Overview on CDSCO
CDSCO stands for Central drug standard control Organization; this body is regulated and comes under the Ministry of Health & Family Welfare, Government of India. The headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002. It has six zonal offices, four Sub-zonal offices, thirteen Port offices, and seven laboratories spread across the country. Drugs and cosmetics have entrusted numerous responsibilities to the central and state regulators to regulate drugs and cosmetics. It aims to implement the uniform application of the Acts and Rules concerned with patient safety, rights, and well-being by regulating pharmaceuticals and cosmetics. CDSCO ensures that its services are transparent, accountable, and consistent to assure the safety, efficacy, and quality of medical products made, imported, and distributed in the country. CDSCO is responsible for preserving patients' safety, rights, and well-being by enforcing the Act and Rules regarding pharmaceuticals and cosmetics. It also governs the effectiveness and quality of medical products produced, imported, and disseminated in the country.
What is SUGAM?
Sugam is the government's online e-governance system, which discharges numerous functions exercised by the CDSCO under the Drugs and cosmetic act 1940. Sugam is the online portal where applicants can apply for NOCs, licenses, registration certificates, and approvals. Sugam also provides the facility of online tracking of the applications submitted by the applicants to obtain the certificates above and documents. It shall also authorize CDSCO officials to process the applications online and generate MIS reports.
Who can register for CDSCO?
Given below are the applicants who can apply for the CDSCO registration?
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
The manufacturing unit cannot directly register itself on the online portal. Corporates need to create login credentials for the manufacturing unit.
Why is there a need to register in CDSCO?
The CDSCO has the authority to approve Registration for a variety of purposes. The following are the various purposes for which an applicant can register on the CDSCO portal:
- Licence to Test
- Registration with the Ethics Committee
- R&D Organization for Formulation
- Registration at a Blood Bank
- Registration of Blood Products
- NOC with Dual Purpose (Trader)
- Sites that BA/BE has approved
- BA/BE and CT sponsors
- Registration for cosmetics
- Import or manufacture drugs
- Export NOC
What are the documents required for the Registration?
The following documents must be attached to the registration application on the CDSCO portal:
- ID Proof Document
- Undertaking issued by the government
- Document of address proof
- In the case of BA/BE Site Registration, a copy of the address proof document as approved by CDSCO is required for Sites that have been approved Registration.
- Manufacturing licenses or wholesale licenses in the case of drug importation or manufacture/registration of blood products/Registration of test licenses.
Procedure for Online Registration
Step-1 Click the 'Login/Sign Up button on the top left-hand side of the CDSCO registration portal.
Step-2 Then, to apply for Registration, select the 'Sign up Here' option. This shall take you to the page titled "Registration Purpose." Click on 'Submit' after selecting 'Registration Purpose' from the drop-down box.
Step-3 The page titled 'Applicant Registration' appears. Fill out the application information form, including information like 'Applicant Type,' 'User Name,' 'Password,' 'Name,' 'Mobile Number,' and 'Email ID.' 'ID Proof Details' and 'Undertaking' must be uploaded. Fill out the 'Registered Indian Address Form,' which includes information such as the 'Organisation Name,' 'Organisation Type,' 'CIN,' 'Address,' and 'Contact Number,' as well as uploading the 'Corporate Address Proof.' After you've filled out all of the needed information on the application, click the 'Submit button.
Step-4 To confirm your registration, an email with a confirmation link will be sent to your registered email address. To activate your account on the CDSCO site, click the link supplied to your email.
Step-5 The application for Registration will be sent to the competent authorities (CDSCO Officials) for approval after the confirmation link is clicked. An email with the approval will be sent to your registered email address once the application has been approved. If your application is rejected, you shall receive a rejection email to your registered email address. Your registration process will be complete once you receive the approval email.
How can we assist you?
- Corpbiz assures you full assistance
- Full assistance in documentation
- Help you in applying for NOC, Licenses and Registration certificate
- End-to end processing
- Proper Follow up with the government authorities
Frequently Asked Questions
CDSCO stands for Central drug standard control Organization is regulated and comes under the health and family welfare ministry. Primary functions are regulation and control over drug importation, approval of new pharmaceuticals and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of specific licenses as the Central License Approving Authority.
The Drugs Controller General (India), Central Drugs Standard Control Organization, receives registration/import licenses for new drugs.
Form 11 or a Test License is provided to examine, test, or analyze limited quantities of pharmaceuticals or medical devices that are otherwise prohibited under section 10 of the Drugs and Cosmetics Act and Rules, 1945.
Applicants must apply to CDSCO headquarters for issuance of a NOC to acquire Form 29 with the papers listed in the checklist and an undertaking and submit an application for obtaining Form 29 in hard copy and soft copy through an email to the respective CDSCO zonal office.
The central authorities are in charge of approving new pharmaceuticals, conducting clinical trials in the country, establishing drug standards, inspecting imported drugs for quality, coordinating the actions of State Drug Control Organizations, and offering expert guidance to achieve uniformity.
If there is any change in the intended study for which this Directorate has already granted permission to conduct BA/BE Study in Form CT-07 and Licence to Import New Drugs/Investigative New Drug in Form CT-17, the applicant shall submit for revision for approval for Major Changes.