In an important update for doctors and patients, the Central Drugs Standard Control Organization (CDSCO) has banned the manufacture, sale, and distribution of certain Fixed Dose Combinations (FDCs) used in the treatment of Type 2 diabetes. These banned diabetes drug combinations include Metformin, Glimepiride, Voglibose, and Dapagliflozin in various strengths.
These FDCs were previously approved by some State Licensing Authorities (SLAs) without proper scientific evaluation by the Drugs Controller General of India (DCGI), which is against the New Drugs and Clinical Trials (NDCT) Rules, 2019.
❌ Which Diabetes FDCs Are Banned?
The CDSCO circular has listed the following 4 banned diabetes medication combinations:
- Metformin Hydrochloride 500mg (Extended Release) + Glimepiride 3mg + Dapagliflozin 10mg
- Glimepiride 1mg + Metformin Hydrochloride 500mg
- Glimepiride 2mg + Metformin Hydrochloride 500mg (Sustained Release) + Voglibose 0.3mg
- Metformin Hydrochloride 500mg (Prolonged Release) + Voglibose 0.2mg
These combinations were not evaluated for safety or efficacy before being marketed, which poses a serious risk to public health.
⚠️ Why Were These FDCs Banned?
According to the CDSCO:
“These combinations were licensed without adequate review and approval under the NDCT Rules, 2019. This can result in unsafe drug interactions and adverse reactions.”
The decision came after show-cause notices were issued to manufacturers, and some companies voluntarily surrendered their licenses.
Many companies claimed they received licenses from State Licensing Authorities and were unaware of the violations. However, the lack of uniform regulatory enforcement has raised concerns.
📢 What Should Doctors Know?
The Drug Controller General of India (DCGI) has instructed all State and UT Drug Controllers to:
- Stop the production and sale of these banned combinations
- Investigate the matter under the Drugs and Cosmetics Act, 1940
- Ensure no unapproved FDCs are allowed in the market
💊 Impact on Diabetes Treatment
Doctors prescribing diabetes medicines should immediately review their prescriptions and discontinue these specific FDC combinations if in use.
The focus should be on prescribing approved, evidence-based therapies for managing Type 2 diabetes to ensure patient safety and effective treatment.
✅ Final Thoughts
This move by CDSCO is a step in the right direction to ensure that only scientifically tested, safe medications are available to Indian patients. As diabetes is a lifelong condition, every medicine used must be properly approved and regulated.
📩 Call to Action for Doctors
🩺 If you’re a doctor, pharmacist, or healthcare provider:
✅ Review your current diabetes prescriptions
✅ Inform patients about this update
✅ Avoid using the banned FDCs listed above
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