Overview of CDSCO Registration

The Central Drugs Standard Control Organisation or popularly called CDSCO, is the National Regulatory Authority established under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare, Government of India. Under Drugs and Cosmetics Act 1940, CDSCO has been entrusted with the task of approval of drugs, conducting Clinical Trials, laying down standards for Drugs, control over the quality of imported drugs imported in the country, coordinating with the activities of the State Drug Control Organisations (SDCO) in order to bring uniformity in the enforcement of the Drugs and Cosmetics Act.

Along with the SDCOs, CDSCO is also responsible for granting licenses for certain specialised categories of critical Drugs such as I.V. Fluids, blood and blood products, Vaccine and Sera.

Organisations that are in the business of manufacturing, importing and export of drugs and cosmetics, Research and Development activities regarding drugs, importing drugs for their examination, conducting studies in Bioavailability (BA) and Bioequivalence (BE) in drugs for export purposes etc. have to obtain CDSCO Registration through its online portal.

Purpose of CDSCO Registration  

There are multiple purposes for which an applicant can register itself at the CDSCO portal. CDSCO can grant registration for the following purposes:

• Test license
• Blood Bank Registration
• Cosmetics Registration
• Blood Product Registration
• Dual Use NOC (Trader)
• Export NOC (Zone)
• Ethics Committee Registration
• BE or BA approved Sites
• Manufacture and Import of Drugs
• Formulation of Research and Development Organisation
• Sponsors (BA or BE and CT)

Who can apply for CDSCO Registration?

The following applicants have been permitted to apply for CDSCO Registration:

• Manufacturers
• Importers
• Indian Agents Corporates
• Foreign Enterprises holding Indian subsidiaries
• It must be noted that a manufacturing unit cannot directly register itself on the CDSCO portal. First, a corporate has to generate login credentials for the manufacturing unit and only then can it login into the CDSCO portal.

Different divisions of CDSCO Registration  

Following are the various divisions of CDSCO:

Cosmetics: according to the Drugs and Cosmetics Act, a cosmetic means any item that is desperately sprayed, rubbed, applied, introduced or otherwise applied to the human body or any part thereof to cleanse, beautify, alter the appearance or promote attractiveness and includes any article intended to be used as a component of cosmetic.

Under the Drugs and Cosmetics Act and applicable rules, the manufacturing of cosmetics is controlled by an examination and licensed by the State Licensing Authority assigned by the concerned State governments. Further, the import of cosmetics in India is regulated under a registration system by the authority appointed by the Central Government.

DCC-DTAB: This is a division that deals with convening and organising meetings of the ‘Drugs Technical Advisory Board (DTAB)’ and ‘Drugs Consultative Committee' for effective observing of rules. It gives suggestions on the matters raised in the administration of the Drugs and Cosmetics Act and Rules. 

BE/BA: Bioavailability refers to the relative amount of drug entering systemic circulation from an administered dosage and the rate at which the drug appears in the systemic circulation. Bioequivalence of a drug is achieved if its extent and rate of absorption are not significantly different from the reference product when administered at the same molar dose. 

Biologics: This division is concerned with biological products, which are medical products made from a variety of sources to treat diseases and prevent or diagnose diseases. These include vaccines, blood and blood products, human cells and tissues, cellular therapies, gene therapies etc.

Medical Devices and Diagnostics: According to the Drugs and Cosmetics Act and applicable rules, medical devices include substances used for in vitro diagnosis and surgical dressings, surgical staples, surgical bandages, ligatures, substances including mechanical contraceptives, surgical sutures, blood and blood component collection bag with or without anticoagulant, disinfectants, insecticides and other devices notified from time to time under Drugs and Cosmetics Act, 1940.

New Drugs: safety and efficacy of the new drug need to be demonstrated before the drug can be manufactured/ imported into India. New drugs include bulk drug substance or phytopharmaceutical drug that has not been used in India to a significant extent or suggested in the labelling and has not been recognised as effective and safe by the CDSCO.   

Import and Registration of Drugs: the import of drugs in India requires making an application for registration and obtaining an import license in consonance with the applicable Act and associated Rules.

Documents required for CDSCO Registration  

Following are the most important documents required for CDSCO Registration which are supposed to be uploaded along with the application:

• Identity Proof of applicant
• Address proof of the applicant
• Undertaking issued by the Government authority
• A copy of BA or BE Site registration approved by CDSCO in case of BA or BE approved Site registration
• Manufacturing license or wholesale license in case of manufacture or import of Blood Product registration or Drugs or Test License Registration

Procedure for CDSCO Registration

Registration and obtaining licenses from CDSCO is a completely online process. Following is the step-by-step procedure of obtaining CDSCO Registration from the CDSCO portal:

• To begin with, visit the CDSCO Registration portal and click on the login option.
• The next step involves clicking on the sign-up option in order to apply for registration. Once the page of ‘registration purpose opens’, select the ‘registration purpose’ from the options provided and submit the response.
• This leads the applicant to the ‘Applicant Registration’ page where details of the applicant is sought such as name of the applicant, address proof, email id, ‘Undertaking’ etc. Thereafter, the applicant is required to fill the ‘Registered Indian Address Form’ which seeks the details regarding the organisation on whose behalf the application is being filed such as ‘Organisation Name’, ‘CIN’, ‘Address’ etc. Once all the details have been filed, the applicant needs to submit the button.
• Having submitted the above mentioned responses, a confirmation link is sent to the registered email id for registration. The link has to be clicked in order to activate the account on the CDSCO portal.
• After the activation of the link, the application is sent to the CDSCO officials for their approval.

If the CDSCO officials approve your application, an email of approval is sent to your registered email id. The registration is completed when the applicant receives the email of approval. In case the application is rejected, a rejection mail to that effect will be sent to the applicant’s email id.

Enterslice can provide you overall advisory and assistance in obtaining CDSCO registration for various purposes. We also provide and hassle-free and seamless process of obtaining licenses provided by CDSCO and SDCOs. We are a team of highly skilled professionals. We offer legal consultancy services too.