June 15, 2005 (Vol. 25, No. 12)

IP Regulations and Supportive Gov’t Commitment for R&D Will Be the Key

Active support from the Indian government for increased funds and infrastructure, such as biotech parks, as well as an emphasis on R&D, will help strengthen India’s biotech sector in the near future, according to M.K. Bhan, M.D., secretary, department of biotechnology, and R.A. Mashelkar, director general, council for scientific and industrial research.

According to Dr. Bhan, in due time, India will follow WTO regulations. Recently the Indian government approved patent regulations, and under the Trade-Related Intellectual Property Rights agreement, India must implement patent protection on pharmaceuticals and biotechnology products this year.

However, there is strong opposition for the patent bill by political parties and Indian pharmaceutical executives. Those in opposition claim the bill will eliminate the availability of low-cost vital therapeutics to poor countries.

“BioAsia 2005” was held in Hyderabad recently to augment the investments in biotechnology, create awareness about the infrastructure availability in Hyderabad, and facilitate interaction between the different players in the biotech community.

Over 300 participants from across the globe attended, and the chief minister of Hyderabad and the governor addressed the delegates. Over 70 B2B meetings were held and 30 memorandums of understanding were signed during the meeting.

Biotech Parks

As part of the “BioAsia” program, the delegates had an opportunity to spend part of a day at ICICI Knowledge Park near Hyderabad. Several states have taken the initiative to establish biotech parks near major universities.

The state of Maharashtra has set up technology parks, one at Hinzewadi near Pune, and a second for agriculture biotech in Aurangabad. Both of these parks are a few hours drive from Bombay. Over 40% of India’s pharmaceutical sales and 30% of all patents filed in India are from companies and academic institutions in Maharashtra.

According to Rajiv Datar, CEO of Shreya Biotechnology (Pune), the 300-acre Hinzewadi park, has facilities for biotech and IT companies. Shreya is building a GMP plant for producing recombinant proteins, including insulin and growth hormone with technology licensed from a U.S. firm.

The focus of new product development in India is in TB, HIV/AIDS, malaria, cholera, cancer, typhoid, and heart diseases.


India is a hub for the vaccine market. In 20032004 it grew at 18.64% and accounted for 47% of the total biopharma segment with sales of US$253 million. GlaxoSmithkline, Wyeth, and Aventis are major multinational players in the Indian vaccine market.

Several domestic players are competing in this market. Major vaccines produced include DPT, DT, BCG, Tetanus toxoid, oral polio, measles, mumps, rubella, hepatitis B, rabies (tissue culture-based), and an injectible typhoid vaccine.

Serum Institute of India (Pune) is the largest global exporter of vaccines and immunobiologicals from India. The company’s flagship products are measles and DPT group vaccines, and it is now working on a quadravalent vaccine that will reduce the number of injections for infants to just one. It has established a marketing alliance with Serono in Switzerland.

Shantha Biotechnology (Hyderabad) markets recombinant hepatitis B vaccine and streptokinase. According to V. Reddy, CEO, “India can position itself as an affordable base for producing vaccines for UNICEF and the developing countries and thereby fill the gap left by multinational companies that no longer find the market of pediatric vaccines profitable enough to operate in.”

Bharat Biotech is producing Revac-B, recombinant vaccine for hepatitis B, using its HIMAX technology. This process eliminates ultracentrifugation and the use of toxic metals while increasing the recovery of antigenic proteins. Revac-B thus became the world’s first recombinant hepatitis B vaccine to be manufactured without the use of cesium chloride. The company also markets streptokinase and is developing a rotovirus vaccine.

Many Indian companies with multimillion dollar revenues in chemical, enzyme, or pharmaceutical areas have also invested heavily in the biotechnology subsidiaries. These include Biocon, Nicholas-Piramal India (Bombay), Panacea Biotech (New Delhi), Reliance, Ranbaxy and Reddy Laboratories.

Nicholas-Piramal has entered into exclusive licensing and co-marketing agreements with global giants like Biogen Idec, Gilead Sciences, and Genzyme.

