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Legal Issues In Regulation Of Nanomedicine In India

Nano technology emerged in the world scenario in 1980. This has been used with huge success in many sectors such as agriculture, healthcare and fertilizer industry. Department of science and technology (DST) launched the Nano Science and Technology Initiative in 2001. In 2006 DST launched the Nano Mission. Nanomedicine is the application of nanotechnology to health.

This includes novel drug, drug delivery system, medical device, diagnostics and sensors biomaterials and imaging. In spite of growing research and application, the regulatory framework is far from satisfactory in India. Since it is an interdisciplinary science, it needs multiple legislations involving drug or device or both. Due to uncertainty in the proper regulation, Research and development (R&D) in the nano medicine is at cross roads. The public private partnership in R&D and its commercialization needs transparent guidelines.

The emergence of intellectual property issues, environmental issues, health risks arising out of nano technology in commercial application needs to be regulated by a robust legal regime. Various legislations on patent, environmental protection, health hazard protection has to be integrated in to under one umbrella for success full legal regime of nanomedicine in India.

The new guide line for the evaluation of nano pharmaceuticals came in to effect in 2019 but it is more about safety aspect rather than comprehensive legislation. The precent article proposes solutions to complex issue of commercial use of nanomedicine. The new government policy is needed for regulation of nanomedicine in India.

Introduction
Nanoscience is one of the fastest emerging and growing technology. It's origin dates back to 1980's i.e., four decades ago this has been extensively used in many sectors like agriculture, healthcare, fertilizer and chemical industry. Nanoscale conversion of any material changes it's physiochemical, biological, mechanical, optical and electronic properties.

These novel properties is utilized in deferent useful activities for example, chemicals, health, energy, consumer products, environment and many other industries. This technology is increasing exponentially in pharma field called Nano pharmaceutical. The application of nanotechnology in healthcare is called nanomedicine.

This includes novel drug, drug delivery system, medical device, diagnostics and sensors biomaterials and imaging. In spite of growing research and application, the regulatory framework is far from satisfactory in India. Since it is an interdisciplinary science, it needs multiple legislations involving drug or device or both. Due to uncertainty in the proper regulation, Research and development (R&D) in the nanomedicine is at cross roads.

The public private partnership in R&D and its commercialization needs transparent guidelines. The emergence of intellectual property issues, environmental issues, health risks arising out of nano technology in commercial application needs to be regulated by a robust legal regime. Various legislations on patent, environmental protection, health hazard protection has to be integrated in to under one umbrella for success full legal regime of nanomedicine in India. The new guide line for the evaluation of nano pharmaceuticals came in to effect in 2019 but it is more about safety aspect rather than comprehensive legislation.

Brief outline of Nanomedicine

  • The nanomedicine is a fast-developing field in various sectors across the globe. Hence the monitoring by the existing agencies as per prevalent rules and laws should.
     
  • Provide an efficient mechanism for regulation, product approval, policy advice and industry monitoring. It is a hard fact that there is no unanimous opinion on the definition of nanotechnology which hinders the construction of a strong framework for nanotechnology and nanomedicine regulation. As per CDSCO and DCGI (Central Drugs Standard Control Organisation AND Drug controller general oh India), a nanomedicine is defined as a pharmaceutical preparation containing nanomaterials intended for internal or external application on the body for the purpose of therapeutics, diagnostics and any health benefits.

    The size scale of nanoparticle ranges from 1 to 100 nanometer in at least in one dimension. However, if the particle size is >100nm and <1000 nm, it will also fall within the definition, provided it has altered or different pharmaceutical characteristics associated with application of nanotechnology compared with API (active pharmaceutical ingredient). At any time, point during the claimed stability period, the particle size range should not decline or alter >10 %.
     
  • Broad classification of Nanomedicine
    1. As per the national institute of health (NIH, USA), Nanomedicine is molecular scale medical intervention for the purpose of prevention, diagnosis and treatment of disease.
       
