Updated on July 06, 2024 06:08:53 PM
CDSCO is the Central Drugs Standard Control Organisation being one of the most powerful organizations of India. CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical & Medical Devices and its positioning with the Ministry of Health and Family Welfare. CDSCO is responsible for the approval of new drugs and granting of licenses under the Drugs and Cosmetics Rules, 1945.
Central Drugs Standard Control Organisation is the National Regulatory Authority (NRA) of India. CDSCO is constantly thriving upon to bring out the transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of medical products which are being manufactured, import and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, Laying down the standards for Drugs, Control over the quality of Imported drugs in the country and coordination activities of state drug control organizations. CDSCO is also responsible for grant of licenses of certain specialized categories of critical Drugs such as Blood and Blood Products, I.V Fluids, Vaccine and Sera.
There are 2 Licensing Authorities under Central Drugs Standard Control Organisation:
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Professional Utilities.
Following is the Key Document Checklist of CDSCO Registration for Pre-Screening of Application
Covering Letter:
It should highlight your purpose behind applying for CDSCO Registration.
Application Form:
TR6 Challan:
You need to provide this specifying the fees for CDSCO Registration.
Power of Attorney:
CDSCO Registration is a process of obtaining approval from the regulatory authority to ensure efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics to be consumed by the masses. CDSCO’s main Job and Objective is to safeguard the Public Health. Make sure to submit necessary documents for the verification process in order to receive a formal revert.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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CDSCO stands for Central Drugs Standard Control Organisation
CDSCO Registration is a process of obtaining approval from the concerned authority to ensure the quality of pharmaceuticals,medical devices and drugs.
‘SUGAM’ is the online registration process for CDSCO.
Covering Letter,application form,TR6 Challan, Power of attorney.
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