CDSCO Approval For Drugs and Cosmetics

CDSCO is a premier government institution established under the Drug and Cosmetic Act 1948. It enforces rules to ensure the safety and efficacy of healthcare products such as drugs, medical devices, and cosmetics. In a nutshell, it governs the entire lifecycle of these products. Presently, this institute issues a variety of approvals and licenses, including cosmetic production approval, test licenses, label compliance, medical device registration, etc. Let’s know more about the CDSCO approval and discover what type of paperwork and procedures apply to the same.

What verticals does CDSCO cover?

Whether you are planning to test a new drug, manufacture a fresh lineup of cosmetics, or avail loan license for drug production, you will need CDSCO’s approval without fail. Here’s what CDSCO covers in general.

Drug

Among all the verticals that CDSCO regulates, the drug division sits at the top owing to its vast applicability and ever-growing health concerns. In brief, it is a prominent area of concern for the authority. From issuing new drug approval to enforcing new standards, CDCSO ensures end-to-end regulation and provisioning of this vertical. It even governs clinical trials, quality control, product marketing, state authority’s functioning, etc.

Medical devices

CDSCO ensures end-to-end legal fencing of these products, be it a matter of registration or sale. It has empowered the DCGI to oversee the entire process cycle.

Cosmetics

CDSCO regulates the production of domestic cosmetics products via its state-level authorities. On the other hand, the central authority governs the importation of cosmetics in India

Biologicals

Biological products fall under the natural product category, which originates from different sources, including human and animal kingdoms. There is a widespread demand for these products, and hence, they must undergo rigorous tests at every step of development. CDCSO regulates these products in their entirety, whether it comes to development, sale, import, or testing.

List of CDSCO Approvals and Registrations

st License for Importer Test License to import Medical Devices (Required Application- MD 16, 17)

• Authorized agent support - Biological


• Test License concerning Manufacture Medical Devices (Required Application- MD 12, 13)


• Post Approval Changes - Drug


• SUGAM Registration- MD/ IVD


• Product Compliance


• Free Sale Certificate from CDSCO for regulated In-Vitro Diagnostics


• New Medical equipment approval (Required Application- MD 26, 27)


• Label Compliance - IVD


• Free Sale Certificate from CDSCO for regulated Medical Devices


• Authorized agent support - Cosmetic


• approval to ship In Vitro Diagnostics (Required Application- MD 16, 17)


• ermission concerning Loan License to Manufacture Class C & D In-Vitro Diagnostics (Required Application- MD 8, 10)


• License to import Medical Devices (Required Application- MD 16, 17)


• Import License of Predicate In Vitro Diagnostics (Required Application MD 14, 15)


• Label Compliance - Medical Device


• Test License for Manufacturer


• Post Approval Changes - Cosmetic


• Import license concerning predicate Medical Device (Required Application- MD 14, 15)


• Authorized Agent Support


• Test License for Importer


• Approval to produce Class C & D Medical Devices (Required Application- MD 7, 9)


• Permission concerning Loan License for producing Class C & D In-Vitro Diagnostics (Required Application MD 8, 10)


• Permission to Manufacture Class A & B In Vitro Diagnostics (Required Application- MD 3, 5)


• Test License for producing In Vitro Diagnostics (Required Application- MD 12, 13)


• Authorized Agent Support - Medical Device


• Approval to undertake Clinical Performance Evaluation (Required Application- MD 24, 25)


• Authentication concerning Loan License for producing Class C & D In-Vitro Diagnostics (Required Application MD 8, 10)


• Permission for Loan License to Manufacture Class A & B In-Vitro Diagnostics (Required Application- MD 4, 6)


• Permission for new cosmetic


• Permission for producing Class C & D In- Vitro Diagnostics(Required Application- MD 7, 9)


• Approval for Loan License to produce Class C & D Medical equipment (Required Application- MD 8, 10)


• Test License for producing In Vitro Diagnostics (Required Application- MD 12, 13)


• Import License (Required Application- 10)


• Post Approval Change- Major/ Minor


• Approval letter issued by CDSCO for In-Vitro Diagnostics

A Guide to Secure Cosmetic License in India

The Ninth Schedule of the Cosmetic Rules 2020 constituents the legal framework for cosmetic production, quality, and import in India.

Applicant, be it a manufacturer or authorized agent, can apply for import approval from the central authority via Form COS-1 on the Sugum Portal.

Similarly, applicants seeking to manufacture cosmetics in India can head to the state licensing authority and apply via a prescribed application form.

List of Paperwork required for Cosmetics Registration

The following list reflects the common documentation required to apply for cosmetic registration in India:

1. List of Ingredients and their percentage contents


2. Labels of proposed products


3. Product specification and testing method for cosmetics


4. Test reports, including heavy metal and microbiological testing


5. Manufacturing license/registration/marketing authorization


6. Certificate of analysis


7. Authorization from the manufacturer


8. Free sale certificate and other relevant documents (if any)

A Guide to Secure CDSCO Approval for Cosmetic Production

An overseas drug producer seeking to carve a market for themselves in India must obtain a cosmetic importer license. Here’s how you can apply for the same:

Step 1: Application & Documents Submission

The first step is to file the online application on the CDSCO-led web portal - Sugam. Once you hop onto this portal, create a fresh account and note down the login credentials. Next, use the same credentials to get access to the application form. Fill out the form with valid details and attach the paperwork as mentioned above. Double-check everything before uploading.

Step 2: Fee Submission

Once you submit the form, head to the payment gateway for the fee submission, the application fee shall vary based on the category you choose and the number of production sites.

Step 3: Application scrutiny

The submitted paperwork shall be routed to the Designated Officer, who will vet the same for accuracy and Compliance. If the inspector finds no loophole in the documents, he/she prompts the licensing authority to grant the approval. Likewise, if the inspector comes across some inaccuracy or non-conformity, the same shall be notified to the application via the Sugam portal.

Step 4: On-site Inspection

The on-site shall be performed by the respective State licensing authority. The officials will perform a thorough vetting of QMS (Quality Management System), standards being used, staff competency, provisioning paperwork, etc.

Step 5: Grant of license

The successful vetting shall lead to the grant of approval in the form of certification. The application, after securing the production approval, shall become eligible to kickstart the cosmetic manufactured as per the CDSCO’s guidelines.

Adviso: Say no to rigorous Compliance with our services

Securing CDSCO approval is vital for the production and import of cosmetics in India. The process can be perplexing and time-consuming, requiring various approvals from the central and state authorities. However, licensing firms like Adviso can help you navigate this process with zero hassle.

By providing end-to-end support, Adviso ensures that clients get their licenses and registrations without any hassle. So, if you're planning to manufacture or import drugs or cosmetics in India, reach out to Advisor today for a hassle-free experience.