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Home / IAS Preparation / DCGI Full Form

Drugs Controller General of India (DCGI) - Overview, Responsibilities, Functions, Regulations & More!

Last Updated on Jan 18, 2024
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DCGI full form is Drugs Controller General of India (DCGI). DGCI heads the Central Drugs Standard Control Organization (CDSCO) department. The department comes under the Government of India. The DCGI is responsible for approving licenses for specified drug categories in India. The DCGI also lays down the requisite standards and quality for drugs. It regards the selling, importing, manufacturing, and distributing drugs in India. The DCGI aims to bring uniformity in enforcing the Drugs and Cosmetics Act.

Topics related to critical political issues form an essential part for the UPSC exam. It comes in the UPSC Exam under the syllabus of the General Studies Paper-II.

This article will discuss in detail the background of the Drug Controller General of India (DCGI). It also looks into its overview, responsibilities, functions, regulations, committees, etc. 

What is the Drug Controller General of India (DCGI)?

The Drugs Controller General of India (DCGI) leads the Central Drugs Standard Control Organization (CDSCO). This organisation comes under the Ministry of Health and Family Welfare (MoHFW). They derive their powers from the Drugs and Cosmetics Act of 1940.

It is a critical post in terms of the health sector in India. It is essential in making regulatory approval for drugs and vaccines in India. The DCGI played a crucial role in approving the COVID vaccines recently.

Title

Description

Current DCGI (2023)

Dr Rajeev Singh Raghuvanshi

Ministry Concerned

Ministry of Health and Family Welfare

Act

Drugs and Cosmetics Act, 1940

Study about the Drug Price Control Order here.

Responsibilities of the DCGI

The DCGI is responsible for multiple works in the health sector. The DCGI also lays down the requisite standards and quality for drugs. It regards the selling, importing, manufacturing, and distributing drugs in India. It also regulates medical and pharmaceutical standards. The DCGI is also the appellate authority to decide upon the quality of the drug. 

  • It prepares and maintains the requisite reference standard for drugs.
  • The DCGI ensures uniformity in implementing the Drugs and Cosmetics Act of 1940.
  • The DCGI conducts the training in this field. It trains the Drug Analysts of the State Drug Control Laboratories and the related Institutions. 
  • The DCGI also analyzes cosmetics as survey samples. It is received from the Central Drugs Standard Control Organization.
  • The DCGI is also the central licensing authority under the Medical Device Rules 2017. It handles the licensing of the medical devices that fall under this Act's ambit. 
  • It also approves the drugs under the Drugs and Cosmetics Act.
  • The DCGI handles the conduction of clinical trials. The DCGI also sets standards for drugs.
  • The DCGI also ensures quality control over drugs imported into the country.
  • It coordinates the activities of various state drug control organizations.
  • It is responsible for registering foreign manufacturers. These makers trade drugs and medical devices whose products are imported into India.
  • It is responsible for granting licenses to import drugs. It is used by Government hospitals or Medical Institutions for their patients' use.
  • It recommends banning harmful or sub-therapeutic drugs. It does so under section 26A of the Drugs and Cosmetics Act.

Read about the Bulk Drug Parks here.

Governance of DCGI

The governance of the DCGI involves the appointment of a qualified individual to lead the organization and oversee its functions. Here are some key points about the governance of DCGI:

  • The government appoints a person to the position of Drug Controller General of India. The appointment is made based on the individual's qualifications and expertise in the field of drug regulation.
  • As of 1st February 2023, Dr. Rajeev Singh Raghuvanshi is serving as the Drug Controller General of India. Prior to him, Dr. VG Somani held the position.
  • The DCGI heads the Central Drugs Standard Control Organization (CDSCO), which is the Indian drug regulatory body. Their responsibilities include ensuring the quality of drugs and cosmetics sold in the country, approving new drugs, and regulating clinical trials.
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Major Functions of DCGI

The DCGI has several important functions related to the regulation and control of drugs in India. Here are the major functions of DCGI:

  • DCGI grants licenses for specific categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
  • DCGI plays a crucial role in setting the standards for the manufacturing, sale, import, and distribution of drugs in India.
  • DCGI is involved in the preparation and maintenance of the national reference standard for drugs.
  • DCGI trains drug analysts from State Drug Control Laboratories and other institutions. They also analyze cosmetics received as survey samples from the Central Drug Standard Control Organization (CDSCO).
  • DCGI also acts as the Central Licensing Authority (CLA) for medical devices falling under the purview of these rules. They coordinate licensing for different classes of medical devices.

Read about Orphan Drugs here.

