Are Investigational New Drug Trials in India A Positive Sign For Healthcare

Are Investigational New Drug Trials in India A Positive Sign For Healthcare

On June 1st, 2021, the Indian Government announced the waiver of requiring prior India bridging clinical trials to be conducted for the US and UK-based vaccines for the novel COVID-19. This move comes in the midst of immense pressure faced by the Government due to the shortage of vaccines, where a huge section of the Indian population, including the youth, are left vulnerable. As this news brought a wave of relief among the general public, it also has caught the attention of Indian epidemiologists, regulators, researchers, and clinicians.

The move was applauded by the professionals in the closed groups of clinical trials management India has, as the decision would promote the efficiency of the healthcare system in the better interest of the general public, as well as frontline workers who are overwhelmed in the second wave of the grueling pandemic. However, two members of the National Institute of Medical Statistics, ICMR, Delhi have spoken about the scientific considerations of such a groundbreaking decision.

What are the grounds for such a waiver?

For the waiver of vaccine clinical trials in India to be considered, the trial must be found in the global pool of the International Clinical Trial Registry Platform by WHO, and the trial for such a drug must be registered in a clinical trial registry of the country of origin. Furthermore, there must be an elaborate disclosure of such drug trial results on the registry to consider the waiver. The waiver of vaccines and drugs may not be processed depending upon its permissibility in scientifically advanced nations like the USA. The priority lies on the level of scientific and research methodology, which should have parameters that take into consideration not just a particular section of the population, but also the global effects of consumption.

Being mentioned on the clinical trial registry vouches, the clinical trial management registry of India has access to all the data collected by WHO’s International Clinical Trials Registry Platform (IRCTP) database regarding Pfizer and Moderna vaccines. These points pertain to the research model, randomization allocation concealment, sample size, and the approval of the ethics committee along with the particulars of regulatory clearances. It makes a vaccine or drug credible scientifically since it has passed all the checkpoints and standards set by the WHO and national clinical trial body.

Do Clinicians and Researchers Have any Concerns Regarding Such Waivers?

There are a few concerns that were addressed by these professionals, stating that the drug bypassing the bridge trials in India may show some adverse effects on the Indian masses. There could be a possibility of the racial and genetic variations being a cause of both short and long-term adverse side effects of such vaccines and drugs widely approved by the WHO. In such instances where the probability cannot be ruled out, an opinion of the scientific committee before granting such waivers is necessary.

In the instance of the current case of India, the Central Drugs Standard Control Organization (CDSCO) is the body that heads clinical trial inspections, oversight, and approvals, while the Drug Controller General of India (DGCI) regulates CDSCO as per the 2019-CT Rules. The aforementioned authorities giving their approval for the importation of COVID-19 vaccines in India indicates that such considerations towards adverse side effects of the drugs on the Indian population have been scrutinized prior to the sanction of the waiver. Additionally, the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) made the recommendation of assessing the first hundred recipients of such emergency approved vaccines before it is given the nod for nationwide distribution, which has also been accepted by the Centre, guaranteeing that there are no angles overlooked.

Conclusion: Are There Trials that Do Not Qualify for Such Waivers?

As invigorating as the news has made the country and its citizens, there arises the question of such waivers being bestowed upon other lifesaving drugs that are still subject to strict protocol and scrutiny. However, drugs for diseases like cancer, H1N1, and HIV, trials do not qualify for the waiver. Drugs of such conditions that have proven evidence for their efficacy can be considered to be put through fast-tracked clinical trials. However, this requires extensive epidemiological as well as statistical research along with clinical parameters. The COVID-19 vaccine waiver may open doors to the possibility of other emergency drugs improving their research for global distribution, which gives us hope for the future, post-pandemic.

Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) 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, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) 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; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

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