IPMMA Webinar: 10 December 2020: Pharma Outlook 2021 & Beyond

Avisha Desai, Project Manager, MMI welcomed all the esteemed panellists, participants and supporting partner Indian Pharma Machinery Manufacturers’ Association (IPMMA). Shehul Sheth, Vice-President IPMMA further welcoming the participants and the panellists gave a short introduction of IPMMA which is now 20 years old with 300+ members employing almost 25,000+ people and exporting to 90+ countries with an annual revenue of $1.5 Million.

Kaushik Desai, IPMMA Advisor and Moderator of the webinar warmly welcomed the entire panel of esteemed speakers. The Pharma sector as a whole is witnessing transformation to cater to the current needs to prepare capabilities of tomorrow. The industry journey with annual revenue of about $ 42 Billion can be attributed to the world class capabilities in formulation development and entrepreneurial activities of the firms to establish India’s footprint in the global market. India is expected to touch $80-90 billion by 2030 with moderate conservative compound growth rate of 7-8%. But to realize this objective industry has to reorient its strategies explore more in the niche drug delivery system, technology plays a major role in the journey. Industry also will have to tap the opportunity of almost $200 million worth of sales of product going off pattern by 2024. The technology that are going to disrupt pharma manufacturing industry globally are 3D printing, Artificial Intelligence, Continuous Manufacturing, Automation, smart manufacturing and digital transformation. The current scenario of pandemic has brought to the fore the use of digitized tools, the way we interact has changed more than the way we can imagine practically living in the digital world.

Prashant Sharma, President – Group Manufacturing & Operations, Zydus Group

The pharma sector has always been a high growth sector with patient centric approach. The pharma is expected to grow continuously however the way we deliver this growth is dynamic and evolving. The pharma industry in the last 10-12 years was shaping its landscape working closely with regulatory agencies to raise the bar for compliance. In last 10 years, although Pharma industry has not been the most efficient, we need to focus on Agility and digitization keeping compliance in mind.

Majorly pharma companies have looked at automation and technology as only compliance and failed to innovate beyond that. We need to build the basics; investment in networks, talents and a good cyber security system. MSME’s can go for digitization with low-cost automation with sensors capturing basic data and instead of going for MES, Printouts of Batch will replace eBMR, could be opted which is much more economical and shows results gradually.

Automation is looked upon from manpower reduction and payback perspective, which will eventually happen but we need to keep a holistic view at its inception. Almost 5-6 years down the line with implementation the payback could be seen. Once we become agile and compliant payback could be observed. The Pharma company leaders need to educate their people to be digitally aware and agile for complex technologies. We should not look at digitalization or remote inspection from compliance perspective. However, if we look at it from operational efficiency and not from audit perspective, compliance would be automatically catered to as an advantage.

Innovation now is a necessity of pharma industry, and we need to build a strong academia-industry interface. We need to check if we are preparing our students to think laterally or simply getting them employed. Performance management system should be rather known as behavioural management system because the way people will behave will be based on the way people are rewarded.

Dr. Palleswara Rao Govada, Director – Formulation Operations, Hetero Labs Limited

The Indian Pharma industry has shown phenomenal growth and it will continue to grow. However, keeping increasing constraints in mind, we need to streamline our operations and at the same time keep focus on the regulatory aspects. Whoever focusses on changing environment and consolidates its base, will definitely prosper with a visible impact in the industry.

Going forward, impact of digitization cannot be overlooked, even the US FDA is recommending the industry to gear up for virtual audits. Pharma industry is very data intensive. For example, in QC, the HPLC or any analytical instrument generates huge amount of data. This data needs to be captured, preserved and retrieved during audits which is an arduous task and even needs to be replicated across all departments. The regulatory bodies require all this data in a consistent manner as a proof of activities in the GMP environment. Data of all the activities on the shop floor also needs to be captured with specific parameters and the system should be able to produce reliable data.

