DCGI - Drugs Controller General of India

DCGI (Drugs Controller General of India) is the head of the Central Drugs Standard Control Organization (CDSCO) of the Government of India. The DCGI approves licenses for specified categories of drugs in India. They include blood and blood products, IV fluids, vaccines, and Sera.

The DCGI is also responsible for laying down standards for India's manufacturing, import, and distribution of drugs. Dr VG Somani is the current Drugs Controller General of India.

About the CDSCO

• CDSCO is the regulatory body for Indian pharmaceuticals and medical devices functioning under the Union health ministry.
• It has its headquarters at FDA Bhawan, Kotla Road, New Delhi 110002.
• CDSCO has six zonal offices in Mumbai, Kolkata, Chennai, Ghaziabad, Hyderabad, and Ahmedabad. Further, it also has four sub zonal offices, thirteen Port offices, and seven laboratories spread across the country.
• Its functions include ensuring the quality of drugs and cosmetics sold in the country, approving new drugs, and regulating clinical trials.

Functions of the DCGI

• To prepare and maintain the national reference standard for drugs
• Regulate medical and pharmaceutical devices in the country
• To ensure that the provisions of the Drugs and Cosmetics Act are enforced uniformly in the country
• To train drug analysts deputed by State Drug Control Laboratories and other institutions
• To survey and analyze samples of cosmetics and drugs received from CDSCO
• To function as the appellate authority if any dispute arises regarding the quality of the drugs

The Medical Device Rules 2017 also empowered the Drugs Controller General of India to act as a Central Licensing Authority for medical devices that fall under these rules. There are four classes of medical devices in these rules: Class A, Class B, Class C, and Class D. The DCGI will direct licensing authority for Class C and D and co-ordinate licensing for Class A and B. The State Drug Controllers will act as the State Licensing Authority for Class A and B.

Current DCGI of India

• Dr V.G. Somani was appointed as the Drugs Controller General of India on August 14, 2019, on deputation for three years.
• He replaced Dr S. Eswara Reddy, who then held the position of DCGI on an ad-hoc basis.
• Before being appointed as DCGI, Dr V.G. Somani served as the Joint Drugs Controller (India) of CDCSO.
• Dr V.G. Somani completed his M. Pharm and PhD in Pharmaceutical Sciences from Nagpur University, India.
• As a Joint Drugs Controller (India), he headed the Divisions of Regulation of Medical Devices and In-vitro Diagnostics, Stem cells and Blood Products, and New Drugs. Earlier, he led the divisions of Biologicals, Clinical Trial, New Drugs and Cosmetics, and Enforcements for many years.
• For several years, Dr Somani has been actively involved in the National and International forum for policymaking, training, and selection.

Why in the News?

• Via a notification dated August 27, the Central Government had constituted an 8-member panel for preparing new drugs, cosmetics, and medical device laws.
• The eight-member panel is headed by the DCGI, Dr V.G. Somani.
• The panel was supposed to examine the previous bills and submit a draft document by November 30, 2021.
• However, Dr Somani sought an extension, and the Central Government granted the same. The draft writing process is still ongoing.

FAQs on Drugs Controller General of India [DCGI]

Q.1. Who is a DCGI?

The Drugs Controller General of India (DCGI) is the head of the Central Drugs Standard Control Organization (CDSCO) of the Government of India.

Q.2. Who is the current DCGI of India?

Dr V. G. Somani is the current Drugs Controller General of India.

Q.3. What is the role of DCGI?

The DCGI is responsible for laying down standards for India's manufacturing, import, and distribution of drugs.

Q.4. Why is DCGI Dr V. G. Somani in the News?

The Central Government, on August 2021, had constituted an 8-member panel for preparing new drugs, cosmetics, and medical device laws. Drugs Controller General of India, Dr Somani, headed the panel.