In 2013, there were only 17 clinical trials approved by the Drug Controller General of India. But, the number has slowly increased over the years, and by the year 2017, it reached to 97, which signifies a huge jump of more than 400% in a period of five years. The main reason behind this huge jump is believed to be the alterations made to the Indian clinical trial rules, and the introduction of scientific and balanced guidelines that suit all stakeholders.
However, we mustn’t be happy with the 400% jump seen in the past five years, because the number 97 is nothing compared to the 529 trials done in 2010, 283 trials done in 2011, and 253 trials done in 2012. We can see how huge these numbers were, but we also notice the gradual declining graph in terms of number of clinical trials being approved. So, what is the reason behind this downfall? In the year 2012, a PIL plea was filed by the Swasthya Adhikar Manch in the Supreme Court, which raised an alert over many irregularities in clinical trials like lack of consent, and compensation to patients as required. Then, in 2013, the Ministry of Health and Family Welfare produced a gazette notification, which determined the eligibility for compensation, eventually leading to many drug makers look for other countries to perform trials. The reason behind this was that the clause of compensation could be misused and could act as an incentive to increase participation in the trial. In addition, the approval time of clinical trials also took very long.
Many other clauses like those revolving around investigators limited to undertaking three trials, trials to be conducted only in government hospitals, and the hospitals having 50 beds, etc. But, looking at the downfall, there is being made innumerous changes to the rules. Today, the rules are harmonized with international standards. Now 50% of trials can be conducted in private hospitals, with no restrictions of three trials per investigator. In addition, a formula for calculating financial compensation has also been derived. With all these changes, the clinical trials have come on the rise in India, after a silence of five complete years!
With this silence breaking, the Indian clinical research industry is going to have a rising graph now. In fact, it has been predicted that the future of clinical trials in India will be bright and successful by the year 2025! Take advantage of this situation, and plan up a career in clinical research. Enroll yourself with Avigna Clinical Research India’s online clinical research courses, where you can achieve relevant and professional education about clinical research from skilled and experienced professors. You can choose from options of classroom training, virtual learning, and online training, and enhance your clinical research skills, may it be in a classroom or from the comfort of your home. What’s more? After the course, you are also 100% assured to get guaranteed placement and internship assistance, which will have you placed in the best CROs, Bio-techs, and pharmaceutical companies!
