Drug Controller General of India (DCGI)

The Drug Controller General of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India. In this article, you can read all about the DCGI and the organisation CDSCO, and its role in drug regulation in the country. This is important for the UPSC exam polity and governance segments.

Drug Controller General of India

The Drug Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO).

• CDSCO is the central drug authority in India.
  • CDSCO is a national level regulatory body under the Ministry of Health and Family Welfare.
  • The body is responsible for approving licenses for certain categories of drugs.
  • It is headquartered in New Delhi.
  • There are six functioning central drug testing laboratories under CDSCO.
• The DCGI also establishes standards for the manufacturing, sales, import, and distribution of drugs in India.
• The DCGI also regulates medical and pharmaceutical devices.
• In case of any dispute with respect to the quality of the drug, the DCGI is the appellate authority.
• The DCGI prepares and maintains the national reference standard for drugs.
• He ensures that there is uniformity in the implementation of the Drugs and Cosmetics Act.
• He is responsible for the training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
• He is also in charge of the analysis of cosmetics received from the CDSCO as survey samples.
• The DCGI is also the central licensing authority for medical devices which fall under the Medical Device Rules 2017.

Functions of the CDSCO

The CDSCO is responsible for the following:

• Drug approval under the Drugs and Cosmetics Act.
• Conducting clinical trials.
• Setting standards for drugs.
• Quality control over drugs imported into the country.
• Coordinating activities of the state drug control organisations.
• Registration of foreign manufacturers of drugs and medical devices whose products are to be imported into the country.
• Grant of licences to import drugs by Government hospitals or Medical Institutions for the use of their patients.
• Recommend banning of drugs considered harmful or sub-therapeutic under section 26A drugs and Cosmetics Act.

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