History Of Clinical Trials Rules


All of us who are concerned with or interested in the clinical research field of our country would be aware of the New Drugs and Clinical Trials Rules 2019 that have been in effect since 19 March 2019. But, the journey of clinical trials hasn’t been easy to reach the level where it stands today. There have been lots of ups and downs in the journey, ever since the rules that were set up in the year 1945. There were also lots of amendments made after which we see the current rules that are being abided by so carefully in India. Let us take a look at this difficult and challenging journey that our clinical trials have been through since.

1945 – The first rules for clinical research came up in 1945, where the trials were conducted in accordance with the requirements set out in Schedule Y of the Drugs and Cosmetics Rules 1945. But, there were concerns regarding patient safety and compensation provided to the patients in cases of adverse effects suffered during the participation in clinical trials.

2013 – A Public Interest Litigation (PIL) was filed in the year 2012 by a patient-centric NGO before the Supreme Court of India, claiming malpractices in the conduct of clinical trials by both governmental and non-governmental organizations. As a response to this PIL, certain amendments were made to the rules to regulate the clinical trials conducted in India, and confirm that the approvals were based on all relevant aspects of safety and efficacy. As per the modified rules, there was provision for compensation to an affected participant in case of death or injury during the trial. Also, the new rules included the requirement of obtaining approval by an Ethics Committee, registration of the trial with the Clinical Trials Registry of India, and submission of reports of serious adverse events.

2018 – Then, in 2018, the draft of the current rules was published. Drafted on 1st February, 45 days were given to the stakeholders to send comments on these rules. However, there was much delay in considering the rules and finalizing them; which finally were confirmed and notified on 19 March 2019.

The current clinical trials rules

Now, the latest rules, named as the new Drugs And Clinical Trials Rules 2019, aim to promote clinical research in India through transparent and faster approval processes. As per these rules,

  • Any drugs discovered in India will be deemed approved within 30 working days.
  • Any drugs developed and approved of outside India will be approved to be used in India within 90 working days.
  • Any drug that needs to be used for the first time on a patient will be provided free of cost by the sponsor.
  • Any drugs permitted to be imported in India for sale and distribution needn’t require a clinical trial to be executed in India again.
  • For application for conduct of clinical trials for orphan drugs, there will be no fee charged.
  • In case of any injury caused to the participant because of the clinical trial, medical management will be provided as long as required.
  • In case of death or permanent disability of the participant because of the clinical trial, compensation to the participant will be decided upon by the Drug Controller General of India.

With these incredibly helpful rules having been set up this year, the clinical research industry is all set to boost, making India the next clinical trial ground for foreign companies. Use this opportunity to set up a successful career in clinical research by enrolling at Avigna Clinical Research Institute and getting the best clinical research training in Bangalore!