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

Table 2. Manufacturers and marketers of biopharmaceutical drugs in India
Currently, local Indian companies have the expertise to develop and manufacture several recombinant biotech products sold on the domestic market. The recombinant DNA pharmaceuticals approved for marketing in India include insulin, GM-CSF, G-CSF, interferon alpha, interferon gamma, interleukin, blood factor VIII, streptokinase, HBsAg vaccine, human growth hormone, tPA, erythropoietin, follicle stimulating hormone, and human protein C. The recombinant DNA pharmaceuticals approved for manufacturing in India are HBsAg vaccine, erythropoietin, G-CSF, interferon alpha, and insulin.

In addition to vaccines, India's capabilities to manufacture recombinant protein products have also grown. Companies like Shantha Biotech, Bharat Biotech, Wockhardt, and Biocon manufacture recombinant products such as vaccines, human insulin, and erythropoietin as generic products for the domestic and export market.

Table 3. Foreign collaborations between Indian and foreign biopharmaceutical companies in 2006
With the IPR now in place in India opportunities exist to support investment in production facilities based on licensing and other forms of cross border relationships for all therapeutic products. Indeed, Indian biopharmaceutical companies are also signing more and more collaboration agreements with foreign companies (Table 3).

Research and Development Strength

India's strength in biotechnology R&D has increased in recent years, in part as a result of the government's rising budgetary allocation for the sector, which has increased from $10.1 million in 1988 to $80.875 million in 2005. The areas of high competence in R&D in the biotechnology sector include bioprocess engineering, gene manipulation of microbes and animal cells, downstream processing and isolated methods, extraction and isolation of animal products, stem cell biology, bioinformatics, proteomics, and genomics.12


Despite the progress in the sector, the Indian biopharmaceutical industry also has several weaknesses and faces many threats. These include infrastructure constraints, multiple regulators, irregularity in clinical trials, and low government funding.

Infrastructure Constraints

As mentioned earlier, one area in which other countries have an advantage over India is infrastructure, specifically property and transportation systems. The availability of telecommunications facilities and the cost of these services have traditionally been areas in which India has not performed well. High property rates, stamp duties on land purchase, and the restriction of foreign investment in property in India have been additional hurdles faced by foreign investors. It should be noted, however, that the quality of India's infrastructure has been improving. In particular, the liberalization of the telecommunications sector has resulted in several competing players, which has lowered the cost of telecommunication services and allowed cheap Internet.

Multiple Regulators

The biggest hurdle the Indian biopharmaceutical industry faces is the chain of multiple agencies that companies must deal with. Moreover, current laws prohibit companies from conducting clinical trials in India on drugs discovered abroad and then licensed to an Indian company. Also, there is lack of clear guidelines from the agencies about what is required for clinical trials as well as other aspects. It generally takes approximately 16 to 36 months in India from applicant filing to launching a drug in the market. This delay is because of constraints like lack of trained people in the regulatory agencies , infrastructure, and resources.

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