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| What are the advantages of going to India for clinical research? |
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- Availability: With a booming Indian population, there is an
availability of a large pool of treatment naïve patients providing for
a multiethnic and multiracial base.
- Speed: Owing to the large base, patient recruitment in the country
is rapid, thereby reducing the development process.
- Spectrum of diseases: The country has witnessed the presence of
varied diseases that are not prevalent in the West. These include
diseases such as multi drug resistant pneumonia, hepatitis B,
diabetes and some forms of cancer.
- Economy: While all sectors are leveraging India's benefits with
economy through outsourcing, the drug companies too are tapping
the potential with the country as they can save up to 30 to 50%
overall on the cost of conducting the trials here in India.
- Trained investigators: The investigators in India are generally
trained in the US or Europe and have gained further exposure with
Multinational trials based on the guidelines for GCP.
- Regulatory compliance and standards: Based on the USFDA, any
drug before it is released in the market must first be tested on a
global population.
- Recruitment of subjects: Subject willingness is critical for the
compliance to undergo the full process. In India, with a large
section of the population unable to afford their own treatments,
subjects opt for these trials as they are assured on quality
treatment and healthcare, which would have not been available
otherwise. Hence the subject return rates are amongst the highest
in the world in India.
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| Global consultancy: McKinsey & Co estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country. Pharma giants are also magnetised by India due to the fact that the country offers nearly 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking medical personnel. |
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What questions /objections have there been to outscourcing to India?
The clients are usually sceptical with regards to timeline for regulatory approval. With a dedicated regulatory consulting team who strive to meet the expected timelines, clients are bound to have a positive and encouraging experience.
What is FDA's policy regarding patient populations from India? What is acceptable regarding a more homogenous population that may not fully reflect the US?
FDA has a policy on inclusion of foreign patient data for registration of drugs for marketing in USA. There is no negative or positive bias towards India. A white paper on the subject is on our website. Numerous audits of global sponsors and US FDA in India are a testimony to the level of quality. Data from clinical studies in India have been successfully filed with international regulatory agencies. The overall impression is that the data quality in India is usually excellent.
In oncology, what subspecialties are covered in clinical studies (e.g., Leukemia, Lymphoma, Solid Tumors, Etc.)?
There are premiere oncology institutes in India where all subspecialty investigators are present. There are medical oncologists, surgical oncologists, radiologists, paediatric oncologists, head & neck cancer specialists and breast cancer specialists who are involved in various studies. Thus, most of the subspecialty studies have been conducted in India.
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Has the FDA reviewed or audited the sites?
FDA has been to India and has audited sites in India. FDA has provided a green signal for the same.
Please describe the study site infrastructure (e.g., Pharmacy, Study Coordinators)
The study site depending on the type of study would have the following personnel - Principal Investigator, Co-Investigators, Specialty Physician (depending on type of study, for instance a radiologist, etc), Study Coordinator, Study Nurse and a Pharmacist.
What import issues/limitations are there regarding US drugs coming into India for study? How are these handled?
Import license has to be obtained from the Drugs Controller General of India for import of drugs to India. An application will be forwarded to the regulatory agency along with the clinical trial application with justification as to the number of drugs to be imported. The import license would be awarded along with the approval to conduct the clinical study.
How is cancer care different/similar in India to that in the US?
The medical care to cancer is similar to US, but due to genetic variation there might be difference in the response to therapies in India as compared to US.
What is the regulatory process In India?
For the regulatory process in India click on the icon on the left. |
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EA’s Positioning in the Indian Market
EA (www.ecronacunova.com ) is ranked No. 32 amongst top 50 biotech firms in India as per 2010 June BioSpectrum-ABLE annual survey (http://biospectrumindia.ciol.com/content/BSTOP20/11006154.asp ). In the same survey it ranks as the 7th largest Bio-Services firm. Amongst late phase CRO’s, EA which was set-up in 2005, ranks No 3 behind Quintiles India (estd 1997) and SIRO Clinpharm (estd 1996). EA was founded by D A Prasanna, a GE veteran and invested by Manipal Education and Medical Group (www.manipalgroup.com ), largest teaching hospital network providing patient access. Growth funding is provided by Orbimed Advisors (www.orbimed.com) a $6B healthcare and life sciences fund out of New York.
EA provides Ph I-IV clinical development services and its key value proposition is “Accelerate Pharma time-to-market cost effectively with no compromise in quality”. Quality comes from its team of 300 full time professionals, out of whom 66 are MD/Ph D’s. Studies are conducted using industry standard platforms with GCP/GLP compliance confirmed by study audits of US FDA & other regulators. EA conducts studies in G 8 markets with an understanding of study guidelines for getting marketing authorization in key markets. Speed to market is achieved by an intelligent combination of countries like India and CEE (Central and Eastern Europe). In the last 5 years, EA has recruited 32,140 patients in 152 studies from 2465 sites. EA has conducted over 200 early development studies. Functional service is provided in safety narratives, medical coding, statistical analysis and DM. EA has centers of excellence in oncology, CV, metabolic disorders, stem cell therapy and diagnostic imaging agents. Key customers include top 10 pharma, bio-pharma and medical device companies. |
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