Hailing multiregional clinical trials as a good option to generate data in C-19 pandemic, the Drugs Controller General of India (DCGI) has called on stakeholders in India to initiate early stages of clinical trials to get market access to global drugs in a timely manner.

Dr. VG Somani, DCGI CDSCO

Speaking at Organisation of Pharmaceutical Producers of India (OPPI)’s annual summit, “Changing frontiers of healthcare research in a dynamic and digitized world”, DCGI Dr V G Somani said, “Most of the innovative drugs goes under robust multiregional clinical trial process to include diverse set of patients which gives specifically optimal data and there is no variability anticipated in response to disease pathology then multiregional clinical trial data may become may become robust tool to enable simultaneous access of drug without the need of undergoing similar set of additional clinical trial which helps in rationalising cost and resources.”

Drug development has become more complex with advancement of evolving scientific principles and enhanced understanding of pathophysiology of diseases and development of new medicines following complex clinical development paths.

As earlier explained, many of these are targeting specific ailments of disease pathology depending upon molecular biology and sometimes very disease specific targets, he said.

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Globally there has been transformation in drug development. To adopt quickly adaptive design, enable fast track launches and reliance on data generated multiregional clinical trials without compromising on quality, safety and compliance to regulatory standards was crucial for fast-track launches, he added.

While accessing multiregional clinical trial data, there are no major differences, stakeholders, scientists and regulators have little bit of challenge because of definitive factors like differences in local standards of care, ethnic difference, genetic differences.

In the past clinical trials for the purpose of regulatory approval of the drugs in various countries like Asian countries conducted independently from those countries like the US because of ethnic differences among population which might affect the drug responses, efficacy and safety, added DCGI.

Strategic clinical trials in one region followed by similar development in subsequent regions, used to result in duplication of studies and delayed development of drugs with late market access or access to patients in subsequent regions, he pointed out.

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This took place in various countries. To increase efficacy of drug development and minimize the duplication of unwanted things, the guidelines on ethnic difference in acceptability of foreign clinical trial data was established by ICH of the technical requirement of pharmaceuticals and followed by regulatory implementation in various countries including US, Japan, EU, India, he stated.

He emphasized the need to develop guidelines where there is lack of clarity to make the existing guidelines more efficient.

He also stressed the need to have dynamism in detailing of clinical toxicology studies, clinical development and post marketing authorisation studies, and how digital technologies, AI also help in this regard which India utilised to a large extent during the C-19-period.

During pandemic patients were not able to visit the trial site and doctors were not able to see the patients, but still the clinical trial data valuation was necessary. In those cases, digital technology helps to do those things, MRCT would be a good option for data generation, he said.

“This is not too simple, several factors must be considered for the success of MRCT, if a good outcome is needed from it. We need to take care of regional differences, scientific and general ones, technical expertise, standard of care and attitude, resources etc.

If these differences are considered and managed with local standard operating practices instead of disturbing the entire MRCT protocol, MRCT can be a good approach,” said Dr Somani.

“Regulatory environment must be supportive to make MRCT a success. In India there are New Drugs and Clinical Trials Rules which gives a lot of flexibility.

We encourage people to start early stages of clinical development, so the early data generation can give access to the global product which can serve the needs of the patients,” he added.

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