IDMA, NSF UK launch advanced programme in pharma quality management

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

In a bid to address the dearth of globally certified pharmaceutical quality professionals based out of India, Indian Drug Manufacturers Association (IDMA) has collaborated with UK based NSF Health Sciences to offer a customised course.

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

In a video address, Sudhanshu Pandey, Joint Secretary, Department of Commerce said that this programme is a much needed one. While Indian pharma has been very successful, he highlighted that the industry is also faced with many challenges on various fronts. He feels that this programme will fill the gaps, and train Indian pharma professionals to be at par with their global counterparts. He assured the audience that the batch size would increase in future. Wishing the delegates success with the course, Pandey also said that he would visit during the course to get feedback.

Pegged as the first ever international education programme, the Advanced Programme 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.

The course participants comprise employees from companies like (in alphabetical order) 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 indicates 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.

So what’s different?

Explaining the ‘why’ of such a programme, Martin Lush, Global vice president, NSF Health Sciences, who is spearheading this course along with S M Mudda, Project Director, APPQM and Director-Technical, Micro Labs, 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.

He also opined that due to global events such as Trump’s victory in the US elections, Brexit, global warming, etc. it’s "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."

The individuals who enroll 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.

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 that the ‘ostrich syndrome’, of burying one’s head in the sand when threatened, of denying the presence of a problem, is holding back India’s pharma quality for the 21st century.

Mudda, who has played a major role in conceptualising and tweaking the course for India, gave the welcome address, wherein he explained why IDMA, which as an association generally restricted itself to representing industry issues to the government, decided to involve itself with quality education and certification programmes. Indian pharma has grappled with recurring surprises like import alerts, product recalls, insufficient documentation etc. which had far reaching negative impact on the industry’s perception with global regulators. In the course of engagement with industry, government and regulatory agencies, surveys showed that companies said that the shortage of skilled staff was a major worry.

Thus Mudda said, there was a need for a systems approach, to link the three dots of GMP, quality systems and quality culture. The aim of the course is to improve the compliance ability of the industry and secondly, improve trust and credibility globally and promote Brand India Pharma.

Dr Suresh 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 dais like J Jayaseelan, Chairman, Tamil Nadu, Puducherry, and Kerala state board, IDMA, B T Khanapure, drug controller, Karnataka, CDSCO, too added their appreciation of the course.

Rajsekhar, Asst Drug Controller, CDSCO, Karnataka on behalf of DCGI, 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 and regulatory pressures. Upto now, the relationship between the three pillars of the industry, (patients, doctors and regulators) , was driven by faith. 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. HPCL and GLC orders have reduced. A re rating of the industry is going on. The knowledge gap between patients and doctors is reducing. So we have to be more innovative and cost effective," Shah concluded.

Day 1: Well begun is half done

A day after World Pharmacy Day, in a classroom on Bengaluru’s Acharya Institutes, the 39 professionals whose companies have sponsored them for the course are already in the thick of the course. And have probably realised that this is far from another ‘chalk-and-talk’ course. The walls of the classroom have post-its of their goals, interspersed with charts and other aids.

Participants will leave 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 are a 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. As Mudda comments, 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.