India is fast emerging as one of the most strategic locations for global pharmaceutical companies to conduct their drug research and development. For studies in many therapeutic areas, the Indian sub-continent is desirable because of its large population of qualified patients, lower trial costs, use of English as the primary language, and a well-trained medical community. Increasing government incentives and regulatory support for research and an increasing number of qualified investigative sites are all major benefits of conducting clinical trials in India.
In 2004 Criterium established a data management center in Pune, India as a continuation of its strategy for having a worldwide team provide 24-hour coverage on clinical research projects. The center works in conjunction with Criterium's offices in both the northern and southern hemispheres to handle an ever-increasing amount of data and provide information in real time.
In 2005, Criterium India added Monitoring, Clinical Liaison and Business Development functions to the Pune, office. Personnel in these roles oversee studies in a growing number of Indian sites, and they develop our continuing marketing outreach to clients in India.
“Including India in the clinical development outsourcing network presents a four-fold benefit - it is the most immediate opportunity with the greatest potential benefit in the shortest possible time addressing the most pressing issue today.”
- Dr. Satish Acharya, Pharmalicensing.com (July
Criterium India: Poised to Excel in Clinical Trials:
Criterium India has created a database of investigators who excel in their respective Indications/Therapeutic areas. This represents the best and most experienced team of medical professionals throughout India.
These investigators are well versed in the laws and regulations affecting clinical trials in India. The study teams include:
1) Increasing Global R & D Costs across the board.
2) Increasing Pharmaceutical Development Time- In the US, average development time is now approaching 15 years. Typical clinical studies take up 30-50% of R&D time, a third of which is spent on patient recruitment. As patent protection periods include time spent in R&D, it is crucial to streamline the development process as much as possible.
3) India has a large, heterogeneous population pool of over 1 billion, with large-scale incidences of cancer, diabetes, and other infectious diseases. Shorter recruitment timelines and increased patient compliance are prevalent in India.
4) World Class Facilities: India currently has over 700,000 specialty hospital beds (at approx. 10% of the daily cost of developed nations), 221 medical colleges and English-speaking medical personnel. There is increasing adoption of Good Clinical Practice (GCP) Guidelines.
5) Patent Protection and Intellectual Property Rights Issues have been resolved. Since January 2005, India is now on level with developed nations by becoming compliant with the Trade Related Intellectual Property Rights Act (TRIPS).
6) India possesses a world class data-processing infrastructure for biostatistics and bioinformatics.
7) India possesses large generic drug manufacturing facilities- The focus on marketing generic drugs in the US and Europe will increase radically as many name brands and blockbusters are scheduled to go off patents in this decade.
Because of these factors, clinical trials conducted in India are estimated to grow from $70 million in revenue in 2002 to between $1-1.5 billion in 2010.
The Drug Controller General of India is responsible for giving regulatory permission for the conduct of clinical trials in India.
The DGCI provides approval in 12 weeks from the date of submission. After the dossier is submitted to the regulatory authorities, parallel submission is done to the respective ethics committees of the potential sites, which are usually hospitals.
There are more than 200 Local Ethics committees, which follow the ICH-GCP, and Schedule Y of the Drugs and Cosmetic Act of 1945. These Local Ethics committees are usually affiliated with Clinical Centers; occasionally they function as Independent Ethics committees.
The average ethics committee approval time line is 4 to 6 weeks.
Many hospitals (including government and private facilities) also have Scientific Review Committees (SRC) to review the scientific rationale of the study for better safety and the well being of trial patients.
Once the study is approved by the SRC the study is then submitted to the ethics committee for their review and approval.
DCGI approval is also required for getting approval for a Test License to import trial supplies, which takes approximately 2 weeks.
All the above procedures in parallel processing require a total of 14 weeks on average.
After the DCGI approval is granted for a particular study, the Director General of Foreign Trade (DGFT) is contacted to obtain approvals for export of blood samples out of India. This usually requires an additional period of 2-4 weeks.