Government Trashes Requirement Of A 50 Bed Hospital For Clinical Trials

India undoubtedly has an enormous capacity to contribute to clinical drug development at a global level. An important enabler to obtaining this capacity is balanced, quite predictable and scientifically dependent regulatory approval for clinical trial applications. However, the safety of all Indian participants in the clinical trial is the priority while making sure the regulatory environment remains favourable for clinical research. Clinical trials are an important part of the drug license registration process and shall be made as easy and effective as possible.

In the past, there were several updates to the policy and the guidelines for supervising the efficient conductance of clinical research in India. These measures were accepted by the regulators because of the safety of the Indian patients even though it was quite challenging. But recently, the Indian government has undergone positive evolution for supporting clinical research in India besides keeping a perfect balance with patient safety as well. These changes will bring in some new innovative medicines to all Indian patients as early as possible.

A few years ago, the path of regulations for conducting clinical trials was very simple with a single approval process that included the CDSCO office only. The approval time was only between 8-12 weeks. This offered opportunities to have varied new therapeutic options for use in Indian patients.

But in the year 2014, some of the regulations were done mandatory for all clinical trial sites. One among them was that no clinical trial can be done in sites having less than 50 hospital beds. But this regulation had a big negative impact as sponsors were not able to select investigators with some specific patient population. Choosing an investigator site also became very challenging. Most of the government sites also did not have the required infrastructure to participate in any global trials as per the needs.

But in the year 2016, CDSCO revoked the requirement of 50-bed hospitals for clinical trials. Under the revised regulations, the ECs (Ethics committees) were given the power to decide where a site is suitable for clinical trials, regardless of its bed capacity. Proper examination of the risk and the complicacy that was involved in the clinical trials that are being conducted is taken into consideration. This move was widely accepted by most of the industry and some of the prominent companies who feel like it helps in eliminating all the hurdles for conducting clinical trials in India.

With Indian regulations evolving rapidly in the recent years, it is expected that it will become more conducive for doing clinical trials. It will facilitate rapid approval timelines, enhanced transparency while ensuring patient safety. This will also assist in devising more innovative medicines within the least time possible.