The Central Drugs Standard Control Organization (CDSCO) is a department in India that monitors the quality of drugs and food items sold in the country. To get a CDSCO license you need to register your company with the Registrar of Companies (RoC). Once your company is registered, you can apply for an Establishment Code (EC) number with the CDSCO. You will be required to fill up an application form and submit it along with other documents like proof of address and PAN card.
After submitting the application and other documents, you will receive an acknowledgment from CDSCO. After this, you can carry on with your business as usual and start selling drugs or food products in India.
Who Can Register Under CDSCO?
The following are eligible to register under CDSCO:
Pharmaceutical manufacturers, importers, exporters, bulk drug manufacturers, drug intermediaries, medical device manufacturers, suppliers, Foreign Enterprises holding Indian subsidiaries, Indian Agents, etc.
Documents Required For Registration Under CDSCO
The following documents must be attached to the registration application on the CDSCO portal:
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- Address Proof Document
- ID Proof Document
- Undertaking issued by a Government Authority
- Copy of BA/BE Site Registration as approved by CDSCO in case of BA/BE Approved sites Registration
- Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration
Steps For Online Registration Under CDSCO?
- Open link”www.cdscoonline.gov.in” and then click on”Sign Up Here”
- After clicking on the “Sign Up Here” link for “Registration Purpose” on the portal, a new window will open
- After clicking on the drop-down, list for the Purpose of Registration
- For Import of drugs/Medical Devices/Test Licence
- For Cosmetic Registration
- Ethic Committee
- For Formulation R&D Organisation
- For BA/BE Approved Sites
- Blood Bank Registration
- For Export NOC
- For Test Licence
- Blood Product Registration
- For Import or manufacturer of Drugs
- Dual-use NOC
- Sponsors (BA/BE & CT)
- After selecting the Registration Purpose, the user has to submit by clicking on the “Submit”
- You will be shown the “Registration Form”
- Fill out the “Registration Form”. The username will be corporate email id
- User must upload necessary documents like ID Proof Details, Power Of Attorney, Corporate Address Proof, and Manufacturing License or Wholesale Licenses (Form 20B & Form 21B) Details and the user should keep these documents ready in PDF format before sign up process (For Import of drugs/Medical Devices/Test License).
- Please Select the checkbox to receive SMS alerts?
- After clicking on the “Submit” button, a confirmation link will be sent to the registered email id to verify the registration.
- Users can activate accounts through verification.
- When the user will click on the verification link sent to the user’s registered email id, the application will be sent for approval to the concerned authority(CDSCO Officials)
Purposes For Which CDSCO Registration
- To import pharmaceutical products
- Sell or distribute prescription drugs
- To manufacture pharmaceutical products
- CDSCO Registration can be obtained for the following purposes:
- To start a business, the applicant must be a citizen of India or an Indian company. The applicant needs to submit documents like a PAN card, Tax Clearance Certificate, etc.
- To import pharmaceutical products, the applicant must have a valid import license issued by the DGFT and NOC from the Central Government. After that, The applicant also needs to provide details of the product code, quantity, and brand name of the product that is being imported.
- To sell or distribute prescription drugs, the applicant must have a valid license from CDSCO and proof of registration with the GST Council. After that, The applicant also needs to provide details of the product code, quantity, and brand name of the product that is being sold/distributed.
- To manufacture pharmaceutical products, the applicant must have a valid manufacturing license from CDSCO and proof of registration with the GST Council. After that, The applicant also needs to provide details of the product code, quantity, and brand name of the product that is being manufactured.
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