The part of the proposed amendment laying out what will be required for a clinical trial to be approved and permitted in India is relatively straightforward and includes an option for unannounced inspections of CRO and trial sponsor sites. Many of the provisions in this part were previously included in draft guidance released by the Central Drugs Standards Control Organization (CDSCO).
The amendment also follows the Supreme Court’s rejection of an earlier affidavit on how the government would overhaul its rules governing trials. Under the new draft amendment, the Drugs Controller General of India (DCGI) will be required to ensure that trials:
- Are conducted in compliance with already established good clinical practice guidelines;
- Approved by an ethics committee;
- Registered before enrolling the first patient; and
- Provide an annual status update of the trial, including details on whether it’s ongoing, completed or terminated, and if terminated, the cause for termination.
Adverse events also will need to be reported within 10 days of their occurrence to CDSCO and sponsors will have to provide compensation and medical care for patients experiencing injury or death during or as a result of a trial.
Controversial Issues
However, the part that is causing the most confusion and could be problematic for companies trying to conduct trials in India is related to the reasons for compensation, how the compensation will be calculated by the DCGI and the ability of a sponsor or CRO to appeal such charges, John Lewis, spokesman for the Association of Clinical Research Organizations, told Outsourcing-Pharma.com.
For instance, the section of the amendment on when compensation should be provided says that the sponsor or CRO should provide financial compensation when the investigational product fails to provide the “intended therapeutic effect.” But Lewis notes that this is precisely the reason for conducting a trial – to see if an potential drug will provide a therapeutic effect.
The amendment also says compensation should be provided when there’s use of “placebo in a placebo-controlled trial,” which Lewis says does not even make sense.
In addition, if a sponsor or CRO does not pay for the compensation, the amount of which is determined by the DCGI, then CDSCO can suspend or cancel an entire trial or that company’s entire business in the country. Lewis added that without a well-defined appeals process, it will be difficult for companies to operate without being concerned that all of their operations could be shut down.
Pfizer, Quintiles and PPD have previously paid compensation for trials in India and Lewis also noted that it would not be unique for a CRO as they pay such compensation in other countries too.