Recently, the Central Drugs Standard Control Organisation (CDSCO) has directed state and Union territory drug regulators to immediately halt the manufacture, sale, and distribution of 35 Fixed-Dose Combination (FDC) drugs. 

• The directive follows an ongoing investigation into the approval of these drugs without the mandatory assessment of their safety, efficacy, and therapeutic justification, as required under the Drugs and Cosmetics Act, 1940, and New Drugs and Clinical Trial (NDCT) Rules, 2019.
• The CDSCO emphasized that several such combinations had been approved at the state level without clearance from the Drugs Controller General of India (DCGI) , a violation that raises serious concerns about patient safety and regulatory integrity.

What are Fixed-Dose Combinations (FDCs)?

• Fixed-Dose Combinations (FDCs) are pharmaceutical products that contain two or more active pharmaceutical ingredients (APIs) in a fixed ratio. 
• These include widely used medications such as pain relievers, anti-diabetic drugs, and nutritional supplements.
• Benefits of FDCs:
  • Improve patient compliance by reducing the number of pills a patient has to take.
  • Enhance therapeutic effectiveness through synergistic action of the combined drugs.
  • Lower costs and reduce pill burden for chronic treatments.

Classification of FDCs

• Category I: Existing FDCs already approved in other countries or in India
  • These combinations have documented evidence of safety and efficacy.
  • They typically require minimal additional studies for approval.
• Category II: FDCs of approved drugs with possible pharmacokinetic or pharmacodynamic interactions
  • These may need new clinical trial data due to possible altered drug interactions.
  • Often involves fixed doses of known drugs but in new combinations or dosages.
• Category III: FDCs of approved drugs where one or more ingredients are in modified release form or administered by a new route
  • Requires data to support new pharmacological profiles.
  • Example: A once-daily modified release tablet of two drugs normally taken separately.
• Category IV: FDCs where one or more active ingredients are new drugs
  • These require extensive clinical trials and DCGI approval.
  • Considered new drugs under NDCT Rules, 2019.

About Central Drugs Standard Control Organisation (CDSCO)

• CDSCO is India’s National Regulatory Authority (NRA) under the Directorate General of Health Services, Ministry of Health & Family Welfare.
• Headquarters: New Delhi. 
• Key Responsibilities of CDSCO
  • Safety and Quality: Ensures transparency, accountability, and uniformity in services to maintain the safety, effectiveness, and quality of medical products.
  • Approval of New Drugs: Approves new drugs and oversees clinical trials.
  • Standards for Drugs: Establishes standards for drugs and controls the quality of imported drugs.
• Collaboration with State Regulators
• • Licensing: Along with state authorities, CDSCO grants licenses for critical drugs like blood products, vaccines, IV fluids, and sera.
  • Expert Advice: Provides guidance to ensure uniform enforcement of the Drugs and Cosmetics Act across the country.

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