Guidelines for Evaluation of Nanopharmaceuticals in India

• 25 Oct 2019

Recently, the Government of India released “Guidelines for Evaluation of Nanopharmaceuticals in India”.

• There are no internationally accepted uniform guidelines for nano-pharmaceuticals. The usual consensus for evaluation of quality, safety and efficacy of nanotechnology-based products is to have a case-to-case approach.
• It takes into account the physical, chemical and biological characteristics of the nano-material used and the product, route of administration, the indication for which the product is intended to be used and other related aspects.

Nanopharmaceuticals

• Nanopharmaceuticals is defined as a pharmaceutical preparation containing nanomaterials intended for internal use or external application on a human for the purpose of therapeutics, diagnostics and health benefits.
• Nanomaterial is defined as material having a particle size in the range of 1 to 100 nm in at least one dimension.
• Nano-formulations are not entirely new drugs but medicines that have better quality because of the technology-led delivery mechanisms that are used to make its administration in the body more effective.

Nanopharmaceuticals Guidelines

• These guidelines have been developed in line with the provisions of Schedule Y of Drugs and Cosmetics Rules, 1945 as well as Second Schedule of the New Drugs and Clinical Trials Rules, 2019 with specific requirements for nanopharmaceuticals.
• The guidelines include,
  
  • The nano-size range should be declared in the product specification.
    
    • The particles should be within the claimed nano-size range in all given testing conditions.
  • The detailed methods of the manufacturing process and the impact of nanomaterial waste disposal on the environment should also be declared.
  • The added advantage and possible disadvantage of nanopharmaceuticals in comparison to conventional/traditional drug/API should be clearly stated on the products.
    
    • Though Nanocarrier based targeted drug delivery and nanoformulations have higher efficacy, lower toxicity and are safer than the conventional drugs.
    • A Nanocarrier is a nanomaterial being used as a transport module for another substance like a drug.
  • The stability testing for Nanoformulations should focus on functionality, integrity, size range of nanopharmaceuticals.
  • It will cover nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered nanoscale dimensions, properties.
    
    • It also covers the phenomenon associated with the application of nanotechnology intended to be used for treatment, in vivo diagnosis, mitigation, cure or prevention of diseases and disorders in humans.

Advantages of Guidelines

• The regulatory system for Nanoformulations is expected to be strengthened as the result of released guidelines.
  
  • Indian researchers and industry would be facilitated to undertake research in nanopharmaceuticals product development and commercialization.
• The guidelines will pave the way for significant benefits through such cutting edge technology and contribute to the mission of “Affordable Health Care for All”.

Source: PIB