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Managing Risks and Liabilities in India’s Pharmaceutical Industry: Insights from the 7th Pharma Workshop

March 6, 2023

The Indian pharmaceutical industry is renowned for its competitiveness in both cost efficiency and research and development. According to the Economic Survey 2022-23, the industry has maintained its growth momentum even after the pandemic, and it is projected that the domestic pharmaceutical market will reach USD 130 billion by 2030. In FY21, the country’s pharmaceutical exports grew by a healthy 24%, driven by the demand for critical drugs and supplies due to COVID-19, which were sent to over 150 countries. However, the sector faces challenges such as shortages of key medications, quality and regulatory issues, and fluctuating drug pricing due to a lack of policy stability.

 

Against this backdrop, the Bombay Chamber, under the auspices of the BFSI Committee, organised the 7th Pharma Workshop in association with Title Sponsor, Howden Insurance, Co-sponsor, Go Digit and Knowledge Partner, PwC. The workshop’s theme was Managing Risks and Liabilities in Pharma. Mr Praveen Vashisht, Chairman, Howden India, Howden Insurance Brokers India, welcomed the audience and set the tone for the workshop by discussing three risks affecting the Pharma sector: competitive environment rationale, operational and financial risks, and reputational risks. Mr Vashisht also discussed how Covid-19 exposed weaknesses in the Insurance and Pharma Industries and the impact of reduced demand, cyber threats, and supply chain disruption on these industries. He further elaborated on the three different risk management areas for organisations: measuring the risk, managing the risk, and monitoring the risk.

 

In his keynote address, Mr Srinivas Lanka, Mentor, ElixGlobal, highlighted the importance of each and every risk in the pharma industry. He also discussed how earlier, there used to be 70% API (Active Pharmaceutical Ingredients) imports from China, but the scenario has changed now. In terms of value, currently there is only $3bn API Imports from China compared to $23bn earlier. Mr Lanka spoke about the numerous risks in the pharma industry due to supply chain disruptions, resulting in businessmen losing opportunities and hampering the industry’s growth. He stated that this is now the era of exporting Indian pharmaceutical products in international markets, and every country is facing issues due to forums and their correspondences. He further noted that it is becoming increasingly difficult to develop a large molecule due to supply chain interruptions for manufacturers.

The first session of the day was an interactive fireside conversation on the topic Post-Pandemic Recovery and Current State of the Indian Pharma Sector: Issues & Challenges between Ms Smriti Mishra, Partner, PwC, and Mr Ramesh Swaminathan, CFO, Lupin, which highlighted the operational risk in supply chain management. Mr Swaminathan emphasised the growing importance of the ECLGS scheme and the effect of Govt’s PLI schemes on imports, calling it a strategic move by the government. He highlighted how, moving ahead, cost dynamics are not going to be easy, and the cost of manufacturing is going to increase. In terms of understanding Good Manufacturing Processes (GMPs), India is the best in the world and has a good skill set. However, there is a need for Industry and Government academia collaboration.

 

The panel discussion on the topic: Regulatory Environment for Indian Pharma Business had Mr Ankur Jain, Partner, Risk Assurance, PwC, as the moderator, and Mr Lanka, Mr Amit Pandey, EVP & General Counsel, GSK Pharmaceuticals, and Dr Milind Antani, Lead – Pharma, Healthcare, Medical Device and Digital Health Practice, Nishith Desai Associates, as the panellists. They deliberated on the Pharma Competition Act, various archaic laws criminalising the pharma industry that are still active today, the need to have an intermediary for small pharma companies that don’t have their labs to ensure quality, and the need to increase awareness of the various laws that govern the pharma sector.

 

The final panel discussion of the day on the topic: Emerging Risks, Trends and Risk Transfer Solutions in the Indian Pharma Sector, featured Mr Amit Solanki President, Howden India as the Moderator and Mr Martin Hawkins, Head of Liability, Newline Syndicate; Mr Richard Kelly, Head of Life science, Clinical Trials Insurance Services and Ms Anisha Udeshi, Director Global Insurance and Risk, Cipla as the panellists discussed the need to impart risk training to employees with a qualified risk manager, among other pertinent issues.

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