Why did it take such a long time for PDA to enter the Indian market? Why is India now a preferred destination for PDA?
| Richard Johnson |
PDA is a member-based organisation that has been in existence since 1946. There have been members from India for many years. In the last three years we have been working to establish a firm core of supporters and volunteers to assure that a PDA India Chapter will be sustainable. India is recognised as an important player in the global pharma community, and PDA wants to support this community.
What do you think of recent increased scrutiny of parenteral plants by FDA and global regulatory agencies? How would the industry get affected by this? What role would PDA play?
Worldwide there has been increased regulatory focus on pharma manufacturers, especially as the supply chain and global sourcing have become more complex. Sterile product manufacturing is among the most sophisticated types of processes, and regulators have always focussed on these facilities. PDA works to bring best practices to the industry, and provides expertise, technical guidance and training to the industry and regulators to promote sterile manufacturing.
What are the current challenges for the Indian pharma and biologics industries in the global market? How is PDA going to address these challenges?
All manufacturers worldwide are trying to balance higher expectations for quality and compliance with cost and competitiveness pressures. This is very true in India as well. PDA is an important venue for bringing all parties (manufacturers, technical experts, regulators, academics and suppliers) together to identify the best ways to advance these goals. Through our many activities (conferences, training, technical guidance) we promote harmonisation of these practices.
What role does PDA play in the biologics and pharma industry and how does it interact with the global regulatory bodies?
PDA is a leading international association that works to ‘Connect People, Science and Regulation’. Our activities are focussed on sterile manufacturing of pharma and biopharma products via conferences, training and the development of science-based technical guidance. In these efforts, we often engage with regulators from around the world. PDA has been holding joint conferences with regulators on important topics for more than 25 years, and we have provided training with, and for regulators from many countries and multinational organisations such as US FDA, PIC/S and WHO.
What are PDA’s future plans, globally and specifically for India? Which are the pharma and biologics companies in India that you are currently engaging with?
PDA has a strategic plan whose focus is to advance science-based improvement in the supply of safe and effective healthcare products worldwide. PDA is committed to working with and through our members in India to expand these activities in India. We have met with members from many India-based biologics and pharma companies including Biocon, CIPLA, Dr Reddy’s, and Aurobindo, allied industry partners like Sartorius-stedim, pharma-consulting organisations like Vienni, as well as multinational companies and Central and State Health Authorities. Our chapter board includes members from a diverse group of companies. Currently, Interim Chapter President is Sanjay Singh, who is from Aurobindo Pharma, Interim President Elect is Sanjit Lamba from Eisai, Interim Secretary Amit Sharma from Sartorius, and Interim Treasurer, Ivy Louis from Vienni.
Which are some of the projects that PDA is currently working/will work on, in India?
PDA has several areas of focus that are pertinent to India. Our leadership, guidance, and training in sterile manufacturing is applicable. Our focus on quality systems, biologics, drug delivery technology and supply chain integrity are also areas that can be very applicable in India.
How would you describe the response of Indian pharma and biologics companies to PDA?
I have been impressed by the response we have received. Members, industry leaders and regulators see the need for PDA to be a participant in helping the Indian industry rise to these new challenges, and through that energy and commitment, I am confident that we can be a good partner with the industry in India. Our members worldwide want to engage with their counterparts in India to advance our common goals, safe and effective healthcare products. Every patient, in every country deserves this commitment.