4 Diabetes Medication FDCs including Glimipride Metformin Strength banned by Health Ministry

The banned combinations were flagged in a recent circular (File No. 4-01/2023-DC (Misc. 3)) issued by the CDSCO, which noted that these drugs were being marketed in violation of the New Drugs and Clinical Trials (NDCT) Rules, 2019. The CDSCO stated:

“It has come to the notice of this Directorate that certain Fixed Dose Combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy... This poses a serious risk to public health and safety.”

Among the Antidiabetic agents, strengths of FDCs listed as either cancelled or voluntarily surrendered following show-cause notices are:

1. Metformin Hydrochloride IP 500mg (as extended release form) + Glimepiride IP 3mg + Dapagliflozin Propanediol Monohydrate IP eq. to Dapagliflozin 10mg film coated bilayered tablets

2. Glimepiride IP 1mg & Metformin HCL IP 500mg Tablet

3. Glimepiride IP 2mg, Metformin Hydrochloride IP (As Sustained Release form) 500mg and Voglibose IP 0.3mg Tablet

4. Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet

The CDSCO has warned that such unapproved dosage strength of FDCs, when not subjected to adequate scientific scrutiny, may lead to adverse drug reactions, dangerous interactions, and compromised patient safety.

Upon investigation, manufacturers claimed that the licenses were granted by SLAs, suggesting they had not knowingly violated regulatory rules. However, the CDSCO emphasized the lack of uniform enforcement of the NDCT Rules across states as a contributing factor to such lapses.

The DCGI has directed all State and UT Drug Controllers to, “Ensure that the FDCs in annexure & any other unapproved FDCs shall not be allowed for manufacture, sale, & distribution in the country.”

Regulators have also been instructed to conduct investigations and take action as per the provisions of the Drugs and Cosmetics Act, 1940.