CDSCO Guidelines For Product Registration

The CDSCO Guidelines for Product Registration have been designed to provide a uniform approach and standardisation of the procedure involved in product registration by the various registrars. The following are the main points that are covered in these guidelines:

1. A comprehensive definition of ‘product’, covers both finished goods and semi-finished products.
2. The role of a registrar in product registration, including what makes up a completed application form.
3. The requirements for submission of an application for product registration together with supporting documents, such as sample certificates and other relevant documents.
4. Guidelines on submission of applications for detailed classification (D&C), standard specifications (SS) and technical specification (TS).

The CDSCO has been given specific powers under this act which include:

1. Ensuring that all drugs and cosmetics sold in India meet international standards;
2. Monitoring the sale of drugs & cosmetics in India;
3. Monitoring manufacture of drugs & cosmetics;
4. Enforcing compliance with laws against sale of counterfeit drugs & cosmetics;
5. Enforcing compliance with other laws governing manufacture and sale of drugs & cosmetics

Requirements for Common Submission Format for Registration of bulk drug(s) and finished formulation(s) in India

1. Covering Letter–
2. An Authorization letter
3. A duly filled Form 40 as per the proforma prescribed in the Drugs & Cosmetics Rules, signed & stamped by the (Local Authorized Agent/manufacturer)
4. TR 6 Challan
5. Power of Attorney
6. A duly attested/notarized (in India) and valid copy of Wholesale License for sale or distribution of drugs under Drugs and Cosmetics

Steps For Online Registration

1. Step 1: Go to the CDSCO registration portal and select the “Login/Sign Up” option in the top left corner of the page as your first step.
2. Step 2: Next, select “Sign Up Here” to submit an application for registration. The “Registration Purpose” page will then be shown. Click “Submit” after selecting “Registration Purpose” from the list of choices in the drop-down box.
3. Step 3: The page marked “Applicant Registration” loads. Fill out the application form, which asks for information on the “Applicant Type,” “User Name,” “Password,” “Name,” “Mobile Number,” and “Email ID.” Upload the undertaking and the “ID Proof Details.” and Fill out the “Registered Indian Address Form” (which includes the “Organisation Name,” “Organisation Type,” “CIN,” “Address,” “Contact Number,” and “Corporate Address Proof”) and submit it. Click the “Submit” button after filling out the application completely.
4. Step 5: To complete the registration, a confirmation link will be issued to your provided email address. To activate your account on the CDSCO portal, click the link that was supplied to your email address.
5. Step 4: The registration application will be sent to the relevant authorities (CDSCO Officials) for approval when You click on confirmation link

Documents Required To Register With CDSCO

The following documents must be submitted with the registration application on the CDSCO portal:

1. Identification Document
2. A commitment issued by a government body
3. Address Verification Papers
4. A copy of the BA/BE Site Registration that CDSCO has approved, if
5. Sites approved by BA/BE Registration
6. Licenses for manufacturing or distribution in the case of import or
7. Registration for the production of drugs, blood products, and test licences

Read Also:  Top 5 Innovative FinTech App Ideas for Healthcare Business in 2022