Bitter medicine
Name-Shame-Blame-Train. This has been the pharmaceutical industry’s mantra to manage non-compliance. We’ve been through the first three phases; now its time for the last to kick in. With news coming in of yet another import alert (Sun Pharma’s Karkhadi plant), we have no more time to lose.
The collective wisdom on successful and sustainable execution of good manufacturing practices (GMPs) exists in our industry but the key is that senior management has to take the lead; only then will the rest of the flock fall in line. So promoters and the C-suite have to invest both time and money in people, processes and systems.
Over the years, managements have invested in key personnel responsible for quality, using fat compensation packages as a retention strategy. With experienced personnel few and far between, they had no choice. Today, we are facing a backlash. Non-compliance is resulting in import bans, leading to facilities closing down and job cuts. Its an open secret that when one such laid off employee failed twice in his attempts to get a new job, he chose to spill the beans on his former employee, leading to yet another ban. How else could he secure the future of his two children?
But while disgruntled employees are a very compelling reason for managements to take care of their personnel, there is a greater need to invest in developing and continuously updating their skills and knowledge. And that’s where training comes in. This issue of Express Pharma, with a GMP focus, has a cover story (‘Train to Gain’, pages 26-29) on how training institutes focussing on GMP have seen a steady increase in business. Yet another story (An arduous endeavour?, pages 30,31) highlights how our dismal non-compliance history is holding back API exports to the EU.
But beyond training and upskilling, the industry needs to build an all pervasive culture of quality. We have to be prepared for inspectors knocking on our factory gates at any time. A recent inspection started with a discussion between the key site personnel and inspectors. At the end of the briefing, when the personnel got up to leave, they were asked to leave behind their notes/dairies. Similarly, inspectors asked to visit adjacent manufacturing facilities and found gross violations in total contrast to the squeaky clean facility which was on the inspection list. Thus we need to go way beyond SOPs and experts writing for this issue tell us how. SM Mudda, Executive Director-Technical & Operations, Micro Labs believes that it is time that the Indian industry approaches this issue with a learning mindset as against a victim mindset and use this opportunity as a catalyst for change (pages 32-34). Ram Balani, CEO-Founder, FDASmart points out that SOPs created by Indian pharma companies don’t meet US FDA purposes because either they are not adequately mapped back to the respective statues or are not enforced diligently in practice (pages 35,36)
Similarly, Swapna Narayanan, Managing Director, Information Mapping India focuses on the critical need for a good documentation system (pages 37, 38) while Dr Kavita Mehrotra, Head, Global Strategic Alliances, UL and colleagues make the point that quality and compliance is not an event, but a culture driven by the management (pages 39-41). We hope this issue of Express Pharma helps pharma companies in their journey towards compliance. ‘Comply or die’ is truly the only way forward.
Viveka Roychowdhury
Editor
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