Measures to meet the needs of increased regulation and quality while reducing manufacturing costs and risks in the life sciences industry were discussed
Usha Sharma, EP News Bureau – Mumbai
Rockwell Automation recently organised a life science symposium in Mumbai on ‘Leveraging Technology to Ensure Quality and Compliance’. Key industry leaders discussed and recommended measures to meet the needs of increased regulation and quality while reducing manufacturing costs and reducing risk in the life sciences industry, at the symposium.
Gopal Nair, Director, International Society for Pharmaceutical Engineering India Affiliate presented data on the Indian pharma growth story and touched upon the opportunities and the challenges in the sector. He also spoke on leveraging technologies in the life science sector. He expressed his concerns on pharma exports and mentioned that the growth rate for export of pharma products to the US from India is declining. He also highlighted that over the last three years, the proportion of warning letters received from the US FDA by Indian pharma companies have reduced.
He also stressed on the need for ensuring GMP and data integrity in the pharma industry and cited the Ranbaxy case as an example of how lack of data integrity cost the company its reputation in the global market. He also indicated that the future factories of the Indian pharma industry should be completely driven by automation.
Rishal Shah, Member, Indian Pharma Machinery Manufacturers Association and Managing Director Jekson Vision briefed the delegates about the IPMMA and its initiatives to boost the Indian pharma machinery manufacturers in both the domestic as well as in the international markets.
Warford Reaney, Founding Partner and CEO, Aveta Lifesciences – US – Quality and Compliance Consultant informed that in the US anything related to healthcare is either a product or a medical device. He also shared a detailed note on the FDA quality metrics guidance which is in the draft stage. He opined that automation is the need in the Indian pharma industry and the future looks good. Referring to a KPMG report, he indicated that by 2020, it is likely that there will be upward movement in organic growth by 8.6 per cent.
Dilip Sawhney, Managing Director – India Rockwell Automation spoke on the SMART manufacturing process. He emphasised that in order to realise SMART manufacturing, the manufacturers need to come together and establish the concept of ‘Connected Enterprises’. In this, the entire (manufacturing) chain have to collaborate and share their collected data for better delivery and smoother work processes.
Anil Kumar Kartha, Site Head – Patalganga Cipla talked about the top challenges faced by the pharma companies. He informed that the US FDA hopes that the future data integrity issues will do down in future. He cautioned his industry peers that unless the right validation processes are adopted there is no point on installing high tech software systems.
Dev Bakshi, Managing Director, Tapasya Engineering Works delivered a note on solutions to enable quality by design; machine builder’s perspective. He also highlighted that innovation is not to make the product complicated or difficult but to design in such a manner that it simplifies the process with the help of technology. Rockwell Automation also organised technical sessions for the participants.