Introduction:
Medical Research and Drug Development process is of significant nature and as well requires extreme care. There is no legit excuse for any type of error. So in order to ensure that research and results are safe, Clinical Trail takes place. Basically, Clinical Trial is a customary set of practice, which helps to certify a new drug molecule as Proper, Safe, Valuable and Effective, before that particular drug reach in the market. The process of Clinical Trial involves, as any research which is conducted, will assign Human Participants or group of Humans, as to the health-related interventions, so in order to evaluate the research effects.
Clinical interventions comprise drugs, cells, and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. Criminal Trials are considered as Necessary and Requisite component in the Drug Development Process, which has been recognized and acknowledged by Ministry of Health & Family Welfare (MoH), the ministry in charge of drug regulations and the CDSCO, which serves as the central authority for discharging functions of the Central Government under the DCA and DCR.
Developments in Clinical Trials
The process of change in regulatory in India took place with the 59th Report of Parliamentary Standing Committee on Health & Family Welfare on the functioning of the CDSCO in the year 2012. The check and analysis by the PSC’s on the situation of Public Outcry in India, especially for vulnerable and weak population, which includes tribal, children, women, mentally and physically challenged, as they were treated as Guinea Pigs, and this practice was extremely publicized and exposed by NGO’s and Media, and a large number of PIL were also filed, one of the high profile case, which was filed in Supreme Court was Swasthaya Adhikar Manch Vs Union of India & Ors [1].
As regulatory approval process in India was halt mostly and because of this the government issued multiple orders, because of this reason, in the year 2014-15, there was a further decline in Criminal Trials in India, as international sponsors, considered that rapid and frequent changes in the regulatory, is non-transparent and random. In order to ensure the compliances with Schedule Y, a technical, apex, and an expert committee was constituted. Newly released guidelines, includes, covering the Compensation Point, which has the Formula to determine the quantum of compensations for death during Clinical Trials, new regulations also include medical management for all Clinical Trials, and also include reporting of serious events, video recording of the consent process, compulsory registration of Ethics Committee. Although many amendments were made in the regulations from time to time, and this had shaken the confidence of International Sponsors.
In the year 2016, the Prime Minister Office announced that, in order to promote the economic and social growth perspective of India, certain amendments and changes need to be made in the regulations, as to make into a major hub for both manufacturing pharmaceuticals as well as innovation in medical research.
Another initiative was also introduced by the government as Digital India and Ease of Doing Business in India, as for the expansion purpose of the digital portal for online Clinical Trial Applications. In 2018, a draft for New Drugs and Clinical Trials Rules, 20189 (draft CT Rules) under DCA were published with an aim to have separate, simplified, and comprehensive regulations for new drugs and CTs.
The provisions include, as to reduce the possibilities of any injury, delinking the causality of injuries with the accountability of the sponsor as to provide the medical management, the requirement to pay interim compensation by the sponsor within the time limit of 15 days of the receipt of Ethics Committee notice, provision of post-trial access was also included, and this need to be provided by the sponsor to Clinical Trial, cost-free, only when such trial has no alternative therapy available and also the investigational new drug or new drug has been found to be beneficial to the trial subject by the investigator[2].
The draft indicates the healthcare prospective in India, by providing enhanced support for new drugs, which are projected to treat serious or life-threatening diseases.
New Drugs and Clinical Trial Rules, 2019
In the year 2019, the Ministry of Health and Family Welfare, and ultimately appropriated steps and rules in this regard and notified the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under the guidance of the Drugs and Cosmetics Act, 1940 (D&C Act), consequently getting an end to a long-drawn-out process to codify the rules applicable to clinical trials. Earlier, Clinical Trials were conducted in accordance with the requirements which are set out in the Schedule Y of the Drugs and Cosmetics Rules, 1945. As in 2012, a PIL was filed by a patient-centric NGO, before the Apex Court, for malpractices in the conduct of Clinical Trials by the Government and Non-Governmental Organisations, and also independent investigators, and Supreme Court stated that the approvals of clinical trials, should be based on the relevant parts of safety and efficiency, mostly in terms of assessing the risk versus benefit to the patients.[3]
Certain amendments were made in 2013, to regulate the clinical trials, which are conducted in India. Rule- 122 DAB was inserted in the D&C Rules, and it provides for payment of compensation to affected criminal trial subject, as in case of injury or death, during a clinical trial. The quantum of compensation was to be determined by the Licensing Authority.
Rule 2(w) defines a “new drug” to include, ‘a drug, which includes active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent’, ‘a drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims’, ‘a fixed-dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio’, ‘a modified or sustained-release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority’, or ‘a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell-derived product, gene therapeutic product or xenografts, intended to be used as drug’. Stem cell-based products are, therefore, also deemed to be “new drugs” under the NDCT Rules
Conclusion
As NDCT rules have replaced Part XA and Schedule Y of the D& C Rules and new rules regulate the proper recognition of components of New Drugs and Clinical Trials, as this leads to greater transparency and organization, in the regulatory requirements as for conducting the clinical trials in India. The major concern issue is in concern that the D&C Act is completely silent on the issue of compensation and the major issue is with the compensation formula, which is contained in the NDCT rules.
References:
[1] Writ Petition (WP) 33 of 2012
[2] Krishna Sarma and Manisha Singh, ‘https://www.fdli.org/2018/10/clinical-trials-in-india/’
https://www.fdli.org/2018/10/clinical-trials-in-india/
[3] Swasthya Adhikar Manch, Indore & Anr. Vs. Ministry of Health & Welfare and Ors., W.P. (C) 33/2012.
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