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

Mashelkar Committee Task Force Report was released in August 2005 and its recommendations were implemented on April 1, 2006. According to the report, approximately 90% of the organisms used by biotech companies, which are from category I and II, and recombinant pharmaceutical products derived from living modified organisms (LMOs) will now be regulated by the GEAC. According to the Mashelkar Committee Report, LMOs are defined as only those organisms modified by r-DNA techniques through human interventions where the end product is a living modified organism. The regulatory objective of GEAC should be confined to regulation of proposals, which involve the large-scale use of LMOs from environmental angle.

Evaluation of the product safety, efficacy, clinical trials, market authorization, and postmarket surveillance is the mandate of the DCGI. The product in which the end product is a LMO has the potential for propagating or replicating in the environment and, therefore, needs a higher level of regulation as compared to products derived from LMOs in which the end product is not a LMO. Further more, the magnitude and probability of environmental risk depends on the extent of use of LMOs in the R&D and production units. In case of imports, this risk is not there especially in cases of import of therapeutic proteins in finished form. Because the report of the Mashelkar committee declares that approximately 90% of the organisms used by biotech companies are from risk categories I and II, they are out of the purview of GEAC; the approval of GEAC is required only for organisms falling under the risk groups III and IV.

Another initiative of the government is its biotech strategy policy, which is now on the table in the parliament.11 According to the biotech strategy policy guidelines, DBT will act to facilitate a single-window clearance mechanism for establishing biotechnology plants. Large animal testing facilities with good laboratory practices (GLP) are central for testing candidate vaccines and biotherapeutics. Testing facilities will be created for genetically modified organisms and LMOs. Genetically modified organisms (GMOs) are organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination. This technology is known as modern biotechnology or genetic engineering or recombinant DNA technology. It allows selected individual genes to be transferred from one organism into another to give new traits to the recipient.

The government has also framed policies for the promotion of biotech parks. The DBT will promote and support at least 10 biotech parks by 2010. The biotech companies located in these biotech parks will receive concessions such as a tax holiday under Chapter U/S 10B of the 1961 Income Tax Act and duty-free importation of equipment and instruments.

The Indian government is also facilitating the growth of the biopharmaceutical sector by promoting biotechnology clusters where there is close proximity of industry, academic institutions, and research laboratories.

Several states also have undertaken significant initiatives to develop bioclusters, incubators, and centers of biotech excellence that include policies to pave biotech growth and fiscal incentives like tax holidays, capital subsidies and energy concessions, and support for biotech parks that provide access to telecommunications, bandwidth, power, and other infrastructure required for smoother operations.

In 2000, the Andhra Pradesh (AP) state government set up the Genome Valley to host almost all the major players in the field of biotechnology. It declared an area of approximately 600 sq. kms. as the Genome Valley. The AP government aimed at providing high quality infrastructure at a reasonable cost with integrated services to biotech manufacturing units by setting up a series of Biotech Parks. One of them is India Knowledge Park (IKP); this was made in partnership with Indian Credit and Investment Corporation of India (ICICI) Bank. IKP has been leasing out and ready-to-use modular laboratory units. IKP has also been providing a range of infrastructure and administrative support services to create a congenial stress-free environment.


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