A Primer on Central Health Institutions and the realm of Clinical Trial in India

A Primer on Central Health Institutions and the realm of Clinical Trial in India

Author(s): Arihant Singh & Arnab Chatterjee

A Primer on Central Health Institutions and the realm of Clinical Trial in India

Abstract

With the commencement of the phased unlocking of the country which is still reeling from the adverse effects of the COVID – 19 pandemic for the last four months, there is now an emergence of a new dimension to this global crisis and it is the battle of finding an effective cure for this fatal and contagious virus. The emergence of innovative and new technologies in the manufacture and development of drugs and vaccines has not only been a significant and positive contribution to this modern era of the human race but will also definitely pave the way for the prospective future. With the increasing trend which is being witnessed in the rising collaborations of the private sector and the national governments, there is now an optimistic hope that it will undeniably be a progressive stride towards the endeavour to find a cure. In this scenario, it is our utmost necessity and responsibility to comprehend the framework of the central health establishments of India currently functioning in this pandemic along with understanding the regulatory structure for clinical trials. There has been a considerate effort made by the authors to divulge into the scope of these institutions, their functioning, and the statutory nature of the clinical trial being conducted in India which forms the basis of this paper. This paper also seeks to deliver an international perspective with regard to the current vaccines that are being primarily used in the treatment process of the infected persons.

Keywords: COVID – 19, Drugs, New Drug, Clinical Trial, Ethics Committee

Introduction

These are unprecedented times and the COVID – 19 pandemics has only aided that process by thrusting the global community into an abyss of uncertainties. The primary health care institutions are crumbling with massive pressure, which is being exerted on them due to the ever-rising rate of infections being detected and therefore it becomes a paramount need to attain and acquire a crystal clear and comprehensive understanding of the central health institutions which are the key stakeholders in this pandemic and the crucial role they are playing in this process. In the backdrop of this pandemic, there has been initiated the process of clinical trials for the development of an effective vaccine which is a need of the hour and therefore in the Indian context, there has to be a uniform framework for the clinical trials on human subjects/participants. These frameworks and guidelines form the mainstay for the process from its initiation until the successful result of each and every phase of the trial. There has been an infusion of new drugs which are being developed by numerous biotechnology companies and therefore there is now created a situation where these regulatory and statutory conditions and prerequisites have to be complied and to fast track these clinical trials, there can be gross violations committed by these companies of the requirements and therefore we need to have a fundamental awareness and understanding to avoid this conundrum.

Central Drugs Standard Control Organization

A Brief Overview:

The Central Drugs Standard Control Organization (“CDSCO”) which has its headquarters in New Delhi and works under the aegis of the Directorate General of Health Services, Ministry of Health and Family Welfare (“MoHFW”), is the apex regulatory authority accountable for the regulation of drugs, cosmetics and clinical trial of drugs and cosmetics under the Drugs and Cosmetics Act, 1940 (“Act”) which is the foremost legislation for the regulation of drugs and cosmetics in India. The CDSCO has six zonal offices spread across the country along with four sub-zonal offices, thirteen port offices and seven central laboratories under its direct control.[1]

The foremost functions and duties of CDSCO are:

  1. Regulatory Control over the import of drugs.
  2. Manufacture, Sale and Distribution of drugs.
  3. Laying down the standards of drugs.
  4. Regulation of the quality of drugs imported from outside India.
  5. Approval of new drugs and clinical trials.
  6. To conduct the meetings of the Drugs Consultative Committee (“DCC”) and the Drugs Technical Advisory Board (“DTAB”).
  7. Approval of certain licenses as Central License Approving Authority is also significantly exercised by the CDSCO.
  8. Coordinating the activities of State Drug Control Organisations.
  9. Providing expert advice for fostering uniformity in the effective and efficient enforcement of the Act.[2]

Drugs Technical Advisory Board

DTAB is a central board constituted under Section 5 of the Act by the central government to advise it and the state governments on technical matters that may arise from the implementation of the Act and to perform any other functions as may be assigned to it under the Act. It can regulate its procedure, prepare bye-laws and conduct its own business with the prior approval of the central government. It can also establish sub-committees for predefined periods not exceeding three years for the disposal of certain matters. The board consists of the following members that are categorised as Ex-Officio and other members:[3]

Ex Officio Members:

  1. Director-General of Health Services (Chairman of DTAB)
  2. The Drugs Controller, India.
  3. Director, Central Drugs Laboratory, Calcutta
  4. Director, Central Research Institute, Kasauli
  5. Director, Indian Veterinary Research Institute, Izatnagar
  6. President of Medical Council of India.
  7. President, Pharmacy Council of India.
  8. Director, Central Drug Research Institute, Lucknow.

