Indipharm: your gateway to clinical trials in India

IndiPharm provides Western pharmaceutical and biotechnology companies a full range of global quality Clinical Research Organization services efficiently, effectively and at a very competitive cost. As a joint U.S.-Indian CRO, IndiPharm blends strong Western presence for client interface and client services with an Indian operation to execute clinical trials in India faster and at a lower cost. IndiPharm is committed to maintaining the highest quality research standards. As the number of global clinical trials increases, patient recruitment is becoming increasingly expensive and time consuming. IndiPharm’s capacity for rapid and inexpensive Indian patient recruitment provides great value to its clients. IndiPharm’s nationwide network of GCP-compliant clinical trial investigators and sites has demonstrated its efficiency and effectiveness in many quality global clinical trials including several oncology trials.

The need for a new frontier
Western pharmaceutical and biotech companies need to increase productivity, decrease costs, and shorten the time to market for new drugs. The costs of Clinical Trials needed to gain regulatory approval represent roughly two-thirds of the typical billion dollar cost of developing a single NCE. A critical need therefore is conducting clinical trials that provide lower cost and faster recruitment without compromising the quality of the research.

Why India?
India provides a number of significant advantages for the outsourcing of clinical trials because it offers a large patient population, low per patient trial cost, and a highly qualified professional medical community, plus global quality hospitals and clinical research facilities. Furthermore, with a highly developed IT and data collection capability and no language barrier, India has become an important destination for clinical trials.

India background
Until recently, there were few clinical trials conducted in India by Western pharmaceutical and biotech companies, primarily because of regulatory hurdles. Recognizing the significant advantages that India offers to multinational companies and the potential and benefits of conducting clinical trials in India, the Government of India made major changes in 1999 with the Amendments to Schedule Y of the Drugs and Cosmetics Act. These changes formalized the definition and conduct of clinical trials; specified the responsibilities of the sponsor, the investigators, and the Ethics Committees; developed guidelines and procedures for importing drugs for clinical trials; instituted required compliance with GCP; specified the requirements for informed consent; and defined the structure, content and formats of clinical study reports. In addition, the Indian Government provided increased protection for intellectual property (IP).

India advantages
India offers the following major advantages for conducting clinical trials:

• “Western” disease distribution
• High patient numbers
• Patients generally “therapy naïve”
• Many tertiary care and specialty hospitals
• Large number of highly-qualified and western-trained medical specialists
• Lower Cost
• No language barriers
• IT-based advantages

India projections
The cost per patient for trials in India is approximately 40 to 60% of the cost in Western nations. More importantly, patient recruitment can be greatly accelerated, and this provides a major advantage in terms of shortening the time to market for a new drug. Based on these advantages and those listed above, the number of clinical trials in India is expected to grow exponentially over the next five to ten years. It has been estimated that in 2005 only 1% of global clinical trials were conducted in India. This percentage is projected to grow to 15% of global trials by 2011. The charts below illustrate the effects of such rapid growth, projecting that by the year 2011 over 300,000 patients will be enrolled in clinical trials in India. McKinsey projects that within five years, 1,500 to 2,000 GCP studies will be conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 50,000 clinical research professionals.

IndiPharm projections based on information from The Boston Consulting Group
and Business Communications Co.

India’s capacity to meet increasing demands
India has substantial capacity to meet the rapidly growing demand for clinical trials. India has 300 universities, over 750 graduate and post-graduate programs, and about 50 million college graduates. There are over 700,000 medical professionals and over 600 ICH/GCP compliant sites. Furthermore, the Indian Government and industry have cooperatively taken a number of major steps to strengthen the infrastructure for conducting clinical trials. New GCP standards have been established, a number of comprehensive training programs have been developed, and many new graduate and undergraduate programs have been initiated. English is the medium of transaction in higher education, business and medicine.

These measures have led to the creation of a large pool of specialist clinical investigators who are GCP-trained and compliant, and who have participated in numerous international clinical trials. Supporting these investigators is a large pool of trained clinical research professionals. In addition, the Government also streamlined the process for regulatory review of clinical trials to facilitate protocol approvals (as described below).

The regulatory approval process
Clinical trials are regulated by the Drugs Controller General of India (DCGI), who is now responsible for assuring that all clinical trials are ICH/GCP compliant. The DCGI approval process categorizes clinical trials into two types. If the study protocol has already been approved by the cognizant regulatory authorities in one or more developed countries (such as the U.S., Canada, U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within 2 to 6 weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. It is also important to note that the institutional IRB approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting the study protocols in place and initiating the trials, leading to the initiation of trials in a much shorter time than many other countries.

