IDMA, NSF Health Sciences launch training programme in pharma quality management

The Indian Drug Manufacturers Association (IDMA), in collaboration with UK-based NSF Health Sciences announced the launched of a customised intensive education and skill development programme targetted at pharma quality assurance professionals. The aim is to develop ‘change agents for quality excellence and to make India the centre of excellence for pharmaceutical manufacture’.The initiative is the latest in a series of endeavours by industry associations to re-skill pharma professionals, in response to the prolonged regulatory woes being faced by some companies in India, stemming from poor GMP compliance.

IDMA-NSF’s Advanced Program in Pharmaceutical Quality Management (APPQM) is reportedly designed specifically for Indian companies who want to succeed in US and European markets. Designed as both as an education and mentorship programme, the intense and challenging MBA style programme will provide participants education related to best industry practices in quality culture, quality management, regulatory compliance, manufacturing operations, leadership skills, skills in risk based decision making, advanced problem solving, crisis management, simplification and lot more, according to the brochure. Delegates will complete a written assessment for each module. Successful candidates will be awarded an internationally recognised Certification from NSF and IDMA.According to the APPQM brochure, the course fee for a batch of 30-40 attendees, of approximately 8100 GBP + 15 per cent service tax plus actual travel and stay expenses at the venue, Acharya College, Bengaluru. Exclusive hire of the faculty for 40 tutor days of in house training would come to around 150000 GBP compared to 10000 GBP for the entire programme.

In his welcome address at at the launch of the APPQM, S M Mudda, Chairman Regulatory Affairs Committee, IDMA and Director – Global Strategy (Technical), Micro Labs, thanked Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India for his patience and support over the past year as IDMA went through the process of selecting a partner to make global pharma quality certification more available and accessible in the country.Mudda also highlighted the value proposition of the course saying,”Wouldn’t an employer prefer to spend Rs eight lakhs approx per employee and develop in-house expertise, rather than relying solely on external expertise?” He exhorted his colleagues to educate their QA staff “as they are the face of the company during inspections” and reminded them that remediation costs far outweigh the prevention costs.

The meet was also addressed by SV Veerramani, Immediate Past National President, IDMA and Founder & Chairman, Fourrts (India) Laboratories who briefed the audience on IDMA’s initiatives for ‘Building Brand India’ followed by Deepnath Roy Chowdhury, National President, IDMA and Managing Director, Strassenburg Pharmaceuticals. As Chief Guest at the launch, Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India reiterated his support for this initiative, saying, “Quality is all about trust – within the organisation, with the regulator and finally with larger society. If you invest in  quality, profits will automatically follow.”The meet was also address by O Sadhwani, Joint Commissioner FDA, Maharashtra, Mumbai and Dr K Bangarurajan, Deputy Drugs Controller (I) CDSCO, West Zone Mumbai. Both dignitaries applauded IDMA for this excellent initiative and taking training to the next level. This would be a good investment, as well equipped and trained personnel are a big asset to any organisation. They also expressed their desire to support IDMA in making this joint training programme a huge success.

Explaining the contours of the APPQM, Martin Lush, President NSF, UK emphasised that the NSF – IDMA collaboration was based on shared beliefs that ‘people’ were the active ingredient of every medicine, patients were at the centre of everything both organisations did, and a firm belief in the ‘fix the roof when the sun is shining’ approach. MNCs like Pfizer and Sanofi Pasteru have recoreded positive feedback of the course. In terms of return on investment, Lush cited savings attributed to SOP simplification ($1.2 million), getting batch manufacturing records (BMR) right first time ($2.2 million), reduction in cycle time and work in progress, increase in plant utilisation by 37 per cent, staff turn over reduced from 19 per cent to 3 per cent, and reduction of repeat deviations ($ 1.6 million).

The meet ended with a Vote of Thanks from Daara Patel, Secretary-General, IDMA.