DCGI FRAMES GUIDELINES TO ENSURE PRODUCT TRACEABILITY

DCGI FRAMES GUIDELINES TO ENSURE PRODUCT TRACEABILITY - UPSC Source: https://www.dgca.gov.in/- Org. Structure

Why in the news?

  • In order to guarantee product traceability across the pharmaceutical supply chain, the Drugs Controller General of India (DCGI) has developed new standards.
  • With this action, the growing threat of fake and inferior medications in India is to be addressed.

About the Guidelines

  • Objective: The purpose of the rules is to identify and reduce the hazards associated with adulteration and counterfeit medications by requiring traceability along the whole supply chain, from manufacturing to distribution.
  • Implementation: In order to guarantee product integrity, these standards mandate that all parties participating in the pharmaceutical supply chain—manufacturers, distributors, and logistical companies—maintain thorough records.
DCGI (Drugs Controller General of India)

  • Function: DCGI is in charge of the Central Drugs Standard Control Organization (CDSCO), which is in charge of authorizing new medications, overseeing clinical studies, and guaranteeing the security of medical supplies in India.
  • Creation: The “1940’s Drugs and Cosmetics Act” created DCGI agency.
  • Headquarters: New Delhi.
  • Head of DCGI: Dr. Rajeev Singh Raghuvanshi.

Drugs and Cosmetics Act, 1940

  • Objective: To guarantee the safety, effectiveness, and quality of medications and cosmetics, the Act controls their import, production, and distribution into India.
  • Important clauses: It contains regulations pertaining to clinical trials, drug approval, and the legal structure governing the distribution and sale of pharmaceuticals.