807 627 2381
Metacorp
/
General Registration
/
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. 

Get Started
Get Started
Call Now   807 627 2381
Contact Now
Arrange a Callback
Contact Us

CDSCO License Registration | Central Drugs Standard Control Organisation 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.

 

Get a Callback
Contact Us

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
To discuss a project
Project Discussion
Project Callback
End to End Certification Services – How we do it
01
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.
Our few valuable clients
partnerLogo
partnerLogo
partnerLogo
partnerLogo
partnerLogo
partnerLogo
partnerLogo
partnerLogo
partnerLogo
partnerLogo
View All Clients
All Clients
Why Choose Metacorp
10 + years
Pollution Board Consulting
1000 +
CTE CTO Certificates issued
180+
EIA-EC Certificates issued
5+ years
CDSCO Consulting for medical device import
700 +
CGWA / HWRA NOCs
800 +
CPCB EPR certificates issued for Plastic, battery, electronics
1000 +
MOEF NOCs for HW import
300 +
DGFT Licenses for import of restricted items
Why Metacorp

About Metacorp

We are the pioneers in offering environmental consulting services to our patrons, giving us the first mover advantage & keeping us ahead of our competitors.

Very experienced in filing, monitoring & issuance of CTE, CTO, Waste Management Authorization from State Pollution Control Boards

  • Very strong and experienced sales & documentation teams.
  • Very experienced liaison managers with offices in multiple locations across India
  • Extensive experience in end to end project certifications management
  • An acute understanding of the real challenges faced by our patrons and innovative solutions for compliance ready organizations.
  • Business ready for onboarding multiple customers with varied certification requirements
  • 100+ existing channel partners ready to contribute for finding efficient environment certifications for our esteemed patrons.
Whatsapp Metacorp

Metacorp ITES Private Limited

We are specializing in Business registration, Factory Setup Licensing, General Registration, Company Registration, Corporate Compliance And Legal Advisory services in the India.

Company

Services

Company Policies

Business Registration

Waste Management Authorization

CPCB EPR Certification

Corporate Compliance

Environment Compliance

Factory Setup Licensing

General Registration

Call Us

Email Us



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.


Copyright © 2024 Metacorp ITES Pvt. Ltd. All rights reserved.