In February, FDA Commissioner Hamburg became the first-ever U.S. FDA commissioner to make an official visit to India. In a blog post back on February 11th – prior to her trip – Hamburg noted that India is the U.S.’s 2nd largest supplier of over-the-counter and prescription drugs. One line, in particular, stands out: “Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.”
FDA’s Hamburg: Problems in India’s Pharma Manufacturing Same as Rest of World
Of course it’s always good news to have high-profile individuals remind us that instances of lapsed quality don’t reflect on the entire subcontinent’s pharma infrastructure.
It’s also common sense.
It’s recognition that these kinds of quality issues are not representative of India…or China…or the U.S. …or really anywhere around the world. And that’s how it should be: the pharma business is – above and beyond everything else – about quality & safety…wherever you are. Having your regulatory and safety standards questioned in the life science industry is never a comfortable position to be in. If you want to compete globally, you need to meet the highest possible safety and GMP standards and eliminate compliance as a concern.
In a Scrip Intelligence article about Hamburg’s comments from February 12 (the emphasis is mine): “Media reports from Delhi also quoted Dr. Hamburg as saying that the problems encountered by FDA investigators in India were similar to those around the world in manufacturing when asked whether the deviations at Indian sites were alarming.”
The article also notes that “Indian firms that meet FDA norms have been keen to shrug off any attempt by competitors to paint the entire domestic industry with the same brush in the wake of a series of compliance issues at Indian sites over the recent past.”
I think “shrug off” comes across as a bit more carefree than the reality (no one likes to have their company stereotyped – especially when the company’s regulatory success is a source of pride). But the Indian pharma industry certainly has good reason to see this crop of regulatory problems as an aberration and not the norm. After all, Indian companies accounted for 40% of all drug master files to date and 37% of ANDAs in 2012. But they only accounted for 12% of US FDA warning letters.
The Regulatory Media Snowball
If three major U.S. pharma manufacturing sites were to be shuttered for non-compliance, the entire world would turn its attention to “Subpar U.S. Drug Manufacturing Safety” (in bold, 50-point font) or some such similar shocking headline. And I’m sure most of the unaffected pharma companies in across the United States would have similar concerns about being lumped in with instances of subpar quality.
A piece over at The BRICSPOST back in September provides some insight into the growing importance of India to the U.S. healthcare market:
India is the biggest overseas source of medicines to the United States and is home to over 150 FDA-approved plants, including facilities run by global players. These include difficult-to-make products having technological entry barriers, and also niche products that require dedicated facilities and clinical trials and are not economically viable for many generic players.
In a later post from India, Commissioner Hamburg further emphasized the global nature of quality issues, writing:
In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world.
In response to the recent spate of violations here in India, former president of Ranbaxy Ramesh Adige had an excellent suggestion: “Organize joint inspections in India and the U.S., and make arrangements for both countries to share information, exchange skill-sets and foster transparency and mutual trust.”
Fact: If you’re looking to achieve regulatory success, it’s hard to beat the enhanced flow of information, transparency and trust.
Pharma has historically been a locally-regulated industry with global implications. CMOs such as Neuland Labs face this daily – meeting the multiple regulatory standards of far-flung markets. To achieve this, Neuland doesn’t distinguish between Western markets and local markets. Instead, we rely on delivering one standard (the highest) – which is what Commissioner Hamburg emphasized in her post.
The silver lining to the recent comments by Hamburg? A growing awareness that this is – in fact – a global industry that demands global solutions – and that cooperation and information-sharing are first step towards a stronger industry.