Clinical Research India

India is fast emerging as one of the most strategic locations for global pharmaceutical companies to pursue their drug research and development. Pharmaceutical research companies targeting promising treatments to be introduced to the world market cannot miss a country that offers many major assets. One major factor favoring inclusion of the Indian sub-continent in any study is its large population base of qualified patients for recruitment for studies in many leading therapeutic areas. Other factors include generally lower trial costs in part due to English being the primary language of communication and education, a well-trained medical community, and increasing government incentives and regulatory supports for research.

The establishment of a data management center in Pune, India by Criterium in 2004 was a continuation of its global strategy of enabling its worldwide team to offer clients 24 hour coverage on all its clinical research projects, while handing an ever increasing amount of data to continue to provide “information in real time”. This center also works in conjunction with Criterium’s offices in South Africa, The Netherlands, and The United States.

In 2005, Criterium India added Monitoring, Clinical Liaison and Business Development functions to the Pune, India office to both oversee studies that are occurring in a growing number of Indian sites, and to develop a marketing outreach strategy to clients in India for additional clinical services.

Factors that continue to make India attractive for Future Clinical Trial Outsourcing:

“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 2006)

Major Contributing Factors:

1) Increasing Global R & D Costs- estimated to have increased 23 fold in the past 28 years through 2006.

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.

An Overview of the Indian Regulation Process for of Clinical Trials:

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 being 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 are constituted in line with 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 set ups) also have Scientific Review Committees (SRC) to first review the scientific rationale of the study for better safety and 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 the approval for 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 in the view of getting approvals for export of blood samples out of India. This usually requires an additional period of 2-4 weeks.

Criterium India: Poised to Excel in Clinical Trials:

Criterium India has set up a database of Indian Investigators who excel in their respective Indications/Therapeutic areas. This represents the best and most experienced team of medical professionals throughout India.

Indian investigators are well versed with laws and regulations required for the efficient conduct of clinical trials in their country. These study teams include: a) Principal Investigators who have great experience with Clinical Trials, and are specialists in their field; b) Medical and Non medical staff to ensure smooth conduct of trials; and c) Social workers that are appointed on certain trials as the study’s needs require. (per the requirements of study needs).

Clinical trials in India have also occasionally undergone several regulatory /sponsor audits. When this occurs, the Indian Investigators have proven to be superior in meeting International and Regulatory standards. Indian clinical trial data has been successfully been able to travel to US FDA for several approvals.