Guidelines For Evaluation Of Nanopharmaceuticals In India

26 Oct 2019

Recently, the Ministry Science & Technology released Guidelines for Evaluation of Nanopharmaceuticals in India, in New Delhi.
The Guidelines are developed by Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare and is an outcome of all concerned Inter-Ministerial efforts coordinated by DBT.

Aim

To ensure the quality, safety and efficacy of nanopharmaceuticals.
To encourage the commercialization of nanotechnology based inventions by increasing their benefit-to-risk ratio.

Need for Guidelines

There are no specific guidelines for development and evaluation of nanopharmaceuticals in India, there is a need to formulate comprehensive guideline focusing on the quality, safety and efficacy of nanopharmaceuticals for their therapeutic use and application.

About the Guidelines

The 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.
The guidelines define the nano-pharmaceuticals and categorise it according to its level of degradability and organic or inorganic nature.
It applies to the nano pharmaceuticals 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.
However, these guidelines do not apply to the conventional drug with incidental presence of nanoparticles or drug products containing microorganisms or proteins, which are naturally present in the nanoscale range.
These are also not applicable to medical devices, in vitro diagnostics, tissue engineered products using nanotechnology and nanoparticle modified cell based therapies.

Nanopharmaceuticals

A nanopharmaceutical is defined as a pharmaceutical preparation containing nanomaterials (1 to 100 nm in at least one dimension) intended for internal use or external application on human for the purpose of therapeutics, diagnostics and health benefits.

Categorisation

Broadly, all nanopharmaceutical preparations will be treated as New Drug which will be evaluated by CDCSO. They are divided in to following four categories:

Category I: The drug is a new molecular entity and the nanocarrier is also new and not approved in any country.
Category II: The drug is a new molecular entity not approved in any country, but the nanocarrier is already used / approved for other nanopharmaceuticals.
Category III: Conventional/ traditional form of the drug is approved in well regulated countries and/or India but the nanocarrier system is new and not approved in any country.
Category IV: Conventional/traditional form of the drug and the nanocarrier system both are approved as a specific formulation in well regulated countries, but yet not in India. It should be subjected to abbreviated/ bridging studies as per Second Schedule of NDCTR.

Benefits

Nanopharmaceuticals offer the ability to detect diseases at much earlier stages and the diagnostic applications could build upon conventional procedures using nanoparticles
Nanopharmaceuticals can enable target specific delivery of drugs and therapeutic molecules minimizing off target effects and toxicity.
Nanopharmaceutical have higher efficacy, lower toxicity and are safer than the conventional drugs.
Nanopharmaceutical reduces the cost of drug discovery, design & development and enhances the drug delivery process. This results in improved success rate which enables faster introduction of new, cost-effective products to the marketplace.

Impact of Guidelines

Way to Effective Research: These guidelines will pave the way for effective translational research towards development of novel nanoformulations. Indian researchers would be facilitated to undertake research in line with the regulatory guidelines and is expected that Industry would be keen to participate from the beginning of the research pipeline towards product development and commercialization.
Facilitating Decision Making: It will facilitate the decision making by regulator during clearances to newer products based on nanotechnology and similarly to researchers to get clearance for their products to launch in market.
Benefits to End Users: End users will also be benefited by the quality assured anticipated products in the market in accordance to the guidelines.
Private Investments: It will help attracting private investments in the country since these guidelines would strengthen the regulatory system.
Safety Guidelines for Other Domains: It will give impetus to initiate activities for developing safety guidelines for other domains like agri-inputs and agri-products, cosmetics, implantable devices, through interventions of nanotechnology.
Contribute to Affordable Health Care for All Mission: The guidelines will pave the way for significant benefits through such cutting-edge technology and contribute to the mission on "Affordable Health Care for All".

Way Forward

India is a developing country with a huge population burden. In this regard, development of cost effective quality enabled products is important which can be achieved through cutting edge technologies like nano-interventions.
The nanotechnology intervention has opened a new horizon for targeted delivery of approved drugs and repurposing of drugs. Every year several new nanopharmaceuticals/ nanomedicine are being introduced into the market globally.
It is one of the most important steps for delineating quality, safety and efficacy assessment of the novel nanoformulations and the rapid progress in this emerging field is expected to change the current therapeutic practice in near future.
It is intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals and will encourage the Indian innovators and industries to develop and commercialize new nanopharmaceuticals which will make our country a global leader in this area.