In a major move aimed at protecting public health, India’s top drug regulatory body has ordered a nationwide halt on the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs. These include popular painkillers, nutritional supplements, and anti-diabetic medications that have been circulating in the market without proper safety checks.
The Central Drugs Standard Control Organisation (CDSCO), which oversees drug safety and approval in India, has instructed state and Union Territory drug controllers to not only stop the distribution of these combinations but also re-evaluate their entire approval process to prevent such lapses in the future.
What Are Fixed-Dose Combination (FDC) Drugs?
FDC drugs are pharmaceutical products that combine two or more active ingredients in a fixed ratio into a single dose form. While this can improve convenience for patients and increase adherence to treatment plans, the combinations must be scientifically tested for safety and efficacy before reaching consumers.
Unfortunately, that hasn’t always been the case.
Why the Crackdown?
The CDSCO’s latest move comes after it was found that a number of FDC drugs were being manufactured and sold across India without the required safety and efficacy evaluations.
Essentially, some manufacturers had been granted licenses by state authorities to produce and sell these drug combinations without getting the green light from the central drug regulatory body — a mandatory step under India’s drug laws for what are considered “new drugs.”
This practice violates the New Drugs and Clinical Trials (NDCT) Rules, 2019, under the Drugs and Cosmetics Act of 1940, which clearly state that any new combination drug must go through a rigorous scientific review process before being approved.
Skipping these steps poses a significant risk to patients, as untested combinations could lead to harmful drug interactions, unexpected side effects, or even long-term health issues.
A History of Warnings Ignored
This is not the first time that regulators have raised alarms. Back in 2013, the CDSCO had flagged the issue of state licensing authorities bypassing central approval when it came to FDCs. Despite repeated reminders and follow-up letters over the years, the problem continued to persist.
As recently as February 2024, another reminder was sent to state authorities urging them to stay in compliance with the regulatory framework. Yet, many continued to issue licenses for unapproved drug combinations, prompting the CDSCO to finally intervene more firmly.
What Happened Next?
When the CDSCO issued show-cause notices to manufacturers of these unapproved drugs, many of them defended their actions by saying they had obtained valid licenses from their respective state drug authorities. However, this only exposed a deeper issue — the lack of consistency in drug regulation enforcement across the country.
Some state licensing authorities (SLAs) eventually canceled the approvals for these drugs or the manufacturers themselves voluntarily surrendered their licenses after being served notices.
But for regulators, this wasn’t enough. The CDSCO has now taken a clear stance: until an FDC drug has been properly evaluated and approved by the central body, it cannot be sold in the country, regardless of state-level permissions.
What This Means for Patients
If you’re someone who takes combination drugs — for pain relief, diabetes, or as a supplement — this announcement might feel unsettling. The good news is that this crackdown is actually a step toward making medicines safer and more reliable.
When medications are sold without full testing, patients are essentially being used as test subjects. By reinforcing stricter controls and ensuring all drugs go through proper evaluation, the CDSCO is helping to make sure that what’s on your pharmacy shelf is both safe and effective.
Consumers are advised to check their prescriptions and consult with their healthcare providers if they are using any combination medicines. Most pharmacies will stop selling the 35 listed drugs following this order, and safer, approved alternatives are likely already available.
What’s Next?
The CDSCO has asked all states and Union Territories to immediately review how they approve fixed-dose combinations and to ensure they follow the proper regulatory steps. The idea is to enforce one standard across the country, instead of allowing a patchwork of rules that can lead to confusion and potentially dangerous outcomes.
The list of the 35 banned FDCs has been shared with local authorities, and enforcement actions are expected to follow. At the same time, drug manufacturers are being urged to cooperate with regulators and avoid introducing any new drug combinations without central approval.
Why It Matters
India is one of the largest pharmaceutical producers in the world, and millions rely on its medications daily. Ensuring that all drugs — especially complex combinations — are properly tested and approved is critical not just for public health in India, but also for maintaining trust in Indian-made medicines globally.
The crackdown is also a reminder of how crucial it is for regulatory systems to work hand-in-hand at both central and state levels. When gaps exist, it’s the public that ultimately bears the risk.
The Bottom Line
The CDSCO’s decision to ban 35 unapproved FDC drugs is a bold and necessary step in strengthening India’s drug safety standards. While this may temporarily disrupt the availability of certain medicines, it’s a welcome move that prioritizes long-term health and public safety.
As the country moves toward a more unified and transparent drug approval process, patients can hopefully look forward to a future where every pill they take is backed by science — not just a license.