    2. As per the European science foundation, Nanomedicine is the science and technology of diagnosing, treating and preventing disease and traumatic injury, of reliving pain and of preserving and improving human health using molecular tools and molecular knowledge od the human body.
       
    3. As per the European technology platform (ETP), Nanomedicine is the application of nanotechnology to health. It exploits the improved and often novel physical, chemical and biological properties of materials at the nanometric scale.
       
  • Depending on the properties of the nanoparticles, it has been classified into various types:
    • Biodegradable or Non-biodegradable
    • Organic or Inorganic or Multicomponent
    • Nanocarriers loaded with API or APIs converted to nano form
    • All nano pharmaceutical preparations will be treated as investigational new drug (IND)
       
  • Clinical uses for nanomedicines:
    Nanomedicine has given a new wing to the researchers to fly in the area of medical research. Nanotherapeutics is FDA approved (USA) for clinical use in treatment of cancer, high cholesterol, autoimmune disease, fungal infections, macular degeneration, hepatitis etc. Additional medical application for nanoparticles or in the field of vaccinations, MRI contrast agents, fluorescent biological labelling, protein identification, DNA structure probing, drug and gene delivery agents, pathogen detection and the separation of biological molecules and cells. However the health risks of nano molecules has to be evaluated as a new drug for prolonged period of monitoring.


Current Legal Regulations Of Nano Medicine In India:

There are various acts/guidelines which regulate the nanomedicine field in India. The oldest being Drugs and Cosmetics Act, 1940 and the latest is Guidelines for Evaluation of Nano pharmaceuticals in India 2019. There are altogether eight (8) which is presented in the tabular form (Table 1).

Though the government has tried to modify and update the legislation and guidelines related to drugs in last 80 years many times but these are still not sufficient enough to regulate the production, use and research of nanomedicine in India there is lack of clear guidelines to various agencies regulating the nano regulation.

These regulatory authorities are more inclined towards the safety aspects of consumers, patients and researchers along with adverse effect on climate. Since the emergence of nanomedicine is a global phenomena with a bright future application in different fields, India also needs a proactive comprehensive policy to encourage the growth of research and application in nanomedicine area. The legal regulation should be easer to fallow and stringent in nature to prevent the health hazards and climate damage.

Table 1:

Act Scope
Drugs and Cosmetics Act, 1940 Import, manufacturing, sale, distribution of drugs
Drug and Cosmetics Bill, 2013 Extends to vaccines, RNA, living modified organisms, stem cells, gene therapeutic products. Proposes to delineate medical devices
Drug Price Control order, 1995 Controls pricing of drug
Guidelines on Similar Biologics, 2012 Similar biologics
Bio-Medical Waste (Management and Handling) Rules, 1998 Management and handling of bio-medical waste
Draft Bio-Medical Waste (Management and Handling) Rules, 2016 Management and handling of bio-medical waste
Draft Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries, 2016 Safe handling of nanomaterials
Guidelines for Evaluation of Nano pharmaceuticals in India 2019 Nano pharmaceuticals in the form of finished formulation as well as API of a new molecule or an already approved molecule with altered nano- scale dimensions, properties or 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.

Regulatory overview:
shortcomings of various legislations/acts/guidelines

Shortcomings
Definition of nanomedicine is not included, Generic drug marketing requires approvals based on equivalence studies without considering safety studies

Does not define nanomedicine

In light of its scope & definition most of the nanomedicine may be excluded from its ambit

Nanomedicine not defined in the guidelines, there are no provisions for disposal or assessment of effect on environment

The rules do not extend to institutes

The guidelines mention that the nanomaterial hazardous waste containers shall be collected and disposed of as hazardous waste following the standard procedures, However, currently it is not known what the best possible way of disposing nanomaterial waste is & No monitoring or enforcement mechanism is provided to ensure adherence to these guidelines

The guidelines mention more about safety aspect rather than comprehensive legislation

Regulatory Overview: Life Cycle Of Nano Medicine

  • The lifecycle of a nanomedicine product can be divided into seven major stages: conception, research, product development, protection of IPR, clinical trials and safety assessments, release in the market and post market monitoring
     
  • When we analyze the life cycle of nanomaterials, it will be revealed that many areas of laws eg laws relating to occupational health, factory, chemical substance, hazardous substance, consumer, waste, environment, packaging and labelling, medical devices, safety, intellectual property etc. may be relevant in the discussion of different aspects of nanomedicine.




