INDIA'S RISK-ADDED PROPOSITION
India's challenges and weaknesses associated with biomanufacturing include weak infrastructure, quality management problems,
intellectual property (IP) issues, inadequate financial support, and an unclear regulatory environment. While all these are
receding, there are still lingering perceptions and realities of technical insufficiency, quality problems, and foreign IP
risk. Biomanufacturing is capital- and knowledge-intensive, rather than labor-intensive. As such, one of India's strengths,
its relatively low-cost, talented labor pool, does not support this manufacturing segment. In biomanufacturing, any cost advantage
can swiftly be wasted through technical or regulatory mistakes, loss of proprietary data, or supply problems associated with
biotech-trained labor or logistics infrastructure.9
WEIGHING THE RISKS
Western biopharmaceutical executives have cited India's risky IP climate as one of the major reasons their companies have
chosen not to offshore manufacturing to India. In addition, concerns exist over the ability of Asian manufacturers to be
cGMP and FDA compliant, to have qualified management and a good track record, and in general to have the collective know-how
to operate at Western standards. However, with narrowing developmental pipelines, looming patent expirations, and the failures
of would-be blockbuster products, Big Pharma is looking to cut costs wherever it can.
Asia is certainly going to continue to be a major destination for much of the offshoring of small-molecule drug manufacturing
in the short-term, and biologics in the longer term. India's perception in the West is evident from a decision by Wallace
Pharmaceuticals, an established Indian maker of formulations and active pharmaceutical ingredients (APIs) in 2004, to purchase
Florida-based Goodwin Biotechnology, an established biopharmaceutical CMO. Goodwin announced that it was in talks to provide
its CMO services to Indian biopharmaceutical companies, chiefly because the intricacies of biopharmaceutical production require,
"an intimate knowledge of what the US FDA expects, how to deal with the FDA, and ultimately, the flexibility to protect the
drug sponsor's investment by continuously evolving the processes to the FDA's satisfaction. To do that successfully from India
would prove extremely difficult."10
To date, about a dozen Indian biopharmaceutical companies have announced that they are equipped to make biologics for foreign
clients. Success in attracting business has been modest, however, and has mostly included contracts for relatively simple
APIs and intermediates, and vaccines in particular. Some noteworthy examples of homegrown Indian companies that have demonstrated
or are buying world-class capability in biologics manufacturing include:
- Biocon, India's largest biopharmaceutical company that produces a humanized anti-EGFR monoclonal antibody for the treatment
of head and neck cancer. Biocon also makes insulin products for US-based Bentley, Invitrogen, and BMS, and exports statins,
which require some biotech-type manufacturing steps, through US distributors. For other clients, Biocon makes enzymes and
biologic APIs for immunosuppressants.11
- Serum Institute remains one of the world leaders in vaccine production. Its product line includes MMR, a quadrivalent vaccine
for diptheria, tetanus, pertussis, and hepatitis B, rabies vaccine, and a recombinant hepatitis B vaccine.
- Intas (ranked #12) provides through its Celestial Biologicals group manufacturing and marketing of plasma-derived products—
mainly albumin, immunoglobulin, and coagulation factors (factors VII, VII , IX, XI, and fibrinogen).
- Avesta Biotherapeutics and Research (ranked #50), a joint venture between Avesthagen and Cipla, purchased Swiss-based Siegfried
Biologics, which is expected to be used by Avesta to manufacture its biopharmaceutical products.
- Bharat Biotech (ranked #6) makes a haemophilus influenza B conjugate vaccine for Wyeth Lederle, and a human lactoferrin product
for Agenix, Inc.12 Acambis Plc., a UK-based vaccine developer, has a manufacturing and marketing agreement with Bharat for a Japanese encephalitis
Some major Indian pharmaceutical companies such as Dr. Reddy's and Wockhardt are keenly involved in this developing segment.
Dr. Reddy's currently markets two generic biologics that are versions of Roche's Rituxan and Amgen's Neupogen. Wockhardt has
announced that it will introduce one biopharmaceutical product every year, with plans to seek alliances with biotech companies
in the US and the EU.