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Regulatory compliance at the shop floor is a key gap that needs to be bridged

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Hemant Deshpande, Managing Partner, Pollux Life Science Solutions, in an interaction with Viveka Roychowdhury, elaborates on the skill gap between academia and industry and how Pollux’s three level skilling programme, ‘Emerge – A success Elevator’ will help bridge this gap

By your estimates, where are the most crucial skill gaps in the Indian pharmaceutical/ life sciences sector today?

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Hemant Deshpande

In Indian context, the exclusive focus during academic sessions is on conceptual knowledge without much reference to the application of the concepts and its relevance in business environment as is the practice in developed countries. To put it in simplistic terms, it is like training a driver of a car or a pilot of an aircraft on a simulator and putting him on job without internship or finishing school.

On the other hand, the industry expects the application of the concepts, thorough understanding of the process, dos and dont’s about handling of equipment identification and handling the exceptions.

To my mind, the most crucial and significant gap in Indian pharmaceutical/ life sciences sector today is at the manufacturing stage loaded with critical regulatory compliance. Needless to say, with maximum US FDA approved manufacturing plants outside the US being in India, we have the benefit of carrot by way of remunerative revenue but also face the stick during regulatory inspections for a solitary error made in isolation by a fresh or relatively young pharmacy entrant at the shop floor. In revenue terms, this not only impacts the image of the company and industry but also the country as destination. I think regulatory compliance at the shop floor is a key gap that needs to be bridged by equipping the staff with skills among several others.

While, skill gap between the academia and industry has always been a subject of a frequent debate, it has only received the necessary attention after Life Science Sector Skill Development Council (LSSSDC) incubated by Ministry of Skill Development stepped in.

How is this impacting the prospects of both the industry as well as professionals who have chosen to make their careers in this sector?

The fact of the matter remains that a large percentage of student fraternity are inclined towards securing employment rather than a well thought career selection. A part of this blame can be attributed to academia for not undertaking the qualitative counselling process beyond the quantitative academic marks and entrance tests. The absence of counselling results in mid-career crisis, saturation etc as also leads to high job hopping and attrition rate.

Moreover, the entire economic burden of moulding the raw talent into a skill-full job-ready professional over a period through trial and error falls on the industry.

The DCG(I) has mandated that by January 1, 2018, ‘no person shall be employed in any pharmaceutical/ bio-pharmaceutical manufacturing units unless he has obtained a formal diploma or degree in the relevant area, or has been certified by the LSSSDC or equivalent organisation in the area in which he is deployed.’ How are companies strategising to get on track to meet this deadline?

Industry response has always been a peculiar one, waiting for someone else to make the first move. The notice by DCG(I) was issued in August 2016 and the industry took some time to understand the implications as also the practical issues involved in compliance. Having said that, in the past couple of months the industry through its cluster organisations — OPPI and IDMA — had series of meetings with LSSSDC to evolve a joint coordinated action on the subject. On its part, LSSSDC has also issued guidelines and FAQ’s for easy understanding of the industry.

Pollux Life Science Solutions has been given the mandate by LSSSDC to conduct broad-based skilling courses for the pharma industry. What job profiles will these training courses cater to? Can they be customised, tailored as in house training modules for individual companies?

Pollux has been affiliated for four job roles for Mumbai and Pune centres:  quality control chemist, quality assurance chemist, manufacturing chemist and medical sales representative.

In the next few months, by June end, Pollux plans to add five more roles (drug regulatory affairs, clinical research, lab technician, manufacturing assistant, maintenance assistant) and expand its reach to Nashik, Aurangabad, Nagpur, Goa and Daman.

Thus Pollux has planned to reach out to the western region with a large basket of roles, which will cover about 90 per cent of the overall job functions in the pharma industry.

Although LSSSDC has defined a specific pattern and curriculum for each job role training, we at Pollux have kept a flexibility of incorporating the additional training modules as per  customer needs.

What has been the response so far, in terms of which companies, how many individuals have attended or signed on for these courses, etc? How many such courses have already been conducted and where?

The industry has responded cautiously but with some element of enthusiasm on the prospect of getting much better trained, skilled and employable resource from the skills development project. Around 15 companies in Mumbai have responded and shown inclination to enter an arrangement with Pollux. We plan to enter into a formal MoU with these companies by start of June 2017.

The LSSSDC skills development is covered under a specially designed programme of Pollux called ‘Emerge – A success Elevator’ which is a three level build up. The first two levels include a comprehensive understanding of pharma industry, career options and guidance. It is ideally suited and designed for the undergraduates of science and pharmacy as the objective is to facilitate them to select a career of liking and choice within the pharma chain.

The third level is the LSSSDC skills training for the graduates and for a specific role. The training includes class room and practical understanding through internship with pharma companies.

The first batch of all four roles in Mumbai and Pune is planned from May 15, 2017, immediately after the annual exams conclude.

What will be the cost per course, module? Who will be bearing the cost, the employee or employer?

The affiliation of Pollux as a training partner of LSSSDC is in open category which means it does not include the funding under Pradhan Mantri Kaushal Vikas Yojana (PMKVY). Hence, the cost to the students for each job role would be in the range of Rs 15,000-20,000 which is around three to four per cent of their total costs in acquiring the formal degree.

In order to cater to a vast pool of aspiring students belonging to economically weaker sections, Pollux is contemplating to obtain affiliation under PMKVY to ensure that these sections of students are not deprived of quality learning due to lack of resources.

The pharma industry in general and companies have the option to sponsor such students as part of their corporate social responsibility and in turn get a well-trained human resource.

On its part, Pollux offers a wide range of options to employers, starting from hiring the trained resource at a nominal cost to participating in the process right from initial screening of the students, providing internship and absorbing the trained resource based on vacancies and credentials of the candidate.

This year’s budget allocated Rs 2,200 crore ($ 325 million) for the next phase of the Skill Strengthening for Industrial Value Enhancement (STRIVE) initiative. Can employers access these funds to meet the DCG(I)’s mandate? If so,  what is the process?

As I understand, the compliance of DCG(I) mandate is called Recognition of Possessed Learning (RPL). At the initial stage, the assessment process is free of cost to those companies with annual turnover less than Rs 150 crores. I believe that such companies can get advantage of the budget allocation to some extent, though we are also seeking clarity on the same.

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