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ROLE OF CLINICAL REGULATION LAWS IN MAKING INDIA A HUB FOR HUMAN TRIAL

INTRODUCTION

Clinical trials or human trials are research initiatives that test drug behavioural intervention in humans before a drug is released in the market for public use. Clinical trials have become an essential step to introduce drugs into the market to combat various ailments. Clinical trials have been a point of contention in India, yet India’s clinical regulations since 2013, the Drugs and Clinical Trial Rules 2019[1] and the growing medical industry have made it a hub for human trials.[2] India’s clinical regulation laws allow for a streamlined regulatory process, whilst providing a cost-effective sample space for drug testing. Conducting clinical preliminaries puts India in a position to bargain more cost-effectively when the drug being tested is introduced in the Indian market. “India now has the potential to increase global clinical trials in the country by five times in the coming years.”[3]

Clinical Regulation laws were framed with the intent to help grow the medical industry in India, but have instead allowed for large pharma companies (private sector) to hold a monopoly with minimal government intervention. The joint report by PwC India and the US-India Chamber of Commerce states that the private sector in India is favourable for large biopharma companies to conduct clinical trials faster and more easily with access to a diverse group of patients. “India has an overall clinical trial participation of three per cent but contributes upwards of 15 per cent to the global burden of most highly prevalent diseases, representing an untapped potential for top pharma.”[4]  Essentially, the clinical regulatory laws paired with the lack of awareness amongst the majority of the population that participates in clinical trials, makes India an ideal hotspot for human trials.

CLINICAL REGULATION LAWS IN INDIA

Numerous laws and acts have been issued to govern clinical trials in India. The current regulatory standards are based on the rules set by the International Conference of Harmonization, which is led by the USA, Europe, and Japan. The Indian Council of Medical Research (ICMR) 1947, plays an essential role in governing clinical trials, which was drafted to help promote invention and an exploration culture in India’s medical field. “The Drugs and Cosmetics Act[5], The Medical Council of India (MCI) Act[6] expresses that all clinical trials in India should follow the ICMR rules of 2000.”[7]

Furthermore, the Drug Controller General of India is responsible for regulating administrative endorsements of Clinical trials in India. The ICMR also has a Central Ethics Committee on Human Research (CECHR) that monitors the functioning of the Institutional Ethics Committee (IEC). The clinical trials are controlled by Schedule Y of the Drugs and Cosmetics Rules, which are authorized by the DCGI’s office, which similarly oversees the management of all the clinical trial proposals submitted in India.

Although Clinical Regulation laws have been established in India, they have not always been successful in ensuring the fair conduct of the trial. Despite the initiation of moral surveys, clinical regulations are far from sufficient because not all Ethics Committees (EC) are lawfully administered. ECs have been found to lack an adequate number of staff members equipped with the proper skills to supervise exhaustive audits. The DCGI’s office is not prepared to even overview the existing clinical trials being conducted in India. There is also a lack of codification of clinical regulations, as the understanding of rules shifts upon crossing state borders.[8]

Moreover, the lack of codification allows for foreign pharmaceuticals to exploit and infringe upon clinical regulations set by the legal system, as seen in the case of GlaxoSmithKline Pharmaceuticals v Union of India.[9] The court’s ruling regarding the HPV vaccine in the case often acts as jurisprudence in the Indian judiciary and clarifies the responsibilities of sponsors, clinical researchers, etc. The lack of case law for clinical trials has stagnated the reformation of clinical regulation, which has in turn made it unsuited to conduct an ethical and efficient clinical trial. Further the shortage of judicial precedent on the liabilities in trials conducted in third countries, the Court’s ruling can facilitate clarifying and enforcing transnational obligations. The stagnated growth of the judiciary has led to numerous problems faced by the common citizens who partake in clinical trials. This raises alarming concerns regarding the sudden rise of clinical trials being conducted in India.[10]

