Updated on July 06, 2024 06:08:52 PM
The Central Drugs Standard Control Organisation along with state regulators are responsible for granting licenses for Specialized Categories of Critical Drugs such as blood and blood products, I.V fluids, Vaccine and Sera. Drugs Import License is required to Import Drugs into India by following government regulations.
CDSCO is the National Regulatory Authority (NRA) of India. In India, Import, Manufacturing, Sale and Distribution of Drugs is regulated under Drugs & Cosmetics Act 1940 and Rules 1945.
Drugs are referred to the Medicines utilized for Internal or External use, such as Medicines for diagnosis, treatment, mitigation, prevention etc.
A Drug is a medicine or medication taken to cure any symptoms of an illness or medical condition. The use may also be as preventive medicine that has future benefits but it does not treat any existing or pre-existing diseases or symptoms.
CDSCO registration is an online procedure to be done on the official website of Central Drugs Standard Control Organisation at SUGAM portal. This is a required prior registration process to be completed for acquiring the license for Drug Import.
CDSCO registration is a process to take an approval from the official authority to ensure the efficiency and quality of Drugs. 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 of activities of state drug control organization by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Following steps can be noted to understand the procedure;
You need to visit the official website of CDSCO, then you have to apply on the registration portal which is “SUGAM”. Click on the ‘SIGN UP HERE’ option to apply for the registration.
Fill up the space with your required details. Fill the ‘Applicant Registration Form’ providing the necessary personal and organizational details.
Complete the application process by submitting the required documents for the verification process for authorizing the Drug Import License.
A Confirmation link will be sent to the registered email Id to verify the registration. To activate your account on the SUGAM portal, you need to click on the confirmation link.
Once the Confirmation link is clicked, the application for registration will be sent to the concerned authority, to the CDSCO officials for approval of the license.
After completing the whole procedure, your documents will undergo a verification process to see any secrecy. If the officer gets satisfied with the whole document procedure then the License for Drug Import will be authorized to you.
Importance of Drugs Import License can be seen as follows:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
CDSCO stands for Central Drugs Standard Control Organisation which is responsible for authorizing the Drug Import License to the Individuals who deals with it in the domain. Owning a CDSCO License gives official access to deal with import activity and have several Importance.
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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Central Drugs Standard Control Organisation.
DCGI,Drug Controller General of India regulates Pharmaceuticals and Medical Devices under CDSCO.
Identity proof of the applicant,address proof of the applicant,undertaking issued by the government authority,Copy of BA/BE (Bioavailability/Bioequivalence) approved sites registration.
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
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