Although many pharmaceutical institutes have come up even in rural areas, the talents are not up to the mark as per industry requirements. The curriculum needs to be revamped to better suit industry needs. The faculty in the institutes should be trained by Industry in a systematic way which then in turn can train the students in the right perspective.

S. M. Mudda, President, NSF India Director, Misom Labs Ltd., Malta

We need to challenge the myth that the regulatory standards have their gradation which starts with Schedule M, WHO then Europe and then the FDA. Eventually this myth makes us believe that we are yet to reach there. To dispel this myth, the understanding that the regulatory practices for compliance globally are the same, has to seep in. Compliance standards are minimal and keep evolving dynamically as per need of the time. We certainly need to upgrade our Schedule M and GMP requirements at par with global requirements by setting our GMP framework. Hence, we need to bring GMP concepts and philosophies into regulations and rest should be supported by guidelines. Any deviation from regulatory guidelines is a punishable offence resulting into a pushback from different sectors giving a notion of incapability. However, if it is received as a guideline, it gives a flexibility. We need to take a radical view of upgrading ourselves where we create a global framework.

Most important factor is ‘the people’. I see compliance as legacy and reputation, our license to operate, our credibility, it’s our image that brings the business – the customer to us.

Our GMP compliances are consistently inconsistent. Be it digitization, automation, cost control measures should be within the quality systems framework to make them sustainable. Although we are upskilling our people in the industry along with the capabilities, we need to have the Systems approach. We can improve upon a quality system by taking one part at a time viz. data integrity, digitalization and so on. This has to be brought into culture and culture evolves gradually. We need to develop leaders who are leaders of quality systems integrating it with business.

We need to shift from traditional approach for skill building which is mere studying and passing exams; as a professional course much more is expected from the institutes. He quoted a famous philosopher “Being taught is the major obstacle to learning” because the focus is on what is the right answer that will help me get the grades? Education is the ability to deal with situations of life in the areas where you have aptitude and abilities. Dire need is to impart “Learn how to Learn” in contrast to our current focus – data and information.

Dr. Viranchi Shah, Sr. National Vice President, Indian Drug Manufacturers’ Association and Managing Director, Saga Labs.

Mr Shah shared an analogy of a circus in his opening remark, how the person moves from one swing to another without falling down. The way things are dynamically changing across the world, our industry cannot stay put on the same swing. We need to move to the next swing which requires a lot of effort from our side to reorient the entire industry.

Exports for Indian Pharmaceuticals have grown by almost 15 percent in first two quarters in 2020. Despite the pandemic, the industry has grown and there are many upcoming opportunities in next few years on the manufacturing front through Atmanirbhar Bharat initiative. For any kind of growth in this industry we need to have the regulatory Compliance. Cost is another key factor; we need to be very vigilant about the cost to build and cost to operate. Third factor is, being customer-focused. Irrespective of our business nature, as a contract manufacturer, direct marketer, or research-based company, we need to identify and understand who is our customer; realign with them and the changing reality.

Since most MSME’s are into contract manufacturing, to scale to global level, cost and compliance are the two major factors for their success. For SME’s the compliance should come before cost, reiterating Mr Mudda “We need to be in a state of Continuous Compliance” otherwise MSME’s will be unable to demonstrate their capabilities.

Atmanirbhat Bharat is an applaudable vision shared by our honourable Prime Minister. In terms of formulations, we are majorly Atmanirbhar (independent) apart from few patented ones. Major challenges for us are the API, the Intermediates and the KSM’s where the government and the industry are focussing on.

The experts foresee agility, R&D infrastructure, digitization, Operational excellence, and integration of all growth factors for scalability and compliance in focus as outlook for pharma 2021 and beyond.

Ankit Vora, Senior Project Manager, MMI thanked all the industry stalwarts, moderator Kaushik Desai and IPMMA for their support and to all the participants for their active engagement in the webinar.