07/04/2020 - Health

KEY POINTS

·         The government is considering temporarily relaxing clinical trial norms as a few pharmaceutical companies are looking to develop a vaccine for the novel coronavirus (Covid-19).
The Central Drugs Standard Control Organisation (CDSCO) said in a notification that various challenges might arise during the conduct of clinical trials in the wake of the outbreak of Covid-19, which could lead to difficulties in complete adherence to the approved protocol and regulatory provisions.

·         The regulatory authority said while the rights, safety, and well-being of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.

·         The industry needs such relaxations are required for the ongoing clinical trial programmes on Covid-19, as well as the fresh ones.

·         Currently, Cadila Healthcare and Serum Institute of India are working on a vaccine for Covid-19. These projects are in the pre-clinical stage, but human trials will start eventually.

·         With the viral outbreak reaching Stage 3 of the pandemic (which implies transmission within the community where the source of the infection cannot be easily traced) in most countries, it is imperative to fast-track research on the same. Global research bodies have already indicated that in 2020, there would be several human clinical trials across the globe.

·         While most experts feel that commercialising any Covid-19 vaccine is unlikely before FY22, Zydus is working round the clock to develop a vaccine at the earliest. The recombinant measles vaccine will induce long-term neutralising antibodies that will protect against infection.

·         As such India has a stringent regulatory environment for clinical trials. As a result, only 1.2 per cent of the global clinical trials take place in India.

A clinical trail is a research study  conducted on humans/animals to know the efficiency,side effects etc. of a  new drug/modified drug.The Central Drug Standard Control Organization's approval and ethics committee approval are the prerequisites for starting clinical trails in India.

Covid-19 and Importance of speediness in Clinical Trails : 

There is no vaccine/medicine till date for treating the patients infected with Covid-19.Many countries including India started trails for the discovery of vaccine.In India,Hyderabad based vaccine manufacturer Bharat-Biotech started developing vaccine and issued a statement that it is going to start human trails within 4 months.It takes several months after the discovery of drug to come into the market because of various norms in Clinical trails.Generally new drug/vaccine has to pass four phases before its usage.These norms are really essential keeping in mind the public health.But in these extra ordinary circumstances,the regulating authority CDSCO relaxed some norms mentioned under Drugs and Cosmetics Act,1940, which are not that much mandatory.

Steps taken by CDSCO for the speediness in Clinical Trails :

Taking in to consideration of the present situation,CDSCO relaxed around seven provisions which delay the process of clinical trails in India.These provisions include waving of drug effects on animals,decreasing the timeline for the approval of clinical trail applications,Easy import of drug compositions etc,.Already some of the stringent norms were eased in the recently released Drugs and Clinical Trails rules 2019.

Way forward :

In this scenario,speediness of clinical trails is one side of a coin and the safety of the individuals who came forward for the clinical trails including public health is the other side of the coin.Many clinical trails in India in the past accompanied with the exploitation and loss of precious lives especially the lives of people under below poverty line.So,Government of India needs to look at the both sides of the coin and has to act necessarily and even drug/vaccine manufacturers keeping the pandemic situation in mind should follow ethics and moralities.