Much needs to be done for Indian manufacturers to graduate from being considered "manufacturers for the developing world"
to the "manufacturers for the developed and the developing world."
Significant improvements have been made to the country's regulatory system. A systematic, science- and risk-based approach
for review of regulatory filings and inspections has been put in place. However, there is a need to ensure greater transparency
in the decision-making process so that the outcomes can be more consistent. The current system involves multiple organizations
(e.g., the Department of Biotechnology, Central Drugs Standard Control Organization) and ministries of the government. A single
point of decision-making and accountability will make the system more efficient, credible, and better coordinated, and will
reduce confusion and delays that are otherwise suffered at times by the industry. In addition, basic training in areas such
as GMP, documentation practices, scale up, technology transfer, and validation is needed by the industry and regulators.
Creation of modern technology platforms that can support the regulatory authorities in making appropriate decisions during
the review and inspection process is needed. For example, approaches such as rapid analysis of a drug lot, fingerprinting,
and use of chemometrics to quickly facilitate decision-making on product quality are already in practice by some of the major
global regulatory agencies, and India could benefit from these technologies.
The Indian Pharmacopoeia Commission (IPC) is in the process of overhauling its monographs for biotech products. As a creator
of the minimum standards that a biotech drug must meet in order to be a commercial product, IPC can play a crucial role in
contributing to the success of the Indian biotech industry by using a science-based and risk-based approach when creating
Professional organizations such as the Parenteral Drug Association (PDA) have been effective in the US in bringing the industry
and regulators together in the form of various task forces to create best practices for industry and regulators. International
trade organizations, such as the American Chemical Society (ACS) and International Society for Pharmaceutical Engineering
(ISPE), also have been effective in the US by encouraging dialogue between academia and industry through conferences and other
India could benefit from similar academic–industry collaborations. The Small Business Innovation Research Initiative (SBIRI)
from the Department of Biotechnology (DBT) is one step in this direction.
Quality by design (QbD) has gained significant momentum lately in the biotech industry with both regulators and the industry
investing financial and staffing resources to implement the approach (13, 14). A QbD approach is likely to be expected of
Indian manufacturers when they apply for FDA or EMA approval of biosimilars. The Indian biotech industry should see this as
an opportunity to innovate and come up with more efficient ways of product development and commercialization without compromising
product quality and consistency.
In summary, significant challenges lie ahead for the Indian biotech industry. The government, industry, academia, and regulators
need to work together to surmount them. The business case for doing so exists as demonistrated herein. It remains to be seen
whether India will capitalize on its strengths and emerge as a dominant global manufacturer of biosimilars.
Anurag S. Rathore* is a member of the faculty of the Department of Chemical Engineering at the Indian Institute of Technology, firstname.lastname@example.org