Other Members:

  1. Two persons who are nominated by the Central Government from among the persons who are in charge of controlling drugs in the respective States.
  2. One person who is elected by the Executive Committee of the Pharmacy Council of India, to be selected from among the teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college.
  3. One person, to be elected by the Executive Committee of the Medical Council of India, from among the teachers in the field of medicine or therapeutics on the staff of an Indian university or a college.
  4. One person who is nominated by the Central Government from the pharmaceutical industry.
  5. One pharmacologist who is elected by the Governing Body of the ICMR.
  6. One person to be elected by the Central Council of the Indian Medical Association.
  7. One person to be elected by the Council of the Indian Pharmaceutical Association.
  8. Two persons holding the appointment of Government Analyst under this Act, who are to be nominated by the Central Government.[4]

Drugs Consultative Committee

The DCC is a committee having an advisory nature constituted under Section 7 of the Act by the central government to advise the central government, respective state governments and the DTAB on any matter to ensure the uniform implementation of the Act throughout the country. The DCC consists of two representatives of the central government who are nominated by the central government and one representative of each state government who is nominated by that particular state government. It has the power to regulate its procedure and can meet as and when the central government requires it to do so.[5]

New Drug:

Whenever any individual or organization intends to manufacture or introduce a new drug into the market or import it from outside the country with the sole of the objective of human consumption then the concerned party has to take the requisite and in-principle approvals from the CDSCO under the Drugs and Cosmetic Rules, 1945 (“Rules”).[6] The term ‘New Drug’ has been defined under Rule 122-E of the Rules in the following fashion:

“122E. Definition of new drug

For the purpose of this Part, new drug shall mean and include –

(a) A drug, as defined in the Act including bulk drug substance or phytopharmaceutical drug which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:

Provided that the limited use, if any, has been with the permission of the licensing authority.

(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.

(c) A fixed-dose combination of two or more drugs individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.

Explanation – For the purpose of this rule –

(i) All vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21;

(ii) A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.”[7]

Since we have now been familiarized with the definition of a new drug, we can now make an effort to have a better understanding of the approval process for a new drug. Rule 122A, 122B, 122DA, 122DAB and 122DD of the rules contain within them all the relevant information and the data required for approval of clinical trial and/or to import or manufacture of a new drug for marketing in the country and other relevant requirements.[8]      

Rule 122A talks about the application for permission to import a new drug and the requisite forms that have to be submitted and the fees that have to be paid and the relevant information and data that has to be furnished under Appendix I, IA and IB to the Schedule Y of the rules and on what criteria the Licensing Authority will come to its decision whether to grant the permission or not.[9]

Rule 122B enumerates the application procedure for the manufacture of a new drug and the requisite forms that have to be submitted, the fees that have to be paid, the relevant information and data that has to be furnished under Appendix 1, 1A or 1B of Schedule Y of the rules.[10]

Rule 122DA explains the procedure that has to be abided, a requisite fee to be paid and the forms to be submitted for conducting clinical trials for New Drug/Investigational New Drug and it lays down three phases of clinical trials:

  1. Phase – I (Human Clinical Trials) with information submitted as per Schedule Y of the rules.
  2. Phase – II (Exploratory Clinical Trials) based on the data collected from the Phase-I of the trial.
  3. Phase – III (Confirmatory Clinical Trials) based on the data collected from Phase-I and Phase-II of the trial.[11]

Rule 122DAB explores how the financial compensation has to be period in case of death or injury during the clinical trial and what all the facilities will be provided to that individual or his/her nominee or sponsor in case of death. This rule also makes an effort to list out the reasons because of which the injury or death is caused in the clinical trial then financial compensation will be paid.[12]

Rule 122DD talks about the registration of Ethics Committee (“EC”) and its modalities under Appendix VIII and XII of Schedule Y of the Rules.[13]

Drug Controller General of India

The Drug Controller General of India (“DCGI”) is a department working under the supervision of the CDSCO whose sole role comes into play in the approval process for a Drug Substance or a Drug Product. The DCGI also has a responsibility in the approval process of specific categories of drugs like Blood Products, IV Fluids and Vaccines in India along with setting the criteria for the manufacturing, sales, import and distribution of drugs in India. The major functions of DCGI are:

  1. It conducts the training of Drug Analysts deputed by the State Drug Control Laboratories and other central organizations.
  2. It acts as an appellate authority for the resolution of disputes concerning the quality of drugs.
  3. The maintenance and preparation of the national reference standard.
  4. It brings about a sense of consistency and standardization in the enforcement of the Act. 

