Newer technology will disrupt the pharma manufacturing process

During the panel discussion experts discusses about New technologies: Challenges in incorporating quality and compliance. It was part of the road show activities of 7th Pharma Pro & Pack Expo co-located with IndiaLAb Expo and Analytica Anacon, held in Bangalore

Due to global competition, uncertainties in supply cost, ever rising labour cost and decreasing product life cycles are some of the few challenges faced by the Indian pharma industry and experts feel that they can be addressed with the help of newer technologies.

Moderating a panel discussion on ‘New Technologies: Challenges in incorporating quality and compliance,’ in Bangalore, Kaushik Desai, Secretary General, IPEC India said that "The Indian pharma industry has witnessed newer technologies like automation, digitisation, computerisation, high speed lines and now Pharma 4.0. These newer technologies are associated with new dosage forms, novel drug delivery system, biosimilars, nanotechnologies etc, we do not have much choice to think about it, but to adopt these newer technologies in our day to day operations."

Highlighting the relevance of newer technologies in day to day activities, Desai pointed out, "The technology is walking at a very fast pace and it is more dynamic while the industry corresponding regulatory change or support. Newer technology is expected to lower cost, speed up production, and improve product development and faster delivery mechanism."

Joining the panel discussion, Sridhar S Rao, Principal Consultant- Pharma feels that embracing newer technologies requires an open mind and readiness for the newest innovation. He also believes that different companies need to reduce their disparities among themselves and create a platform where knowledge and capabilities are shared. During the discussion, he indicated that recent observations and warning letters from the developed worlds are largely due to lack of data management skills and other related aspects. Hence, the Indian pharma industry needs to adopt newer technologies which will reduce the complexities in the world. Indicating its effects, he pointed out that there are a few companies who are reluctant to such tech adoption mainly because they are afraid of its complexities.

The technology, which is going to change and disrupt the pharma manufacturing process are 3D printing, artificial intelligence, continuous manufacturing and automation. US FDA is also encouraging companies towards continuous manufacturing from batch manufacturing. The newer technologies require willingness to adopt the change, as there is a major trend underway to develop flexible plants which are capable of producing multiple products, even in a smaller batches rather than building a plant based on a single blockbuster drug.

Commenting on the technology’s transformation and its necessity in the pharma industry, Ariff Khan BJ, President – Manufacturing Operations, Recipharm mentioned that tech transformation in packaging will drive growth of the pharma industry. However, he feels that India doesn’t have sufficient technological knowledge and it is largely due to the rigid mindset and therefore industry needs to rethink their competencies and do an evaluation and build a strong resource. Pointing out a cost advantage, he mentioned that due to cost advantage global giants are coming to India, if we gear ourselves for newer technologies there is a long way to go.

Following this, the next panel member Prashanth GN, Senior Vice President – Quality, Strides Pharma Science stressed on need of documentation management. He said that if we are aiming to further strengthen our capabilities in the global pharma market then we need to get away with the manual updation process. He also hinted that there is a lack of transparency at all levels in the different departments of the pharma industry- nearly 75 per cent global leaders receive the minimal level of information from their companies, hence there needs to be dashboard which can update everyone at a time.

Though the newer technologies will improve the efficiency will also require a substantial investment. Commenting on the possible benefits and its viability, Jatish N Sheth, Director Srushti Pharmaceuticals said, "Automation is the way forward, but the it is so expensive that small and medium sized companies can not even afford it. Hence, they need to continue with traditional methods. While giving an eg; of trace and track and 3D printing, which are crucial and key move for the betterment of the industry, due to cost factors, companies are finding reasons for delaying its implementing schedule." Sheth suggests, "It is a responsibility of the machinery manufacturers to design a concept which is a cost effective and also in-line with the regulatory compliance. Beside this, it should be economically viable for manufacturers."

The experts also emphasised on a point that there is no choice but to adapt to new technological advances to remain competitive and highlighted that Indian regulators are also now open in accepting newer technologies during their inspections. Also IPMMA should start training on new technologies for the benefit of pharma industry and develop indigenous technologies which are affordable.

The panel discussion was part of the road show of 7th Pharma Pro & Pack Expo co-located with IndiaLAb Expo and Analytica Anacon. It was the fifth 5th in the series, started with Mumbai – Goa – Indore – Ahmedabad- Bangalore now planned in Chennai and Vizag and then Hyderabad.

By Usha Sharma

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