Legal Issues in Regulation of Nano Medicine:

  • Similar to the notion that not all chemicals are harmful, nanomaterials are of no exception, although there are some nanomaterials which are used in a ubiquitous scale in consumer products that are highly predicted to be injurious. For such nanomaterials, law should immediately intervene.
     
  • Main scientific challenges of implementation of legislation are the definition of nanomaterials, safety assessment (methodology for risk assessment), control of products containing nano materials (market regarding labelling and traceability, analytical methods, sampling, etc.), and quality assurance tools (reference methods and materials)
     
  • One of the main reasons behind non-legislation is that there is a significant knowledge gap between the health and environmental effect of nanotechnology. Since all the tests and experiments are laboratory based, people are not sure about the adverse effects of nanotechnology.
     
  • The main problems are public trust, potential risks, issues of environmental impact, transparency of information, responsible nanoscience's and nanotechnologies research.
     
  • Therefore, this is crucial to consider the adequacy of the existing legal framework whether such legal framework is enough to regulate nanomedicine. The answer is no, the current conventional legal provisions relating to drugs, chemicals and waste management etc. are not sufficient in the case of nanomedicine and new law/regulatory frame work should be enacted.
     
  • Nanomedicine being a multidisciplinary field poses various challenges with regards to its regulation. To overcome this concern, India like many other nations has initiated steps to characterize the regulatory landscape for nanotechnology and its applications including nanomedicine. however, neither of these are suitable for every application of nanotechnology nor do they cover the entire lifecycle.


Need for New Legal & Regulatory framework in India:
Keeping in view that nanomedicine is emerging and challenges are yet to be fully unraveled, a soft governance strategy such as noncertification system to supplement the hard regulation may be adopted. Therefore, a three-tier governance framework, which can be used by the policy makers for developing a pathway for regulation of nanomedicine in India was proposed by Bhatia and chugh (2017). The model is based on regulatory space, policy regime, sites of governance and lifecycle of the nanomedicine product.

The proposed framework has a combination of hard and soft governance mechanisms and regulates at three levels starting from research, premarket and post market with an essential component of implementation and enforcement. The governance framework regulates in terms of biosafety, biosecurity, regulatory pathway, accessibility and intellectual property. Such a framework aims to ensure further growth of the technology and address risk(s) effectively.

Regulatory space of nanomedicine in India:
Following are the three major regulatory space of nanomedicine in India:

  • Producers (Institutes and Companies
  • Policy makers and enforcers (Central government and State governments)
  • Consumers/users (Institutes, Companies and Patients)



Sites of governance of nanomedicine in India
The main sites of governance are research, production, testing and use. The research is being done in the Universities and Institutes of scientific research (includes central/state/Private Universities) e.g. Indian council of medical research, Indian institute of science, National Institute of pharmaceutical education and research (NIPER), Tata institute of fundamental research etc.

Many pharmaceutical companies have their own research and development (R & D) centres across India which are actively involved in nanomedicine research either alone or in collaboration with the multinational companies. The research is also done in incubators, innovation and science parks.

The production of nano particles are done in the companies having the incubators and research facilities along with manufacturing units. There is also contract manufacturing in modern days. Companies with prototype facilities do participate in production.