Indian Council of Medical Research

The Indian Council of Medical Research (“ICMR”) is the supreme health research institution which is funded by the Department of Health Research, MoHFW, for the formulation, coordination and promotion of biomedical research in India and is among the oldest research bodies in the world. It has attempted to resolve and address the growing demands of scientific advances in biomedical research and finding of the practical solutions to the health problems in the country.[14]

ICMR at its inception was first established as the Indian Research Fund Association (“IRFA”) when the first meeting of its Governing Body was held on November 15, 1911 where the Articles of Association and the formation of a Scientific Advisory Board were considered for the first time. It was only in the year of 1949 when the IRFA was restructured as ICMR with Dr. C.G. Pandit being appointed as its first Director.[15]

ICRM’s vision is translating the research conducted into action for improving the health of the population.[16] ICMR has a clear mandate and mission that has been laid down by it and which can be summarised as follows:

  1. Formulation, coordination and promotion of biomedical research.
  2. Conduct, coordinate and implement medical research for the benefit of the society.
  3. Translating medical innovations in to products/processes and introducing them in to the public health system.[17]
  4. Generate, manage and disseminate new knowledge.
  5. Increase focus on research on the health problems of the vulnerable, the disadvantaged and marginalized sections of the society.
  6. Harness and encourage the use of modern biology tools in addressing health concerns of the country.
  7. Encourage innovations and translation related to diagnostics, treatment, methods/ vaccines for prevention.
  8. Inculcate a culture of research in academia especially medical colleges and other health research institutions by strengthening infrastructure and human resource.[18]

ICMR has three vital functioning organs which form the mainstay of its everyday functioning and they are the:[19]

  1. The Governing Council;
  2. The Scientific Advisory Board and;
  3. The Executive Council

We will now try ascertaining and comprehending the role of EC with regard to the guidelines issued by the ICMR under the subordinate head of ‘Ethical Review Procedures’. The scope of the ICMR’s “National Ethical Guidelines for Biomedical and Health Research Involving Human Participants” (“Guidelines”)that were laid down in 2017, covers all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.[20] 

According to the guidelines, the composition of an EC for the clinical trial should be of a multi-disciplinary and multi-sectoral approach. It goes on to specify that the EC shall have an equal representation of age and gender along with the proposition that 50% of the members should be not from the ICMR but from other medical institutions in the country. There should be at least seven to fifteen members and a minimum of five members for meeting the criteria of a quorum. The guidelines stipulate that there should be created an equilibrium in the medical, non-medical, technical and non-technical members so that a holistic and an all-inclusive EC can be established for its efficient working.[21]

The basic responsibilities of the EC with regard to the clinical trials have been defined by the guidelines in a very detailed and comprehensive manner:

  1. To ensure the protection of the dignity, rights, safety and well-being of the research participants.
  2. Ensuring that there is ethical conduct of research by the investigator team.
  3. Efficient performance of functions through the initial and continuous evaluation and assessment of all scientific, ethical, medical and social facets of research proposals received by it in a neutral, opportune and autonomous method.    
  4. Regular and timely monitoring visits to the study sites as and when needed.[22]

ICMR has been at the forefront in the COVID – 19 pandemics by playing an active part in the consultation process with the Government of India in the releasing of the guidelines for vaccines trial along with the proposed health protocols that have to be followed and which have been drafted in consultation with the MoHFW, Government of India. We have been regularly coming across as to how the ICMR has been determined to fast track the different phases of vaccine for combating this virus and has also to this extent in a recent incident made a statement on July 06, 2020, declaring that a dedicated COVID – 19 vaccines would be made available by August 15, 2020, which was later clarified by ICMR by saying that that it was “only to expedite duly approved clinical trials without compromising on the safety and security concerns”.

According to the ICMR Guidelines of 2017, the term ‘Clinical Trial’ has been defined as follows:

“A clinical trial is any research/study that prospectively assigns human participants or groups of humans to one or more health-related intervention(s) to evaluate the effects on health outcomes. The intervention could be drugs, vaccines, biosimilars, biologics, phytopharmaceuticals, radiopharmaceuticals, diagnostic agents, public health interventions, socio-behavioural interventions, technologies, devices, surgical techniques or interventions involving traditional systems of medicine, etc.”[23]

Certain general stages that have to be followed for clinical trials according to the guidelines have been summarised below:

