India's entry in global GCP clinical trials, which began almost a decade ago, is now about to take off in a big way. The 2002 estimated clinical trial market of $30-35 million is projected to reach $ 250-300 million (Centerwatch) or $1-1.5 billion (McKinsey) by 2010. The slow and steady market of 2002 is expected to rise rapidly from 2005, due to increasing interest of global companies following the anticipated regulatory changes. However, the perceptions of global community about these changes are likely to influence the Indian clinical trials market beyond 2005.
Watershed year 2005
Several major events have occurred in 2005 making it a watershed year. Some of these are:
" Amendment to Schedule Y
" Passage of Intellectual Property Right (IPR) bill
" Article criticizing Indian clinical trials environment
" Launch of CDSCO/WHO GCP Training programmes
" First US FDA inspection of a global trial
Schedule Y
Several provisions in Schedule Y have positive impact e.g. removal of phase lag, legal support to GCP, definition of responsibilities of all stake holders, formats for ethics committee, consent form, clinical trial report etc. However, pharma industry is concerned about certain provisions e.g. composition of ethics committee (EC), fixed membership for quorum of EC, investigator undertaking, inclusion of phase IV studies, periodic safety reports etc. There is a general feeling that amended Schedule Y may lengthen the submission process for clinical trial approval. Besides, the investigator undertaking may dampen the enthusiasm of investigators towards clinical trials.
IPR Bill
The passage of IPR bill was a major step towards a fully TRIPS compliant IPR regime. However, the international pharma companies are concerned about some of the provisions e.g. definition of compulsory licensing, pre-grant opposition, no patent for salts, esters, isomers without a significant difference in efficacy from new chemical entity. Besides government's recent move to negotiate price with patent holder company may make foreign companies rethink on India as a research destination.
Unfavorable Article
Dr Nandy and Gulati in their article " A New Colonialism - Conducting Clinical Trials in India " in the April 21 issue of New England Journal of Medicine is highly critical of recent regulatory changes, current ethical issues of illegal unethical trials in illiterate patients, lack of regulatory expertise, inadequate infrastructure and paucity of GCP trained investigators. The article suggests a need to make stringent regulations to protect the Indian patients. These views will make potential global pharma companies concerned about quality and ethics of Indian trials.
GCP Training programmes
WHO-CDSCO have launched GCP training programmes which are coordinated by Dr Urmila Thatte, Dept of Clinical Pharmacology Nair Hospital, Mumbai. These programmes cover foundations of GCP, amended Schedule Y, ethics and consent process and responsibilities of the investigators and the sponsors. The response to pilot programmes in Mumbai for all four stake holders - sponsors, investigators, ethics committees, and regulators - has been enthusiastic. This programme, which will be soon rolled out to other cities, provides the much needed government boost to academia- industry training efforts.
US FDA inspection
One major hurdle, over last few years for Indian trials, was the question: Is the quality of Indian trials acceptable to US FDA? Recently, US FDA conducted inspection at Indian sites involved in a global trial. The investigator site went through the challenging inspection successfully without any major findings. This experience would bolster the confidence of global companies and regulators about quality of Indian investigators and the data.
The year 2005 has brought mixed blessings to the industry. It is too early to judge impact of the above events. Only time will tell whether 2005 was a milestone or a speed breaker on India's clinical research odyssey!
(The author is president ClinInvent Research Pvt Ltd, Mumbai. E-mail: arunbhatt@clininvent.com)