Over the past few years, India has become one of the preferred destinations for global clinical trials, thanks to the strong patient pool, trained investigators and low trial costs in the country. Above all, it is the quality of the services offered by Indian firms that made global market to accept the country's clinical trial services. All global pharmaceutical companies face the challenge of maintaining quality, while there is a pressure on time and cost of trial.
International conference on harmonisation - good clinical practices (ICH-GCP) and schedule Y express the need for procedures of quality control (QC) and quality assurance (QA) that all stakeholders have to establish and how the role of QA department caters to the need of generating quality data clearly.
In the wake of acceptance of data in the foreign market, sponsor companies and clinical research organisations (CROs) in India have become vigilant with respect to the infrastructure that is required to be built to conduct regular audit(s) and QC checks during a clinical trial. A lot of articles have been written emphasising the efforts taken by the pharmaceutical companies and CROs to deliver the quality data.
In spite of all the efforts taken by the sponsor companies, what is lacking in the country's clinical trial scene is regulatory inspection.
Inspection is an important step to ensure that all the stakeholders stick to proper implementation of these initiatives before promoting and introducing alterative procedures to regulate clinical research. The health authorities play a pivotal role in ensuring that we accomplish most of our objectives.
It is agreed that the proposed changes in schedule Y are a major step forward in the direction of GCP compliant trials and has provided a good regulatory support. But in spite of all that, health authorities have yet to inspect the clinical trials at the sites. It was announced by drug control general of India (DCGI) that trial inspections shall start from early this year, but so far there has been no news on this activity.
It is well agreed that GCP is a shared responsibility between sponsor, investigator, regulatory authority and ethics committee. Also with the amended schedule Y, health authorities have theoretically enforced the GCP compliance, but still with no practical inspections the onus of GCP compliance still rests with the sponsors and to an extent with the investigators.
It has been read in many articles that like Food Drug and Administration (FDA), Indian regulatory authority is also in the process of setting up teams for assuring ethical conduct of clinical trials.
While imparting training to the clinical research professionals with respect to regulatory inspections, we have ample data to demonstrate FDA audits, inspections and their results. But unfortunately, there is no data available for clinical trial inspection in India.
As far as the FDA is concerned, once a new drug application (NDA) is submitted to the regulatory authority for review and potential approval, the clinical trial sites and the investigators are inspected by the authorities as a part of their usual practice.
Also, currently the data says that, FDA is conducting 50 inspections outside the US. It mainly comprises of study oriented (97 per cent) and investigations oriented (3 per cent) respectively. It also states that the number of non US inspections has increased by more than 50 per cent owing to a greater number of pivotal studies conducted outside US.
By amending Schedule Y, health authorities in India have definitely provided a helping hand to the sponsors and CRO(s) in understanding the systems and procedures, enabling the integration of India in global clinical development.
Now what we desperately need is the well defined inspection procedure from well trained professionals within health authorities. Doing this, the following benefits would be achieved:
● Less rejections of marketing applications
● Help to sponsors on improvement of their quality systems
● Enforcement of quality GCP compliance by regulatory
● Better outcomes on FDA audits and inspection
Once regulatory inspections start happening, India can stand up with pride and proudly claim its rich and quality compliant systems and procedures along with other developed countries.
(Deepti Goel is an assistant professor with Institute of Clinical research India, Bangalore)