  1. All clinical trials must be planned, conducted and reported in a manner that ensures and safeguards the dignity; rights, safety and well-being of participants so that they are protected.
  2. Before a trial is initiated, predictable risks and inconveniences should be weighed against the projected benefit for the individual trial participant and/or society. A trial should be initiated and continued only if the anticipated benefits justify all the risks that are involved.
  3. All clinical trials must be conducted in accordance with the Indian Good Clinical Practices guidelines, the Declaration of Helsinki of 2013, the Guidelines, the Act, the Rules, and applicable amendments including the Schedule Y of the Rules, and other relevant regulations and guidelines, wherever they are applicable.
  4. The participants right to agree or decline consent to take part in the clinical trial must be respected and her/his refusal should not affect the routine care.
  5. Applicable regulatory approvals must be taken from the ICMR.
  6.  All clinical trials must be registered with the Clinical Trial Registry – India (“CTRI”).[24]

New Drug and Clinical Trial Rules, 2019

The Backdrop

The role of a medicine or a drug in a human being’s life plays an important role as all other necessary amenities do. What medicine does to an ill person is what water does to a normal human being and that is to revive the person suffering from any illness and ultimately proving to be a lifesaver. In a developing country like India, where only a minuscule percentage of 3.6% of the total Gross Domestic Product is spent on the healthcare system as stated by Organisation for Economic Co-operation and Development (“OECD”), the fight to become a healthier nation is on its full swing.[25] To this effect, the Government of India brought about the new and improved iteration of New Drugs and Clinical Trial Rules, 2019 (“New Rules, 2019”) on 19th March, 2019. To bring about this regulatory framework was the doing of the MoHFW along with the Act as an important piece of legislation. To gain traction in making a healthier nation, it was imperative to have a framework where a universal regulation of all the relevant aspects related to medicinal drugs could be looked into.

The Regulatory Framework

In a nutshell, this whole regulatory framework can be divided into seven major heads and they are as under:

  1. Important Definitions.
  2. The Authorities Involved.
  3. Role of the EC for the Clinical Trial, Bioavailability and Bioequivalence Study.
  4. Clinical Trial on New Drugs and Investigational New Drugs.
  5. Compensation.
  6. Manufacture of New Drug or Investigational New Drug for the purpose of Clinical Trial.
  7. Importation of New Drug for Sale or Distribution.[26]

Thus to give a complete view of the New Rules these abovementioned heads would need to be considered and one would get the intention of this legislation as to why this regulatory framework was even brought in the first place.

Important Definitions

Before taking the discussion any further, one should be apprised of some key definitions which are laid down in the New Rules, 2019 and it has been dealt with in Rule 2 which contains all the relevant definitions and some of which are mentioned below:

  1. 2(1) (c): Active Pharmaceutical Ingredient means “any substance which can be used in a pharmaceutical formulation with the intention to provide pharmacological activity; or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease; or to have direct effect in restoring, correcting or modifying physiological functions in human beings or animals.”[27]
  2. 2(1) (h): Biomedical and Health Research means “research including studies on basic, applied and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioural); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not include clinical trial as has been defined in clause (j).”[28]
  3. 2(1)(j): Clinical Trial in relation to a new drug or investigational new drug means “any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying the following:
  4. Clinical or;
  5. Pharmacological including pharmacodynamics, pharmacokineticsor;
  6. Adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.”[29]
  7. 2(1)(o): Ethics Committee means, for the purpose of:
  8. Clinical trial, a committee constituted under Rule 7 and registered under Rule 8 of the New Rules, 2019;
  9. Biomedical and Health research, a committee constituted under Rule 16 and registered under Rule 17 of the New Rules, 2019.[30]
  10. 2(1)(r): Investigational New Drug means “a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.”[31]
  11. 2(1) (hh): Sponsor “includes a person, a company or an institution or an organization responsible for initiation and management of a clinical trial.”[32]

A bare reading of some of these crucial definitions provides us with an idea of the scope of this regulatory framework which deals with a clinical trial of a new drug and how it would create an impact over a common person. For the sake of brevity, the definition of a new drug isn’t mentioned above as it is not much different from the one mentioned in the Rules.

Authorities Involved

As provided under Chapter II of the New Rules, 2019 there is a mandate for having a Central Licensing Authority (“CLA”) and DCGI, India appointed by the Central Government in the MoHFW which shall be the said authority under Rule 3.[33]

Further, there is also a provision present which specifies the necessity of having a Controlling Officer on whom the powers would be delegated by the DCGI and the said officer shall not be below the rank of Assistant Drugs Controller, India under Rule 5 of the New Rules, 2019.[34]

Role of the EC for the Clinical Trial, Bioavailability and Bioequivalence Study

Conducting any clinical trial on a human subject would not ever be feasible until and unless there is a monitoring body of individuals so as to ensure no harm is caused to the concerned person and for this reason, there is a mandate of having an EC on board and the same is given in Chapter III of the New Rules, 2019. Before going on to elucidating the role of the EC in this regulatory framework, it would be pertinent to know the need for having such a committee in this regulatory framework.

