Biopharmaceuticals in India: Evolving from Generics to Innovator Drugs - The new patent regime is challenging the Indian biopharmaceutical industry to transition its focus from process innovation and


Biopharmaceuticals in India: Evolving from Generics to Innovator Drugs
The new patent regime is challenging the Indian biopharmaceutical industry to transition its focus from process innovation and generic manufacture to novel product innovation.

BioPharm International
Volume 21, Issue 4

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.


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,


1. The Patents (Amendment) Act. Gazette of India. 2005; Apr 5.

2. Patent shall be available for any inventions, whether products or processes, in all field of technology, provide they are new, involve an inventive step and are capable of industrial application.

3. Mishra A. Possible impact of TRIPs on Indian healthcare system. The pharm rev. 2005.

4. Maskus KE. The role of intellectual property rights in encouraging foreign direct investment and technology transfer. J competitive int Law. 1998.

5. Fostering the knowledge revolution. YES bank report on Indian biotechnology industry. 2006.

6. Biospectrum. 2006 Jun.

7. IT enabled services in India–a focus on competitiveness. KPMG;2002.

8. Biospectrum. One billion industry. The third annual Biospectrum-ABLE industry. 2006.

9. Department of Biotechnology.

10. Notification vide dated 1.4.2006, Adoption of the recommendation of the Dr Mashelkar Task Force on r-pharma.

11. National Biotechnology Development Strategy draft 2005. Department of Biotechnology. Ministry of Science and Technology. Govt of India.

12. Ernst and young. Beyond border; 2005.

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