CDSCO License Registration | Central Drugs Standard Control Organisation Certificate

CDSCO License Registration | Central Drugs Standard Control Organisation Certificate

Central Drugs Standard Control Organisation (CDSCO)

Why Choose Us

MetaCorp is an organization where we explore and nurture efficient procedure for CDSCO registration 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. Every day, we challenge ourselves to bring our absolute best to clients, the public and one another. If you're looking for consultancy for Central Drugs Standard Control Organization certificate, contact Metacorp for reasonable cost of CDSCO Registration, certification, documents, etc. We invest in our people and innovation to create an environment in which people are proud to associate and work with Meta Corp. 

  • We support and assist our clients with our updated knowledge and rich experience, including the introduction of cutting-edge technologies. 
  • We also have expertise in assessing environmental performance, legal compliance, CDSCO guidelines for ethics committee and state-of-the-art environmental analysis.
  • We focus on reducing our customer's compliance costs of Central Drugs Standard Control Organization registration for positive growth and profitability that helps earn our clients' trust.
  • MetaCorp offers all the certifications and licenses for all types of business activities, such as food business licensing, AYUSH licenses, drug licenses, CDSCO registration certificates, CDSCO medical device registration in India, and many more. 
  • We start the application process as soon as you give us the go-ahead to maintain a vigorous pace all along. 

Under the Directorate General of Health Services, Ministry of Women, Child & family welfare, Government of India, established the Central Drugs Standard Control Organisation (CDSCO), to perform the functions envisaged in The Drugs & Cosmetics Act, 1940. In order to ensure the safety, efficacy and quality of the medical products manufactured, imported and distributed in the Union Territory of India there has been the constant endeavour of the CDSCO to bring out a high level of transparency, accountability and uniformity in its services. To handle the specific tasks of regulating chemicals, drugs, pharmaceuticals and medical devices in India, 8 divisions were made by Central Drugs Standards Control Organisation (CDSCO). These are:

  • Bioavailability/Bioequivalence (BA/BE) studies
  • New Drugs Development and permissions
  • Import & Registration of Drugs and Cosmetics
  • Biological studies
  • Cosmetics regulation 
  • Medical Device & Diagnostics permissions
  • The Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC)
  • Clinical Trials

To perform any of the below-stated activities, a pharmaceutical company or a new drugs research & development company has to first apply to the Central Drugs Standard Control Organisation Certificate for its permission for the same. After the satisfaction of the CDSCO with the details of the applicant such as experience, previous work, knowledge, infrastructure, product registration guidelines CDSCO etc, the applicant is issued a certificate to perform the following activities. 

  • Medical Device & Diagnostics permissions
  • Import & Registration of Drugs and Cosmetics
  • Biological studies
  • Bioavailability/Bioequivalence (BA/BE) studies
  • New Drugs Development and permissions
  • Cosmetics regulation 
  • Clinical Trials

Under The Ministry of Health & Family Welfare, CDSCO, a nodal agency for monitoring of the existing drugs & pharmaceuticals, the introduction of new drugs & pharmaceuticals in the Indian market, individual/institute/business entity planning to import new drugs & formulations in India,  and to conduct Clinical trials/ bioavailability/bioequivalence studies, is required to get the CDSCO license to do so prior to the actual import of the substance.

To import drugs and substances which are not included in the Schedule X of the Drugs & Cosmetics Act, 1945, an individual or business entity is allowed if possesses a drugs manufacturing license or a drugs wholesale license.

Documents required for CDSCO registration:

1. Drugs wholesale license or drugs manufacturing license mentioning the products approved

2.  Valid RC duly attested by the Indian agent/ manufacturer.

3.  Permission from CDSCO under rule 122A, if a new Drug is to be imported

4. Original labels/ specimen labels attested by the importer for bulk drugs/ finished formulation as per Rule 96 & 97 of the Drugs & Cosmetics Act, 1945

Documents required

1. An Undertaking by the applicant detailing the required facilities such as equipment, instruments & personnel for the manufacturing of medical devices

2. List of equipment, and instruments used for manufacturing

3. List of qualified personnel employed by the applicant

4. Justification of submitted quantity to be manufactured by the applicant

5. Test protocols for testing finished medical devices/equipment

6. Quality Management Certificates from the war material supplier

7. Manufacturing license issued by the State Pollution Control Board

8. Site Layout / Site Plan

9. Certification of a site with a detailed raw component

10. DPR/Process Flow Chart

Documents Required for CDSCO Registration:

1. Covering Letter mentioning the purpose of application
2. Authorisation from the manufacturer (duly authenticated)
3. Filled in Part-I of Second Schedule D
4. List of Ingredients along with its percentage contents
5. Labels of proposed products
6. Specifications and testing methods
7. Pack insert
8. Manufacturing Licenses/undertaking for no provision of manufacturing license in the country.
9. Free Sale Certificate (duly authenticated)
10. Non Animal Testing Declaration
11. Declaration for Heavy Metal and Hexachlorophene content.

Firstly the applicant must visit a centralized system for applications, SUGAM portal of the CDSCO. Then, he/she is required to choose the kind of certification to apply for. Then the required documents are uploaded and the company details are entered into the system. Once the application is completely ready and the requisite fee for Central Drugs Standard Control Organisation registration is submitted, the application is forwarded to the concerned officer of the CDSCO, who performs a site inspection and issues clarifications. After the inspection queries are answered satisfactorily, the CDSCO certificate is issued then permission is granted for a particular activity and the conditions under which it can be performed. 

Introduction

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.

About Our Company: 

Meta Corp was established with the aspiration of becoming one of the most trusted accounting and consultancy organisations that provide CDSCO Registration Services in India, having 7+ years of Experience providing services that include: Business Registration, Factory Setup Licensing, General Registration/Certificates, Corporate Compliance/Filings, Environment Compliance. We aim to revolutionize our client's; accounting, taxation, and finance needs with a set of cutting-edge technologies and a congregation of experienced and renowned professionals with competence in a varied range of professional services. 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 business process, the business owners have to often follow tedious and long-winding Government procedure for Central Drugs Standard Control Organisation registration  which tend to burden and derail their focus. 

 

How We Do It

Enquiry
Enquiry

A customer may leave his/her contact number on the Contact Us form in our website, visit our office or call us on the IVR number given on the website

Dedicated Manager
Dedicated Manager

Once the new customer is logged in, a dedicated manager is allotted to provide a personalized service to our esteemed patrons.

Application Submission
Application Submission

Once the required documents are provided to us, we complete the documentation in no time and apply online/offline to the particular Authority.

Regular Update
Regular Update

At each stage and during the application processing, till the end to end delivery, we keep our clients posted on a regular basis.

Service Delivery
Service Delivery

It is our constant endeavor that our esteemed patrons do not have to wait for the final service delivery and with minimum cost.

Our Clients

Cafe VSB
Two Shef
Shahid Enterprises
Modicare
Meatigo
Malabar Coco
Iqbal And Sons
Genesasis
Fruits Of Earth
Elista
Abott
Arista
CRX
Dr Lal Chandani

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