CDSCO Drugs Import License - Fees, Procedure, Documents

Updated on May 06, 2024 06:37:29 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.

Registration for CDSCO Medical Device

What are Drugs in CDSCO?

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.

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What is CDSCO registration For a Drug Import License?

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.

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Procedure for CDSCO Drugs Import License

Following steps can be noted to understand the procedure;

Step 1:CDSCO registration Portal

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.

Step 2:Filling up the details

Fill up the space with your required details. Fill the ‘Applicant Registration Form’ providing the necessary personal and organizational details.

Step 3:Submitting the documents

Complete the application process by submitting the required documents for the verification process for authorizing the Drug Import License.

Step 4:Call for Confirmation

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.

Step 5:Approval from the Authority

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.

Step 6:Issuance 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.

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Importance of CDSCO Drugs Import License

Importance of Drugs Import License can be seen as follows:

  • Improving a Company’s Reputation: Holding a CDSCO license serves as proof of completing the government policy and working under all the terms and conditions, which improves the reputation of the Company in the domain.
  • No Custom Stoppage: Having a CDSCO license shows the transparency of following all the government policies for the import activity of Drugs. In India, import, manufacture, sale, and distribution of drugs are regulated by DCGI under the Central Drugs Standard Control Organisation.
  • Safeguard the Public Health: The vision and mission of Central Drugs Standard Control Organisation is to protect, promote, safeguard, and enhance the public health by assuring the safety, efficacy, and quality of Drugs to be consumed by the masses.
Benefits for Bone Marrow Cell
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CDSCO Fee for Product

The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.

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Documents required For CDSCO Drugs Import License

Documents for Bone Marrow Cell

Important documents required in the process are as follows:

  • Covering Letter
  • Form 8 or 8-A
  • TR6 Challan
  • Testing Protocol
  • Product Label and Brochures
  • FSC Certificate in the Country of Origin
  • Notarized Agreement
  • Ethics Committee Approval
  • Original Power of Attorney
  • Plant Master File
  • Drug Master File
  • Copy of BA/BE site registration as approved by CDSCO in case of BA/BE approved sites registration
  • Manufacturing license or wholesale license (in the case of Import)
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Conclusion

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.

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Frequently Asked Questions

What is the full form of CDSCO?

Central Drugs Standard Control Organisation.

Who regulates Pharmaceuticals and Medical Devices under CDSCO?

DCGI,Drug Controller General of India regulates Pharmaceuticals and Medical Devices under CDSCO.

What documents are needed for the process of acquiring a CDSCO license for Drug Import?

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.

How to start the CDSCO online registration Process?

The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.

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