Govt prohibits manufacture, supply, sale of 328 FDC drugs

• The government has prohibited the manufacture, sale or distribution of 328 fixed-dose combination (FDC) drugs for human use with immediate effect.

• The health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, covering 6,000 brands.

• Certain painkillers, antibiotics, antiseptics for treatment of mouth and throat conditions and anti-diabetic drugs got a relief but with some restrictions.

About the FDC drugs?

• An FDC drug includes two or more active pharmaceutical ingredients combined in a single dosage form.

• In which is manufactured and distributed in fixed doses.

• The major advantage of FDCs has improved medication compliance by reducing the pill burden of patients.

• However, if an adverse drug reaction occurs it may be difficult to identify the active ingredient responsible for causing the reaction.

Irrational FDCs

• The Drug Technical Advisory Board (DTAB). expert panel probing the efficacy of 349 banned FDCs gave its report to India’s top drug advisory body.

• The panel after considering these drugs “irrational”, citing safety issues and lack of therapeutic justification, recommended continuing the ban.

• It also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.

• The Supreme Court has earlier suggested the DTAB to decide the fate of these drugs.

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Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

Prelims level: FDCs

Mains level: Issues in Pharma Sector.

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