Drugs Controller General of India (DCGI) is the head of department of the

Central Drugs Standard Control Organization The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics , pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Jap ...

of the

Government of India The Government of India (ISO: ; often abbreviated as GoI), known as the Union Government or Central Government but often simply as the Centre, is the national government of the Republic of India, a federal democracy located in South Asia, c ...

responsible for approval of licences of specified categories of

drugs A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalat ...

such as blood and blood products,

IV fluids Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutrie ...

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...

s, and sera in India. Drugs Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.

Function

DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India. * Preparation and maintenance of national reference standard. * To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. * Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions * Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation) With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules. Out of four Classes of medical devices from Class A to Class D, DCGI will be the direct licensing authority for Class C and Class D devices, whereas it will coordinate licensing for Class A and B devices through State drug controllers, who will act as State Licensing Authority or SLA.

Governance

The government on 14 August 2019 appointed Dr. VG Somani as Drug Controller General of India (DCGI). Dr. VG Somani succeeded S Eswara Reddy, the interim DCGI who was appointed in February 2018. DCGI heads the Indian drug regulatory body the Central Drugs Standard Control Organisation (CDSCO), whose functions include ensuring the quality of drugs and cosmetics sold in the country, approval of new drugs and regulating clinical trials.

Zonal Offices Of CDSCO

The central government have established 6 zonal offices of CDSCO (Central Drugs Standard Control Organisation) at

Mumbai Mumbai (, ; also known as Bombay — the official name until 1995) is the capital city of the Indian state of Maharashtra and the ''de facto'' financial centre of India. According to the United Nations, as of 2018, Mumbai is the second- ...

Kolkata Kolkata (, or , ; also known as Calcutta , the official name until 2001) is the capital of the Indian state of West Bengal, on the eastern bank of the Hooghly River west of the border with Bangladesh. It is the primary business, comme ...

Chennai Chennai (, ), formerly known as Madras ( the official name until 1996), is the capital city of Tamil Nadu, the southernmost Indian state. The largest city of the state in area and population, Chennai is located on the Coromandel Coast of th ...

, and

Ghaziabad Ghaziabad () is a city in the Indian state of Uttar Pradesh and a part of Delhi NCR. It is the administrative headquarters of Ghaziabad district and is the largest city in western Uttar Pradesh, with a population of 1,729,000. Ghaziabad Muni ...

Hyderabad

Ahmedabad Ahmedabad ( ; Gujarati: Amdavad ) is the most populous city in the Indian state of Gujarat. It is the administrative headquarters of the Ahmedabad district and the seat of the Gujarat High Court. Ahmedabad's population of 5,570,585 (per t ...

, various Sub-Zonal offices and Port offices, which works in close collaboration with the state control administration and assist them in securing uniform

enforcement Enforcement is the proper execution of the process of ensuring compliance with laws, regulations, rules, standards, and social norms. Governments attempt to effectuate successful implementation of policies by enforcing laws and regulations. Ena ...

of the Drug Act.

References

{{Reflist

External links

Central Drugs Standard Control Organization
Government of India Drug safety Pharmacy organisations in India National agencies for drug regulation