In a major move to strengthen drug regulation and patient safety, India’s Central Drugs Standard Control Organization (CDSCO) has issued a sweeping directive to all states and union territories to immediately halt the manufacturing, distribution, and sale of 35 unapproved Fixed Dose Combination (FDC) drugs. The directive, released under the authority of Drug Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, also extends to other FDCs whose safety and efficacy have not been scientifically evaluated.
What Are FDC Drugs?
Fixed Dose Combination (FDC) drugs are pharmaceutical products that combine two or more active ingredients into a single dosage form, such as a tablet or capsule. These “cocktail drugs” are designed to simplify treatment regimens, improve patient compliance, and, in some cases, enhance therapeutic outcomes. However, without rigorous testing and scientific validation, FDCs can pose serious health risks.
Why Did DCGI Take This Step?
The decision came after the DCGI observed that several state drug licensing authorities had approved these FDCs without following the safety and efficacy protocols mandated by the New Drugs and Clinical Trials (NDCT) Rules, 2019.
In a strongly-worded letter dated April 11, 2025, Dr. Raghuvanshi wrote:
“The marketing of such FDCs without scientific assessment is a serious risk to public health and calls for immediate regulatory intervention.”
Among the 35 banned FDCs are drugs used for pain relief, diabetes, hypertension, neuropathic pain, fertility treatments, and nutritional supplements.
Key Issues That Led to the Ban
- Violation of NDCT Rules (2019): These drugs were approved without mandatory safety evaluations.
- Lack of Regulatory Uniformity: Different states followed inconsistent approval processes, creating regulatory gaps.
- Potential Adverse Effects: Without proper scientific analysis, drug interactions and long-term effects can cause harm, including:
- Nausea, dizziness, and headaches
- Kidney or liver damage
- Hormonal imbalances
- Development of antibiotic resistance
What Are the Pharmaceutical Companies Saying?
Upon receiving show-cause notices, several drug manufacturers defended themselves by stating they had legally obtained licenses from state authorities. This response highlighted a deeper issue—lack of centralized enforcement and differing interpretations of drug laws across states.
Industry representatives argued:
“We haven’t violated any rules. The licenses were granted by competent authorities in respective states.”
This has underscored the urgent need for a unified drug policy and centralized regulatory oversight.
What’s Next for States and UTs?
CDSCO has laid down a clear roadmap:
- All state drug controllers must review and revoke approvals of unverified FDCs.
- Suspicious or unapproved FDCs must be immediately removed from the market.
- Future approvals must comply strictly with NDCT Rules.
- The drug approval system must embrace scientific validation and transparent procedures.
What Is NDCT Rules, 2019?
The New Drugs and Clinical Trials (NDCT) Rules, 2019, serve as a comprehensive framework for evaluating new medicines and conducting clinical trials in India. Their main goals include:
- Ensuring safety and efficacy before any drug approval
- Protecting patient welfare during clinical trials
- Mandating expert reviews and scientific scrutiny before market entry
Experts Applaud the Move
Dr. Manjula Verma, a senior clinical pharmacologist, said:
“FDCs can be beneficial when supported by data. But using them without trials is a recipe for disaster.”
Dr. Arun Tiwari, a pharma regulation expert, called the CDSCO directive a “long overdue reform.”
“The Centre’s decision will help enforce regulatory discipline across states. It’s high time we standardized our drug approval system.”
Final Thoughts
The CDSCO’s bold action marks a critical shift toward stricter drug regulation in India. This move prioritizes patient safety over market convenience and calls for uniformity in how medicines are approved and monitored across the country.
While it may pose short-term challenges for manufacturers, the long-term benefits of a more transparent and scientifically sound pharmaceutical ecosystem are undeniable. The onus now lies on state authorities to swiftly act on the directive, ensuring that untested and potentially dangerous FDCs are no longer available to Indian patients.
This is more than just a regulatory shake-up—it’s a much-needed leap towards safeguarding public health in India.
