Overview of CDSCO Registration

CDSCO creates drug regulations, maintains quality control over imported drugs, coordinates the activities of the State Drug Control Organisation, and facilitates expert advice on the consistency of the Drugs and Cosmetics Act's enforcement. Any organization involved in the manufacturing, import, or export of pharmaceuticals or cosmetics must get a CDSCO Registration using the online SUGAM portal.
The Drugs & Cosmetics Act, 1940 and Recommendations, 1945 have given federal and state regulators explicit responsibilities for the management of drugs & cosmetics. It intends to apply the Act's and its Rules' provisions consistently in order to safeguard patients' rights, safety, and well-being by restricting the use of medications and cosmetics. CDSCO is constantly working to improve openness, accountability, and standardisation in its services in order to guarantee the safety, efficacy, and quality of the medical products produced, imported, and distributed in the country.
According to the Drugs and Cosmetics Act, CDSCO is responsible for licensing new medications, carrying out clinical trials, creating drug standards, keeping an eye on the calibre of medications imported into the country, and coordinating state-level activities.
                                     CDSCO Registration

Objectives of CDSCO Registration

Some of the key objectives that are to be fulfilled through the CDSCO rules and regulations have been provided below:
Agile Checklist Obtaining the Test Licence and the Trader Dual Use No Objection Certificate

Agile Checklist To facilitate Blood Bank Registration and Cosmetics Registration
Agile Checklist Authorized sites with the abbreviation BA, which stands for bioavailability or bioequivalence
Agile Checklist Drug production as well as importation; registration of the ethics committee; formulation by the research and development organization
Agile Checklist No Objection Certificate for Export Related to Any Specific Zone
Agile Checklist Blood Product Registration for registering blood products

Who Can Apply for CDSCO License?

The applicants who may submit an online CDSCO Registration application in India are as follows:

Agile Checklist Foreign Manufacturer

Agile Checklist Indian Agent 

Agile Checklist Foreign manufacturing having a registered office in India

Licensing Authorities Under CDSCO

In order to give CDSCO registration online, there are two licensing authorities, which consist of:

SLA or State Licencing Authority:

The CDSCO Medical Device Manufacturer Registration that falls under Classes A, and B & Wholesale License for Medical equipment and IVD (in-vitro diagnostics) be issued by the SLA.

CLA or Central Licensing Authority:

For intravenous (IV and medical equipment that falls under Classes C and D, the Central Licencing Authorities (CLA) are in charge of issuing the CDSCO production or wholesale license. In addition, it is in charge of issuing cosmetic import permits for India. 

Different divisions of CDSCO

                                types of cdsco

Cosmetics Import Division: 

Cosmetics are defined by the Drugs & Cosmetics Act as any substance that is purposefully patted, sprayed, utilized, or used on the human body or any part of it for decorating, cleaning, shining, or changing the appearance. This involves any substance intended to be applied as an ingredient of cosmetics. According to the Act and its corresponding rules, the manufacturing of cosmetics is subject to examination and licensing by the State Licencing Authorities designated by the relevant State Governments, whereas the import of cosmetics is regulated by a system of registration by the authority designated by the Central Government.


It makes recommendations regarding how the Drugs and Cosmetics Act and Rules should be amended to address issues highlighted during the administration of the Act and its implementing rules. The conference is also organized by DCC-DTAB to ensure that the rules are checked effectively. DCC-DTAB also plans the meeting to ensure that the rules are followed to the letter.


Bioavailability, also known as bioavailability, is the quantity of medicine that reaches the intrinsic circulation and is thereafter capable of having an active effect on the organism. When two medications perform identically in all respects by giving in equal amounts, they are referred to be (bioequivalence) pharmaceuticals.

Drug Import and Registration: 

The import of medicines into India is governed by Chapter III of the Act and Part IV of the Rules. Drug Registration and import license requests are handled in accordance with the Drugs & Cosmetics Rules.

New Drugs: 

Before a drug product may be approved for manufacturing, import, or manufacture within the nation, it must demonstrate its safety and effectiveness for use in humans. As defined by Rule 122-E of the Drugs & Cosmetics Rules, new drugs are those that have not been used to a significant degree in India under the conditions suggested in their labelling and have not been recognized as secure & operational by the authority mentioned under Rule 21 of the relevant affirmation. This includes phytopharmaceutical drugs as well as new drugs that contain bulk drug substances.

Medical Devices and Diagnostics: 

The Act & Rules of Drugs & Cosmetics issued thereunder, which were passed in 1945, now exclusively govern notified Medical Devices in India as drugs. It includes Stapes, sutures, bandages, ligatures, blood, and its component collecting bags with/without anticoagulants are materials used during artificial insemination identification and incision dressing. Substances include insecticides, intrauterine devices, antiseptics, and prophylactic methods.


