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

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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

Skilled workforce: The biopharmaceutical industry requires a pool of highly skilled scientists. Currently, India has a talent pool of 15,000 scientists in the biotech sector.7 This pool has been developed over the past two decades, mainly as a result of the active support of Indian government's Department of Biotechnology (DBT).

India's population of 400 million—which is the second-largest English speaking population worldwide, after the US—includes 3 million science graduates, 700,000 postgraduates and 15,000 PhDs in the sciences. China, another major player in this segment, produces about 50,000 graduates annually from technical schools, but many Chinese scientists do not speak English, and many of those who do, migrate to other countries.6

Overall, India's English-speaking workforce rates high in qualifications, capabilities, quality of work, and work ethics. In a recent survey by KPMG done in a report titled IT enabled services in India—A focus on competitiveness, that compared three aspects of "people factors"—skills, costs, and institutions—India outran competitors such as Singapore, Hong Kong, China, the Philippines, Mexico, Ireland, Australia, and Holland.7

Infrastructure: According to KPMG's ranking of five countries—India, China, the Philippines, Ireland, and Mexico—based on three infrastructure factors (telecommunications, property, and transportation), India ranks the lowest in all three categories. In spite of its low overall ranking for infrastructure, however, India has more than 800 pharmaceutical manufacturing facilities that comply with the World Heath Organization's (WHO) good manufacturing practices (GMPs) and more than 70 pharmaceutical and biopharmaceutical plants that have been approved by the US FDA.8 Half of these are plants that manufacture active pharmaceutical ingredients (APIs) for the traditional pharmaceutical sector and the rest are finished dose formulation and bulk drugs. In addition, the number of Indian facilities that do not meet GMP standards is likely to decline in the future. Schedule M of the Indian Drugs and Cosmetics Act of 1940 and Rule 1945 were revised in July 2005 to require the Indian pharmaceutical and biopharmaceutical industry to comply with international GMP standards. As a result of these increased requirements, consolidation is likely in the industry as organizations unable to meet the new requirements are taken over by companies with more expertise.

Environmental factors: According to the KPMG report, in terms of environmental factors (divided into fiscal, political and regulatory, and institutions), India ranks higher than China and the Philippines. With respect to the fiscal subfactor, however, India is on par with China. Also, India does not rank as high as the Philippines, Ireland, and Mexico with respect to the political and regulatory environment, and ranks equally with the Philippines but not as high as China, Ireland, or Mexico with respect to institutions.

Government Initiatives

The central and state governments of India are actively supporting the outsourcing industry by implementing favorable policies. One example is through bilateral collaboration programs that the DBT has formed with more than 20 countries.9 During the 9th Five-Year Plan, India signed bilateral collaborations with countries including US, Sri Lanka, Sweden, UK, Germany, Myanmar, Belarus, Russia, and Switzerland, and formed multilateral collaborations with SAARC and ASEAN. The activities covered in these collaborations include joint research and development projects, human resource development, joint workshops, and academia–industry interaction.

The Indian government has also taken several important steps recently to promote the biopharmaceutical sector in particular. First, it has established the Mashelkar Committee Task Force to streamline the regulation of biopharmaceuticals.10 The task force also streamlines the regulatory process for the approval of all recombinant DNA products. It specifies the timelines for various approvals by the regulatory committees-RCGM approval for pre-clinical animal studies: 45 days; Drug Controller General of India (DCGI) approval for human clinical trials protocol: 45 days; DCGI examination of clinical trial data and response: 90 days; and concurrent DCGI and Genetic Engineering Approval Committee (GEAC) decisions: 45 days.

Another important highlight of the report is that it has recommended the constitution of a Standing Technical Advisory Committee on Biotechnology Regulation under the chairmanship of an eminent scientist to redress and look into the various regulatory aspects and make issue-based recommendations on case-by-case basis before any deviation from the regulatory mechanism.


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