WHAT IS CDSCO?
In India, CDSCO is responsible to give its approval for all the new drugs and carry out clinical trials under the Drugs and Cosmetics Act, 1940 (“Act”) and under Drugs and Cosmetics Rules, 1945 (“Rules”). Furthermore, it provides standards for the drugs in market and controls & manages the quality of the imported cosmetics and drugs in the country with the purpose to bring more uniformity in the implementation of the Rules and Act.
The main objective of regulating the matters concerning drugs and cosmetics is to ensure safety, well being and health of the patients. It also controls the quality and efficiency of these medical product manufactured, distributed and imported in the country.
WHO CAN Obtain CDSCO Registration?
The given below are the applicants who can apply for CDSCO Certification Online:
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
WHAT ARE THE PURPOSES FOR OBTAINING CDSCO REGISTRATION?
The different purposes for which CDSCO is granted to any applicant who can register under the portal are
- Manufacture or Import of drugs
- Registration of Cosmetics
- Test License
- Export NOC (Zone)
- Registration of Ethics Committee
- Formulation of R&D Organization
- Registration of Blood Bank
- Registration of Blood Product
- Dual Use Non Objection Certificate (Trader)
- BA or BE Approved Sites
- Sponsors for BA or BE and CT
STEPS FOR ONLINE CDSCO REGISTRATION
- Step 1: Open the CDSCO registration portal and click on ‘Login or Sign Up’ button on the portal.
- Step 2:Next, for registration click on the ‘Sign Up Here’ option. Select the ‘Registration Purpose’ from the given options in drop-down box and click on Submit.
- Step 3:This opens the ‘Applicant Registration’ page wherein the applicant details shall be filled such as the ‘Applicant Type’, ‘Name’, ‘User Name’, ‘Password’, ‘Email ID’ and ‘Mobile Number’. The details of ‘ID Proof’ and ‘Undertaking’ shall be uploaded. The ‘Registered Indian Address Form’ which contains particulars such as the ‘Organisation Name, Type’, ‘CIN’, ‘Address’, ‘Number’ and the ‘Corporate Address Proof’ shall be uploaded by clicking on the ‘Submit’ button.
- Step 4: A confirmation link is sent to the registered email id for verifying the registration. The link sent to on the email must be clicked to activate the account on CDSCO portal.
- Step 5: Then the application for registration is sent to the CDSCO Officials for approval.
If the application is approved, an email of the same is sent to the registered email id which shall confirm the registration.
In any case, if the application is rejected, then a rejection mail is sent to the registered email id.
WHAT ARE THE DOCUMENTS REQUIRED FOR CDSCO Certification?
- ID Proof
- Government Authority issued Undertaking
- Document of the Address Proof
- In case of BA or BE-approved sites registration, Copy of the same as permitted by CDSCO
- In case of the Manufacture or Import of Drugs or Blood Product Registration or the registration of a Test license - Manufacturing License or Wholesale Licenses of the same.
How does ASC help?
- Technical Expert Assistance
- Complete online process of CDSCO Certification
- End-to-end solution in compliance with the process
- Track Application status and deliver the CDSCO certificate in the timeframe.
Faq's on CDSCO Registration
Rule 33 of the Drugs and Cosmetics Rules states that a license in Form-11 shall be granted for importing drugs in small quantities for the purpose of examination, analysis and testing
Yes. A CDSCO registration license is mandatory for running a blood bank. Running a blood bank without a license will constitute an offence under the Drugs and Cosmetics Act 1940 and the rules made thereunder.
Yes. Cosmetics are regulated by the Drugs and Cosmetics Act 1940. An application in Form 42 needs to be filed for registering imported cosmetics products with the Central Drugs Standards Control Organisation (CDSCO). Once the CDSCO registration is approved, a registration certificate shall be generated in Form 43.
CDSCO registration in India shall be valid for a period of 3 years from the date of its issue following which it shall be renewed.
The Drugs Controller General of India (DCGI) leads the Central Drugs Standard Control Organisation (CDSCO). DCGI functions within the CDSCO and functions as its CEO. CDSCO functions within the Ministry of Health and Family Welfare.