Guidelines for evaluation of Nano pharmaceuticals in India

The Guidelines for Evaluation of Nano Pharmaceuticals are important steps for delineating the novel Nano formulations’ quality, efficacy, and safety assessment. It was announced by Dr. Harsh Vardhan, the Union Minister for Science and Technology & Earth Science. These guidelines provide consistent, transparent, and regulatory pathways for Nano Pharmaceuticals. Moreover, Nano Pharmaceuticals are introduced into the market by the delivery of nanocarrier-based drugs. These drugs are lower toxicity, higher efficacy in nature. And these are safer than other drugs. Thus, let us study the Nano Pharmaceuticals in India, its benefit, and their impact. Also, the guidelines would strengthen the regulatory system. 

Nano Pharmaceuticals

Nano Pharmaceuticals is a pharmaceutical preparation. It contains nanomaterials (in 1 to 100 nm) considered for internal use or external application on humans. It is to provide diagnostics, therapeutics, and health benefits. This preparation is treated as a New Drug. CDCSO evaluates it.

The Nano Pharmaceuticals are divided into four categories. 

Category 1

The drug and nanocarrier are new. Any country does not approve of these. 

Category 2

The drug has a new molecular entity. But nanocarriers have been used and approved for some Nano Pharmaceuticals.

Category 3

The conventional form of the drug is approved in well-regulated countries, including India. But nanocarriers are new and not approved. 

Category 4

Both Drug’s conventional forms and nanocarriers are approved in many regulated countries. But it is not approved in India.

Need for Guidelines

India has no specific guidelines for the development and evaluation of Nano Pharmaceuticals. So, there is a need for guidelines for Nano Pharmaceuticals. These guidelines can focus on Nano Pharmaceuticals’ quality, safety, and efficacy for their therapeutic use and application.

About the Guidelines

• The guidelines are generated in line with Schedule Y of Drugs and Cosmetics Rules provisions in 1945. And 2019 by Second Schedule of the New Drugs and Clinical Trials Rules
• The guidelines for evaluation categorize Nano Pharmaceuticals to their level of degradability and organic or inorganic nature
• The guidelines appeal to Nano Pharmaceuticals in the form of finished formulations with Active Pharmaceutical Ingredients
• These guidelines do not apply to conventional drugs with the incidental presence of nanoparticles or microorganisms, or proteins containing drug products
• Also, it is not applicable for medical devices, in-vitro diagnostics, or tissue-engineered products, which use nanotechnology and nanoparticle-modified cell-based therapies

Impact of Guidelines

• Way to Effective Research 

The guidelines are the route of effective translational research toward developing novel Nano formulations. 

• Facilitating Decision Making

Based on nanotechnology, the guidelines will facilitate the decision-making by the regulator during clearances to newer products

• Benefits to End Users

According to the guidelines, the end-users also benefit from quality assured anticipated products in the market

• Safety Guidelines for Other Domains

It will follow safety guidelines for the domain. Such as agri-products and agri-inputs, cosmetics, and implantable devices by nanotechnology interventions

• Private Investments

The guidelines of evaluation strengthen the regulatory system. So, it will help in private investments

• Contribute to Affordable Health Care 

The guidelines are an additional benefit of cutting-edge technology. It helps the mission of “Affordable Health Care for All”

Advantage of Nano Pharmaceuticals

• Nano Pharmaceuticals can detect diseases at much earlier stages. So, the diagnostic applications can be made based upon the conventional process with the help of nanoparticles
• It can empower target-specific delivery of drugs. And therapeutic molecules can minimise effect and toxicity
• It has lower toxicity and higher efficacy. So, it is safer than other drugs
• Nano Pharmaceuticals decrease the cost of drug discovery, design & development. Also, it increases the drug delivery process. So, it improved the success rate

Central Drugs Standard Control Organisation (CDSCO): Function and its details

• About the CDSCO

As we know CDSCO (Central Drugs Standard Control Organisation) is a Central Drug Authority. It is for discharging functions assigned to the Central Government. It works under the Drugs and Cosmetics Act

It has six zonal offices, four sub-zonal offices, seven laboratories, and 13 port offices under its control. 

The Function of Central Drugs Standard Control Organisation

• Regulatory control over the import of drugs
• Meetings of the Drugs Technical Advisory Board and Drugs Consultative Committee
• Approval of new drugs and clinical trials
• Approval of licences by Central Licence Approving Authority

Conclusion

From the above discussion, we understand the guidelines for evaluation of Nano pharmaceuticals in India. We know that Nano-formulations are not only drugs but medicines. It has better quality because of the technology-led delivery mechanisms. It is used to make its administration in the body more effective. The guidelines of Nano pharmaceuticals were generated in 1945 by Schedule Y of Drugs and Cosmetics Rules and in 2019 by the Second Schedule of the New Drugs and Clinical Trials Rules. The guidelines would strengthen the regulatory system. So, it helps in the private investments. It is safer than other drugs because it has higher efficacy and lower toxicity.