In order for India’s biopharmaceutical players to compete effectively on the global scale for biosimilars market by 2020, the private sector as well as Government of India (GOI) will have to invest a considerable amount of capital in building the manufacturing capacity and skills base to provide the necessary enabling environment. The Department of Pharmaceuticals, GOI in partnership with Association of Biotechnology Led Enterprises (ABLE) and PricewaterhouseCoopers (PwC) have attempted to address this opportunity and provided the key recommendations into six broad sections, which you can read about here.
The first section is focused on the research & development area of the biopharmaceuticals sector which is divided into seven sub-sections.
1. Build protein characterization laboratories and GLP-certified animal study facilities
The biopharma product development process includes both the method of manufacture and high-end bioanalytical product characterization to verify the equivalence in quality to the original drug. Foreign regulatory authorities require evidence to the applicable standards as part of the regulatory submission. The validated product (bioanalytical-proof) is then tested in a GLP-certified animal laboratory and the data from bioanalytical studies and animal tests are submitted to the regulator for permission to conduct a clinical trial.
India currently has very few GLP-certified animal laboratories and only one GLP-certified protein characterization laboratory at the National Centre for Biological Sciences (NCBS) in Bengaluru. The country needs at least four more GLP-certified laboratories. The GOI should therefore fund the construction of the necessary facilities in national scientific institutions and laboratories, as well as in CROs. It should also promote collaboration between academia and industry. In addition, the GOI should offer duty waivers or other incentives to encourage existing service providers to branch into biologics development, using the Research-as-a-Service (RaaS) model – which would, in turn, attract multinationals wanting to outsource such activities and improve revenue generation. India’s public institutions are not equipped to provide such services because they do not have sufficient understanding of the regulatory requirements.
2. Create a national animal breeding facility
India needs a National Animal Breeding Facility to produce high-quality animals for preclinical studies and to generate certified data that meet international standards and scrutiny. Recently, the GOI announced plans to establish a large centre to breed dogs and monkeys for use in clinical research, and the Department of Pharmaceuticals has invited expressions of interest from both public and private institutions with relevant biomedical expertise. However, at least one rodent facility and two large-animal facilities are required to develop MAbs and biosimilars by the biopharma industry in the country. The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), acting under the aegis of the Department of Forestry, currently controls all animal facilities, including registrations, but lacks the expertise to conduct proper scientific inspections and is understaffed. Therefore, the GOI need to intervene to better equip the CPCSEA to match the international standards.
3. Provide financial assistance for ensuring compliance with global standards
All facilities for characterizing proteins, breeding animals, conducting animal studies and performing viral testing will need to operate to international standards. Therefore, the GOI needs to provide financial assistance with the cost of hiring consultants to advise the global regulations.
4. Expand viral testing and evaluation facilities
India does not have enough facilities for testing and evaluating the viral safety of biologics derived from characterized cell lines of human or animal origin, in compliance with International Conference on Harmonization guidance ICH Q5A (R1). The GOI will have to consider constructing more testing and evaluation facilities. At the same time, the Indian regulatory agencies need to ask for the ‘viral clearance’ as a pre-condition for approval of all domestic biomanufacturing plants.
5. Promote the development of preclinical service providers
Consider the fact that the market for toxicology and bioanalytical services is worth about $12 billion and only 15% is outsourced. The GOI could provide credit and/or tax incentives to help preclinical service providers establish such facilities in the country. There are not many facilities for offering such services other than bioanalysis and toxicology studies to speed up the number of early drug candidates being developed by companies and to outsource these activities.
6. Provide practical support for conducting clinical trials worldwide
Any Indian biosimilars company that wants to sell a biosimilar in a regulated market will be required to conduct clinical trials of that biosimilar against the reference product in the country concerned. This represents a major financial risk, therefore, the GOI could provide assistance in engaging consultants to design and execute world-class trials.
7. Simplify the procedures for importing and exporting biologics
The procedures for importing comparator drugs, test materials, Genetically Modified Organisms (GMOs) and Living Modified Organisms (LMOs) into India for research purposes, and for exporting biologics out of India, for clinical studies in other countries, are very cumbersome. India also lacks cold storage facilities (and most biologics are heat-sensitive).
The GOI should therefore simplify the process for importing biological samples and participate in negotiating government-to-government treaties for handling biologics (which would make it easier to export biosimilars that are manufactured in India). In addition, it should encourage the construction of cold storage throughout the supply chain and mandate faster clearance times at customs to avoid loss of material in transit.
In the next blog post, I will discuss the manufacturing and commercialization aspects of the biopharmaceuticals sector, as it pertains to India’s vision 2020 strategy.