Overview of Clinical Trials in India

Pharmaceutical Law and Regulations

Pharma companies focus on innovation and technology by developing strong strategy for scientific and clinical affairs. The professionals and consultants who work in the pharmaceutical sector assist healthcare companies by defining and supporting the various clinical activities. A company depends heavily on the right launch of current and future pharma products in the market. Consultants help the companies in development of clinical studies and scientific strategies to support the launch of pharma products, which are mostly accompanied with filing of pharma patents. The best practices include providing leadership, training and direction to the R&D team as per protocol requirements, preparing SOPs (standard operating procedures), and thoroughly reviewing the applicable laws and regulations.

During the initial few months of the coronavirus pandemic, the first line of defence was provided by non-pharmaceutical interventions (NPI), including lockdowns and face masks. While the world was coming to terms with newly discovered phrases like social distancing, home quarantine, self-isolation etc., the pharmaceutical companies were working non-stop behind the scenes to develop a viable vaccine candidate.

Under normal circumstances, the drug development process as per USFDA involves a minimum of five (5) steps, covering discovery, development, preclinical research, clinical research, FDA submissions and review, followed by post-market safety monitoring. These steps usually require a minimum of ten (10) years, out of which at least six (6) to seven (7) years are spent in the clinical trials.

For Covid-19, companies have been able to launch a vaccine in less than 12 months, that too when almost the entire world was battling with lockdown restrictions that impose a burden on freedom and come with a heavy financial cost. Before we rejoice a human being setting foot on Mars, let’s acknowledge this humongous feat achieved by the mankind.

The year 2021 has been full of extremes so far, wherein certain countries like the US and the EU nations are exploring the possibility of introducing “vaccine passports” before their borders are fully opened, while India is facing challenges on the clinical trials front. There have been numerous reports stating that the Bharat Biotech vaccine has been approved without the required efficacy data. In simple terms, efficacy refers to the characteristic of a vaccine to provide the intended or the desired result, in a safe manner. To understand the issues related to efficacy data requirements in India, one needs to review the clinical trial regulations along with the historical precedents.

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Pharmaceutical Laws and Regulations

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History of Clinical Trials in India

The Indian Council of Medical Research reflects the evolution and growth of medical research in the nation over the last nine decades. The Schedule Y of the Drugs and Cosmetics Act was enforced in 1988 and founded the regulatory protocols for Clinical Trial (CT) approvals. The schedule did compel the enterprise to administer Phase III clinical trials for enrolment of a new drug and aided the development of a largely generic Indian pharmaceutical business. Yet, this schedule solely licensed clinical trials at a phase shorter than its global significance. This phase lag hindered the integration of India in international clinical growth. Schedule Y was amended in 2005 to provide more practical descriptions for Phase I to IV. The descriptions and protocols for clinical trial stages are wide and practical. The initial limitations were eliminated enabling the sponsor company freedom to determine these in connection to protocol regulations. The phase lag regulations gave way to approval of concurrent Phase II-III as part of international clinical trials.

Current Legal Framework for Clinical Trials

As per the Drugs and Cosmetics Rules, new chemical commodities cannot be subject to clinical trials without authorization from the Drugs Controller General of India. For enlisting new drugs for commerce in India, submission of data developed on Indian subjects is vital. While performing research, educated consent is the fundamental tenet of clinical research principles. An ethically acceptable informed approval has four key components: disclosure, knowledge, willingness, and competence. Accordingly, the legislative framework administering medical examination in India include:

– The Drugs and Cosmetics Act – 1940 (Schedule Y)

– The Drugs And Cosmetics (II Amendment) Rules, 2005

– The ICMR guidelines, DBT guidelines

– The Medical Council of India Act – 1956

– The Central Council for Indian Medicine Act – 1970

– The Guidelines for Exchange of Biological Material

– The Right to Information Act, 2005

– The Constitution of India

– The Biomedical Research on Human Subjects (regulation, control, and safeguards) Acts, rules and codes of ethics of competent bodies governing the process of medicine, like the Medical Council of India, Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH). Bill – 2005

The New drugs and Clinical trials rule 2019 (New rules) was launched in 2019 to establish distinct regulations for establishment of ethics committes (EC). As stated therein, the EC must obey these regulations and forward their report to the Central Licensing Authority (CLA). The rules apply to all fresh drugs, investigational new drugs for human consumption, clinical examination, bioequivalence research, bioavailability survey, and Ethics Committee. They replace Part X-A and Schedule Y of Drugs and Cosmetics Rules, and the requirements of these rules supersede over all other rules. Further, the new drug descriptions were stretched to include modern therapeutic alternatives like SR (sustained release) / MR (modified release), Novel Drug Delivery Systems (NDDS), Living altered organisms, monoclonal antibodies, stem cell products, gene therapeutic derivatives, xenografts, etc.

As per the Rules, the requirement of waiver of local phase III clinical trials if the drug is authorized and traded in specific nations is subject to certain circumstances and confirming the conduct of Phase IV study. The Phase IV study law is decreased for drugs of particular relevancy, for rare ailments for which drugs are not accessible or are expensive. Animal toxicology, reproduction surveys, teratogenic researches, perinatal studies, mutagenicity, and carcinogenicity analyses may be amended and relieved for imported commodities if the new drug is accessible for more than 2 years in specific regions. In case of locally produced commodities, this relief may be authorized if the drug is traded in other regions for many years. 

Legal Challenges

Although laws concerning clinical trials have developed extensively to harmonize global rules, many challenges persist, wherein authorities are required to be approached to frequently, or the industry processes must be verified on numerous occasions. An important problem that a foreign sponsor encounters in India is the severe deficit of regulatory professionals.

Unlike FDA and EMEA, DCGI does not publish guidance reports furnishing the new understanding of the laws. In contrast, the DCGI’s statement is very subjective and founded on the knowledge of the regulatory specialists. The sponsors must be familiar with discrepancies in the Indian GCP version of ICH-GCP, including the Indian specifications for the creation of the EC, informed consent methods, payment for participation, as well as the functions and obligations of foreign sponsors performing clinical trials. At present, the laws do not allow first-in-man reviews (Phase I) for drugs found beyond India.

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