Making the case for Indian generic manufacturing
American consumers often are surprised to learn about the drugs being prescribed to them. For instance, many people are taken aback to learn that more than 90% of the medicines prescribed by doctors in the United States are generics.
Even more surprising is the fact that more than a third of these drugs likely were manufactured in India. This country’s ability to produce affordable, generic drugs has led to its reputation of being the “pharmacy of the world.”
It stands to reason that when the media raises concerns about the safety and scope of imported generic medicines, consumers question the quality of medicines essential to their health. Recent stories have depicted an industry fraught with quality issues. These concerns raise fears among patients that taking drugs made in India may result in unpredictable effects.
Fortunately, the reality is that the generic medicines manufactured in India are as safe and efficacious as those made in the United States.
To drive forward this commitment to provide safe and quality drugs, The Indian Pharmaceutical Alliance, or IPA, which represents 23 research based national pharmaceutical companies focused on patient health and safety, with a commitment to provide quality drugs to patients throughout the world, have undertaken several focused steps towards excellence in quality. Over the past four years, IPA has worked to:
- Measure and benchmark Indian pharma quality with the rest of the world;
- Create targeted guidelines and best practices in areas of relevance, which are vetted by regulators across the world, including the FDA; and
- Expand the skills and capabilities of quality talent for Indian pharmaceutical companies.
Furthermore, between 2012 and 2016, IPA companies contributed $161 million to generic drug user fees, thereby contributing more than half of the revenue under the Generic Drug User Fee Amendments, which enables the FDA to bring greater predictability and timeliness to the review of generic drug applications, as well as helps to fund the inspection of generic plants.
The footprint of the IPA in the United States is larger than many may realize. The 16 IPA companies that have locations in the United States span 20 states and 60 geographic presences. In total, this represents a combined investment of $4 million and a five-year growth rate of 300%. What’s more, these facilities employ nearly 5,000 people, empowering communities from coast to coast.
Indian companies will continue to expand globally, enriching their manufacturing capabilities to meet the growing demand in the world. The future will see a major role in global health care by Indian pharma, not only in making medicines affordable, but also in strengthening India’s position as a global hub for making innovative and high-quality medicines.
By making bolder strategic moves in uncharted geographies, products and technologies, Indian generic manufacturers seek to reclaim their position as a world-class provider of affordable, high-quality drugs. Ensuring we communicate this vision and quality-centric focus will be essential to the bright future between manufacturers and those who rely on these medicines.
After all, a clear understanding of our record of accomplishment and emphasis on quality supports the ongoing efforts of Indian generic manufacturers to provide quality solutions that ultimately benefit consumers across the globe. Doing so will ensure that even if a customer does not realize they are taking a medicine made in India, they can rest assured it is safe and efficacious.
Radha Iyer is vice president and head of quality and scientific affairs for developed markets at Dr. Reddy’s Labs.