The founding principle behind having an EC is based upon the “Wma Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects” which came about in 1964 and has been amended on several occasions. The Preamble of this declaration at the very outset states that the whole declaration is a set of statements of ethical principles for the conduction of medical research involving the human subject. This is further seen in the ensuing general principles which begin on a note of promise that how a physician must act in accordance with the patient’s best interest and ultimately provide a safe harbour to the subjects. Also kept in high regard are the overall safety and the basic rights of the patient which cannot be compromised with.

It is, therefore, a matter of necessity that ethics in medical research is kept on the forefront and having a separate EC only further the objectives of such declarations. Thus in order for someone to conduct a clinical trial or bioavailability study or bioequivalence study, it is mandatory to get the approval of the EC as laid down in Rule 6.[35]

Rule 7 of the New Rules, 2019 deals with the constitution of the EC and there is a requirement of having a minimum of seven members from varied backgrounds which include medical, non-medical, scientific and non-scientific and it should consist of:

  1. One lay person.
  2. One woman member.
  3. One legal expert.
  4. One independent member from any other related field such as a social scientist or a representative of non-governmental voluntary agency or philosopher or ethicist or theologian.[36]

Other requirements of forming this committee include but not limited to having at least one member having primary interest in a non-scientific subject matter and one person being independent of the institution under sub-rule (5) of Rule 7. Also, another requirement is compliance with the ‘Good Clinical Practices Guidelines’ and other regulatory requirements for the betterment of the trial subjects under sub-rule (6) of Rule 7.[37]

The requirement of registration and the subsequent process is given in Rule 8 which in a nutshell says that the application for registration is to be made to the CLA with the submission of Form CT-101 and the said authority must scrutinize the application and conduct a further enquiry in case necessary.[38] Once the registration is approved it lasts for a period of five years unless it gets suspended or cancelled by CLA under Rule 9.[39]

This doesn’t end here as the functions of EC are laid down in Rule 11 which says that the following functions must be performed while conducting a clinical trial for an individual, institution or organization such as:

  1. To review and approve of a clinical trial, bioavailability or bioequivalence study protocol and other such documents in a specific format and ensure that the rights and safety of the trial subjects are not violated.
  2. Making a review of on-going clinical trials at appropriate intervals and maintaining a periodic study progress report.
  3. In the event of any serious adverse impact upon the trial subject, the EC shall analyse the relevant documents relating to such events and forward the same to CLA for scrutiny.
  4. If at any stage it is opined or seen that the conduction of such clinical trial would likely result in a compromise of the rights or safety of the trial subject may order the discontinuation of the clinical trial.
  5. Providing allowance to any officer authorized by CLA to enter with, or without prior notice, to inspect the premises, any record or document relating to clinical trial and furnish such information to any query made by such authorized person with regard to the conduct of the clinical trial.[40]

Moving along further, Rule 12 enumerates about the Proceedings of EC for clinical trial and it states that no such trial or any related document shall be reviewed by the EC unless at least five members are present such being –

  1. Medical Scientist (preferably a pharmacologist);
  2. Clinician;
  3. Legal Expert;
  4. Social Scientist or representative of non-governmental voluntary agency or philosopher or ethicist or
  5. Theologian or a similar person;
  6. Lay person.[41]

Maintenance of data and other related documents with regards to the functioning and review of clinical trial shall be borne by the EC as stated in Rule 14.[42] In essence, the work of an EC is to ensure that the clinical trial is conducted with taking all the necessary precautions and due diligence because safeguarding the basic human rights and wellbeing of the human participant in such trial is of utmost priority.

Clinical Trial on New Drugs and Investigational New Drugs

The New Rules, 2019 is cantered upon Clinical Trials of New Drugs which would ultimately act as a panacea to the human sufferings and thus not only knowing the definition but getting to be acquainted by the whole process of conducting clinical trials on new drugs cannot be ignored. Chapter V of the New Rules, 2019 deals with the same aspect.

