The Drugs Technical Advisory Board (DTAB) has approved a sub-committee report recommending a ban on 16 Fixed-Dose Combinations (FDCs), citing serious health risks.
- The DTAB is set up by the Union Government under the Drugs and Cosmetics Act, 1940 to advise the Central/State Government.
What Are FDCs?
- FDCs are medicines that have more than one active ingredient (chemical compounds in medicines that have an effect on the body) in a single pill, capsule, or shot.
- They are meant for patients with conditions such as tuberculosis and diabetes for which they need to take multiple medicines regularly.
- They reduce the number of pills the patient needs to take each day, and help improve adherence to the treatment.
Why are FDCs being Banned?
- Lack of Proper Trials: Many banned FDCs were approved without proper clinical trials, as individual ingredients were already approved.
- According to the new drugs and clinical trial rules of 2019 rules, FDCs must be treated as new drugs and approved by the central drug regulator.
- Irrational intake: Some FDCs contain drugs that are unnecessary for all patients.
- Antibiotic Resistance: Overuse of antibiotic FDCs can cause antibiotic resistance, making infections harder to treat.
- Despite previous bans, a 2023 study found that antibiotic FDC sales in India increased from 32.9% (2008) to 37.3% (2020).
- Price Control Evasion: Drug companies often use FDCs to avoid government price controls on essential medicines by marketing them as new combinations.