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CDSCO Registration Certificate

CDSCO Registration Certificate

Get CDSCO registration and certification for your pharmaceuticals & Medical Device business. Metacorp guarantees you 100 percent certificate delivery. Contact us for on-time and reliable certificate delivery. 

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CDSCO Registration certificate

The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare. The CDSCO is responsible for the regulation & approval of New Drugs and Clinical Trials in the country under the Drugs & Cosmetics Rules, 1945 and the Drugs & Cosmetics Act, 1940. The CDSCO laid down the standards for Drugs, controls the imported Drugs’ quality, coordinated the activities of SDCO (State Drug Control Organisation) and facilitates expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act. Any organisation that manufactures or imports or exports drugs & cosmetics conducts Research & Development activities regarding drugs and imports drugs for the purpose of examining conducts BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export purposes needs to obtain CDSCO Registration through its online registration portal. 

Documents Required for Online CDSCO Registration

Following are some documents required for Central Drugs Standard Control Organisation registration during apply online for CDSCO Registration Process:

  1. Identity proof of the applicant
  2. Address proof of the applicant
  3. Upload the copy of BE or BA Site Registrations as issued by CDSCO in case of BE or BA approved sites Registration
  4. Undertaking allotted by a Government Authority
  5. Wholesale License or Manufacturing License in the case of Manufacture or Import of Blood Product registration or Drugs or Test License Registration

Procedure for Online CDSCO Registration

The CDSCO Registration is completely online. Following are the steps by steps procedures for apply online for Central Drugs Standard Control Organisation under the online portal of CDSCO:

  • First, you have to visit the Central Drugs Standard Control Organisation Registration portal.
  • Then you have to apply for CDSCO Online Registration, you have to go to the Registration Purpose page and click on submit.
  • Once you open the Application Registration page, fill in all the vital information as provided in the application form, such as:
  1. Applicant Type
  2. Name
  3. User Name
  4. Password
  5. Mobile Number
  6. Email ID

Fill out the Registered Indian Address Form, which contains details like:

  1. Organisation Name and Type
  2. CIN
  3. Contact Number
  4. Address
  5. Upload the Corporate Address Proof
  • Once you submit the application form correctly, you will get a confirmation link to your registered email id to verify the registration. Then you have to click on the link to activate your account on the CDSCO portal.
  • Once the confirmation link is clicked, then the CDSCO Registration application be sent to the concerned authority for approval.
  • Once the application for CDSCO Registration is approved with Registration fee for CDSCO, an approval email will be sent to your registered email id. In case the application is rejected, an email for rejection will be sent to your email id. Once you get the approval mail, your CDSCO Registration Process will be completed.

Role of Central Drugs Standard Control Organisation (CDSCO) Certification 

Under the Drug & Cosmetics Act, the arrangement of manufacturer, sale & distribution of Drugs is firstly the priority of State Authorities while Central Authorities are only responsible for giving permission to new drugs, clinical experiments in the country, providing standards for drugs, to check the quality of the imported drugs, coordinating with the State Authorities. CDSCO also gives permission to specified categories of drugs such as blood products, I.V. Fluids, and vaccines. Here is the following list of CDSCO Registration Certifications for import of drugs in India: 

  1. Amendment to D & C Rules
  2. Giving permits to new Drugs and clinical trials
  3. Testing of New Drugs 
  4. Import Registration & Licensing 
  5. Grant of test license, Personal License, NOCs for export 
  6. Banning of Drugs & Cosmetics 
  7. License approval of Blood banks, LVP’S, Vaccine, r-DNA Products and some medical devices.

 

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Tags : CDSCO License Registration | CDSCO Certificate Registration

Frequently Asked Questions:

What is the Central Drugs Standard Control Organization (CDSCO)?
What is a CDSCO certificate?
CDSCO permission to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study
CDSCO NOC to Import Drugs(Excluding those specified in schedule X) to the Drugs and Cosmetics rules, 1945
CDSCO permission for manufacturing of medical devices
CDSCO permission for Import of Cosmetics
What is the procedure for online application to CDSCO?
Free initial consultation on legal aspects of daily business activity
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End to End Certification Services – How we do it
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Enquiry by the Applicant
Once any prospect makes a query for any service, a dedicated service manager is allotted to every query.This ensures personalized and focused service for each prospect.
02
Document Collection
We collect required documents from the customer, prepare other declarations/affidavits and submit online/offline application along with Govt. fee submission
03
Certificate issuance
Once the Govt. fee is submitted, we continuously monitor it and provide regular updates to the applicant. We also submit any document deficiency raised by the Authority.
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Metacorp is an organization where we explore and nurture efficient processes to solve legal and compliance issues of new and established businesses. We have a team of 100+ professionals with the sole aim to create a compliance-ready and hassle-free environment for businesses. To start a new business or to run an operational businesses process, the business owners have to often follow tedious and long-winding Government procedures which tend to burden and derail their focus. Our aim is to develop a system in which our compliance expertise work in sync with the situational awareness of the business owners for the perpetual improvement in the efficiency and effectiveness of their business processes.


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