It may not have been his outright intention, but Dr Y.K. Gupta certainly set the scene and piqued the interest of the eager audience ready to receive information regarding multiple aspects of pharmacovigilance that would be lively debated throughout the following two days.

In his keynote speech, entitled, ”Indian Clinical Trial Safety Scenario Pre- & Post Schedule Y Amendment,”  Y.K. Gupta stated that the change in the clinical trial RULE (not guideline – he emphasised), would indeed need to embrace the DIA slogan to “Foster Innovation”. He explained that there was an intention to foster Industry and Academic collaboration within 250 PV centres throughout the country.

He explained the importance of being able predict drug safety aspects including, latent adverse events, combination drug-drug and drug–allopathic reactions, and those emerging in special patient populations. He explained that the field of pharmacogenomics was important as this would help to also predict the return on investment (ROI) relating to the cost of treatment as a whole.

The use of Artificial Intelligence (or as the charismatic Krishna Bahadursingh later described it – AUGMENTED Intelligence) would play an integral role in helping with these predictions; indeed, Dr Gupta explained, this was the direction in which Indian PV activities were heading.

In order to achieve breakthroughs in predictive safety measures, it is impossible to work in silos,” he explained, “therefore, industry, academia and regulatory authorities need to work together.

The audience learned that the new RULE that replaced the schedule Y was to be imminently implemented…..  Some of its salient features were described, including:

  • Better definition of an IND
  • Inclusion of Placebo as an investigational product (there is a need to provide compensation if the placebo causes an ADR)
  • Definition of Orphan drug (the disease occurs in less than five LAKH [500,000] persons in India) and the incentives including waived fees for conducting trials and fast tracked regulatory review.

Our keynote speaker explained that there were some aspects within the rule that had yet to be confirmed, and asked for “suggestions” (off line) from appropriate people in the audience and beyond.

These were mainly focused around post-trial responsibilities of the sponsor in patients in whom the drug was effective, and there was no alternative effective therapy.  Questions related to cases where patients were given access to the drug included:

  • for how long should this continue to be the sponsor responsibility
  • who should be liable for costs of therapy and any potential adverse events emerging given that no “post-marketing” experience was available.

Dr Gupta explained that under the new rule, the Ethics Committees will have more responsibilities.

Consequently, the Clinical Trials Committee requires members to be trained (valid for a period of 5 years), and disqualifications are possible if training is not valid. The delivery of National level training is yet to be determined.

The Biomedical Health Research Committee is responsible for non-regulatory trials, one of its duties is to determine who will give compensations.

Importantly, the committees need to function independently to the clinical trial sponsors, and that oversight should be local (i.e. within the vicinity of the trial centre as opposed to overseas).

Another aspect to encourage the “made in India” approach is the change to the decision timelines for NDA and IND permissions:

  • For discovery, research and manufacture within India, there is a 30-day period prior to decision of approval or rejection. In addition – if there is no decision received within the 30 days “approval” is implied.
  • For the same activities outside India, the waiting period is 90 days, but there is no implied approval for lack of response within the 90-day period.

So although there are still some wrinkles to iron out, the overall aim is to encourage more research and innovation of pharmaceutical agents within India.

Prior to the Opening Ceremony, the audience was treated to an inspiring DIA video loop. The statement, “DIA is where science, healthcare and regulators unite” was certainly demonstrated in this presentation and in all those that followed….

Image Credit: Jametlene Reskp – on unsplash

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