Multinational companies, both foreign and Indian, who want to explore India as a hub for clinical trials are set to get a boost with the new rules for clinical trials. The new rules say that if the drug fails to show the claimed therapeutic effect there’s no need to financially compensate the patient. However, treatment for any potential side effects due to the usage of the drug has to provided free of cost.
These rules will cause major changes in the way the clinical trials function in the country currently. For example a high blood pressure patient will be treated for side effects like kidney disorder or depression (medicine-related) however no compensation shall be paid if the patient’s blood pressure doesn’t go down or they suffer from a stroke (caused due to high blood pressure).
Experts believe that the Indian clinical trials industry which is a worth a staggering $500 million. in revenue and employs around 15,000 people. The Drug Technical Advisory Body, the health ministry’s apex decision-making body recently proposed these changes to rule 122 DAB of the Drugs and Cosmetics Act, which deals with the grant of compensation. Clause C under sub-rule of rule 122 DAB states,
‘Relating to providing financial compensation in case of injury or death due to failure of investigational product to provide intended therapeutic effect may be deleted as there is always a possibility that the investigational product may fail to provide intended therapeutic effect’.
Clinical trials have been under scrutiny for a while afterhealth activists took the issue with the Supreme Court over seeking greater protection for patients participating in trials after large numbers of deaths were attributed to such trials.
The rules also state that those in the placebo group weren’t entitled to any claims for compensation in case of any adverse event. However, the lack of therapeutic effect needs to be explained in detail to the patient before he consents to enter such trial. In a placebo, a patient’s isn’t given any drug but a dummy drug with no health effect to compare it against the effects of the actual treatment.
‘These are encouraging developments. India has a sixth of the world’s population and a fifth of the global disease burden, but less than 1.5% of global trials take place here. This can be changed provided a robust and regulated environment for conduct of clinical trials is created,’ said Suneela Thatte, president, Indian Society for Clinical Research. The government had put in place a set of rules in Jan to streamline compensation and other processes for clinical trials.