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IDMA, NSF UK launch advanced programme in pharma quality management

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First batch with 39 pharma professionals starts at Bengaluru’s Acharya College

In a bid to address the dearth of globally certified pharma quality professionals based out of India, IDMA has collaborated with UK-based NSF Health Sciences to offer a customised course.

Speaking at the launch on World Pharmacy Day on September 25, Chief Guest Dr Sharanprakash Patil, Minister for Medical Education, Government of Karnataka appreciated the initiative by IDMA and mentioned that the global training programme will help take Indian pharma sector to new heights.

In a video address, Sudhanshu Pandey, Jt Secretary, Department of Commerce said that this programme is a much needed one. While Indian pharma has been successful, he spoke of the many challenges that the industry is facing of late. He felt that this programme will fill the gaps and train Indian pharma professionals to the level of global professionals. He assured the audience that the batch size would increase and that he would visit during the course to get feedback. He wished the delegates success with the course.

Pegged as the first ever international education programme, the ‘Advanced Program in Pharmaceutical Quality Management’ (APPQM), includes five intensive modules each of four days duration scheduled every eight weeks. Each module will be assessed through a written examination. Successful candidates will be awarded an internationally recognised certification from NSF and IDMA.

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Delegates during the inauguration function

The course participants comprised employees from companies such as Ajanta Pharma (with as many as four entrants), Astral SteriTech, Aurobindo Pharma, Cipla, Emil Pharmaceuticals, Encube Ethicals, Eucare, FDC, Fourrts Labs, Galentic Pharma, Gland Pharma, INGA Laboratories, Leben Life Sciences, Medopharm, Micro Labs, Mylan Laboratories, S Kent Healthcare, Shanta Biotech, Softgel Healthcare, Steril-Gene Lifesciences, Strides Shasun, Sun Pharma, Swiss Garnier, USV and Zim Laboratories.

With a course fee of Rs 8 lakhs plus 18 per cent GST, not including travel and stay, the price would make most managements hesitate. Except for the fact that it would probably cost a lot more to sponsor a candidate for a similar course in the open market.

Daara Patel, Secretary General, IDMA indicated that most companies have decided to leverage this course as a talent appreciation and retention strategy, carefully choosing the candidates and ensuring that they are most likely to stay and contribute to the company.

Why APPQM?

SM Mudda, Project Director, APPQM and Director Global Strategy (Technical), Micro Labs, who has played a major role in conceptualising and tweaking the course for India, gave the welcome address, and explained why IDMA, which as an association generally restricts itself to representing industry issues to the government, decided to involve itself with quality education and certification programme. Indian pharma has grappled with recurring surprises like import alerts, product recalls, insufficient documentation etc which had a far reaching negative impact on the industry’s perception with global regulators. In the course of engagement with industry, government and regulatory agencies, it became evident that an industry-level response in educating the key personnel in global quality system is necessary. In several surveys conducted, the companies said that the shortage of skilled staff was a major worry.

Mudda said that there was a need for adopting a systems approach and to link the three dots of GMP, quality systems and quality culture through the education of second level quality leadership. The aim of the programme offered by IDMA therefore is to improve the compliance ability of the industry and secondly, improve trust and credibility globally and promote Brand India Pharma by introducing change agents for quality excellence in the industry.

So what’s different?

Explaining the ‘why’ of such a programme, Martin Lush, Global VP, NSF Health Sciences, who is spearheading this course along with Mudda, strongly emphasised that the industry needs to keep the patient at the centre of their business and balance profits and efficiency, legacy and reputation, with customer service.

Looking for the reasons why the Indian cricket team is currently number one in test cricket, he said it was because they got the basics right, consistently.

He referred to the various events, like Trump, Brexit, global warming, etc due to which it is ‘not business as usual.’ He advised Indian pharma companies to ‘educate for the future, not the past,’ quoting author Jim Collins.

Explaining the philosophy behind the course and their teaching methods, Lush said that the aim was to ‘transform the way people think about quality, change the hearts and behaviours, so that they can change their company and the industry.’

Individuals who enrol for this course would move from CAPA (Corrective Action, Preventive Action) to PACA (Preventive Action, Corrective Action). As he pointed out, preventive action rather than corrective action has proved to be cheaper in the long run.

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The course in progress

Lush also thanked Mudda for his vision, passion and resiliency in organising and getting this programme to India and as a mark of respect for the untiring efforts taken by him, conferred the certification of APPQM 2017-18 on him by offering a symbolic mortar and pestle offered to QPs in the UK.

In a video address, Dr Ajaz Hussain, Insight Advice & Solutions, built on the reason why the course will build on Brand India Pharma. He said the ‘ostrich syndrome,’ of burying the head in the sand when threatened, of denying the presence of a problem, is holding back India’s pharma quality in the 21st century. He linked the ability to adopt to quality systems to adult human development and exhorted the participants to use the APPQM course to develop their order of consciousness to at least fourth order to create a self-authored mind.

