A bench of Justices Vikram Nath, Sanjay Karol, and Sandeep Mehta heard a PIL by FMRAI, a national trade union advocating against unethical pharmaceutical marketing and doctor incentivisation practices
Published May 04, 2025 | 7:00 AM ⚊ Updated May 04, 2025 | 7:00 AM
The research covered 107 patients who had developed Ethambutol-induced Toxic Optic Neuropathy, a condition in which the optic nerve is damaged. (Representational Image/Creative Commons)
Synopsis: The Supreme Court on 1 May observed that mandating doctors to prescribe generic medicines could help curb unethical practices by pharmaceutical companies accused of bribing doctors to promote expensive branded drugs. The remarks came during a hearing on a PIL filed by the Federation of Medical & Sales Representatives Association of India, which flagged growing concerns over ethics and affordability
In an oral observation on 1 May, the Supreme Court of India remarked that making it a legal requirement for doctors to prescribe generic medicines could be key to addressing the growing problem of pharmaceutical companies allegedly bribing doctors to promote expensive — and often unnecessary — branded drugs.
A bench comprising Justices Vikram Nath, Sanjay Karol, and Sandeep Mehta was hearing a public interest litigation filed by the Federation of Medical & Sales Representatives Association of India (FMRAI), a national trade union that has long campaigned against unethical pharma marketing.
The petition alleges that drug companies routinely incentivise doctors to push costly branded medicines, raising serious concerns around ethics, affordability, and patient safety.
If there is a statutory mandate for doctors to prescribe generic medicines, this whole issue might just get resolved, the Court observed.
Reacting to the Supreme Court’s comments, Dr Gopal Dabade, President of the Drug Action Forum, Karnataka, told South First that he welcomed the sentiment but warned of ground-level realities that threaten to derail it.
“If you go to Europe or America, ‘generic’ means something very specific. There, when a drug is under patent, it’s sold under a brand name. After about 20 years, once the patent expires, the same drug becomes a ‘generic’ version,” he said.
But in India, it’s quite confusing. Different people interpret ‘generic’ and ‘branded’ differently. “If you go by the European or American definition, we hardly have any branded, patented drugs in India — maybe just four or five percent. Almost everything else is what they would call generics,” he pointed.
“In India though, we look at it differently. Here, if a drug is sold under its chemical name — like ‘paracetamol 500 mg’ — we call it generic. But if you prescribe it by a company’s brand name — like ‘Dolo 650’ — that’s considered a branded drug. So, it really depends on how you define ‘generic’ and ‘brand’ here,” he said.
Also, almost all drug companies in India are basically manufacturers — they aren’t really doing new research. Very few actually invest in developing new drugs. What we’re famous for is manufacturing medicines after patents expire, he also pointed.
Dabade also recalled that the idea of generic-only prescriptions isn’t new. “In 1974, the Hathi Committee had already recommended this. But every time we move an inch forward, we get pushed twenty steps back. Implementation remains a major hurdle.”
Partha Rakshit, General Secretary of FMRAI, was also critical of the Court’s suggestion. “This is not about generic vs branded prescriptions. The real issue is unethical pharmaceutical marketing—and the Supreme Court’s observation seems to shift the burden to doctors.”
Rakshit argued that they long urged the central government to reduce essential drug prices and ensure quality. Since the UCPMP was introduced in 2014, “our demand has been clear: Make it statutory, not voluntary. ‘Pay-for-prescription’ practices by pharma companies are rampant, and without legal backing, unethical promotions will continue unchecked,” said Rakshit.
“But the Supreme Court’s recent observation — suggesting doctors prescribe only in generic names — sidesteps the core issue. The updated 2024 UCPMP claims to be mandatory, yet violations are routine. That’s why we insist it be made enforceable by law,” he said.
He said that he disagreed with the push for generic-only prescriptions — and here’s why: “India lacks the infrastructure to support it. Even so-called generic outlets mostly sell branded generics. Shifting the burden from pharma firms to doctors — and now chemists — is misplaced. Doctors at least choose based on experience; chemists are driven by profit margins. Who ensures quality then?” he asks.
He also pointed that CDSCO’s monthly lists of ‘Not of Standard Quality’ (NSQ) drugs include many generic formulations. Meanwhile, government-run pharma PSUs have been dismantled, and loosely regulated private hubs in places like Sikkim and Himachal now dominate manufacturing. Without robust oversight, patient safety is at risk.
“Prescribing in generic names under current conditions may do more harm than good. Until public manufacturing is revived and drug quality is assured, trusted branded drugs remain the safer choice. The real problem is pharma marketing malpractice. The real solution is making UCPMP legally binding — not shifting accountability to prescribers and dispensers,” pointed Rakshit.
While the Court’s suggestion on generics may appear a step in the right direction, FMRAI leaders believe it misses the forest for the trees.
“This isn’t about generics versus branded drugs — it’s about unregulated profiteering,” Ramesh Sundar, former president of FMRAI, told South First.
He illustrated how companies sell both branded and branded generic versions of the same drug, with the retail price often the same but a significant profit made on the supply chain discount. “For example, a drug might have an MRP of ₹10, but the company sells it at ₹4 to the retailer. The ₹6 difference is pure profit, and the consumer sees no real benefit,” explained Sundar.
Sundar stressed that the real issue is drug price regulation. “Prices should be based on actual production costs. If it costs ₹1 to manufacture a drug, even after adding reasonable margins for marketing and distribution, it shouldn’t end up at ₹10 or ₹100. The current system is nothing short of profiteering,” he said.
He also pointed out the government’s role in promoting the branded drug market under the guise of healthcare affordability. “Most doctors avoid prescribing generics due to the perception that lower prices mean lower quality — a mindset built over years. We were told public sector medicines were poor quality simply because they were cheaper,” Sundar added.
This perception mirrors how consumers view electronics: expensive brands like Sony or Samsung are assumed to be better. However, Sundar argued that even branded drugs don’t guarantee superior quality. “Most multinational companies don’t manufacture their products themselves. They outsource to third-party manufacturers in places like Baddi, Himachal, or Tamil Nadu. So whether a drug is branded or generic, the real issue is the lack of proper regulation — and that’s where the system fails,” he concluded.
Dr Dabade also said that about a year ago, there was a push to get doctors to prescribe generics for Jan Aushadhi Kendras.”But many doctors resisted, fearing pharmacists would pick expensive brands instead. Ironically, expensive brands already dominate the market — so the concern isn’t entirely justified. This isn’t the first attempt at reform. Sadly, we take one step forward and twenty back. Without serious commitment, nothing changes,” he said.
He added that he doesn’t think the Supreme Court judge’s statement — asking doctors to prescribe only in generic names — will hold up. There are too many forces working against meaningful reform.
“People often question the quality of generics. But how do you guarantee the quality of branded drugs? You can’t. Even government data says 3–4 percent of drugs in the market are substandard — and that includes branded products. Multiple studies — by Indian agencies, private groups, even the US FDA — all point to one thing: substandard drugs are a reality, regardless of branding,” he pointed.
He said that the root problem is our weak and compromised drug regulatory system. We don’t have enough drug inspectors — they’re critical to ensuring medicines meet standards set by the Indian Pharmacopeia. It lays out detailed protocols for manufacturing and storage, like who handled which chemicals, how they were stored, and when.
“But in practice, most companies cut corners. That’s how substandard drugs enter the market. And until there’s political will to clean up this corrupt system, real change will remain out of reach,” he added.
(Edited by Ananya Rao)
