Despite high disease burden, clinical trials for drugs low in India

Nagpur: India is home to 17% of the world population and contributes 20% to the world’s disease burden. Despite this, the number and frequency of clinical trials and development of new drugs in the country is very low. Of all the clinical trials being conducted in the world, only 1.4% are in India.
Throughout last week, research oriented medical professionals in the country spent time making people aware of the importance of clinical trials as they marked the International Clinical Trials Week. Indian Society of Clinical Research (ISCR) even came out with a bunch of goals they plan to achieve in coming years. Experts said they believed regulatory challenges, misconceptions about clinical trials and lack of awareness among general public were the most important factors holding back the progress of clinical research in India.
“Millions of patients the world over get access to new and novel medical treatments, thanks to those who have participated in clinical trials and helped in the discovery of life saving medicines and therapies,” said ISCR president Dr Suneela Thatte, head of the pharmacology department of KEM Hospital, Mumbai. Acknowledging the fact that several wrong ideas about clinical trials prevailed among the public, she said all stakeholders needed to work together to rebuild confidence and trust among the global community in doing clinical research in India now that we have a more conducive regulatory environment.
City-based pulmonologist Dr Rajesh Swarnakar, who is also a member of Investigator Council in ISCR, informed that the Drug Controller General of India (DGCI) had come up with a new set of regulations at the directions of Supreme Court after a PIL on the topic was filed. “This is a big step for us, as last year on the International Clinical Trials Day, we all were concerned about losing out on clinical trials due to lack of a regulatory framework. These rules take care of patient safety. In fact, India is the only country where not just the written but video consent of the patients participating in clinical studies has been mandated. Even ISCR works on the motto ‘Patients First,” he said.
“One of the most prevalent misconceptions about such trials is that they treat patients as Guinea pigs. The medicines have already been tested in laboratories or on animals. The human trials are experiments, but controlled ones where side effects are known, anticipated and looked for proactively. Also, not everybody can participate in the trials. There are certain criteria for participants,” informed endocrinologist Dr Shailesh Pitale, who has been the principal investigator in many clinical trials related with diabetes and hormones.
These criteria include the patient who has a condition that is not responding to standard medical treatment or someone who wants to volunteer to advance the understanding of a disease. It takes more than a decade for a new drug to reach the stage of human testing. In fact, only 10 of 10,000 substances identified as potential drugs ever make it to this stage.
What are clinical trials
Before introducing a medicine for mass consumption, it is important to find out all the side-effects connected with it. For this, they are tried on a small group of patients who satisfy certain criteria. These trials are carefully designed and monitored research studies that test drugs, devices or procedures. If the medicine is found less effective or has severe side-effects, it is improved further before conducting another set of trials. When found effective, the medicines are approved for marketing and use by patients.