Permission to Manufacture - Stem Cell Form CT-21 in India

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Do you wish to obtain a manufacturing license to manufacture stem cells in India? CliniExperts, India’s leading regulatory expert, provides comprehensive regulatory solutions for biologicals like stem cells. Our seasoned experts help you submit completed Form CT-21 with due documentation. Our services meet the highest industry standards and ensure that you get your Form CT-23 quickly, hassle-free and without delay.

Permission to Manufacture - Stem Cell Form CT-21 – Overview

To obtain a test license to manufacture stem cells in India, applicants must submit Form CT-21 for grant of permission to import or manufacture stem cells (biologicals), under the guidelines by the Central Drugs Standard Control Organization (CDSCO). The approval of license is granted through Form CT-23. There is no specified validity of the test license from the date of issue, unless suspended or canceled by the CDSCO.

Who Can Apply?

The proposed guidelines are intended to assist manufacturers apply for test license to import or manufacture stem cells.

How To Apply?

The Applicant must follow the following process:

The manufacturer can apply in Hardcopy
The applicant must complete Form CT-21 to apply for permission.
Add the medication's pharmaceutical specifics, trial location details, and any other relevant information.
Add any relevant documents
Pay the application fee

Validity

There is no specified validity of the test license from the date of issue, unless suspended or canceled by the CDSCO.

Fee Involved

The fee for marketing Authorization for manufacturing and marketing of stem cells (Form CT-21 Application for Form CT-23) is Rs. 5,00,000.

Important Documents

Chemical and pharmaceutical information requirements are based on the International Submission requirements of Common Technical Document (CTD). The following documents should be included:-

1. Declarations and commitments by manufacturers and sponsors.
2. CMC data (which includes a master file for the medicine, a manufacturer's file for the drug product, a site master file, a certificate of analysis (COA), detailed manufacturing process, process validation reports and batch stability data for three batches).
3. Summary reports of approved preclinical research studies ( toxicity studies).
4. Reports and summaries of clinical investigations for phase I, II, and III trials.

Timeline to get from

working days from the date of receipt of its application

Essential Tips

Essentials of Permission to Manufacture - Stem Cell Form CT-21:-

Application Details: Manufacturer info and product description.
GMP Compliance: Adherence to manufacturing standards.
Quality Control: Safety, testing, and consistency measures.
Regulatory Compliance: Proof of legal approvals.
Risk Assessment: Identifying potential risks.
Personnel: Qualified staff and training records.
Ethical Compliance: Adherence to ethical and legal standards.

Expert Advise

According to our experts, manufactures must ensure the following to avoid any delays or cancellation of your license

Strict adherence to the Central Licensing Authority guidelines
Detailed manufacturing Process along with PV Reports and Stability study
All clinical trial study details should be mentioned

Frequently Asked Questions

What is an investigational new drug?

An "investigational new drug (IND)" refers to a new chemical or biological material that has not been approved for use as a drug in any country.

Is an ethics committee approval necessary to conduct a clinical trial?

Yes. Each site's clinical trial protocol and accompanying documents must be approved by the Ethics Committee and registered with the Central Licensing Authority before starting the study

How long does the registration process take?

The approval process for EPR registration typically takes around 45 working days

Which is the regulatory body for the Form CT-21?

The central licensing authority, CDSCO is the concerned authority for the approval of Form 46.