Bridging the needs
Western pharmaceutical and biotech companies need to increase productivity, decrease costs, and shorten the time to market for new drugs. India clearly offers the solution for conducting clinical trials that provide lower cost and faster recruitment without compromising the quality of the research. Why then isn’t the number of clinical trails in India much larger than it is today? In the past, several constraints have limited the number of clinical trials conducted in India:

• Communication was an issue because of cultural differences between western countries and India.
• The large time difference created further difficulties in communication and monitoring of the work.
• There were some significant differences between Western and Indian business and operational practices.
• Indian researchers needed to clearly understand the needs of Western sponsors.
• Western sponsors needed to overcome their perception that often views India as a non-traditional “developing” nation that is the “land of the generics”, with limited capacity and uncertain quality of work.
• Western sponsors were also concerned about intellectual property protection.

These issues are not unique to clinical trails. Similar issues have been faced and successfully addressed in fields such as information technology (IT) and business process outsourcing (BPO), where India is now a leading provider of services to Western clients. With recent actions by the government, the regulator, and CROs, these problems are being overcome, and it is expected, as indicated above, that India will experience a very rapid growth in the number of clinical trials.

How can you take advantage of the exciting opportunities offered by India?

Sponsors or CROs who want to conduct clinical trials in India should align themselves with partners who are well versed in all of the following areas:

1. Ability to efficiently navigate the process of filing for regulatory approval to perform the study in India, including applicable translations of informed consent forms and facilitation of all required import/export licenses that may be required.

2. Thorough understanding of the evolving regulatory environment in India, as well as the US FDA, EMEA and other global markets.

3. Deep experience in the business culture of India, and how differences between India and the West can be overcome to assure consistency and quality.

4. Relationships with the top medical institutions and thought leaders across India to assure that quality sites with experienced GCP investigators are involved in the trial.

5. Excellent Medical Governance at all levels of the organization to assure accurate and timely reporting of findings to regulatory authorities.
In addition, having access to a US based office that is fully staffed and well-versed in the Indian system and regulation, and that can provide effective client service and rapid response to client needs, provides the sponsor with the benefit of having minute to minute control and awareness of the ongoing study.

What does IndiPharm offer?

Facility
IndiPharm’s principal research facility, located in Mumbai, India’s financial and medical capital, is a state of the art facility with core competency in GCP and GMP requirements, and is compliant with the requirements of FDA (U.S.), MHRA (U.K.), ANVISAQ (Brazil), Ministry of Health (Turkey), World Health Organization (Geneva, Switzerland), MCC (South Africa) and DCG (India).

With a total clinical research area of 33,000 square feet, the facility houses a 72 bed clinical pharmacology unit, an in-house clinical laboratory with state of the art instruments, and a qualified, trained and experienced technical team.

IndiPharm has established strong relationships with nationally and internationally recognized physicians and clinical investigators, and has created a nationwide network of clinical trial sites that are GCP compliant, have IRBs in place, and offer IFCC compliant laboratories with access to a common laboratory network. Most of these sites are routinely audited by a wide range of organizations. Each site meets the needs of global clinical trials and each is very “recruitment-friendly.” Over 90% of the investigators at these sites are either U.S. or U.K. trained and most are U.S. Board certified, with many having substantial experience in conducting global clinical trials.

Therapeutic areas
IndiPharm offers extensive experience and capabilities in all therapeutic areas, including:

• Oncology
• Infectious Diseases
• Metabolism, Diabetes & Obesity
• Cardiovascular
• Gastroenterology
• Neuropsychiatry
• Pain and Rheumatology
• Women’s Health
• Medical Devices

As an example, IndiPharm has, in the therapeutic area of Oncology, established a strategic alliance with the Indian Cooperative Oncology Network (ICON) whose mission is to expand the availability of oncology investigative sites and provide greater treatment options for patients in India.

IndiPharm services
Our services to Western biotechnology, pharmaceutical and medical device companies include:
• Identification of experienced sites and GCP trained investigators
• Regulatory submissions
• Obtaining all required import/export licenses
• IRB/Ethics Committee submissions
• Clinical protocol preparation
• Site Monitoring/Site Audit
• Medical Monitoring/Safety Reporting
• Coordination of Central Lab logistics and sample handling
• Clinical data management
• Bio-statistical analysis and interpretation
• Clinical Pharmacology unit with additional capability to perform QT studies

Contact Information:
Edward J. Brennan, Jr., MD, FACS
President & CEO
T: +1-610-356-0574
E: Edward.j.brennan@indipharm.com
www.indipharm.com