Dr B Suresh, Vice Chancellor, JSS University, Mysore spoke about the importance of companies investing in their human resources. His perspective was that without knowledge advancement, it will be a challenge to continue the innovation which defines and differentiates this sector and each company.

As he put it, “Industry should hire people who are firstly, knowledgeable and they should be ready to pay for them. And secondly, is the individual capable of continuing to learn and think beyond.”

Other dignitaries on the dias like J Jayaseelan, Chairman, Tamil Nadu, Puducherry, and Kerala state board, IDMA, BT Khanapure, Drug Controller, Karnataka, CDSCO, too added their appreciation of the course.

Rajsekhar, Asst Drug Controller, CDSCO, Karnataka on behalf of DCG(I), wished the participants all the best.

The C-suite perspective

Dushyant Patel, MD, Astral Steritech, who has two employees registered for the course, said that the programme has the potential to change the approach to quality and hoped that it would train “quality leaders to not only perform to perfection but also to perform under pressure.”

Mehul Shah, Founder and MD, Encube Ethicals, who also has two employees in the course, shared his thoughts on the current status of the industry and where this programme comes in. “Most are talking of T(rump) and B(rexit). But it’s more than that. Effective valuation of generics has reduced by one third on the last one year. Industry is compressed due to pricing, competition, regulatory pressures. Up to now, the relationship between the three pillars of the industry, (patients, doctors and regulators), were driven by faith. The knowledge gap between patients and doctors is reducing and expectations from the industry have increased in terms of providing cost effective solutions. Today, he pointed out that the industry is becoming like any other average industry with average profits. He warned that investment priorities, locally and globally, have changed. De-rating of the industry is happening and consequently a decline in the business of equipment/ instrument suppliers of the industry.

Under these circumstances, the need to build capability of our people to simplify work processes and institutionalising the global best practices is the need of the hour, Shah added. He quoted Deming and stated that 94 per cent of the business problems could be solved by adopting a system and risk- based approach. The APPQM will build the capability of our technical staff in designing and implementing a robust pharma quality system. This education will help companies to achieve the objective of right first time in their operations, focus on patient welfare and be more innovative and cost effective, Shah concluded.

Module 1: A great learning experience

The four-day Module 1 saw active participation of all delegates through several working groups that resulted in learning of key quality system elements through group discussions and case studies. The topics covered included creative and critical thinking, problem solving and crisis management, risk-based decision making, accelerated learning, simplification of processes and SOPs and performing well under pressure.

The 39 professionals whose companies sponsored them for the course, have probably realised that this is far from another ‘chalk-and-talk’ course.

Participants left with projects that needed to be implemented at their workplaces and will present the results at the end of the course. The mix of theory with hands on work is a key aspect of the learn-by-doing feature which will make them change leaders at their workplaces.

The participants were good mix of juniors as well as senior pharma professionals, as well as nine applicants who are second generation pharma entrepreneurs, some without a pharma background. Mudda commented that the perspectives coming from this sub group add a management/owner’s view point, which takes the discussion beyond the technical into aspects of corporate policies.

A summary of the learnings was presented in the form of flip charts and posts and a progressive story board of learning was displayed in the class room. The story boards along with descriptive notes were also shared with the delegates.

Feedback from delegates

I would like to thank you very much for spearheading and organising this wonderful workshop. As I was deliberating on today’s learnings, for the first time I realised that this was a unique experience. Truly it was about education and learning and not training.
Swapna Ajit, Encube Ethicals

This shows the excellent planning and tremendous efforts by NSF and IDMA teams for entire programme”
Soni Biren, Sun Pharma

Had a great time, got many concepts cleared, learnt new things, got to know many, shared old memories, cooled the chimp brain a bit, got away from daily chorus, brain stormed in groups, saw the advantages of team. Now looking forward to module 2
Yogesh Gole, Emil Pharmaceuticals

Thanks a lot, Martin for compiling all the sheets and tasks in the form of presentation with descriptive notes for our benefits. This will help us to take forward within the organisation and educate all my colleagues in the same way we learnt and simplify all the complexities within the system. Also, thank you and Rob for all your guidance and taking us through the basics, realities and challenges. Thanks to Mudda sir for arranging the programme and support/guidance during the programme. Looking forward to meet one and all in the next module.
Trupti Bhagat, Astral Steri Tech

Thank you very much to you, IDMA team, Lush and Rob. The course was really designed well to suite our current requirement. It will definitely help all the participants to make positive difference in our day to day working in our organisations. Thanks once again for the initiative and the efforts of one and all
Dr Shashikant Shinde, Mylan Labs

I believe that there is not one but many interesting things about this programme

1) Teaching techniques which help to grasp so much in such subtle ways.
2) The programmes has given a totally new angle to my views of pharma industry and where I fit in.
3) The approaches that we are being educated like influencing behaviour, simplification of systems, risk-based decision making- will have positive influence on me throughout my life

Manan Shah, Executive Director, Leben Lifesciences

At the outset, please accept my sincere appreciation for having designed and organised the most advanced learning programme at Bengaluru in association with NSF
S Sridharan, Managing Director, Eucare Pharmaceuticals

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