. He stated:
“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.”
This means that, on paper, doctors are already expected to prescribe generic drugs rather than branded ones. However, the situation on the ground is more complex.
The government also defended its current policy by stating that the UCPMP prohibits companies from offering any kind of gifts, travel, or hospitality to doctors. However, the policy remains voluntary and its enforcement is limited.
Despite this mandate, it was also brought to the Court’s attention that the National Medical Commission (NMC) had earlier introduced a new set of ethical rules, The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 in which explicitly prohibited doctors from prescribing branded drugs and promoted only generic medicines.
However, in a surprising move, the NMC issued a Gazette Notification keeping these new regulations in abeyance. This effectively paused their implementation, leaving a regulatory vacuum and weakening efforts to control the influence of pharmaceutical companies on doctors.
This contradiction between policy and practice was flagged as a major concern during the hearing. While a mandate exists, its enforcement is inconsistent, allowing unethical pharma marketing practices to continue unchecked.
Applicable Legal Sections
- Article 21 of the Constitution – Guarantees Right to Life and Health.
- Indian Medical Council (Professional Conduct) Regulations, 2002 – Doctors should prescribe drugs by generic name.
- UCPMP Code – Voluntary ethical guidelines for pharmaceutical marketing.
- National Medical Commission Regulations, 2023 – Placed restrictions on branded prescriptions but were kept in abeyance.
Implementation of Laws regarding Generic Medicines
In its response, the Union of India highlighted:
- The Indian Medical Council had already issued directions that doctors must prescribe by generic names.
- The UCPMP clearly prohibits companies from offering gifts, travel perks, or monetary benefits to doctors but is currently voluntary.
- The government is reviewing the 45th Parliamentary Standing Committee Report, which recommends making the UCPMP mandatory through legislation.
However, the National Medical Commission’s 2023 regulations, which aimed to prevent branded prescriptions, are still on hold, weakening enforcement.
Key Issues Highlighted
- Lack of Binding Law: No enforceable rule exists to punish pharmaceutical companies for bribing doctors.
- One-Sided Accountability: While doctors may face action for accepting freebies, the companies offering them often go unpunished.
- Ineffective Regulation: The UCPMP is not mandatory and does not have the power to stop unethical marketing.
- Public Impact: Costly branded drugs are prescribed more often, affecting poor patients’ access to healthcare.
- Over-prescription of branded drugs: Due to incentives and freebies given by pharmaceutical companies, doctors often prescribe branded medicines over generic alternatives, leading to increased healthcare costs and unnecessary medication for patients.
- Unethical promotional practices: Pharmaceutical companies spend enormous amounts to influence doctors and medical professionals, compromising patient welfare.
Impact of Supreme Court’s Observation on Generic Medicine
If the Generic Medicines Supreme Court recommendation turns into a binding order:
- It could lower medicine costs drastically for patients
- Cut down pharma influence on prescriptions
- Improve access to healthcare, especially for low-income families
- Promote transparency and ethics in the health sector
However, quality control for generic medicines remains a challenge. Doctors have expressed concerns about the reliability and availability of certain generics, making monitoring equally important.
Supreme Court Remarks (Quoted)
“Doctors should be mandated only to prescribe generic medicines… In Rajasthan, there is an executive instruction that every medical professional will have to prescribe only generic medicines.”
– Justice Vikram Nath
“If this direction is made across the country, it will make a huge difference.”
– Justice Sandeep Mehta
Final Thought
The Supreme Court’s strong comments in favor of generic prescriptions could be a game-changer for India’s healthcare system. If doctors are legally required to prescribe generic medicines, it could greatly reduce costs and ensure ethical medical practices. The upcoming hearing in July 2025 may lead to more concrete directions, possibly transforming how medicines are prescribed across the country and reinforcing the Right to Health for all citizens.
