Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India
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- Indian System of Medicines
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Biologics
Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include
- vaccines
- blood and blood products for transfusion and/or manufacturing into other products
- allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots)
- human cells and tissues used for transplantation (for example, tendons, ligaments and bone)
- gene therapies
- cellular therapies
- tests to screen potential blood donors for infectious agents such as HIV
- Grant of NOC for issuance of Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of vaccines)
- Approval of Clinical Trial.
- Grant of Marketing Authorization.
- Grant of Registration Certificate, Import License and Test Licence in Form 11.
- Approval of Form 28-D Licensing (Vaccines) under CLAA Scheme.
- Issuance of Export NOC and Permission under Rule 37.
- Approval of Post Approval Changes.
- Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of r-DNA products).
- Approval of Clinical Trial.
- Grant of Marketing Authorization.
- Grant of Registration Certificate, Import License and Test Licence in Form 11.
- Approval of Form 28-D Licensing (r-DNA) under CLAA Scheme.
- Issuance of Export NOC and Permission under Rule 37.
- Approval of Post Approval Changes.
- Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of Stem cells and Cell based products).
- Approval of Clinical Trial.
- Grant of Marketing Authorization.
- Grant of Registration Certificate, Import License and Test Licence in Form 11.
- Grant of NOC in Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of Blood & Blood Products).
- Approval of Clinical Trial.
- Grant of Marketing Authorization.
- Grant of Registration Certificate, Import License and Test Licence in Form 11.
- Approval of Form 28-E Licensing (Blood Products) under CLAA Scheme.
- Grant of NOC for issuance of Form 29 (manufacture of drugs for the purpose of Examination, test or analysis of Veterinary vaccines)
- Grant of NOC for field trials.
- Grant of Marketing Authorization.
- Grant of Registration Certificate, Import License and Test Licence in Form 11.
- Approval of Form 28-D Licensing (Veterinary Vaccines) under CLAA Scheme.
- Issuance of Export NOC and Permission under Rule 37.
- Approval of Post Approval Changes.
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