CDSCO- An authority for drug regulation in India

Pharmacy
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CDSCO- An authority for drug regulation in India, headed by Dr. Rajeev Singh Raghuvanshi (Drug controller General of India)

![|142x129](file:///C:/Users/VANSHI~1/AppData/Local/Temp/msohtmlclip1/01/clip_image002.jpg)CDSCO -Central Drug Standard Control Organisation, is a National Regulatory Authority (NRA) of India. It is the main regulatory body that ensures medicines, cosmetics, and medical devices are safe.

Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002. With zonal offices, four subzonal offices, thirteen port offices, and seven laboratories spread across the country.

Its history falls long back in 1940…

In 1940, the Indian government introduced the Drugs and Cosmetics Act to prevent substandard products from reaching the market. Initially different states handled the rules on their own, but as the demand for cosmetics increased, the need for central authority became essential.

What are the divisions of CDSCO?

  • BA/BE—B.A. stands for bioavailability; it’s a quantity of medication that is taken from a given dose.

  • Clinical Trials- These refers to the study that gives client the access to medical, surgical behaviour.

  • DTAB & DCC—The Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) sessions are coordinated by this division.

  • Cosmetics – According to the Drugs and Cosmetics Act of 1940, section 3(aaa)

  • Biologics – Medical supplies derived from natural sources are known as biological products.

  • Import Registration – The policies for both import and registration are handled in this area.

  • New Drugs – A newly developed drug is defined as anything that contains bulk drug material.

The roles and responsibilities are assigned by the government of India according to the D&C Act, 1940.

  • It accentuates the regulation guidelines for the quality of the medical product manufactured, imported and distributed in the country.
  • It is responsible for the approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country, and coordination of the activities of State Drug Control Organizations.
  • Along with state regulators, it is 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.

What do you think there should be a separate regulatory body for cosmetics and medical devices?

MBH/PS

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Rather than creating entirely new agencies in every country, a practical approach may be to establish independent, well-resourced divisions with dedicated experts for cosmetics and medical devices under a broader health regulatory framework. This can provide specialization without duplicating infrastructure.