CDSCO Revokes The Limit Of 3 Clinical Trials For Investigators

The vitality of drug trials for the promotion of health services can't be over accentuated. Novel drugs, as well as therapies can enhance the quality of life as well as the patient lifespan. While it is true that clinical trials are rapidly increasing with evolving science, the Government of India is also making sure that the safety of all subjects are well protected and the quality of trials that are done in India evolves to international standards.

But before we talk about the recent changes made in medical device regulations in India for clinical trials, you should learn what a clinical trial is and what its phases are. A clinical trial is a systematic study for generating data for verification of the clinical and pharmacological profile or any kind of adverse effect of a new drug on humans.

A clinical trial is one of the efficient ways to establish safety as well as the efficacy of a drug before it is introduced for general use. It is preceded by trials on animals where the effectiveness, as well as side effects, are observed in animals along with the establishment of the drug dose.

It is therefore vital for anybody implementing a trial of any new therapy in humans to know about the particular aims, issues along with the risk or any benefit. It confirms that the chosen options are scientifically sound as well as justified.

Clinical trials are done in four phases. In phase 1, the new drug is administered to a small number of people like a minimum of 2 healthy volunteers under very close doctor supervision. This determines whether the new compound is tolerated by the patient's body or not. Then in phase 2, it is administered to a group of 10-12 participants in about 3-4 centers to know the effect and check for any side effects. In phase 3, it is administered on about 1000-3000 people for obtaining evidence on efficiency and drug safety. If everything is favorable, data is presented to licensing authorities for a commercial license to market the drug. Phase 4 is the surveillance phase when the medicine is available to doctors and its effects are supervised on thousands of patients.

In the year 2014, CDSCO issued a notice regarding the necessity that a prime investigator cannot conduct more than 3 clinical trials in a given period, even though these trials were pro-actively recruiting or are in long term follow up.

But these rules imposed a very negative impact on the development of new drugs. Due to this, the restrictions were finally relaxed by DGCI in the year 2016. According to the new regulations, the number of clinical trials by each investigator and site suitability will depend on the respective Ethics Committee. The ECS after properly supervising all risks and complications that are involved in any proposed clinical trials should decide on how many trials any investigator can undertake and the suitability of a trial site.

Clinical trial investigators along with sponsors and the regulatory bodies play a very important role in conducting high-quality clinical studies. Therefore, a clinical trial should be done and implemented by trained investigators in compliance with all rules and regulations along with record maintenance and reporting. It is vital to maintain the proper standards because any kind of compromise can jeopardize public confidence.