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Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.
Recently, there have been more reports of compliance issues at API and drug manufacturing facilities in India. Kiran Mazumdar-Shaw, chairperson and managing director of Biocon, told Pharmaceutical Technology in an interview that investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed.
FDA compliance issuesPharmTech: What do you think might have contributed to the FDA compliance issues that some Indian drug manufacturers have had over the past few years?
Mazumdar-Shaw: India has nearly 380 FDA-registered facilities, which is the largest number outside the United States. Seen in that context, the non-compliance warnings received by Indian companies are not disproportionate to those received by companies in China and other countries. India’s growing market share in the US draws greater FDA scrutiny.
Despite all the media noise around compliance issues, the fact remains that Indian drug makers have the second-largest share of abbreviated new drug application (ANDA) approvals from FDA after US producers.
A report recently released by FDA’s Office of Generic Drugs (OGD) (1) shows that, out of 90 first-time generic drug approvals in 2015, up to 14 were won by Indian drug companies, most of them for specialized treatments (2).
Over the past few years, regulators across the globe have opted for stricter norms to ensure the quality of medicines, which is evident from the fact that the total number of product recalls and warning letters to pharma companies globally tripled between 2008 and 2014.
Indian pharma companies are working overtime to align their operations and improve their quality control procedures to meet Western regulatory expectations, and I expect the number of warnings to come down in due course.
Investments in facilities and training neededPharmTech: What will be needed to change the situation?
Mazumdar-Shaw: Despite the recent spate of quality-related issues, the reality is that Indian pharmaceutical manufacturers continue to command a good reputation in pharmaceutical manufacturing. Besides the FDA-approved facilities, there are 1400 manufacturing plants with World Health Organization (WHO) GMP approval and over 250 plants that have been cleared by the European Directorate of Quality Medicines (EDQM).
The Indian pharma industry will need to focus and invest more in high-quality manufacturing to maintain its edge as a destination of choice for the production of safe, effective, and affordable medicines. Besides investing in physical infrastructure, companies must invest in talent to ensure an optimal mix of quality control staff and shop floor personnel for delivering the highest quality. There is also a need for greater dialogue with Western regulators to keep pace with the evolving quality and regulatory regime and align people and processes accordingly.
Rebuilding market credibilityPharmTech: There has been some retrenching and ‘onshoring,’ as some US companies have begun to source APIs and other materials from the US and Europe. What will be needed to reverse this trend and regain any lost credibility, on the part of some API suppliers?
Mazumdar-Shaw: To achieve the goal of ‘make in India for the world,’ Indian pharmaceutical companies will have to adhere to current good manufacturing practice (cGMP) guidelines, backed by quality by design (QbD). They will need to bring in more checks on manufacturing processes and rigorously focus on monitoring, causality, and documentation.
It is also imperative that Indian companies ramp up skills on QbD. There is a need to build a strong quality brand to sustain leadership on the mantra of ‘highest quality at the lowest cost’.
India’s role in the global marketPharmTech: What unique strengths do you see Indian pharma contributing to the global market over the long term? What will be needed to get there?
Mazumdar-Shaw: The Indian pharmaceutical industry has played a disruptive role by developing critical drugs at relatively affordable levels. By bringing down the prices of drugs used to treat life-threatening diseases such as HIV, tuberculosis, and cancer by as much as 90%, Indian generic-drug makers have enabled access and saved millions of lives across the developing world.
India’s strengths in drug development and cost-effective drug manufacturing can be key to realizing the vision of addressing unmet medical needs through affordable biopharmaceuticals globally. India can make as much of an impact on global healthcare with biosimilars in the coming years as it has done with small-molecule generics in the past.
Access to capital, quality infrastructure, high-end talent, and an optimal ecosystem that encourages innovation in the country will spur India’s evolution as a biopharma hub and the preferred destination for innovation.
Biosimilars outlookPharmTech: What are your plans in the biosimilars business? What role do you see Indian suppliers playing in this niche?
Mazumdar-Shaw: Biocon, with its rich pipeline of biosimilars under development, is preparing to meet the widespread global demand for affordable biosimilars from patient advocacy groups, non-profits that support healthcare initiatives, and governments with overstretched healthcare budgets. The global market opportunity for biosimilars is estimated to reach around US$24 billion in 2019 (3).
Today, Biocon has one of the largest portfolios of generic insulins and biosimilar protein therapeutics in advanced stages of development and is on track to file for regulatory approvals in US and Europe for four of them in fiscal year 2017. Biocon is confident that, together with our partners around the world, we can build a strong global presence in biosimilars to address the huge need for affordable access to these life-saving and life-enhancing biologics.
India has been among the early adopters, and established the regulatory framework for biosimilars as early as 2012. The industry is well poised to provide cost-effective alternatives to expensive reference biologics for patients and an opportunity for governments across the world to rein in burgeoning healthcare costs.
1. FDA, Annual Report, 2015, Office of Generic Drugs.
2. A. Malik, “USFDA Grants 14 First-Time Generic Drug Approvals to Indian Firms in 2015,” Indian Business Times, April 15, 2016.
3. C. Challener, “Focus on Biosimilars,“ PharmTech.com, Oct. 6, 2014.
Article DetailsPharmaceutical Technology
Vol. 40, No. 6
When referring to this article, please cite as A. Shanley sidebar to, “Steps Closer to the Adoption of Continuous Processing," Pharmaceutical Technology 40 (6) 2016.