Union Health Minister Harsh Vardhan made an announcement that, apart from Covishield and Covaxin, there are around two dozen vaccines that are in the pre-clinical trial stages. As such, it has become imperative for us to understand the underlying medico-legal issues pertaining to clinical trials.
Clinical trials are a set of practices performed to certify and ensure the safety of a new drug molecule. After the amendment to the Indian Patents Act 1970 in January 2005, drugs could be now made by following both the product and process patenting. This has facilitated the emergence of India as a preferred and sought-after destination to conduct clinical trials. The availability of highly trained physicians, nurses and technical personnel and world class medical facilities in India has also added to the cause. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials as a “systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy of the new drug”.
It is no secret that a spate of new drugs and molecules are coming up in the market and these new drugs have been mostly tried on individuals and people from outside our country, belonging predominantly to the Caucasian race. The genetic background, the built of people of our country is very different from that in the Western world and in developed nations. Therefore, it becomes imperative that any medicine which doctors want to use on patients of Indian ethnicity, should be tried on patients from within the country so that they know the effective dosage level, and the side-effects which emerge out of these therapies. Hence, it is very essential that we conduct research and try these new molecules in a clinical setting on day-to-day basis in our country before doctors start recommending these medicines based totally on Western studies.
Until recently very few clinical trials were conducted in India due to regulatory restrictions faced by foreign pharmaceutical companies. However, the Government of India (“GoI”) has realized the potential benefits of conducting clinical trials in India and has amended various provisions of the Drugs and Cosmetics Act, 1940 (“D & C Act”) in 2005 to ease the regulatory restrictions and facilitate clinical trials. For example, the amendments define the term ‘clinical trials’ as well as prescribe the procedure of conducting clinical trials. In addition, the amendments outline responsibilities of sponsors, investigators and the Ethics Committees and has provided guidelines and procedures for the import of drugs for clinical trials into India.
In addition to the D & C Act, the National Medical Commission and the Central Council for Indian Medicine Act, 1970 also regulate the conduct of clinical trials in India. The Indian Council of Medical Research (“ICMR”), the apex regulatory body which regulates clinical trials in India, and was set up in order to promote research culture in India and improve and develop infrastructure for clinical trials. To conduct clinical trials in India approval from the Drugs Controller General of India (“DCGI”) is mandatory. Before the DCGI could approve companies to conduct clinical trials in India, it is compulsory for applicant companies to comply with the requirements for registration as provided by the ‘Pharmaceuticals for Human Use’, ‘International Conference on Harmonization’, and ‘Good Clinical Practices’. Based on the approval process of the DCGI, clinical trials are categorized into two types:
Phase I: In this phase, a new drug or treatment is tested on a small group of healthy people to determine safe dosage, study how the drug works in the body, and see if it has any side effects. The overall safety of the drug is not known during this phase.
Phase II: The drug or treatment can now be tested on a larger group of people to see if it is effective and to further test its overall safety. Rating scales are developed and used to record data during this phase.
Phase III: Now the drug or treatment is ready to be tested on even larger numbers of people. The study will look even more closely at the drug’s effectiveness, if it has any side effects, overall safety, and how it can improve a person’s quality of life. Most drugs that reach this phase are considered for approval.
Phase IV: Once regulatory approval is obtained, the trial can enter into the final phase, which involves monitoring the drug after it has been released to the public. In this phase, researchers look for additional information such as risks, benefits, and optimal or additional uses of the drug. In some cases, this phase is used to test the drug on a sub-group of people (such as patients over a certain age).
International agencies have put up good clinical trial practices and it is mandatory that we should also adopt those particular guidelines because they are reasonably good and are more useful in our country. There has to be an ethical committee before any drug is put to clinical trial. There should be adequate data of stage 1 and stage 2 trials as well as trial on animal model which should give adequate safety margin for the dosage level at which it is being now tried on human beings.
One of the problems in our country is that people may not be educated to the level where they can understand this concept. It is important that whatever clinical trials we conduct should be in the presence of a social worker. Each and every person who agrees to take part in the clinical trial should be informed and made to understand what it is all about, its benefits, the likely side effects, and the methods by which we can address the problems which one might face during the course of the trial. The next important thing is that people are not ‘guinea pigs’. If a trial takes place anywhere in the Western world, the patient is adequately compensated for putting himself through a certain amount of risk. In India, however, at times money is not given and at times even the monitoring is not done properly. Another striking point is that the vital parameters may be affected like liver function, kidney function, effect on heart, and certain enzyme systems. These are the issues which need to be carefully monitored and seen during the course of the drug trial.
WHAT IS ABOUT INFORMED CONSENT TO BE OBTAINED FROM THE VOLUNTEERS? All the subjects ought to be informed about the advantage, adverse effects and the method to be followed for the trial. Their follow-up is also a must. On the failure of any of the above criteria, the organisations conducting the trial becomes liable and that is where legal interference becomes inevitable. WHOM SHOULD THE VACCINE RECIPIENTS ADDRESS THEIR CONCERNS? In view of the present challenges owing to pandemic, I must reiterate that, in the interest of public health, any concern regarding the efficacy and safety of the vaccines against COVID-19 should be aptly addressed by the regulatory bodies including the Indian Council of Medical Research and the National Medical Council. We cannot win this war against the virus if we doubt the safeguarding weapons that are being given to us in the form of vaccines.
The first level at which the legal community need to get involved is at the level of ethics. Any company which plans to start a trial, has to first see that they have the data available, as well as all the safety parameters. To address any eventuality, there has to be a mechanism. Another issue is the confidentiality clause. One of the major reasons why our country does not get too many clinical trials is that we cannot keep the confidentiality of a trial.
The other issue when the legal fraternity gets involved is when there is a problem with the individual; it is the drug company’s responsibility to see that their confidentiality has to be maintained at the individual patient level. In our country, follow-up of the patient is rather poor. So if we want to ensure the follow-up of the patient and see that the trial is conducted for the adequate length of time which will decide whether the medicine is effective, then we have to ensure a methodology which reaches out to the patient so that he/ she understands that he/she is participating and will be compensated. Then the patient also treats it as his moral responsibility that he should follow the trial until and unless there is a reason for him to opt out.
At the moment, we have the Indian Council of Medical Research, which can allow the research protocols to be carried out. Most drug trials that take place in our country are the pre-marketing surveillance trials i.e., the affectivity of the drug has been proven in some other part of the world. For the academia, one difficulty is that there is no proper interaction. The academia’s interaction with the other parties should be at a level where they are made aware of the regulatory mechanism and also of the Guidelines for Good Clinical Practice (GCP). It is always ideal to conduct interaction between regulatory authorities and the medical academia. Most clinical trials depend on the time frame which involves waiting for regulatory approval and effective interaction can help reduce this time bracket.
As an endnote, in view of the present Government’s exuberance to gain political mileage, I find it pertinent to mention that there should be a transparent monitoring system by putting the trial results on a public domain under the Right to Information Act. Perhaps, monitoring of the COVID-19 vaccines can be bettered by forming a monitoring committee consisting of medico-legal experts, socially committed lawyers and government officials.
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