A sneak peak into the journey of Pfizer’s APAC cluster with Vikram Shukla Vice President, PGS - Sterile Injectables & Biotech Operations, APAC Cluster Pfizer
One of the world’s leading Biopharmaceutical industry, Pfizer relentlessly pursues scientific breakthroughs that bring a healthier change in patient’s lives. Utilizing its unique resource base, global presence and scale, Pfizer strives to make a difference not just in local communities but also the world over through advanced medical innovation and distribution of medicines that might not be otherwise available to underserved communities.
Pfizer has multiple manufacturing sites in the Asia Pacific region (APAC) such as India, Australia and China. Vikram leads the Operations for the APAC cluster, and he has been instrumental in transforming Pfizer India site of Vizag (one of the largest injectable manufacturing sites) as a highly productive site that is regulatory complaint with a strong Quality culture along with Diverse and Inclusive culture at all times. He is the driving force of the company and under his guidance the workforce stays motivated to contribute their best.
Vikram is an injectable expert with more than 28 years in the field of Quality and Operations. A gold medalist with a postgraduate degree in Microbiology from the University of Mumbai, Vikram is also an INSEAD Business school Alumni. His areas of expertise primarily being Operations activities, Quality Assurance, GMP and Microbiology.
Vikram is currently working as Vice President, PGS - Sterile Injectables & Biotech Operations, APAC Cluster, taking care of Pfizer sites in Australia, China and India.
Previously, Vikram has worked with various multinational organization in the field of Quality and Operations such as Dr. Reddy’s Labs, Lupin, Fresenius Kabi, Hospira, and Zydus.
Throughout his career Vikram is closely associated with Injectable Manufacturing Facilities and has also worked in Solid Orals and all forms of Injectable namely SVP, LVP, Dry Powder, Lyophilized products, as well as Active Pharmaceuticals Ingredients (APIs) including Sterile APIs.
Vikram is on the Board of Directors for Pfizer Healthcare India Pvt Ltd and also for Zydus Hospira Oncology Pvt Ltd.
Challenges and Opportunities for Indian Pharmaceutical Manufacturing
In India there is a rapid expansion of generic drug manufacturing due to various patents expiring for major drugs in recent times. As such the Indian drug companies are capitalizing on the opportunity to produce cost-effective generic versions for local consumption as well as for international markets thereby helping steer India towards becoming a major global pharmaceutical hub.
The Indian Pharmaceutical Industry has undergone big changes in recent years. Factors such as increased regulatory scrutiny, and the digital revolution have reshaped how pharmaceutical companies handle low-cost manufacturing. Biggest challenges which the Indian Pharmaceutical Industry is facing is related to Quality Culture, high attrition, complexity of technology transfers and low level of automation resulting in increased people dependencies. In this regard, Indian pharmaceutical firms are forming strategic alliances with global counterparts, enabling knowledge exchange, resource sharing and technology. These collaborations can be a major help in addressing complex healthcare challenges.
In Vikram’s view, some of the key requirements for the Indian Pharmaceutical Industry towards becoming a major global Pharmaceutical hub are:
1. Creating an inclusive and diverse workplace environment where colleagues can speak freely and raise their concerns.
2. Creating a culture of quality, where all decisions are made keeping in mind the patient safety first and foremost.
3. Improving and delivering top quartile productivity as per global pharmaceutical industry standards.
4. Continual improvement of quality and product robustness.
5. All time regulatory (ATR) compliance and consistency to meet stringent regulatory expectations
The helps that the healthcare industry is undergoing stringent regulations from US FDA, UK, Australia and other regulators that determine the processes to be robust to navigate complex compliance standards and remain ethical and legal to serve the patients better.