The blog title may scare you for once, wondering how you can take a medication without having it tested and approved. But hold on, there is more to what you have just read. You can trust the Indian government to not risk anyone’s life. So then, what it is about, you may wonder.
What is the no-approval decision for clinical trials?
The fact is that the Indian government has decided not to conduct clinical trials for new drugs that have been tested and approved for use in America, United Kingdom, Australia, and Japan. However, this approval will be permitted only if the global trials of such developed markets included Indian patients. A senior government official confirmed this by giving an example, saying that, “If a US based company conducted clinical trials that also included Indian patients and the drug is marketed in the US, there will be no need for conducting local clinical trials to prove its efficacy in India.”
What is the motive behind this move?
This move is expected to reduce the time taken by pharmaceutical firms to introduce drugs in India, while also preventing duplication of studies. In this way, drugs can be introduced in Indian markets sooner. This seems to be great for those patients who are suffering from serious illnesses and can’t seem to find a solution. Maybe a new treatment that has been developed and approved for Indians out of the country works for such patients.
What other changes have been made?
- After the new Drugs and Clinical Trials Rules 2019, the requirement of local clinical trials has also been waived off for the drugs approved and marketed in the above mentioned countries. The data generated outside the country will be acceptable, provided that the data includes Indians too.
- The government has also removed a clause in the clinical trials rules that commanded the sponsor to pay 60% of compensation upfront in case of death or permanent disability of a patient during a clinical trial. Once it is proven that the injury or death has occurred due to the clinical trial, only then will the company have to pay the total amount in compensation. Also, the government made it compulsory for firms to provide medical management as long as required, or till a time that it is established that the injury is not related to the clinical trial.
- In case of application of conducting a clinical trial of a new drug as part of discovery, research, and manufacture in India, the application will be disposed off within a period of 30 days. And, in case of no communication from the Drug Controller General of India within this time period, the application will be considered approved.
With all these changes made, let us wait and look at how the clinical trials rules work for the country. To help, you can also take up clinical research as your career. And for this, you need the best clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute.
