BIOLOGICALS REGULATORY SERVICES
Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparations that are prepared from living organisms and their products for human use. They include serums, vaccines, antigens, antitoxins, etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents. We provide all-round support in the manufacturing and import of biological products, vaccines, etc. in India, assisting our clients in the detailed filing of the dossier as required and do rigorous and careful verification so as to successfully file the application in one go.
NOC for form 29
Post Approval Changes
If the change modifies the product into a new drug (as per definition under rule 122E of the Drugs and Cosmetics Rules), the manufacturers have to apply for new drug authorization. In case of a change in manufacturing premises, additional product permission is required to concerned state licensing authorities, zonal offices or sub-zonal offices and Central Licensing Approval Authority (CLAA) as per requirements of Drug & Cosmetics Act and Rules.
Clinical Trial Permission (Phase 1, 2 & 3) & GCT
Biological products, like other drugs, are used for the treatment, prevention or cure of disease in humans. In contrast to chemically synthesized small relative molecular mass drugs, which have a well-defined structure and may be thoroughly characterized, biological products are generally derived from living material–human, animal, or microorganism– are complex in structure, and thus are usually not fully characterized.
Section 351 of the general public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of citizenry .” FDA regulations and policies have established that biological products include blood-derived products, vaccines, in vivo diagnostic allergenic products, immunoglobulin products, products containing cells or microorganisms, and most protein products. Biological products subject to the PHS Act also meet the definition of medicine under the Federal Food, Drug and Cosmetic Act (FDC Act). Note that hormones like insulin, glucagon, and human somatotropin are regulated as drugs under the FDC Act, not biological products under the PHS Act.
Issuance of a biologics license may be a determination that the merchandise , the manufacturing process, and therefore the manufacturing facilities meet applicable requirements to make sure the continued safety, purity and potency of the merchandise .
Among other things, safety and purity assessments must consider the storage and testing of cell substrates that are often wont to manufacture biologics. A potency assay is required thanks to the complexity and heterogeneity of biologics.
Because, in many cases, there’s limited ability to spot the identity of the clinically active components of a posh biological product, such products are often defined by their manufacturing processes. Changes within the manufacturing process, equipment or facilities could end in changes within the biological product itself and sometimes require additional clinical studies to demonstrate the product’s safety, identity, purity and potency. Traditional drug products usually contains pure chemical substances that are easily analyzed after manufacture. Since there’s a big difference in how biological products are made, the assembly is monitored by the agency from the first stages to form sure the ultimate product seems needless to say .