The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals, medical devices, and cosmetics .

The CDSCO is responsible for ensuring the safety, efficacy, and quality of health products in India. Its main duties include:

The organization assesses and grants permission for pharmaceutical products through two distinct categories which include “New Drugs” and “Fixed-Dose Combinations.” The organization oversees clinical trial activities to ensure that these studies maintain ethical standards and scientific validity. The organization establishes quality benchmarks which serve as standards for evaluating drugs, cosmetics, and medical devices. The organization monitors drug quality through its various port offices which control all imported pharmaceutical products that enter India. The organization serves as the main body which collaborates with State Drug Control Organizations to establish consistent law enforcement throughout the nation.

📦 What does it regulate?

  1. Pharmaceuticals: Ranging from simple analgesics to complex anticancer

  2. Medical Devices: Currently, CDSCO has widened its scope to include everything ranging from a CT scanner to a simple thermometer.

  3. Cosmetics: The regulation of importation and manufacturing of cosmetic products.

  4. Biologicals: Vaccines, blood products, and sera