Rule 19 lays down the basic groundwork by mentioning that the conduction of clinical trials of a new drug or investigational new drug cannot be conducted by any person or institution or organization unless the following factors are met:

  1. It should be in accordance with the mandate of the CLA;
  2. It should be conducted by following proper protocols mentioned by the EC registered under Rule 8.
  3. There is a bar on all such persons or organization to conduct any such clinical trials which are in derogation with the provisions of these rules.[43]

Rule 21 educates us about the procedure for seeking permission to conduct such clinical trials and it is required to make a proper application to the CLA in the prescribed form CT-04.[44]

Further Rule 22 explains the situation wherein the application after thorough scrutiny by the CLA gets accepted and the permission is granted to the applicant to conduct a clinical trial for a new drug or new investigational drug. However, if the CLA comes across any deficiency in the application, the same is intimated to the applicant for carrying out the necessary rectification.[45]

Rule 23 talks about those drugs which are discovered in India or the research and development is carried out in India be it new drugs or new investigational drugs and such application must be disposed of within thirty working days from the first receipt of the application by the CLA. Also in case, the CLA doesn’t get the required communication by the applicant within the said timeframe the application then is deemed to have been accepted, and thus the process of Clinical Trial would commence.[46]

Rule 24 specifically talks about the drug which is not produced in India and the application procedure is pretty much the same albeit the disposal period of the application, in this case, are ninety days.[47]

One of the important provisions is relating to the condition for grant of permission to conduct the clinical trial and some of the conditions enlisted in Rule 25 are mentioned below:

  1. Approval of the clinical trial protocol is a must to initiate clinical trial proceedings.
  2. The requirement of having EC at every clinical trial site
  3. Mandatory registration of Clinical Trial by the CTRI as maintained by the ICMR.
  4. Submission of six months status report on the clinical trial with regards to its progression or termination to the CLA
  5. Giving report to the CLA in case of any serious adverse event that may take place in a clinical trial within fourteen days of such an event.[48]

Compensation

As was seen in the Helsinki Declaration wherein the underlying principles were based on basic human and medical ethics, the whole process of a clinical trial is something which is given a very serious deliberation. It isn’t something to be conducted without taking due diligence and if any untoward incident happens to any trial subject then it brings along serious ramifications to those who conduct such trials. Keeping this scenario in mind, there has been laid down a separate chapter on the issue of Compensation in Chapter VI of the New Rules, 2019.

Rule 39 states that in case a death occurs to a trial subject while an on-going clinical trial, it is the right of the legal heir to be financially compensated by the sponsor or its representative who had obtained permission to conduct the clinical trial. The same is also the case if any permanent disability or injury is caused to a trial subject, financial compensation must be provided under sub-rule (2) of Rule 39.[49]

Rule 40 specifically talks about providing free medical management to the trial subject in the event of an injury for as long as the subject requires as per the opinion of the investigator.[50]

Manufacture of New Drug or Investigational New Drug for the purpose of Clinical Trial

Rule 52 casts a restriction upon any person from the manufacturing of a new drug or investigational new drug for the purpose of conducting clinical trial without seeking permission of manufacturing from CLA. Form CT-10 is required to be duly filled and submitted to the CLA in order to seek permission to manufacture a new drug or an investigational new drug to conduct a clinical trial.[51]

Once the permission is granted by the CLA, a period of validity is for three years from the date of issue, however, it could be subjected to annulment or suspended by the CLA.[52]

Rule 55 enlists certain conditions for getting the permission and some of them are such as the permit holder must not sell any part of the drug in the market or to any person or institution, the permit holder must keep a tab on the supplies of the new drugs that are manufactured and distributed for clinical trials and when any new drug manufactured for clinical trial purpose is found to be of sub-standard quality, the same shall be destroyed.[53]

Import or Manufacture of New Drug for Sale or for Distribution

Chapter X of the New Rules, 2019 deals with the importation and manufacture of a new drug for sale or distribution. This is the stage when a new drug needs to be brought about in the market for commercial purposes.

Rule 75 requires a person who intends to import a new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation for sale or distribution in India to make an application in Form CT-18 along with the payment of the requisite fee to the CLA.[54]

The conditions for seeking approval to import new drugs in order to sell or distribute these drugs have been laid down under Rule 77 of the New Rules, 2019 and must comply with the following conditions:

  1. They shall conform to the specifications laid by CLA
  2. Labelling must be done according to the Act.
  3. Only those claims must be made which are approved by CLA
  4. The packaging must contain the following “WARNING: To be sold by retail on the prescription of a ……………only” which shall be in a red box;
  5. With every import it must contain a test or analysis report of the drug.[55]

Similarly, the conditions aren’t much different when the permission would be sought to manufacture new drugs for sale or distribution under Rule 80 of the New Rules, 2019.[56]

