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Permission for Clinical Trial (Phase 1, 2, 3) and GCT for Manufacturer

Permission for Clinical Trial (Phase 1, 2, 3) and GCT for Manufacturer

 

 

Introduction

Biologicals are large, complex substances produced using recombinant DNA technology. These include vaccines, blood products, stem cells or other DNA products. The Central Drugs Standard Control Organization (CDSCO) plays a vital role in regulating the manufacture and import of these biologicals in India. It not only ensures their safety, efficacy and quality, but also enforces the regulations on the companies that manufacture it.

Biologicals are the vital products for various health conditions such as arthritis, HIV, hepatitis and many more. However, the manufacture and approval of biologicals is often rejected due to incomplete paperwork due to the stringent regulations. Our role here at CliniExperts is to ensure that our clients are aware of these guidelines and accomplish them accurately so that their product is approved to go out in the market. Our well-trained staff applies both creativity and technology to create and expedite approvals.

 

 

Permission for Clinical Trials 

  1. The phase I clinical trial can be carried out in India or other countries depending on where the substance was discovered and should be submitted along with the application
    1. Phase I trial should be carried by trained personnel only
    2. The trial may be carried out at 1-2 centers
    3. Each dose should be given to at last 2 subjects to compare the results
  2. After permission is granted, Phase II and III trials can be carried out
    1. Phase II trial should be conducted in at least 10-12 subjects in each dose level
    2. The trial should be performed at 3-4 centers by personnel trained in therapeutics
  3. Phase III trials are required to be conducted in India before the consent to market the drug is conceded
    1. Phase III trial should be conducted in a minimum of 100 subjects
    2. The trial should be performed at 3-4 centers to verify the safety and efficacy of the drug
    3. But if the drug was discovered in India then it should be studied in at least 500 patients over 10-15 centers
  4. For new biologicals developed and marketed in India, the CDSCO requires the following documents:
    1. Form 44
    2. Treasury Challan of INR 50,000
    3. Source of bulk drugs and raw materials

 

 

Global Clinical Trial (GCT), CDSCO 

The application for the GCT is a series of 31 categories that needs to be provided regarding the clinical trial being performed. Concisely, the categories include:

  1. Investigational Medicinal Product
    1. Name of biological
    2. Summary of its chemical and pharmaceutical properties such as dosage forms and stability data such as melting point, boiling point and reactivity
    3. Summary of non-clinical studies such as animal studies and animal pharmacology
    4. Summary of clinical studies such as Phase I/II/III trials as to how, where and when the studies were performed
    5. Justifications for the proposed studies and how they will help the patients
  2. Summary of protocol
    1. Patient population
    2. Study design such as randomized controlled or double blind experiments
    3. Subject selection criteria on how to patients were selected for the study
    4. Assessment of safety and efficacy
    5. Total number of subjects in India or globally
    6. Consent forms to make sure that patients were treated ethically during the trial
    7. Standard of care for subjects for any side effects experienced by the patients
  3. Regulatory Status of the biological by the government of India
  4. Description of PI & Sites
    1. Includes names and addresses of the institutions where the trials were conducted

 

 

CliniExperts: Your One-Stop Shop

  1. We offer complete support for our customers to overcome the hurdles associated with the provisions of the Drugs and Cosmetics Act of 1940 & Rules 1945
  2. We are committed to get you permissions for clinical trials and GCT by the CDSCO
  3. We help our customers understand and fill out all the forms required for their procedures
  4. We cater to our customers from start through finish in a timely manner so that their biologicals can go out in the market and treat patients
  5. We strive for success and customer satisfaction which means we also aid in any additional safety reporting