New Delhi: In a decisive move to protect public health, India’s Central Drugs Standard Control Organisation (CDSCO) has outlawed 35 fixed-dose combination (FDC) drugs, effective April 11, 2025. This sweeping ban targets unapproved medications, including popular painkillers, anti-diabetic drugs, and nutritional supplements, found to contravene the New Drugs and Clinical Trials (NDCT) Rules, 2019 under the Drugs and Cosmetics Act, 1940. The decision underscores India’s commitment to rigorous drug safety standards and raises critical questions about regulatory oversight.
Understanding Fixed-Dose Combination (FDC) Drugs
Fixed-dose combination (FDC) drugs integrate two or more active pharmaceutical ingredients (APIs) in a fixed ratio within a single dose, such as a tablet, capsule, or injectable. These formulations aim to treat specific conditions by harnessing the combined effects of their components. For instance, a single pill might blend a pain reliever with a muscle relaxant to alleviate chronic back pain more effectively.
Under the NDCT Rules, 2019, FDCs are classified as “new drugs” if they:
- Combine two or more individually approved drugs in a fixed ratio.
- Modify the ratio or therapeutic claims of an existing approved FDC.
FDCs are categorized into four types based on their composition and regulatory status. Their appeal lies in several advantages:
- Enhanced therapeutic outcomes: Thoughtfully chosen combinations can produce synergistic effects, improving treatment efficacy.
- Simplified regimens: A single dose reduces the number of pills a patient must take, boosting adherence.
- Cost efficiency: FDCs often cost less than buying multiple single-ingredient drugs.
However, these benefits hinge on thorough safety and efficacy testing, a step bypassed by the banned FDCs, prompting the CDSCO’s intervention.
Why Were These 35 FDC Drugs Banned?
The CDSCO’s crackdown addresses a significant regulatory lapse: the 35 FDCs were licensed by state and Union Territory drug controllers without prior CDSCO approval, violating NDCT Rules, 2019. This oversight allowed drugs to enter the market without verified safety or efficacy data, posing substantial risks to public health.
On April 11, 2025, Drugs Controller General of India (DCGI) Dr. Rajeev Raghuvanshi issued a stern directive to state drug controllers, citing the “serious risk to public health and safety” posed by these unapproved FDCs. The letter highlighted that some drugs were manufactured, sold, and distributed without mandatory evaluations, potentially leading to adverse reactions, harmful drug interactions, or ineffective treatments.
This issue has deep roots. In January 2013, the DCGI first raised concerns about state-issued licenses for FDCs classified as new drugs, which required central approval. Despite subsequent reminders, including a February 2025 letter, some state authorities persisted in granting licenses without CDSCO oversight, leading to uneven enforcement of drug safety laws.
When confronted with show-cause notices, manufacturers defended their actions, claiming compliance with state-issued licenses. However, the lack of scientific validation for these FDCs—evidenced by missing safety and efficacy data—compelled the CDSCO to act. The result was either the cancellation of licenses by state authorities or voluntary surrender by manufacturers, culminating in the ban of 35 FDCs.
The Complete List of Banned FDC Drugs
The banned FDCs span a range of treatments, from diabetes and hypertension to pain management and nutritional support. Below is the comprehensive list of the 35 prohibited combinations, previously licensed by state authorities but now deemed unsafe due to inadequate testing:
- Dapagliflozin + Glimepiride + Metformin
- Cilnidipine + Metoprolol Succinate
- Etodolac + Paracetamol + Chlorzoxazone
- Trypsin-Chymotrypsin + Diclofenac + Paracetamol
- Glucosamine + Diacerein + Methyl Sulfonyl Methane
- Nimesulide + Serratiopeptidase + Paracetamol
- Diacerein + Glucosamine + Methyl Sulfonyl Methane
- Levocetirizine + Montelukast + Ambroxol
- Nimesulide + Paracetamol + Serratiopeptidase
- Paracetamol + Chlorzoxazone + Aceclofenac
- Ofloxacin + Ornidazole + Racecadotril
- Cefixime + Ofloxacin + Lactobacillus
- Diacerein + Glucosamine + Boswellia Serrata
- Etodolac + Paracetamol + Serratiopeptidase
- Pantoprazole + Domperidone + Levosulpiride
- Glucosamine + Methyl Sulfonyl Methane + Boswellia Serrata
- Diacerein + Methyl Sulfonyl Methane + Boswellia Serrata
- Trypsin-Chymotrypsin + Diclofenac + Serratiopeptidase
- Glimepiride + Metformin + Voglibose
- Trypsin-Chymotrypsin + Diclofenac + Methyl Sulfonyl Methane
- Paracetamol + Aceclofenac + Chlorzoxazone
- Paracetamol + Diclofenac + Chlorzoxazone
- Etodolac + Paracetamol + Methyl Sulfonyl Methane
- Cefixime + Lactobacillus + Ofloxacin
- Paracetamol + Chlorzoxazone + Nimesulide
- Drotaverine + Mefenamic Acid + Paracetamol
- Glucosamine + Diacerein + Boswellia Serrata
- Serratiopeptidase + Diclofenac + Paracetamol
- Diclofenac + Methyl Sulfonyl Methane + Paracetamol
- Glucosamine + Methyl Sulfonyl Methane + Diacerein
- Paracetamol + Diclofenac + Serratiopeptidase
- Pantoprazole + Domperidone + Simethicone
- Trypsin-Chymotrypsin + Diclofenac + Boswellia Serrata
- Nimesulide + Paracetamol + Methyl Sulfonyl Methane
- Pantoprazole + Domperidone + Simethicone + Activated Dimethicone
These drugs, once widely available, are now barred from manufacture, sale, and distribution across India.
