Preparation of Documents for New Drug Application (NDA) in India: When any pharmaceutical company in India wants to manufacture or import a new. The phytopharmaceutical drug has to apply to seek permission from the licensing authority, Drug Controller General of India (DCGI) by submitting the data as given in Schedule Y of Drugs and Cosmetics, Act 1940 and Rules 1945. To prove its efficacy and safety in the Indian population, it has to conduct clinical trials by the guidelines specified in Schedule Y and submit the report of such clinical trials in the specified format to FDA.
FDA Botanical Drug Development Guidance describes appropriate development plans for botanical drugs to be submitted in New Drug Applications (NDA) and specific recommendations on submitting Investigational New Drug applications (IND). The term botanical means products that include; plant materials, algae, macroscopic fungi, and combinations thereof. FDA guidance recommends that IND must contain sufficient information to demonstrate that the drug is safe for testing in humans and that the clinical protocol is properly designed for its intended objectives.
In addition to general regulatory requirements for an NDA, non-clinical pharmacology/toxicology studies, clinical evidence of efficacy and safety for botanical drugs, there are special requirements to ensure the safety and quality of botanicals as follows:
- Description of product and documentation of prior human experience.
- Description of botanical raw materials used and known active constituents or chemical constituents.
- Botanical raw materials.
- Botanical drug substance and drug product: Identity, chemical characterization, manufacturing processes, biological assay, specifications, stability, current good manufacturing practices, and environmental assessment.
Evidence to ensure therapeutic consistency:
- Botanical raw material control test
- Quality control by chemical test(s) and manufacturing control.
- Biological assay
- Clinical data: Dose-response data and multiple batch clinical data.
In India, ASU drugs have been under the purview of the Department of AYUSH and regulatory requirements for phytopharmaceuticals are under the purview of the Central Drugs Standards Control Organization (CDSCO). This gazette notification defines regulatory provisions for phytopharmaceuticals and regulatory submission requirements for scientific data on quality, safety, and efficacy to evaluate and permit marketing for an herbal drug.
In Schedule Y, the newly added Appendix I describes data to be submitted along with the application to conduct a clinical trial or import or manufacture of a phytopharmaceutical drug in the country. The regulatory requirements for NDA for the phytopharmaceutical drug include; standard requirements for a new drug-safety and pharmacological information, human studies, and confirmatory clinical trials. For phytopharmaceutical drugs, there is a lot of stress on:
- Available information on the plant, formulation, and route of administration, dosages, and therapeutic class for which it is indicated and the claims to be made for the phytopharmaceutical and supportive information from published literature on safety and efficacy and human or clinical pharmacological information.
- Data generated on:
- Identification, authentication, and source of the plant used for extraction and fractionation.
- Process for extraction and subsequent fractionation and purification.
- Formulation details of the phytopharmaceutical drug.
- The manufacturing process of formulation.
- Stability data.
The new phytopharmaceuticals regulation permits the development of the drug-using advanced techniques of solvent extraction, fractionation, potentiating steps, modern formulation development, etc.
After NDA approval from CDSCO, the marketing status of the new phytopharmaceutical drug would be like that of a new chemical entity-based drug.
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