The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. It is the responsibility of CDSCO for approving new drugs and conduct of clinical trials in India under the Drugs and Cosmetics Act, 1940 (“Act”) and Drugs and Cosmetics Rules, 1945 (“Rules”). It also lays down standards for drugs and controls the quality of imported drugs and cosmetics in the country for bringing about uniformity in the enforcement of the Act and Rules.
CDSCO regulates the matters relating to drugs and cosmetics as provided under the Act and Rules for ensuring safety, rights and well being of the patients. It also regulates the efficiency and quality of a medical product manufactured, imported and distributed in the country.
The Act and Rules entrust various responsibilities to the Central and State Regulators for the regulation of drugs and cosmetics in India. CDSCO is the Central Drug Authority which discharges the functions assigned to the Central Government under the Act. It also provides expert advice to State Drug Control Organisations and co-ordinates their activities. CDSCO and the state regulators are jointly responsible for granting licenses for certain specialised categories of critical drugs such as vaccines, blood and blood products, IV fluids, and sera.
Any organisation that imports or manufacturers or exports drugs and cosmetics, conducts R & D activities concerning drugs, imports drugs for the purpose of testing, conducts Bioavailability (BA) and Bioequivalence (BE) studies in drugs for export purposes need to obtain registration under the CDSCO through its registration portal.
The following applicants can register on CDSCO online portal:
Note – A manufacturing unit cannot register directly on the portal. A corporate needs to create login credentials for the manufacturing unit through which they can log in on the portal.
CDSCO can grant registration for different purposes. The different purposes for which an applicant can register under the CDSCO portal are:
The registration under the CDSCO portal is entirely online. The steps for obtaining registration under the CDSCO portal are:
Step 1: Go to the CDSCO registration portal and click on the ‘Login/Sign Up’ button, which is on the top left-hand side of the portal.
Step 2: Next, click on the ‘Sign Up Here’ option to apply for registration. This will open the ‘Registration Purpose’ page. Select the ‘Registration Purpose’ from the options in the drop-down box and click on ‘Submit’.
Step 3: The ‘Applicant Registration’ page opens. Fill the applicant details form which contains the details such as the ‘Applicant Type’, ‘User Name’, ‘Password’, ‘Name’, ‘Mobile Number’ and ‘Email ID’. Upload the ‘ID Proof Details’ and ‘Undertaking’. Fill the ‘Registered Indian Address Form’ which contains details such as the ‘Organisation Name’, ‘Organisation Type’, ‘CIN’, ‘Address’, ‘Contact Number’ and upload the ‘Corporate Address Proof’. After entering all the details on the application, click on the ‘Submit’ button.
Step 4: A confirmation link will be sent to your registered email id to verify the registration. Click on the link sent to your email to activate your account on the CDSCO portal.
Step 5: Once the confirmation link is clicked, the application for registration will be sent to the concerned authority (CDSCO Officials) for approval.
After the application is approved, an email of the approval will be sent to your registered email id. In case the application is rejected, a rejection mail will be sent to your registered email id. Once, you receive the email of approval; your registration will be complete.
The documents required to be attached along with the registration application on the CDSCO portal are:
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