Committee on Drug Regulatory System (CDRS)

The Committee on Drug Regulatory System (CDRS) is a specialized committee that plays a role in the drug regulatory system in India. Here are some points about the CDRS:

  • The CDRS is set up to evaluate and make recommendations for strengthening the drug regulatory system in India. It focuses on improving the efficiency, transparency, and effectiveness of regulatory processes.
  • The committee consists of experts from various fields. This includes pharmaceuticals, medical sciences, drug regulation, and public health. It may also include representatives from relevant government departments and organizations.
  • The CDRS conducts assessments and reviews of the drug regulatory system. It identifies areas for improvement, and provides recommendations for policy changes and reforms. It may also propose measures to enhance regulatory capacity and address emerging challenges.
  • The CDRS collaborates with stakeholders such as pharmaceutical companies, healthcare professionals, and regulatory authorities. It gathers inputs and perspectives for its evaluations and recommendations.
  • The findings of the CDRS can influence policy decisions and reforms in the drug regulatory system. It aims to ensure the safety, efficacy, and quality of drugs available in India.

Read about the United Nations Office on Drugs and Crime UNODC here.

Functions of Committee on Drug Regulatory System

The overhauling of drug regulation in India is a tough task. The work is vested with the Committee on Drug Regulatory System. It was entrusted with the responsibility to find the issues plaguing the drug regulations in India. 

  • The Committee was tasked with solving the problem of spurious or substandard drugs.
  • The Committee sought to overhaul how patents are granted for incremental innovation.
  • The Committee looked into several legislations related to drug regulation in the country. 

Regulations under CDRS

The Committee envisaged several regulations to improve drug regulation in India. It suggested a roadmap for the implementation of these measures. 

  • The Committee cited non-uniformity in the interpretation of the provisions of drug laws as an issue. Their implementation was said to be suffering from bottlenecks.
  • The Committee reiterated the setting up of a National Drug Authority (NDA). The NDA was earlier envisaged by the Hathi Committee Report (1875).
  • It called for a professionally managed CDSCO. The CDSCO could be given the status of the Central Drug Administration (CDA). 
  • It called for top-class technical and investigative skills, appropriate infrastructure and adequate resources. 
  • It recommended that the Central Drug Administration (CDA) could be formed as a separate office. It would be under the ambit of the Ministry of Health and Family Welfare (MoHFW).
  • The Committee recommended that the State Drug Control Organisations be urgently strengthened. It should be provided with competent and trained human resources and with adequate budgets. 
  • The Committee also suggested that the various associations play a more active and collaborative role. It would help in combating spurious drugs in the country.

Read about the International Day Against Drug Abuse and Illicit Trafficking here.

Conclusion

The DCGI plays a crucial role in drug regulation in India. The problem of fake, illegal drugs is a genuine issue India faces today. Efforts were made via the Mashelkar panel to cover this issue. However, there were limitations associated with the report. Dr Mashelkar resigned from the committee. He was faced with the charges of plagiarism and Pro-MNC recommendations. However, the overall recommendations were of much importance to the health sector in India. The recommendations suggested by the committee have yet to be implemented fully. Efforts could be made in this regard with the aid of the DCGI to ensure the overhauling of the drug regulation system in India.

Read about Drug Abuse here.

We hope all your doubts related to the Drug Controller General of India (DCGI) are addressed after going through this article. Testbook also provides comprehensive notes for Civil services and various other competitive examinations. like content pages, live tests, GK and current affairs mocks, and so on. Ace your UPSC preparation with Testbook. Download the Testbook App now! The UPSC aspirants can also take the help of Testbook’s UPSC Online Coaching to boost their UPSC Exam preparation!

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DCGI Full Form FAQs

The current Drug Controller General of India is Dr Rajeev Singh Raghuvanshi. He was appointed in 2023 after the interim DCGI PBN Prasad’s short term.

The Drug Controller General of India is appointed by the Appointments Committee of the Cabinet led by the Prime Minister. It acts on the name recommended by the UPSC Panel and approved by the Health Ministry.

The Drugs Controller General of India is the leading authority. It comes under the Central Drugs Standard Control Organization. This comes under the Ministry of Health and Family Welfare. It is a critical post in terms of the health sector in India. It is essential in making regulatory approval for drugs and vaccines in India

The Government of India constituted an Expert Committee in 2003. It was for India's drug regulatory system and infrastructure. It was mandated to examine the broader issues related to the health sector in India. It looked into the recommendations of earlier committees. It looked into the progress made so far. It also saw the bottlenecks associated.

The Central Drugs Standard Control Organization (CDSCO) is given certain responsibilities. It approves New Drugs, conducts Clinical Trials, and lays down the standards for Drugs, etc. It was formulated in 1940 in lieu of recommendations of the Chopra Committee (1930).

The Committee on Drug Regulatory System made recommendations about the Central Drug Administration. It could be formed as a separate office under the Ministry of Health and Family Welfare. It also recommended strengthening the manpower. The technology in the drugs sector in India should receive a boost.
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