The pharmaceutical industry is one of the largest and fastest growing industries of the world which highly focuses on quality and effective systems. Achieving excellence along with continual and sustainable development is very important in this industry to be competent. In this edition of our newsletter, we bring you one such tale from the pharmaceutical industry, when an organization tackled all the challenges and has been moving on the path of excellence. Mr. Sanjay Jain – EVP (Operations) for Amneal Pharmaceuticals shared his views on the generic pharma industry and how progressive organizations from the pharma sector have been working towards continual improvement and organizational transformation. Below is an excerpt from the interview.
Faber Infinite (FI): We have a subscriber base of around 20,000+ readers across 8 countries, our readers would want to know more about the global generics pharma market in the world?
Mr. Sanjay Kumar Jain (SKJ): Generic pharma market is growing across the world and there are many reasons contributing to it. The population is growing old and everyone wants to live a healthy long life. With the changing lifestyle/food habits, the diseases have increased; be it obesity or diabetes. Moreover, the improvement in the per capita income of the people has also made the drugs more accessible for the people. These are the few main reasons why we are witnessing such growth in the pharma industry. With the current growth rate, we expect the total pharma industry to be around USD 1.12 trillion by 2022. (source: https://www.business-standard.com)
FI: Every industry has its own challenges. What are peculiar challenges unique to your industry?
SKJ: The pharmaceutical industry is a highly regulated industry since we are dealing with the medicines and hence safety, quality is given the highest priority. A unique industry challenge, I see is, for companies to sustain the regulatory compliance and meeting expectations of various gatekeepers like FDA and other authorities while exporting goods to USA, Europe or regulated markets. Another challenge, which I see, is the competition among the generic medicine manufacturers. This is also impacting spent on R&D by the pharma companies. Research and development are essential for the future growth of any pharmaceutical organization to develop complex products and invent new molecular entities.
FI: Right sir! Moving ahead, progressive organizations in the pharmaceutical industry are charting their own success path and setting trends for others to follow. What is it that differentiates these organizations from others?
SKJ: Progressive organizations have defined a vision to achieve their growth targets and goals which they set for a certain period. What I see is that they heavily invest in R&D for the development of more complex generic products and the niche products that will take them to another level in the coming years. They have clear strategies for the regulatory filing of the newer products to avail the sales exclusivity, specifically in the US markets. The most important thing is maintaining the robust quality systems and satisfy the regulators during the audits with respect to compliance which happen regularly. Manufacturing quality products at a very cost-efficient price for the customers to win their confidence and loyalty. Such factors make these organizations more competent and more efficient in their progress and future growth.
FI: We would love if you could share some success stories of the transformation journey you were a part of.
SKJ: In recent past when I have seen regulatory sanction on some of the pharma companies in the industry like warning letter, import alert etc because of poor quality systems and a few data integrity issues. These occurrences inspired my team to implement high-quality standards at pharma manufacturing sites where the systems are quality and compliance driven. The auditor should be happy and satisfied when he/she sees reviews the systems. In Amneal, I have faced multiple US FDA inspections in the last six years and our audits were concluded without any non-compliance or minor observations in all these inspections. It gives a lot of confidence when the auditor audits you, challenges you on every aspect and is satisfied with the compliance level. I am proud to be a part of such organization.
FI: That’s wonderful sir! It definitely is a feat. We would love to know your views on Faber’s role in the organizational transformation journeys you were part of.
SKJ: Faber founders are very young, energetic, knowledgeable and experienced people and when we met them we knew that they are going to add value to our organization as consultants. Team Faber Infinite organized multiple workshops, training sessions for the employees, closely monitored every process, creating milestones and helped us to reduce throughput and cycle time… and save capital for the organization. Not only that, the entire interaction with our employees has helped us in bringing value to our organization and to the stakeholders, with increased employee accountability and ownership. I really appreciate Faber Infinite for their role and help in our transformation journey.
We sincerely thank Mr. Sanjay Kumar Jain and team Amneal Pharmaceuticals for being a part of iFaber – the official newsletter of Faber Infinite and sharing their valuable insights.
Written & Compiled by Faber Kishlay & Faber Mayuri.
