Beleaguered by warning letters and import recalls, pharmaceutical companies in India seem to be finally investing in upskilling their employees. This year’s annual GMP special issue (Express Pharma, May 16-31, 2017) has experts highlight some of these skilling initiatives. As Ranjit Madan, CEO, Life Science Sector Skills Development Council points out, the cost of errors due to substandard skills at any level, far outweighs all costs incurred to undergo the exercise, be they time or resources, including monetary.
And cost is obviously a determining factor. Which is why ex-US FDA and current head of NIPTE, Dr Ajaz S Hussain’s insights on strategies for making high pharmaceutical quality affordable, a continuation of his previous articles for Express Pharma, is very relevant for both academia and industry stakeholders.
Prodded by the DCG(I)’s mandate that by January 1 next year, all employees associated with the manufacturing process should have some form of accredited certification, there is now a flurry of companies and professionals inquiring about and signing up for various skilling programmes. The courses range from the Advanced Program in Pharmaceutical Quality Management (APPQM) conducted by NSF in association with the Indian Drug Manufacturers Association (IDMA) to Pollux Life Sciences’ courses, affiliated to LSSSDC, which start from counselling of science and pharmacy undergraduates to training of graduates for roles ranging from quality control chemists and the like. SM Mudda, Chairman, Regulatory Affairs Committee, IDMA and Director – Global Strategy (Technical), Micro Labs underlines the need to go beyond training (the how of a practice) to education (the why of the how). True education is about changing not just actions but mindsets. Martin Lush, Global Vice President, Pharma Biotech and Medical Devices, NSF Health Sciences thus stresses that their courses, like the APPQM, aim to “change the way people think.”
The severity of the skill gap in India’s pharma sector can be gauged from a June 2015 survey by Deloitte, titled ‘Managing growth through better compliance management’. A high 64 per cent of survey respondents attributed non-compliance to shortage of skilled staff (in their risk and compliance teams), followed by challenges in implementing cGXP guidelines (52 per cent).
Proactive companies have always had in house skilling initiatives. To name just one, Zydus Cadila’s QueST – Quality excellence by Sustainable Transformation — which started in 2015, according to their annual reports. During a panel discussion at IPA’s Indian Pharmaceutical Forum 2017, Pankaj R Patel, CMD, Zydus Cadila – Cadila Healthcare spoke of the company’s tie up with two pharmacy and science colleages. As part of this programme, second year students train at Zydus Cadila – Cadila Healthcare during their vacations and if good enough, are later absorbed post graduation.
But commitment from the top management is clearly not enough. This year’s article from McKinsey cautions that only a few companies have been able to build a quality culture where everyone from the ‘top floor to shop floor’ takes ownership of quality and feels responsible for it. Industry response has tended to be “waiting for someone else to make the first move,” as Hemant Deshpande, Managing Partner, Pollux Life Science Solutions points out, and this has cost the sector dearly in terms of global reputation. We hope that our 2018 GMP edition will have more good news for us.