Health Risks Posed by Unapproved FDCs
The absence of rigorous testing for these FDCs introduces several health risks:
- Adverse drug reactions: Unverified combinations may trigger unexpected side effects, ranging from mild discomfort to severe allergic reactions.
- Harmful interactions: Combining APIs without studying their interactions can lead to dangerous outcomes, such as increased toxicity or reduced efficacy.
- Ineffective treatments: Without efficacy data, these drugs may fail to treat the intended condition, delaying proper care and worsening health outcomes.
- Systemic public health threats: Widespread use of unapproved drugs can strain healthcare resources and erode trust in India’s pharmaceutical sector, a global powerhouse.
The CDSCO’s action reflects a zero-tolerance stance on compromising patient safety, reinforcing the need for scientific validation in drug approvals.
What Should Consumers Do?
If you are using any of the banned FDCs, take immediate action to protect your health:
- Cease use: Stop taking the medication to avoid potential risks.
- Consult a healthcare provider: Discuss safe, approved alternatives with your doctor or pharmacist.
- Verify prescriptions: Cross-check your current medications against the banned list.
- Report side effects: Inform your healthcare provider or India’s pharmacovigilance program about any adverse effects experienced.
Pharmacies have been directed to remove these drugs from their inventories. Consumers should exercise caution, avoid purchasing these medications, and prioritize prescriptions from trusted healthcare professionals.
The Road Ahead: Enforcement and Reforms
The CDSCO has outlined a robust enforcement strategy to ensure compliance with the ban:
- License revocation: State regulators must cancel all existing licenses for the banned FDCs.
- Vigilant monitoring: Drug enforcement teams at ports, airports, and regional zones will oversee adherence to the ban.
- Process overhaul: State and Union Territory drug controllers are tasked with reviewing and aligning their approval processes with NDCT Rules, 2019.
Looking forward, the CDSCO is expected to spearhead a nationwide review of drug approval protocols. This initiative aims to close regulatory gaps, enhance coordination between central and state authorities, and prevent future violations. Such reforms are critical for maintaining India’s reputation as a leader in safe, high-quality pharmaceuticals.
Why This Matters for India and Beyond
The ban on 35 FDCs is a pivotal moment for India’s healthcare landscape. It highlights the importance of stringent regulatory oversight in safeguarding public health, particularly in a country with a vast and diverse pharmaceutical market. By addressing lapses in the approval process, the CDSCO is setting a precedent for accountability and transparency.
For consumers, this serves as a reminder to stay informed about the medications they use. For manufacturers, it underscores the non-negotiable need for compliance with safety standards. Globally, this move reinforces India’s commitment to upholding high standards in its pharmaceutical industry, which supplies affordable generics to millions worldwide.
Conclusion
The CDSCO’s ban on 35 unapproved FDC drugs is a bold step toward prioritizing patient safety and regulatory integrity. By halting the manufacture, sale, and distribution of these medications, India is addressing a critical public health risk and reinforcing the importance of evidence-based drug approvals. Consumers must act swiftly to transition to safe alternatives, while regulators and manufacturers work to prevent future oversights. As India navigates this regulatory overhaul, the focus remains clear: protecting lives through rigorous science and unwavering accountability.
Frequently Asked Questions (FAQs)
What are fixed-dose combination (FDC) drugs, and why are they used?
FDC drugs combine two or more active ingredients in a fixed ratio within a single dose, such as a tablet or capsule. They are used to improve treatment outcomes, simplify medication regimens, and reduce costs by combining drugs that work synergistically for conditions like diabetes, pain, or infections.
Why did the CDSCO ban these 35 FDC drugs?
The CDSCO banned these FDCs because they were licensed by state authorities without prior safety and efficacy evaluations, violating NDCT Rules, 2019. This lack of testing posed risks like adverse reactions and ineffective treatments, prompting the ban to protect public health.
What health risks do these unapproved FDCs pose?
Unapproved FDCs may cause unexpected side effects, harmful drug interactions, or fail to treat the intended condition due to unverified efficacy. These risks can lead to serious health complications and delay proper care.
What should I do if I’m taking one of the banned FDCs?
Stop using the medication immediately, consult your doctor for safe alternatives, check your prescriptions against the banned list, and report any adverse effects to your healthcare provider or India’s pharmacovigilance program.
How will the CDSCO enforce the ban and prevent future issues?
The CDSCO is enforcing the ban by revoking licenses, monitoring compliance through drug enforcement teams, and directing state regulators to align with NDCT Rules, 2019. A broader review of drug approval processes is planned to ensure consistent safety standards.
