Two reports, released in early June, have both good news and bad news for the pharma industry in India. The good news is that the sector seems to have become more proactive about addressing data integrity concerns. Over one third of the total data integrity reviews conducted by EY were done proactively by GMP compliance conscious companies.
But the bad news is that lapses in data integrity continue to rise. In a survey conducted by the firm, ‘Analysing the state of data integrity compliance in the Indian pharmaceutical industry’, more than 30 per cent of the over 170 respondents had received inspectional observations such as Form 483s, warning letters, import alerts, statement of non-compliance with GMP etc. issued by global regulators. Clearly this is still a work in progress, with as much as 28 per cent respondents admitting that their organisations did not have a fraud reporting mechanism in place. These laggard companies run the very real risk of whistle blowers turning to social media platforms.
In fact, 76 per cent of the respondents in Deloitte India’s survey report, ‘Managing Growth Through Better Compliance Management’, indicated that their organisations relied on whistle blowing channels to detect fraud, non-compliance and malpractice. That may be good news, but not all companies took this further: on detection of fraud, 85 per cent of respondents representing 33 companies said they launched an internal investigation by a specially appointed committee, while 82 per cent confirmed that some form of disciplinary action was initiated.
The change from a reactive to a proactive stance has been recent but fast, says Rajiv Joshi, Partner, Fraud Investigation & Dispute Services, EY. It would seem that there’s a realisation that prevention is better than cure. Joshi even goes so far as to say that promoters/ top management in these proactive pharma companies are looking at the increased monetary spend on such compliance reviews as an investment for the future, almost like insurance against future regulatory risk.
But the numbers of such proactive pioneers is still small. Dr Ajaz S Hussain, former Deputy Director at US FDA’s Office of Pharmaceutical Science and now an advisor to EY, puts this dithering down to a lack of confidence and the fear of even greater regulatory scrutiny. His answer is that if regulators see that you are proactive, they will be more encouraging, because they realise that you are trying to correct your systems. Over time, a sincere and sustained effort to improve will rebuild the trust between global regulators and Indian pharma companies.
Hussain also has a message for all regulators: the heterogeneity between regulators needs to be reduced because it is sending mixed messages to the industry. Inspectors need to be trained to have a uniform approach to inspections. Clearly, this is one message he wants his former colleagues at the US FDA to hear.
The interesting thing is that when it comes to becoming more proactive about compliance, size does not matter. Drawing on his observations in the past few years as an advisor to Indian pharma companies facing the brunt of regulatory non-compliance, Hussain says that he sees leadership at smaller companies changing the mindset of their employees much faster than at their bigger older peers, possibly because the latter come with a larger set of legacy problems while the smaller ones can leapfrog older technologies. In fact, Joshi sees a lot of SMEs as front-runners in compliance systems because it is a ‘comply or die’ situation. With just two or three manufacturing facilities, a single import alert could cripple them financially.
Born and educated in India, Hussain spent more than three decades in the US, and was with the US FDA from 1995-2005 . So, he is in a unique position to put his finger on the nub of the issue. Indians are brought up to respect, nay obey seniors and therefore do not raise the red flag often enough. Also, he points to how regulators in India chose to blame processes rather than people for compliance lapses. But he’s happy to report that attitudes are changing fast. He says clear and precise communication from the leadership, both corporate and policy makers/ regulators, can change mindsets overnight.
And we don’t need to lose our Indianness in the process. Hussain’s LinkedIn blog post, ‘Dil Se; don’t be too quick to discount our wisdom traditions’ talks about discovering that a quality mindset is not alien to our culture. So citing the famed ‘chalta hai’ attitude is nothing but a cop out. Put that way, my take is that millions of Indian families still churn out homemade pickles, chutneys and other sun-dried savouries that stay uncontaminated till the next season, often without recourse to any refrigeration. Thus, quality SOPs and GMPs are very much part of our DNA. All it takes is a discipline, dil aur dimage se (from both the head and heart.)