Medical items classified as biological are mostly derived from various natural sources, and the majority of biologicals are on the market today. Similarly, to some drugs, some biological substances are intended to treat illnesses and other medical issues. The prevention or diagnosis of illnesses also uses other biological products or objects.


These include human organs, cells, and tissues used in transplants, gene, and cellular therapies, tests to identify blood donors, and plant extracts that are used to treat and diagnose allergic reactions.

Documents for CDSCO Registration

Agile Checklist Cover Letter stating the purpose of applying for the registration

Agile Checklist Power of Attorney duly signed & notarized

Agile Checklist Details of the Manufacturer Entity

Agile Checklist Details of the Authorized Agent's

Agile Checklist Details of the products to be manufactured

Agile Checklist Undertaking & Declarations for No-Animal Testing

Agile Checklist No Heavy metal of Hexachlorophene content in the product

Agile Checklist Details of the components for manufacturing products

Agile Checklist Label of the product, if required

Agile Checklist List of ingredients along with the percentage 

Agile Checklist Testing Reports and testing procedures used for product 

Agile Checklist Wholesale Licence or Manufacturing Licence

Agile Checklist Free sale certificate duly notarized/apostille 

Agile Checklist Copy of ISO Certificate for quality manuals 

Agile Checklist Plant Master File

Agile Checklist Site Master File

Agile Checklist Process flow chart

Registration Process of CDSCO

                          how to apply for cdsco


The process of acquiring CDSCO registration is a completely online process that can be completed at the convenience of your home. Provided below is the  step-by-step process to obtain registration under the CDSCO portal:

Step 1: Signup and get Login credentials: 

Go to the CDSCO SUGAM PORTAL and select the Signup option. Then, the applicant needs to fill out every field necessary for the application, such as name, date of birth, address, nationality, email address, and password for accessing the account, and click submit. Following submission, the candidate will get login details at the email address they provided.

Step 2: Fill & Submit Form: 

After accessing the portal, the applicant shall go to his account and select the required form depending on the desired category of registration and the location for registration. Then fill out the information about the applicant organization and its authorized representatives along with the required pdf docs for registration. Revise the form once before submission to prevent errors, and submit the form.

Step 3: Verification & Forwarding of the Application: 

An email with an authentication link will be forwarded to the email address provided by the applicant.  After verification, the application shall be forwarded to the approval authority.

Step 4: Grant of CDSCO Registration: 

Post the verification, the applicant will further receive a confirmation for approval/rejection of the application through an email address after which the registration certificate could be downloaded through the portal.

Benefits of CDSCO Registration

There are numerous ways in which the CDSCO Registration has proven beneficial, a few of which are listed below:

Enhances Brand Reputation: 

CDSCO Registration in India enhances the brand's reputation and serves as a crucial means to attract customers for a business entity which enables registered individuals to increase their market share.

Legal Compliance With Regulatory Body: 

It is crucial for guaranteeing regulatory compliance It is possible to incur substantial fines and penalties for failing to register for CDSCO online even when you are required to.

Assurance of Safety & Quality: 

For the benefit of the customer's interest and protection, the CDSCO registration ensures the quality and safety of the medical equipment & products.

Allows Access to the Global Market: 

It allows you to tap the innovations and products in the global market and deliver the same in Indian markets.

Role of Agile Regulatory

Obtaining the CDSCO registration could be a bit challenging due to the complex process of the documents required and the processes involved. However, with the right amount of guidance and consultation, you could easily acquire CDSCO registration within the prescribed time. At Agile Regulatory we are committed to helping budding entrepreneurs by enabling them to acquire business licenses smoothly and carry on their business.


CDSCO Registration is a quality certification process in India for medical devices and cosmetic items, ensuring safety and quality compliance with established standards before launch into the Indian market.

A Medical Device Import License is granted by CDSCO to ensure compliance with safety and quality standards.

CDSCO issues a Medical Device Manufacturing License in India to allow a company to produce medical devices by ensuring compliance with quality standards.

A cosmetics import license is issued by CDSCO, which allowing the import of cosmetic products in India to esure the quality and safey.

Through the website of the relevant state's drug authority, drug license verification is possible online. To check the information about the drug license online, you must enter the specific drug license number.

The following users may obtain CDSCO registration through the SUGAM portal- Importer, Indian authorized Agents, A foreign company with an Indian subsidiary Business entities in India.

A drug company that operates in two or more states is required to obtain a drug license specifically for each of those states for which a location-specific drug license registration is required. Therefore, if the controlled substances are distributed or sold in more than one location, a separate application must be made to each state, except migrant vendors and a license will be issued for each location.

Unless it is revoked and suspended by the department, a CDSCO license is valid for five years.  By accessing the CDSCO SUGAM portal, inputting the license number, filling out the renewal request form, and submitting the necessary documentation together with the renewal cost, before its expiry. After which, the authority will issue a renewed license.

Yes, in order to imported, sell, stock, distribute medical device in India, an importer of must secure both an import license and a medical device wholesale license.

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