In search for a vaccine

As the world is coming to terms with tackling the brutal attack of the COVID – 19 viruses, the fight to find a suitable and full proof vaccine has been rampant and some of the leading countries of the world are at the forefront, at least twelve in number.[57] Right from Oxford University to China, where this whole saga emerged, India is also making big strides forward in order to come up with a vaccine. To this effect, two candidates have emerged namely Bharat Biotech and Zydus Cadila. As claimed by the World Health Organization Director-General, Mr. Tedros Adhanom Ghebreyesus, that “the near future doesn’t give bright hopes and COVID – 19 isn’t going to die down soon.”[58] Thus it is imperative that a feasible solution is found because the death toll is on a momentous rise. Representing India’s fight are two candidates, one is COVAXIN being developed by Bharat Biotech, a company which was founded in 1996, and Zydus Cadila and its own ZyCoV-D. Recently both these pharmaceutical companies have sought permission from the central drug regulator of India that is the DCGI to begin human clinical trials. However, the expedited approach is desired by the two candidates yet the Principal Scientific Advisor to the government Professor K Vijay Raghavan has equivocally said that the clinical trial process won’t be compromised merely to expedite the drug manufacturing.[59] Also in the global front, a vaccine called Remdesivir which was originally developed by Gilead Sciences, a United States of America pharma company is being allowed for treating the COVID – 19 infected patients in India as an “investigational therapy” under emergency-use authorisation[60] and added to this the Sechenov First Moscow State Medical University in Russia has emerged to have successfully completed the human trial for the first COVID – 19 vaccines in the world.[61] Coming from a country like Russia where the confirmed cases of COVID – 19 stands at about seven and a half lakh and overall being fourth in rank, this definitely offers a ray of hope.

CONCLUSION

With the culmination of this research one thing that can be opined to a fair degree of certainty is the impression where the purchase of a drug is something beyond the monetary factor involved from a consumer’s perspective. Rather we can say that the process right from the initial stage of conceptualization of the vaccine to its actual manufacturing and a whole lot of deliberations that are involved in the testing process so that the end product efficaciously serves the ultimate purpose of mitigating an individual’s ailments. One thing that this global pandemic has educated us about is the significance of principal health establishments of our nation. The immensely vital role that they have played thus far in overseeing a medical catastrophe like COVID-19 and in this regard getting acquainted with institutions such as CDSCO, DCGI and ICMR has shown that it was indeed a commendable effort of the policymakers who thought of including these as part of the central framework of medical organizations. Along with this two other chief pieces of legislations namely the previously deliberated ICMR Guidelines, 2017 and the New Rules, 2019 pertaining to the clinical trials have put forward to us that our nation in terms of the policy framework is quite well equipped to tackle this unprecedented state of affairs. Globally it has been well documented that the pursuit of finding a workable solution to this contagious and communicable virus has not just posed a scientific conundrum but also made the policymakers think on their feet so as to avoid any further deterrence in reaching out to the ultimate cure. It will definitely take time to find a workable response to such an intricate health concern and therefore having an all-inclusive outlook would only further the cause of eradicating this COVID-19 pandemic.                    

[1] CDSCO, (Jul. 14, 2020, 19:26 PM), https://cdsco.gov.in/opencms/opencms/en/About-us/Introduction/

[2] CDSCO, (Jul. 14, 2020, 19:26 PM), https://cdsco.gov.in/opencms/opencms/en/About-us/Functions/

[3] The Drugs and Cosmetics Act, 1940, §. 5.

[4] Id.

[5] The Drugs and Cosmetics Act, 1940, §. 7.

[6] The Drugs and Cosmetics Rules, 1945.

[7] The Drugs and Cosmetics Rules, 1945, Rule 122-E.

[8] CDSCO, (Jul. 12, 2020, 11:10 AM), https://cdsco.gov.in/opencms/opencms/en/Drugs/New-Drugs/.html

[9] The Drugs and Cosmetics Rules, 1945, Rule 122-A.

[10] The Drugs and Cosmetics Rules, 1945, Rule 122-B.

[11] The Drugs and Cosmetics Rules, 1945, Rule 122-DA.

[12] The Drugs and Cosmetics Rules, 1945, Rule 122-DAB.

[13] The Drugs and Cosmetics Rules, 1945, Rule 122-DD.

[14] ICMR, (Jul. 12, 2020, 11:10 AM), https://main.icmr.nic.in/content/about-us

[15] Id.

[16] ICMR, (Jul. 13, 2020, 12:00 PM), https://main.icmr.nic.in/content/vision-mission

[17] ICMR, (Jul. 10, 2020, 09:00 AM), https://main.icmr.nic.in/content/mandate

[18] Id. at 15.

[19] ICMR Official Website, (Jul. 11, 2020, 15:00 PM), https://main.icmr.nic.in/content/committees-0

[20] ICMR, National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, ( Jul. 1, 2020, 13:00 PM), https://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf

[21] Id. at Pg. 27.

