By Team Metacorp on 01 Aug 2022
What is CDSCO?
CDSCO stands for The Central Drugs Standard Control Organization, a National regulatory body that comes under the Directorate General of Health Services, Ministry of Health & Family Welfare, to regulate cosmetics, pharmaceuticals and medical devices. Its headquarters are located in FDA Bhawan on Kotla Road in New Delhi, and it maintains offices all over the Nation, including six zonal offices, seven sub-zonal offices, thirteen port offices, and seven laboratories.
The Central Drugs and Standard Control Organization (CDSCO) is allotted tasks by the Indian government with reviewing all medical devices, including implants and contraception. The CDSCO is a Central Authority of Drugs for carrying out duties under the Central Government's Drugs and Cosmetics Act.
The Medications and Cosmetics Act of 1940 outlines different duties for federal and state regulators concerning the regulation of drugs and cosmetics. It anticipates that the provisions of the Act and Rules, which were designed to ensure patient safety, rights, and wellbeing through the regulation of pharmaceuticals and cosmetics, will be applied consistently.
Why The Central Drugs Standard Control Organization ?
For the purpose of regulating medications and cosmetics, the Drugs and Cosmetics Act, 1940, and rules 1945 have given a variety of powers & responsibilities to the Central and state regulatory agencies. The CDSCO is constantly working to improve the consistency, accountability and transparency of in the field of health services.
Granting permits for specific specialized categories of crucial drugs, such as blood and blood products, intravenous fluids, vaccines, and sera, falls within the responsibility of the CDSCO.
Where are the CDSCO offices located?
There are 6 zonal offices of CDSCO listed below:
1. NORTH ZONE: Ghaziabad
2. South Zone: Chennai
3. East Zone: Kolkata
4. West Zone: Mumbai
5. Hyderabad Zone
6. Ahmedabad Zone
There are 7 sub-Zonal offices as well:
CDSCO also has 13 port/airport Offices. These are:
2. Chennai port
3. Chennai Airport
8. Kolkata Port
9. Kolkata Air Cargo
11. Mumbai Custom House
12. Mumbai Air Cargo
13. Mumbai Nhava Sheva
The Name of the 7 laboratories under CDSCO are:
1. CDL (Central drug laboratory), Kolkata
2. CDTL(Central drug testing laboratory), Mumbai
3. RDTL (Regional drug testing laboratory), Guwahati
4. RDTL (Regional drug testing laboratory), Chandigarh
5. CDL (central drug laboratory), Kasauli
6. CDTL, Hyderabad
7. CDTL, Chennai
What is the mission of CDSCO?
The mission of the Central Drugs Standard Control Organization is to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.
The organization is responsible for drug regulation in India. It issues final licenses for manufacturing, import, and export of drugs, recommends standards to be followed by manufacturers, and monitors compliance with these standards. It also maintains a database of approved drugs.
How does CDSCO work?
As a regulatory body, CDSCO is in charge of ensuring the security and caliber of all medical products produced, imported and distributed across the nation.
The role of CDSCO is comparable to those of the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, and the National Medical Products Administration (NMPA) of China.
The Central Drugs Standard Control Organization (CDSCO) comes under the purview of Directorate General of Health Services (DGHS) and includes the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC) and controls pharmaceuticals and medical devices within the Ministry of Health and Family Welfare .
According to the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945, the manufacture of cosmetics is governed by a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments, whereas the import of cosmetics is governed by a system of registration by the Licensing Authority appointed by the Central Government. The Drugs Controller General oversees the entry of cosmetics into India and issues the registration certificate.
The primary regulatory agency for drugs in India is the Central Drug Standards Control Organization (CDSCO), whose chief executive, the Drug Controller General of India (DCGI), is in charge of approving the production of medical devices. For medical device producers, sellers, and retailers, a CDSCO license is necessary.
The CDSCO is in charge of approving clinical trials, setting standards for drugs and new drugs, monitoring the quality of imported drugs into the nation, and coordinating the efforts of state drug control organizations. They carry out this function by offering professional guidance during the uniform application of the Drugs and Cosmetics Act.
Central Drugs Standard Control Organization has eight divisions:
4. New Drugs
6. Clinical Trials
7. Import & Registration
8. Medical Device & Diagnostics
What are the functions of CDSCO?
CDSCO'S functions include:
1. Clinical studies and the approval of novel medications
2. Registration and licensing for imports
3. Participation in the WHO GMP Certification Program.
4. Drug and cosmetics prohibition
5. Permission to test granted
6. Permission to examine a personal license
7. The central lab conducts drug testing.
8. Keeping an eye on negative medication responses.
9. The release of the Indian Pharmacopoeia.
10. Technical advice is provided.
Central Drugs Standard Control Organization's principles and mandate:
According to the about us page of CDSCO Portal, the CDSCO stakeholders work with openness, responsiveness, professionalism, impartiality, consistency, honesty, truthfulness in order to fulfill the mission and mandate of the CDSCO. That they are drafting rules, regulations, and guidance materials to address modern challenges while adhering to the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945. They assist in the uniform application of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945 requirements, serving as the Central license approving authority in accordance with the 1940 Drugs and Cosmetics Act and 1945 Rules. Collaboration with other international organizations of a similar nature and training for Indian regulatory staff are also some of their principles.
To sum up
The Central Drugs Standard Control Organization (CDSCO) is an autonomous body established under the Drugs and Cosmetics Act, of 1940. It is responsible for ensuring that drugs, cosmetics, and medical devices are manufactured in a proper manner, with adequate quality and safety features.
The organization plays an important role in controlling and monitoring medicines as well as other medical devices in order to protect public health. CDSCO also works towards ensuring that there is no adulteration of medicines or medical devices with other substances, thereby ensuring the highest level of quality control.
Through their efforts, CDSCO has made huge contributions toward ensuring that India gets international recognition as a pharmaceutical hub and becomes a global hub for quality medicine manufacturing.
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