Who can apply for CDSCO License?

In India, manufacturers and importers need to obtain the Central Drug Standard Control Organisation (CDSCO). The drugs and Cosmetics Act of 1940 has laid down the regulations for the stakeholders to obtain these licenses. This license is provided to the manufacturer after the completion of a stringent process. The applicant has to apply for the CDSCO license through the SUGAM portal, the license shall be granted upon the successful submission of the documents and payment of the requisite fees.

Which entities can apply for CDSCO License?

There are a few entities that can apply for a CDSCO license:

• Indian Agents
• Importers
• Foreign Enterprises that have an Indian subsidiary and;
• Body corporate

What are the purposes for which a person can apply for the CDSCO license?

A person can apply for the CDSCO license for the following purposes:

• Import of drugs
• Manufacturing of the drugs
• Registration of Cosmetics^[1]
• NOC for export
• Test license
• Creation of an R&D organisation
• Registration of Blood bank
• Dual use NOC
• BA/BE site approval
• Sponsors (BA/BE and CT)

Documents Checklist before you apply for CDSCO License

The following documents must be prepared and ready before you apply for a CDSCO license

• A cover letter specifying the purpose for applying.
• Power of attorney- it must authorise the signatory to carry out the licensing process on your behalf. The documents should have the manufacturer’s complete details, complete details of the authorised agent, details of the product and the validity of the POA.
• The applicant must also have the following undertakings and Declarations:
  • A duly filled undertaking
  • Declaration stating that no animals were used for testing
  • A declaration that harmful contents such as Hexachlorophene are not present in the product
  • A complete application form
• Documents that list the details of the ingredients
• A copy of the product label showing the- product bane, details of the manufacturer, license of the manufacturer (if any), registration certificate number and other relevant information required as per the rules of the drugs and cosmetics act.
• CDSCO manufacturing license (if applicable)
• CDSCO Free sale certificate issued by the government or medical organisation of the country of origin.
• Licensing fee as applicable
• Documents for the testing report- specification of the cosmetic and the testing methods used

Procedure to apply for CDSCO License

The procedure to apply for the CDSCO portal be online:

• The applicant must log on to the SUGAM portal on the CDSCO portal. Then click on the ‘Login/Sign up button. This button will be available on the top left-hand side of the portal.
• Click on the Sign-up Here button later, then go to the apply option. Now the ‘registration purpose’ page shall appear. Select this option from the Registration purpose option and click on the submit button.
• The page will redirect to the applicant registration. Here the applicant needs to fill in the details such as Applicant Type, Name, Mobile number, User Name, Password and Email ID.
• The applicant must fill in the details such as the Registered Indian Address Form organisation name, organisation type, Address, CIN, and Contact number.
• The applicant must also upload the documents for Corporate Address proof
• Once all the details are furnished, then click on the Submit button.
• Later a confirmation link will be sent by CDSCO to your registered email id to complete the verification of the registration. When the applicant shall click on this email, then his account of the CDSCO portal.
• After the registration confirmation, the application shall be sent to the CDSCO authority for approval.
• If the application for CDSCO is rejected, then the mail for rejection shall be sent to the registered email id.
• If the application for the CDSCO license is approved, then a mail regarding the grant of the license shall be sent.

Validity for the CDSCO License

It will take about 6-9 months after the submission of the application and regulatory fees to obtain the CDSCO License. The registration shall be valid for a period of three years. If the application is due for renewal, the same must be applied for six months in advance of the expiry of the registration certificate.

Conclusion

The CDSCO license is mandatory for all the stakeholders such as importers, manufacturers and sellers to obtain if they want to sell cosmetics, drugs or medical devices in India. The CDSCO license will enable the authorities to determine that the product sold in India is of good quality and has complied with the regulations of the state. If anyone is found selling the products without proper registration or a CDSCO license, then they shall be liable to hefty fines and imprisonment.

Read our Article:What is the CDSCO Dual Use NOC