When you read some of the news regarding pharma manufacturing in India, the headlines are not good. Much of the narrative is negative and seems to be spiraling downward. Unfortunately, in today’s world the perception is often the reality, and the reality has us shaking our heads in wonder.
FDA commissioner Margaret Hamburg has come out with a clear statement on the situation: Indian companies have to take more responsibility for quality control. Oh, and by the way, the FDA is also ramping up cGMP audits in India. When the FDA makes these kinds of statements, the industry listens.
Good. Getting all of these issues out and in the open can bode well for a different future for manufacturing. It is a future important to the pharmaceutical industry and healthcare consumers around the world. The issues being uncovered can be cleansed by greater visibility as well as a better understanding of quality control practiced by the rest of the world. When you increase oversight you usually do it for a reason. You usually find more of what you were looking for as well. On that note, India should take heed: The FDA is watching. As FDA Commissioner Hamburg has pointed out, 25% of all the drugs used in the United States are supplied from India. For that reason we should all be looking, and some of us may also be able to help.
I have worked for a contract research, development and manufacturing organization with assets in India, and am fortunate to have close Indian contacts and friends in the industry. I have also consulted with pharmaceutical sponsors on the viability of placement of work there. From this perspective I can tell you that it is not a good feeling to see these reports about the Indian industry. There will be no piling on here, but no excuses either. I found it rather apropos that Commissioner Hamburg’s statements were pre-dated by only hours by these two top stories in FiercePharmaManufacturing’s daily newsletter:
1. The FDA catches another Indian drug maker falsifying data
2. Ranbaxy halts production at 2 plants to tackle its regulatory mess
The first, according to the newsletter, was in regard to “a penchant for messing with drug analytics to get the data companies need for drugs to be approved…” The second, well…we have all followed the story of the second. That it is now as much a Japanese quality control issue (for Daiichi Sankyo) as an Indian one adds to the drama. To be clear, most of the bad behavior surrounds the manufacturing of generics. This is just a suggestion, but maybe the global generics sponsors should be exerting more of a positive influence, and demanding more from their providers.
But this news leads to an even bigger question: What does all of this mean to the CROs/CMOs in India working with global pharma sponsors on biology, medicinal chemistry, and early and later stage development programs? Companies like GVK BIO, SAI LIFE SCIENCE, and JUBILANT? These companies cannot help but feel the taint, even if very much undeserved. In an early February article (see here) I wrote: “For India, the challenge remains a communications effort to better demonstrate why pharma should continue to increase outsourcing to that country as a whole. Look for a public relations putsch of more articles and media attention focused on increasing reliability and improving conditions there. For now, price is the advantage in India, but that distinction will mean less and less to pharma if infrastructure and other issues are not seriously addressed and effectively communicated.” Well, the “other issues” continue to surface and now all involved need to play a role in making things better.
FDA seems to be stepping up to the plate: Inspections of drug plants in India increased to 195 in 2012, from 11 in 2002. It is creating an Office of Pharmaceutical Quality to improve oversight of all types of pharmaceuticals, from brand name to over the counter. This is good news. Furthermore, the FDA is also working directly with the drug industry to come up with new standards and data to identify drug plants that go afoul of cGMP rules and which require inspection. That is even better news. India can use some help, and the entire industry needs to step up.
This will have many wondering: What do sponsors with current outsourcing needs do in the meantime, particularly those with positive experiences and who are feeling more comfortable working with Indian providers? How do you fight the flow of bad light (mixing wave and particle theory)?
Let me try to draw a wide analogy here. Consumers have voted their pocketbooks in the aisles of many retailers, including Walmart. Is the pharmaceutical industry (and governments, and healthcare systems) pushing price to the point where it is resulting in pain in the quality department? There is a lot of industry talk of moving to strategic relationships over tactical “one-offs.” Recent experience and hearsay inform us this is still a checkered reality. Quality suffers when market economics calls for corner-cutting, longer bench hours, or unattainable expectations. Global sponsors and the Indian providers need to be open as to what goals – financial and scientific – can be met, and which are good for the industry and healthcare consumers in the long run.
Be it in the pursuit of new drugs or generic adaptations, sponsors need to instill a trust in their providers that relationships are stable and based on price AS WELL AS standards of quality and safety second to no other region. These are the influences from the outside that will help India make the right decisions for all involved. After that it is up to the Indian industry to move forward.
When it comes to bad news, it is said that no timing is good timing. But the stakes for India are high right now. The country is in the middle of a battle with Chinese providers for global pharma customers and a sustained flow of deals. The only way both sides can win is if quality reigns superior for sponsors.