PHARMA 4.0 - the time has come
We have addressed in part one of the current series of articles on Pharma 4.0 in the previous issue and noticed that the world has in the last year, witnessed the most significant disruption unprecedented in history. The pandemic has made a phenomenal impact on the industrial world, where the supply chains have been adversely affected. The Pharma Industry has been at the forefront as it was their role that came under the spotlight.
In part one Pharma 4.0, it was covered the aspects of:
- Data Integrity by Design,
- Data Integrity- Manufacturing Systems (MES) for Pharma Companies and
- AI, Robotics – applications in Pharma and Biopharmaceuticals.
In the next series, we will cover the following aspects:
- Robotics in Pharmaceuticals – safety and contamination concerns
- Data Integrity and cCGM Compliance and Regulatory Audits
- Drug Repurposing – a solution that needs to be looked
- Reshoring a Nation’s API and Pharmaceutical Production – ‘Reverse Swing’
- Pandemic and Supply Chain Disruption – Digital route to deliver Covid Vaccine in India
The world has witnessed now, especially in this pandemic, that the importance of the pharmaceutical industry and is going to increase as we go further. We have witnessed how the pharma companies worldwide focussed on developing the vaccines and bringing out the vaccine in less than 15 months as against a few years for any vaccine in the earlier years. For sure, some of these have been released for ’emergency use’ but not without doing the requisite trials as per drug protocols. There will be a paradigm shift from the earlier blockbuster drugs, from the previous mass production to the advent of customized and specialized drugs to a smaller set of patients. In other words, it means more and more effective solutions to the patients’ ailment.
Besides, the world is going to witness the following significant trends and disruptions in the Pharmaceutical world as under:
- Increased use of technology for new drug discovery
- Customized medicines are increasingly supported by technology.
- Technology-based Apps that are going to bring the patient closer to the medicos – better interaction to shorten the time and real-time patient monitoring
- Telemedicine: medicines on the net backed with online medical consultations
- Supply Chains: that need to be strengthened as we will see the increased use of biopharmaceuticals medicines requiring stringent temperature controls during the entire length of the drug supply chains to ensure drug product integrity.
- Increased use of IT-enabled systems in manufacturing reduces the drug- human interaction and is replaced by technology-enabled solutions to ensure GMP compliance. Avoiding or rather ensuring that element of human error is kept at bay and all this will also help in making the manufacturing force at the plant level away from drug exposure effects during the manufacturing processes.
We have noticed that companies worldwide are becoming more concerned about ensuring that the supply chains do not get impacted due to pharma manufacturing hubs. The companies are trying their best to reduce their dependence on the key starting materials. We are sure that such steps will reduce reliance, but global support will indeed remain in the long-run, and humans need to learn to live with interdependencies for a better world.
Gurmeet Singh is Director Pharma Networks – a veteran for over 30 years in the Indian Pharmaceutical Sector. He worked with some of the best pharma companies at the decision-making levels in companies like Ranbaxy, Wockhardt-Swiss and Ireland, Orchid Pharma and Midas GmbH. He was also associated as Pharma Development Consultant with DNDi – Drugs for Neglected Diseases initiative – a Geneva based R&D organization. Mr. Singh is a Bachelor at Law (LL.B), a Post Graduate in Management Studies and Post Graduate Diploma in Intellectual Property Rights Law. He can be contacted on email@example.com and +919703599123