Concerned with declining pharma exports in the recent past, the Ministry of Commerce & Industry has tried to burnish the brand image of India’s pharmaceutical sector. A key initiative has been to host regulators at iPHEX, an International Exhibition for Pharma and Healthcare. Pharmexcil’s efforts at IPHEX and other such international exhibitions finally seem to have borne fruit with a 9.7 per cent jump in exports in 2015-16.
Speaking at the fourth iPHEX, the Union Commerce Secretary, Rita Teaotia commented that the nearly 33 per cent growth in exports to the US market in the last fiscal, despite several domestic companies facing the heat from US FDA last fiscal, showed that the companies are capable of taking on these regulatory challenges.
Her colleague, Sudhanshu Pandey, Joint Secretary, Department of Commerce took the same line when I interviewed him at iPHEX. He said that Indian pharma’s regulatory woes have attracted a disproportionate level of negative press even though the ratio of 483s issued to India-based plants is not disproportionate. (See his interview: The companies who export must comply with the regulations of the importing country; pages 18-19)
He also makes an interesting argument for allowing countries to choose the methods as per their national health requirements, which might be common among some countries. PIC/S is one convention, we could have another, he suggests. Can a globally connected world have different levels of quality standards for medicines? It’s anyone’s guess where this discussion will go.
The Express Pharma May 16-31 issue, is a GMP special issue, with a line up of global experts giving their perceptions on this vexing topic. With global regulators now making it clear that senior managements will be held accountable for lapses in quality, has the ‘elephant in the boardroom’ been finally acknowledged and addressed?
Yes, adherence to GMP guidelines is the agenda for top managements but senior management is not talking much about it beyond the usual press statements. With good reason, as regulators do not like to be preempted. Industry insiders refer to the case of a big Indian pharma company which faced a backlash when they called a press conference stating that they were confident that a recent plant inspection had satisfied global regulators and the import ban on that facility would soon be lifted. The inspectors were not amused and the company had to sweat it out longer than expected.
But the numbers do support the Joint Secretary’s assertion that India gets disproportionate bad press. A McKinsey white paper titled ‘Quality Excellence: The next frontier for the Indian pharmaceutical industry’, released in February this year pointed out that India’s share of US FDA inspections of pharma manufacturing sites went up to 11 per cent in 2015 (135 upto September 2015, extrapolated for the whole year), from an average of six per cent (102 inspections in 2011-2014). Yet the proportion of OAI +VAI (Official Action Indicated + Voluntary Action Indicated) decisions remained the same: 65 per cent during 2011-2014, compared to 63 per cent in 2015. (See pages 22-25: Building quality excellence in pharma)
So, should we dismiss these quality concerns? No way. In fact, the Joint Secretary emphasises that the companies who export must comply with the regulations of the importing country. But India is not the only country grappling with quality. According to the McKinsey report, between 2008 and 2014, the number of product recalls and warning letters (WLs) to pharma companies globally tripled. At least one pharma facility worldwide entered into a consent decree every year since 2008 globally.
Which is why capacity building is crucial and not something that can happen overnight. It will happen one facility, one location at a time.
A former member of the US FDA, Dr Ajaz Hussain, Founder CEO, Insight Advice & Solutions today conducts training programmes for pharma companies. In his article, (pages 20-21: Pharma quality assurance in 21st century: Sharper focus needed on education, training and experience) he advices that leaders of India’s pharma sector should set up Global Institutes of Pharmaceutical Quality (GIPQ) which will contribute to the knowledge and expertise needed to improve regulatory science and policy across the globe.
Given the size of the industry, it may take another two-five years before we see a measureable improvement but things have already started moving in the right direction. For example, Indian Pharmaceutical Alliance and McKinsey are in the process of preparing data integrity guidelines, borrowing from various global drug regulatory systems. Nine out of 10 WLs to Indian pharma companies cite data reliability issues so tackling this gap could address a significant chunk of lapses.
IPA and McKinsey is also in the process of conducting a quality culture survey across six major Indian pharma companies to serve as a benchmark for the industry. These are but initial steps, but momemtum will build up once the bigger pharma companies start reaping the benefits of embracing quality as an opportunity rather than a risk.