Irregularity in Clinical Trials
The attractiveness of a country for clinical trials depends on various factors, one of the most critical of which is speed
and the quality of data. Speed is affected by factors including the time it takes to obtain regulatory approvals, the Ethics
Committee (EC) approval, and patient recruitment and retention. The Ethics committee grants approval to conduct genetic research
involving humans and to provide genetic services which are within certain ethical principles and procedures in order to minimize
harm, and to maximize benefits, to those human beings who may participate in such research. Ethics policies have been formulated
to harmonize with Ethical Guidelines for Biomedical Research on Human Subjects developed by the Indian Council of Medical
Research in 2000. The committee covers the areas of basic research, genetics, genomics, and education and legal aspects. Data
quality, on the other hand, is largely influenced by the culture of following good clinical practices (GCP), ethics, documentation,
and record keeping. Though the doctors have excellent skills and patient coverage, their lack of experience in conducting
trials according to GCPs is undeniable. Furthermore, it is unclear whether Indian laws permit an international company to
carry out a Phase 1 trial in India concurrent to trials conducted abroad. Currently, the general practice is to allow sponsors
to repeat Phase 1 trials in India after submission of Phase 1 data generated outside India Phase 2, 3, and 4 trials can be
carried out concurrently with other global trials for that drug.
Low Government Funding
In terms of government funding, the government of India spends 1% of its gross domestic product (GDP) on health sector research,
whereas the US government spends 7–9% ($17.9 billion) of its GDP on biotech research and development each year. Funding by
the Indian government in this sector also is low in comparison with other developing countries. Although initiatives are being
taken to enhance the investment but they are scattered and sporadic. As India still lacks established institutions such as
the primary funding agency for the R&D. Approximately 52% of US R&D expenditure is borne by the government. Although India
has launched the Small Business Innovation Research Initiative (SBIRI) scheme through DBT to support small and medium size
enterprises through grants and loans. The scheme will support pre-proof of concept, early stage innovative research, and provide
mentorship. This is on the line of Small Business Innovation Research (SBIR) grants of US to fund small business development
of biomedical discoveries. India also lacks an Act like Bayh Dole Act United states in which institutions receives US research
grants own the intellectual property generated from such research. Local ownership fosters entrepreneurship as well as a strong
incentive for university-industry research collaborations.
SWOT ANALYSIS
The discovery, research, and development of drugs are becoming increasingly challenging and expensive world-over. India offers
multinational drug companies a competitive edge by providing a low cost base in research, clinical development, and manufacturing.
With the advent of the product patent regime by the Indian Patent Amendment Act 2005, Indian companies are now attempting
to reinvent themselves as innovators by building patenting capabilities and pursuing discovery-led research strategies. Because
the Indian biopharmaceutical industry lacks the resources to make this transition on its own, it will need to do this in collaboration
with foreign companies. Fortunately, the arrival of a stronger intellectual property regime also makes the industry more attractive
for multinationals to collaborate. This change will provide a greater incentive for original drug discovery and development
in India, which will eventually create opportunities for Indian companies to develop new competencies through collaborative
research and global alliances.
To attract foreign collaborations, however, there are certain key issues that need to be addressed in India including human
resource development, instilling patent culture, infrastructure development, and the simplification of regulations covering
research, product approval, and intellectual property.
The initiatives taken by the government to promote the biotech sector are appreciable, and these steps may have a productive
effect if they are implemented efficiently. Once these milestones are achieved, then the time is not far when the Indian biopharmaceutical
industry will become a novel drug industry by practicing a collaborative model.
Rakhi Rashmi is research scholar at Jawaharlal Nehru University, New Delhi, +91 9810674596, rakhi.rashmi@gmail.com
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