[22] Id. at Pg. 33.

[23] Id. at Pg. 69.

[24] Id. at Pg. 69 & 70.

[25] Puja Mehra, India’s economy needs big dose of health spending, Livemint (Apr 08, 2020, 10:52 PM), https://www.livemint.com/news/india/india-s-economy-needs-big-dose-of-health-spending 11586365603651.html

[26] The New Drugs and Clinical Trials Rules, 2019.

[27] The New Drugs and Clinical Trials Rules, 2019, Rule 2(1) (c).

[28] The New Drugs and Clinical Trials Rules, 2019, Rule 2(1) (h).

[29] The New Drugs and Clinical Trials Rules, 2019, Rule 2(1) (j).

[30] The New Drugs and Clinical Trials Rules, 2019, Rule 2(1) (o).

[31] The New Drugs and Clinical Trials Rules, 2019, Rule 2(1) (r).

[32] The New Drugs and Clinical Trials Rules, 2019, Rule 2(1) (hh).

[33] The New Drugs and Clinical Trials Rules, 2019, Rule 3.

[34] The New Drugs and Clinical Trials Rules, 2019, Rule 5.

[35] The New Drugs and Clinical Trials Rules, 2019, Rule 6.

[36] The New Drugs and Clinical Trials Rules, 2019, Rule 7.

[37] Id.

[38] The New Drugs and Clinical Trials Rules, 2019, Rule 8.

[39] The New Drugs and Clinical Trials Rules, 2019, Rule 9.

[40] The New Drugs and Clinical Trials Rules, 2019, Rule 11.

[41] The New Drugs and Clinical Trials Rules, 2019, Rule 12.

[42] The New Drugs and Clinical Trials Rules, 2019, Rule 14.

[43] The New Drugs and Clinical Trials Rules, 2019, Rule 19.

[44] The New Drugs and Clinical Trials Rules, 2019, Rule 21.

[45] The New Drugs and Clinical Trials Rules, 2019, Rule 22.

[46] The New Drugs and Clinical Trials Rules, 2019, Rule 23.

[47] The New Drugs and Clinical Trials Rules, 2019, Rule 24.

[48] The New Drugs and Clinical Trials Rules, 2019, Rule 25.

[49] The New Drugs and Clinical Trials Rules, 2019, Rule 39.

[50] The New Drugs and Clinical Trials Rules, 2019, Rule 40.

[51] The New Drugs and Clinical Trials Rules, 2019, Rule 52.

[52] The New Drugs and Clinical Trials Rules, 2019, Rule 54.

[53] The New Drugs and Clinical Trials Rules, 2019, Rule 55.

[54] The New Drugs and Clinical Trials Rules, 2019, Rule 75.

[55] The New Drugs and Clinical Trials Rules, 2019, Rule 77.

[56] The New Drugs and Clinical Trials Rules, 2019, Rule 80.

[57] Dipu Rai, The vaccine candidates that come as a ray of hope during the Covid pandemic, India Today (July 11, 2020, 17:49 PM), https://www.indiatoday.in/diu/story/the-vaccine-candidates-that-come-as-a-ray-of-hope-during-the-covid-pandemic-1699506-2020-07-11

[58] Scroll Staff, Covid-19: WHO says no return to normal for foreseeable future, chastises leaders for mixed messages, Scroll (July 14, 2020, 10:00 PM), https://scroll.in/latest/967430/covid-19-who-says-no-return-to-normal-for-foreseeable-future-chastises-leaders-for-mixed-messages

[59] Press Trust of India, India COVID-19 vaccine trials: No compromise on rigorous evaluation, says Scientific Advisor Vijay Raghavan, The Financial Express (July 10, 2020, 09:28 PM), https://www.financialexpress.com/lifestyle/health/india-covid-19-vaccine-trials-no-compromise-on-rigorous-evaluation-says-scientific-advisor-vijayraghavan/2020284/

[60] Abantika Ghosh, Govt ‘reviewing’ remdesivir use for Covid after hospitals report liver damage in patients, The Print ( Jul. 3, 2020, 20:50 PM), https://theprint.in/health/govt-reviewing-remdesivir-use-for-covid-after-hospitals-report-liver-damage-in-patients/454169/

[61] DH Web Desk, Russia completes Human Trials of World’s first Covid-19 vaccine, Deccan Herald (July 13, 2020, 04:04 PM),https://www.deccanherald.com/science-and-environment/russia-completes-human-trials-of-worlds-first-covid-19-vaccine-860577.html

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