The testing of nanoparticles are done through clinical trials following the strict ethical protocol and monitoring guidelines. This is done in humans in government or private medical institutions. The trials in animals or subject to regulations like PETA and others. The lab testing are done at the research facilities of the institutes, Universities and companies (Pharmaceutical or Medical diagnostic device manufacturers)

Regarding the use of nanoparticles, general public (Consumers) and patients (For various diseases like cancer, cardio vascular diseases etc) form the major chunk of users. Even the nanomedicine are used in University and Institutes for research, in hospitals and clinics for diagnosis ( e.g. MRI Scan contrast ) and treatment. The companies use in production of novel drugs and devices.

Conclusion and way forward
The proposed framework from Bhatia and chugh has a combination of hard and soft governance mechanisms and regulates at three levels starting from research, premarket and post market with an essential component of implementation and enforcement. The governance framework regulates in terms of biosafety, biosecurity, regulatory pathway, accessibility and intellectual property. Such a framework aims to ensure further growth of the technology and address risk(s) effectively.

More advancement with specific relevance to regulatory questions is still needed, precisely regarding the consensus implementation of the definition of nanomaterials, the enforcement of product labelling for the presence of nanomaterials, the development of methods for safety testing and risk assessment of nanomaterials and better availability of quality data on nanomaterials for regulatory purposes.

The nano regulation should address the issues of all the stakeholders and the model for control can be based as the structure of pollution control board (central and state) in India that is two tier system of control. Or there should be a robust umbrella legislation which includes all the aspects of nanomedicine regulation (i.e., research, trial, production, use, monitoring and reporting) because multiple legislations and acts preset a complex picture for all the stakeholders and the development of this new branch of science is being retarded in pace.

References:

  1. Tinkle, S., McNeil, S. E., M'hlebach, S., Bawa, R., Borchard, G., Barenholz, Y. C., et al. (2014). Nanomedicines: addressing the scientific and regulatory gap. Ann. N. Y. Acad. Sci. 1313, 35-56. doi: 10.1111/nyas.12403
  2. Bhattacharya S, Bhatti M. Creating capacity for nanotechnology research and innovation in India. In India Science and Technology, Bhattacharya S, Kumar N, Mandal K, Mehra K, Nath P, Pohit S, Raina R, Eds. Cambridge University Press: New Delhi, 2013, pp. 215-221
  3. Drug Products, Including Biological Products, that Contain Nanomaterials Guidance for Industry/Apr-22- US FDA
  4. http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm. Accessed March 9, 2016.
  5. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000345.jsp&. Accessed March 9, 2016
  6. Dana, D.A., 2010. Can the law track scientific risk and technological innovation? The problem of regulatory definitions and nanotechnology. Faculty working papers, paper 113
  7. Savolainen, K., et al., 2013. Nanosafety in Europe 2015-2025: towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations. Finnish Institute of Occupational Health
  8. Ali A, Sinha K. Exploring the opportunities and challenges in nanotechnology innovation in India. JSSPI. 2014, 2, 227-251
  9. Front. Chem., 20 August 2018 Sec. Analytical Chemistry
  10. Malayan Law Journal Articles/2014/Volume 3/Nanotechnology within the Legal and Regulatory Framework: An Introductory Overview
  11. Nanotechnology: Regulatory Outlook on Nanomaterials and Nanomedicines in United States, Europe and India. Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2020, 7, 225-236
  12. A multilevel governance framework for regulation of nanomedicine in India. Nanotechnol Rev 2017; 6(4): 373-382
  13. https://www.fda.gov/science-research/science-and-research-special-topics/nanotechnology-programs-fda

Award Winning Article Is Written By:
  1. Nalin Choudhary, PhD scholar
    Email: [email protected]
  2. Professor Ritu Gupta, PhD - Gitam School Of Law, Gitam University, Andhra Pradesh, India.
  3. Nidhi Nalin, B Tech, MS, PG DPM(NMIMS) - Project Executive in Pulse Advanced research Centre, Nacharam, Hyderabad

Awarded certificate of Excellence
Authentication No: SP224489047993-1-0922

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