Take us through your journey in the Indian as well as the global pharma industry.
My journey in the Indian pharma industry started with Ranbaxy Laboratories. After completing my PhD from the National Institute of Immunology, I wanted to be in academics and research. However, life had something else in store for me. I reluctantly joined Ranbaxy, but ended up spending more than 20 years in the industry, of which 12 years were at Ranbaxy and 11 years were at Dr Reddy’s Labs. At Ranbaxy, I was one of the few who started the NDDS team and initiated 505b(2) development for the first time in India. Later on, I took an internal transfer to the conventional generics team.
After 12 years at Ranbaxy, I switched to Dr Reddy’s Labs in Hyderabad. The first eight years at Dr Reddy’s were with Proprietary Products BU and we were mandated for pharma product innovation. Products were being developed for the US market. In a short time of eight years, the team developed, filed and got approval for seven innovative pharma products through 505b(2) regulatory path, not an easy achievement for a company of our size and resources. All the seven products got approval in the first cycle of review with the US FDA. Later, we also worked on multiple innovative products for India and EM. During this period, I had an opportunity of multiple F2F meetings with global regulatory agencies like the US FDA and MHRA.
While at Dr Reddy’s, I also got an opportunity to attend and complete ISB-Kellogg Global Advanced Management Programme and multiple DRL’s signature “Annual Leadership Summit” at Boston where we were taught by HBS professors in classroom settings. The later part of my work with DRL was spent in establishing a dedicated R&D team for Emerging and India markets called BRaIN (Branded and Innovation).
Both Ranbaxy and DRL provided me with extensive global exposure. I got the opportunity to travel and work with partners and teams in the US, France, the UK, South Korea, China, Russia, Japan, South Africa, Netherlands, Romania and Sweden. This helped me develop a global perspective on the pharma business.
Experience with Ranbaxy gave me the opportunity to build strong technical competence with great execution skills. It taught us to hold the bull by the horn and not run away from problems and looking for long-lasting solutions. Stay and training at DRL helped me become a mature leader with a global perspective. I could develop great soft skills, essential for leadership roles.
After having spent more than 10 years with DRL, and more than 20 years in corporate pharma, I was looking for a more impactful role where you have the opportunity to contribute to activities which can create a long-lasting impact on society. The current role as Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission (IPC) gives me that opportunity. Our interventions help improve and maintain quality of medicines being sold in the country. It directly touches millions of lives on a daily basis.
It’s been over a year now since you joined IPC. Tell us about all that you have achieved during this stint.
A lot has been achieved in the last one year. First and foremost has been the change in mindset. The organisation has become more receptive and open to stakeholders. Customer-centricity has improved. We created a platform on Telegram – IP Discussion Forum, with a current membership of 850 members, mostly from industry and majorly from MSMEs. Members are resolving their issues and doubts instantaneously. The best part is that solutions are coming from members only. IPC is facilitating the discussion on the platform. Accountability has increased at every level, team members are answerable, and decision making is data-driven and faster.
On the pharmacopoeia side, the inventory of Impurity Reference Standards has grown by 70 per cent, 165 to 277, the highest increase in any single year since IPC’s inception. Multiple awareness programmes, some of them in collaboration with organisations like USP, SMPIC on pharma quality are being conducted for customers. On an average, once a month, I am personally speaking on one or the other platform on pharma quality, issues and probable solutions for India. Offtake of IPRS is improving, which is an indicator of increasing quality cautiousness among manufacturers.
IP is on its way to becoming at par with other leading global pharmacopoeias. We are introducing dissolution specifications in the Prolonged Release Formulation monographs, which was not there till now. For the first time, we are implementing “Flexible Monograph” policy in IP. There is an increased focus on the veterinary part of IP. We have a new Veterinary Expert Committee working, that is aligned with IPC’s methodology and frameworks. We are initiating the development of digital IP. If everything works as per plan, we should be able to launch digital IP during the current year, 2022.
On the pharmacovigilance side, we have demonstrated significant growth on all the growth indicators. The number of AMCs has increased from 346 to 530+, the highest increase in any single year since the start of PvPI. The number of adverse event reporting has grown. We initiated the celebration of the National Pharmacovigilance Week (17th to 23rd September) for the first time, and it is going to be an annual phenomenon from now onwards. The number of centres for MvPI has grown three times, and so has the adverse event reporting in the medical device domain. There is a new energy in the system. It is just the beginning of IPC phase-II.
What are the major targets that you wish to achieve during your tenure here?
During my tenure, I wish to bring IP at par with leading pharmacopoeias of the world like USP, BP and EP. We want to start few applied educational programmes which will supplement our quality improvement goal. We also want to become source of trained manpower for the pharma industry, especially in analytical and quality domains. We want to initiate structured research programmes in the quality and regulatory domain. We would like to start PhD programme in these areas. If you search for an institute which can be identified with their contribution in the pharma quality domain, it is difficult to find. Whereas, for other specialisations like dosage form development, pharmacology, medicinal chemistry, phytochemistry, etc, you can easily find researchers and institutes both. We have to fill this gap if we have to address the problem of medicine quality in this country.
On the pharmacovigilance/materiovigilance side, we want to graduate from a data collection and regulatory recommending agency to larger healthcare data analytics centre. We want to use the adverse event data for more use and benefit of the society. We want to increase public awareness about the pharmacovigilance programme whereby patients and their family members start reporting the adverse events on their own and not get influenced by practitioners. There is a lot to be done.
Since you have been a corporate leader for years, and now you are on the other side of the fence as a policymaker. Do you see yourself as a bridge between the pharma industry leaders and the policymakers? Since you might be aware of the challenges faced by both the sides, is it going to help in designing better policies for the pharma sector?
The answer is yes. My experience and exposure is already being used in multiple policy initiatives. My presence in the government system is helping by presenting the customer’s perspective.
What have been your key learnings in the past one year? Any change that you wish to bring in IPC as an organisation?
The past one year has validated many management and leadership concepts. Irrespective of corporate or government, these concepts work everywhere. Some of them being: it is important to ask the right questions in any system; to work with “keep it simple” approach; delegation; lead by example, if we demonstrate then only we can demand, etc.
At IPC, there was a strong foundation built in the last 10 years. We are trying to build next-level IPC over this strong foundation. The IPC of the future will be more open and collaborative — a knowledge-generating centre, place to look towards for “quality and regulatory” advisery and a partner in improving pharma quality in this country and beyond.
Apart from the pharma domain, what other areas interest you?
Spirituality, leadership development and organisational building.
What is the one thing that always motivates you to keep following your goals – be it professional or personal?
“You are here to support life.”
akanki.sharma@expressindia.com
journoakanki@gmail.com