Panacea Biotech is a leading manufacturer of vaccines. The company’s oral polio vaccine received WHO-GMP certification, and its anthrax vaccine is in Phase I trials.

Panacea Biotech has entered joint ventures for vaccine manufacturing with Chiron Vaccines (Emeryville, CA) and thermostable vaccine production with Cambridge Biostability (Cambridge, U.K.). Panacea Biotech is also negotiating a collaboration with ApoLife (Detroit), for using ApoLife’s yeast-based technology for the production of therapeutic humanized antibodies.

Wockhardt (Bombay) has an USFDA/EMEA-confirmed manufacturing facility for recombinant biotechnology, and the company is producing three products: Biovac-B (hep B) vaccine, Wepox (erythropoietin), and Wosulin (r-DNA human insulin).

Biotech Start-ups

The biotech sector in India is still a conglomeration of small and medium-sized companies. The major hurdles for biotech start-ups are finding seed capital, regulatory reforms, lack of R&D focus, and intellectual property rights. In spite of those hurdles numerous companies have sprung up in India.

Magene Life Sciences (Hyderabad) is part of M.P. Chary’s group of knowledge-based companies. Magene offers a range of contract services from downstream processing to assay development and bioinformatics.

Some of the upcoming biotech companies include Avesthagen, Bangalore Genei, and Gangagen.

Gangagen is developing phage therapy for antibiotic-resistant bacteria. The company has a laboratory in Bangalore and offices in California and Ottawa.

Bacterial phages reproduce upon entering the bacterial cells, subsequently killing the host cell during phage multiplication. This can cause potential problems because of the threat of a sudden release of endotoxins from killed bacteria. Gangagen scientists engineered endolysis-deficient phages, which can kill bacteria without lyses, and the company is developing products for biomedical and agriculture applications using these engineered bacteriophages.

Clinical Trials

India offers great advantages in conducting clinical trials. These include speed of patient enrollment, which is higher than in Western countries, an excellent pool of qualified doctors and investigators, expertise in computer skills like data management, a heterogeneous population, and conformation to ICH and GCP guidelines.

India also provides a unique opportunity to discover the functional significance of human genome sequences because of its genetically diverse patient population.

In addition, because of its IT expertise, India also offers advantages for bioinformatics. With over 76 full-fledged hospitals catering to more then 1,200,000 patients every day, Maharashtra is regarded as a preferred state for conducting clinical trials in the country.

Raptim Research has marketing infrastructure in the U.S. and several European countries, conducts clinical trials for multinational pharma and is growing rapidly, according to Rajan Shah, CEO.

Multinational companies, such as Eli Lilly, are already reportedly spending over 10% of annual turnover on clinical trials in India. According to M.V. Nagendra, M.D., CEO of Asiatic Clinical Research (Bangalore), the biggest share of outsourcing in biopharma will be in clinical trials. He has assembled a competent team of physicians, scientists, and IT professionals, several of whom have returned to India after obtaining experience with U.S. companies.


At the “BioAsia” meeting, Sandesh Seth, from AmerAsia Capital Partners in New York, outlined a strategy for developing biotechnology companies using the strengths of both India and the U.S.

According to Seth, the U.S. venture capital community is taking a cautious approach toward investing in biotech in India as it is believed that the U.S. biotechnology model is not likely to work in India for the next few years.

Several factors have been cited, including deficiencies in biological testing capabilities and lack of sufficient R&D management talent. However, explained Seth, one of the business models that could overcome these hurdles is for a company to base its front end in the U.S. for R&D management, business development, and financing combined with a back office in India. This could open the doors for U.S. technology and financing while utilizing India’s potential in many areas of drug development, clinical trials, and manufacturing.

Alan Levi, CEO of Pfizer (New York City) global R&D, emphasized that globalization of R&D is essential for cost control and acceleration of drug development. India offers not only scientific talent but also many customers for all new drugs.

However, the road blocks are weak IP protection, limited laboratories doing basic research (due to lack of grant programs such as NIH SBIR funds), and lack of an entrepreneurial spirit. Strong commitment and clear vision are needed from the Indian government to resolve these issues.

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