In February 2019, the Government of India introduced first draft regulatory guidelines for evaluation of nanopharmaceutical products for therapeutic use in the country. The draft guidelines once finalized will speed up commercialisation of nanotechnology-based medical innovations by establishing transparent and predictable regulatory procedures. Nano-pharmaceutical, a combination of nanotechnology with pharmaceutical and biomedical science, is an emerging field focusing on targeted drug delivery for improved efficacy and safety of pharmaceuticals.
Scope of the Guidelines
The guidelines will be applicable to the nano-pharmaceuticals finished formulation and API of new molecule or an already approved molecule with altered dimensions, properties or phenomenon associated with the application of nanotechnology. However, these guidelines will not apply to conventional drugs which are present with incidental nanoparticles or microorganisms which are naturally present in drug products.1
Information Required for Evaluation of Nano-pharmaceuticals
Evaluation of nano-pharmaceuticals requires following data to be submitted to the regulatory authority, though the content of information will be decided from case to case basis -
- A brief introduction on nano-pharmaceuticals
- Chemical and pharmaceutical information
- Animal pharmacology
- Animal toxicology
- Human / Clinical pharmacology
- Therapeutic exploratory trials
- Therapeutic confirmatory trials
- Special studies
- Regulatory status in other countries
- Prescribing information
- Samples and testing protocol/
Note- These guidelines are developed along with the provision of the Schedule Y of Drugs and Cosmetics Rules, 1945, and with requirements for nano-pharmaceuticals. These guidelines provide guidance for specific requirements of chemical and pharmaceutical information, non-clinical data and clinical data relevant for any product developed based on nanotechnology. The Schedule Y requirements are applicable to all the new drugs whether based on nanotechnology or not. However, due to complexity involved in the nano-technology based products, a 'case by case basis' approach should be adopted for evaluating their quality, safety and efficacy.2
General requirements and guidelines for manufacturing/import of any new nano-pharmaceuticals or to undertake clinical trial for same has already been specified in the Drugs and Cosmetics Rules, 1945. However, the complexity in nanotechnology necessitates the system of 'case by case approach' with involvement of varied expertise for successful development of nano-pharmaceuticals.
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