PROBLEMS FACED DUE TO CURRENT CLINICAL REGULATION LAWS

The current Clinical Regulation laws are ill-equipped to deal with the large pharmaceuticals involved in clinical trials. Numerous health activists have raised concerns regarding the outsourcing of clinical trials, as pharmaceutical conducting the trials can choose to pay less attention to ethics. Pharmaceuticals often choose developing countries like India, as these countries tend to have a lack of uniformity in terms of accessibility to healthcare amongst the general population. This provides the false idea of clinical trials acting as the availability of healthcare amongst the poverty-stricken population, who may not possess the literacy to make an informed decision. “Furthermore, doctors tend to be held in high regard, which means that patients are not likely to question the suggestions made by medical professionals. Less care may be taken by doctors responsible for enrolling volunteers, for example, when their hospital budget is dependent on the number of trial participants.”[11] Essentially, patients may not be educated or aware of the situation, which affects the patient’s ability to assess risk as well. Large pharma companies can exploit this due to the disparity in the judiciary about moral liability held by clinical researchers and sponsors.

More so, patients are also acquired through the prospects of a last-resort treatment. Large pharmaceuticals will often set up a network with doctors and hospitals, who will in turn recommend to their terminally ill patients to join the clinical trial. The prospects of experimental treatment are the only option, as current Western medication has reached its limit. These patients are often not in the right state of mind to decide as they may be still grappling with their mortality. The shortage of proper specialists in Ethics Committees (EC) and regulatory laws allows pharmaceutical to pay less attention to the moral duty they owe to participating members.

In addition, people tend to participate in clinical trials due to monetary desperation. In countries like India, large pharmaceuticals have historically conducted clinical trials on patients usually from a low-income background. Large pharmaceutical will often offer money to these patients, incentivizing them to participate in clinical trial research. These people participate because of their need for money to sustain their livelihoods and often convince other family members to partake as well. The concerned citizens may not have the means to make an informed and educated decision, in turn allowing large pharmaceutical companies to acquire patients at a lower cost. Essentially, pharmaceutical can exploit the loopholes within the judiciary whilst conducting clinical trials.

CONCLUSION

In conclusion, there has been a surge in acceptance of clinical trials during and post-pandemic in India. An increase in clinical trials can be beneficial for the rapidly developing medical industry. The medical industry in India has gained attention across the world for its growing pharma industry (private sector). India’s regulatory reforms have helped attract foreign attention, making it a hub for human trials in recent times. The initiative to accept more clinical trials can play out to be beneficial for increased collaboration and the foundation of group bolster.

Despite making reforms over the years to the Clinical Regulatory laws, the lack of judicial precedent has hindered the legislation from making monumental changes to better the regulation laws. The loopholes in clinical regulations have led to numerous inefficiencies and human rights infringements. The lack of standardized regulations across the state has led to haphazard conduct by the likes of the Ethics Committee. Essentially, India’s role as a hub for clinical trials has provided it with an opportunity cost. India has the potential to grow its medical industry and better its infrastructure, but is presented with the opportunity cost of doing so with non-uniform regulations whilst sacrificing efficient moral conduct.

Author(s) Name: Ishaan Singhee (OP Jindal Global Law University, Sonipat)

Reference(s):

[1] New Drugs and Clinical Trial Rules 2019

[2] T Thacker, ‘India Emerging as a Top Destination for Clinical Trials, Says Report’ (The Economic Times) <https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/india-emerging-as-a-top destination-for-clinical-trials-says-report/articleshow/100022411.cms> accessed 11 June 2023

[3] ‘India Emerging as Favourable Destination to Conduct Global Clinical Trials: Report’ (The Economic Times) <https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/india-emerging-as-favourable-destination-to-conduct-global-clinical-trials-report/articleshow/99951510.cms> accessed 11 June 2023

[4] Ibid

[5] Drugs and Cosmetics Act 1940

[6] Medical Council of India Act 1956

[7] Sudha PS, ‘How Ethical Are Clinical Trials in India?’ (2007) 2(3) India Law Journal <https://www.indialawjournal.org/archives/volume2/issue_3/article_by_sreesudha.html> accessed 22 June 2023

[8] Ibid

[9] GlaxoSmithKline Pharmaceuticals v Union of India & Ors (2013) 2 SCC 753 

[10] ‘Human rights violations in clinical trials in India, the case of the HPV vaccination project’ (ECCHR) <https://www.ecchr.eu/fileadmin/Fallbeschreibungen/Case_Summary__Clinical_Trials__2014-02-11.pdf> accessed 11 June 2023

[11] Ibid