As you may know by now, the new drugs and clinical trials rules for 2019 are out, which are expected to promote clinical research in the country through a transparent process of yielding faster approvals. These changed rules will impact long term growth of CROs in India.
As per the new rules –
- Any drug discovered or invented in India, proposed to be manufactured and marketed in the country, will require approval for clinical trials within 30 working days by the CLA. And, in the event of no communication from the CLA within the stipulated time, the permission to conduct the trial shall be assumed to have been granted.
- The clause for compensation of up to 60% of the amount upfront by the sponsor to the patient in case of death or permanent disability within 15 days has been eliminated.
- For the drugs approved and marketed in UK, Australia, European Union, Canada, US, and Japan, the drugs will be considered approved to be marketed in India too, thus making the process easier and faster.
With all these changes, it is makeover time for the Indian clinical trial industry, making drastic improvements in the field. It has been claimed that the market will be growing at 12-15% CAGR between 2015 and 2025. However, it may also pick up faster if the rules made are implemented in 2019 and show results by 2020, while saving time and cost for multinational companies.
But, why India?
Both India and China are on the list for foreign companies based out of US and Europe to make a trial market. While China was the better option for these companies a while ago, the scenario has changed after the new rules made in 2019. India has now become a viable option for these companies. American and European drug companies can include Indian subjects in their multi-field trials, and get benefits from new regulations in India from 2019 onwards. India offers a variety of cases with high incidence of diseases, cancer cases, neurological cases, and more. In addition, the best healthcare systems are now available, with better and convenient detection, monitoring, and follow up during clinical trials. Furthermore, digital revolution is touching all major metros and mini-metros, making it possible to monitor patients in real time. Other countries like Africa and Indonesia have communication issues, while India offers easy language with easy policies and better infrastructure. Last but not the least, the Indian government has the tendency to facilitate more companies who consider the Indian market as a ground for clinical trials.
What’s next?
The CRO market in India is currently driven by only a few big names, with smaller ones struggling to keep pace. More and more mid-sized companies need to be incentivized to promote healthy competition and break down the monopoly of big names in the market. This will directly bring down the cost of conducting clinical trials in India. Drug companies will thus look forward to such less expensive and convenient clinical trials in India, rather than opting for other countries where language, convenience, and costs could be a problem.
You should also speed up your decision of taking up the best clinical research training in Bangalore by a reputed institute like Avigna Clinical Research Institute, so that by the time the Indian clinical research industry has become robust, you are ready to set up your career in the field!
