What is the Central Drugs Standard Control Organisation (CDSCO)?

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What is the Central Drugs Standard Control Organisation (CDSCO)? Blog Image

Overview:

The Central Drugs Standard Control Organisation (CDSCO) has become the sole authority for issuing manufacturing licences for new drugs meant for exports, withdrawing the power from state governments amid heightened global scrutiny of Indian made drugs

About Central Drugs Standard Control Organisation (CDSCO): 

  • It is the National Regulatory Authority (NRA) of India for the medical devices industryunder the provisions of the Drugs and Cosmetics Act.
  • It is responsible for overseeing the import, manufacture, sale, and distributionof medical device in the country. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards.
  • It works under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
  • The Drugs Controller General of India (DCGI) is the head of the CDSCO.
  • Headquarters: New Delhi.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for,
    • Approval of new drugs;
    • Conduct of clinical trials;
    • Laying down the standards for drugs;
    • Control over the quality of imported drugs in the country;
    • Coordinationof the activities of State Drug Control Organizations;
  • CDSCO, along with state regulators, is jointly responsible for the grant of licenses for certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.
  • The CDSCO conducts inspections and audits to ensure that medical device companies are complying with regulations related to safety, quality, and efficacy.

Q1: What is the Drugs and Cosmetics Act, 1940?

Drugs and Cosmetics Act regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licences and permits. Its main objective is to ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards. The associated Drugs and Cosmetics Rules, 1945, which were formulated in association with the 1940 Act, provide provisions for classifying medications into schedules and instructions for the storage, sale, presentation, and prescription of each schedule.

Source: Centre takes away state powers for issuing NOC for export of drugs