Dr. Reddy’s Embarks on New Quality Improvement Programs

Dr. Reddy’s Laboratories recently appointed Mark Kikuchi as CEO for its North American generic pharmaceuticals business, and the company has also been working on broad-based projects to modernize and improve manufacturing and quality. Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, shared some details with Pharmaceutical Technology.

PharmTech: Please discuss any new business initiatives underway at Dr. Reddy’s, as well as plans for R&D, manufacturing, and quality.  

Iyer: With our global philosophy of 'Good Health Can’t Wait,' our strategy continues to focus on building our pipeline of APIs, complex generics, biosimilars, and differentiated products. We will continue to tap on our internal capabilities but will also move into partnerships with external co-development or contract development/manufacturing partners to manage risks.

Our strategy is a single global approach to developing products for key markets in the United States, India, European Union, Russia, and China.  To accomplish our strategy, we continue to build a local presence in these markets with a variety of approaches, ranging from plant expansions to building new facilities. We are also developing strong alliances with local and global partners while exploring various channels for market access. 

PharmTech: Like other manufacturers around the world, Dr. Reddy’s has had its share of manufacturing and quality issues with regulators. Has the company changed the way it is approaching quality and compliance? Please discuss investments and initiatives, and overall short- and long-term plans in this area. 

Iyer: In support of our growth strategies, we have taken a closer look at our operations and have embarked on an organizational transformation journey. At the top of this list is process and quality improvement, and we are launching initiatives across our organization to help improve the bottom line. We believe it is even more critical for us to look ahead in terms of quality by creating a balance between the need to address the issues identified and improving quality as we continue to grow. 

We have identified several foundational processes that we plan to use, such as developing value-stream maps across the product lifecycle, using process maps to see and close our gaps. In order to achieve our goals, we need to understand and plan at the organizational, regional, and local country levels, to ensure that we are taking cultures, values, local politics, and laws into account. We have embarked on significant efforts in the areas of quality improvement, change and process management, process integration, and product management, and have engaged experts to help us where necessary.

PharmTech: How is the company using pharmaceutical quality-by-design (QbD) concepts?

Iyer: We have a process in place that drives QbD in our drug development efforts, which covers all the key elements of QbD, including critical quality attributes, target product profile, risk assessments, design space, and control strategy. To ensure the effectiveness of the design concepts, we plan to continue building on the process by providing guiding tools for product developers to make better decisions, while also giving them space to innovate, create, and plan. These tools help our drug development staff make better informed trade-offs during the execution of plans. 

PharmTech:  What is the company doing in the area of optimizing data integrity? 

Iyer:  We have already implemented a number of remediation initiatives to assure data integrity and continue to build upon them using various preventive strategies. These include moving to electronic data and managing vendors for whom data integrity is a key component of quality agreements. In addition, we are using risk-based approaches, and providing behavioral training that includes data integrity in system selection and validation phases.

PharmTech:  How is your company investing in and using new technology, e.g., IT, analytics, Industrial Internet of Things, artificial intelligence, and virtual or mixed reality?

Iyer: In support of our process and quality improvement initiatives, we are implementing digital programs in several of our operations. For example, to eliminate the significant efforts put in generating and maintaining batch records and logbooks, we have implemented OSI-Pi integration to manufacturing execution systems. This approach allows us to collect process data, alarms, events, and batch event data in some of our plants. 

We are also working on proof-of-concepts projects in machine learning, and already have data in early stages of R&D to learn and implement these concepts. We have multi-year digitization plan and roadmap for investment into key value-added technologies. 

PharmTech: Please comment on plans in biopharmaceuticals, precision medicine, and biosimilars.

Iyer: Given the significant growth in demand for innovative biological products, our strategy includes exploring opportunities in the biosimilar space. We are also looking to leverage the value of our current biological assets in oncology-which are already available in emerging markets-to the developed world, including the US. 

In addition, we are building a new biosimilar portfolio of products for future growth that includes a global development strategy and external alliances and investments.