CDSCO (CENTRAL DRUGS STANDARD CONTROL ORGANIZATION)

INTRODUCTION 

CDSCO is controlled and regulated by the Directorate General of Health Services, which is part of the Government of India's ministry of health and family welfare. The Central Drugs Standard Control Organization is headquartered in New Delhi and operates several zonal offices across the country. Additionally, CDSCO collaborates together with Central Drug Laboratories to conduct quality management studies. 

The CDSCO collaborates with the Drugs Technical Advisory Board and the Drugs Consultative Committee to oversee manufactured products as the authority, whilst the Central Drugs Laboratory tests certain medicines. 

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The central authorities are responsible for approving new medicines, conducting clinical trials throughout the region, establishing prescription regulations, monitoring the efficacy of manufactured drugs, coordinating the activities of State Drug Control Organizations, and offering professional guidance in order to achieve uniformity in the administration of the Drugs and Cosmetics Act. On the other side, state agencies are responsible for regulating the production, marketing, and delivery of medications, which includes authorizing drug testing facilities, authorizing drug formulas for manufacture, conducting pre-and post-licensing checks, and supervising the manufacturing process for drugs made by respective state units and those sold in the state. These authorities are established according to the 1940 Drug and Cosmetics Act and 1945 Rules.

    WHO IS THE HEAD OF CDSCO?

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

•     CDSCO is India's central drug regulator. 

•     CDSCO is a statutory agency at the state level, reporting to the Ministry of Health and Family Welfare. 

•     It is responsible for approving licenses for specific classes of drugs and has its headquarters in New Delhi. 

    ROLES AND RESPONSIBILITIES OF CDSCO

CDSCO operates six functional central substance research facilities. 

•     Additionally, the DCGI sets requirements for the manufacture, selling, import, and distribution of pharmaceutical products in India. 

•     In addition to diagnostic and prescription products, the DCGI oversees them. 

•     In the event of a disagreement about the quality of the medication, the DCGI is the final arbiter. 

•     The DCGI develops and retains the national medication reference standard. 

•     He maintains consistency in the administration of the Drugs and Cosmetics Act. 

•     He is also responsible for educating Drug Analysts delegated by State Drug Control Laboratories and other Institutions, as well as for the study of cosmetics obtained as survey samples from the CDSCO. 

•     However, the DCGI serves as the national regulatory authority for electronic products covered by the 2017 Medical Device Rules.

   HEADQUARTERS OF CDSCO

The National Regulatory Authority (NRA) of India is the Central Drugs Standard Control Organization (CDSCO), which is part of the Directorate General of Health Services in the Ministry of Health and Family Welfare of the Government of India. Its headquarters are located at FDA Bhawan, Kotla Road, New Delhi 110002, and the organization also operates six zonal offices, four sub zonal offices, thirteen port offices, and seven laboratories throughout the region.

    WHAT IS THE DIFFERENCE BETWEEN DCGI AND CDSCO?

The Drugs Controller General of India is the director of the department within the Government of India's Central Drugs Standard Control Organization (CDSCO) that is responsible for approving licenses for prescribed categories of drugs in India, including blood and blood components, intravenous fluids, vaccinations, and sera whereas is an Indian National Regulatory Authority for pharma and medical device control to give permission for a clinical trial in India.

India's Drugs Controller General is accountable to the Ministry of Health and Family Welfare whereas CDSCO comes under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

The DCGI establishes the standards and consistency requirements for the manufacture, sale, import, and distribution of drugs in India.

DCGI is the chief executive officer of India's drug regulation agency, the Central Drugs Standard Control Organization (CDSCO), which is responsible for ensuring the consistency of medicines and cosmetics distributed in the country, approving new products, and overseeing clinical trials.

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Author:

Vainy Kacharia
Mumbai
I am an eminent 3rd year BA LLB student of NMIMS University. I have an inclination in the field of legal studies since I like to stick to the path of obeying rules and justify the wrong-happenings with the right people . I have an engrossment to grow myself working as corporate lawyer .