DRUGS AND COSMETICS ACT

DRUGS AND COSMETICS ACT

Subject: National Legislations

Context: Delhi High Court on Monday pulled up the Drug Controller Department of Delhi for not properly examining how BJP MP Gautam Gambhir procured a huge quantity of COVID-19 medicines.

Concept:

• The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India.
• The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards

DRUGS AND COSMETICS RULES, 1945

• The Drugs and Cosmetics Rules, 1945 are the set of rules under The Drugs and Cosmetics Act, 1940.
• It contains provisions for the classification of drugs under given schedules.
• It also contains the guidelines of drugs for their storage, sale, display, and prescription of each schedule.

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO)

• CDSCO is the National Regulatory Authority (NRA) of India.
• Its headquarter is in Delhi.
• The Drugs & Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilities to central & state regulators for the regulation of drugs & cosmetics.
• It envisages the uniform implementation of the Act & Rules for ensuring the safety, rights and wellbeing of the patients.

Under this act, CDSCO is responsible for:

• Approval of Drugs
• Conduct of Clinical Trials
• Laying down the standards for Drugs
• Control over the quality of imported Drugs in the country
• Coordination of the activities of State Drug Control Organizations
• Bring out the uniformity in the enforcement of the Drugs and Cosmetics Act.