GSK_Annual_Report_2021

Statutory Reports GlaxoSmithKline Pharmaceuticals Limited 38 Your Company’s warehousing and distribution network continued to deliver high levels of customer service on time and in the right quantity, while maintaining the supply chain fundamentals. Your Company is also implementing automation initiatives within supply chain operations to proactively track products until they reach the customer. This insight into customer requirements not only supports business growth but also ensures a positive impact on the society and the ecosystem. (c) Opportunities, risks, concerns and threats With the pandemic leading to lockdowns and other curtailments, Outpatient Departments (OPDs) at hospitals remained shut and doctors either stopped functioning or avoided visiting clinics for most part of the year. This had a significant impact on generation of new prescriptions, a critical growth driver for the pharmaceutical industry. With the gradual relaxation in lockdown rules and the introduction of COVID-19 vaccines, hospitals and clinics started returning to pre-COVID activity level. Though operations were again impacted by the second wave of the pandemic at the start of FY 2021-22, the situation is expected to start normalising again as the surge ebbs. Your Company’s investment in digital initiatives, deep customer relationships and a resilient supply chain will continue to ensure high service levels across stakeholders and give it a competitive advantage. Several experts have predicted that India may experience future waves of COVID-19, which could further stretch the country’s healthcare ecosystem. Thismay also impact your Company’s ability to service its patients and HCPs on time. With agile business continuity processes in place, your Company will, however, ensure that optimum levels of production and supply chain reliability are maintained. Over the medium to long-term, your Company remains positive about delivering healthy growth. The outbreak of the global pandemic has also created raw material (Active Pharmaceuticals Ingredients or APIs) related disruptions for the Indian pharmaceutical industry. Your Company has long-term loan licenses with various Contract Manufacturing Organisations (CMOs) that should help it tide over such unpredictable situations with minimum impact. However, in the event of an extended period of shutdown, there are risks of supply disruption and higher input costs. From a long-term advocacy perspective, your Company is working closely with industry associations and policy makers to propose a more predictable, transparent API pricing regime, that will be a win- win for all stakeholders. Your Company operates in a price-regulated market. Adverse regulations on product prices may impact revenues and profit margins. To mitigate these, your Company periodically assesses its product portfolio to make it more diversified, with focus on high-volume growth products and operational efficiencies to control costs. With the revised National List of Essential Medicines (NLEM), expected to be released by the Government later in 2021, your Company is engaging in various stakeholder discussions on NLEM. The healthcare policy landscape in India is at an inflection point. Amid the pandemic, the uptake and acceptance of new areas of healthcare delivery, such as telemedicine, e-pharmacies, Over-the-Counter (OTC) medicines, are at an all-time high. New Government regulations could redefine the healthcare sector in the long term, and your Company is in discussion with policymakers and stakeholders on the subject. (d) Regulatory affairs Your Company applied to Central Drugs Standard Control Organisation (CDSCO) for registration of (i) Herpes Zoster Vaccine (recombinant, adjuvanted) [Shingrix] for prevention of Herpes Zoster and Post-Herpetic Neuralgia in adults aged ≥50 years; (ii) Belimumab Solution for Injection 200mg/ml [Benlysta] for treatment of adults with systemic Lupus Erythematosus and Lupus Nephritis; and (iii) indication expansion for Quadrivalent Inactivated Influenza Vaccine (Fluarix tetra) for use in adults over 64 years of age. A Global Clinical Trial (GCT) application was approved during the year, for conducting a multi- country phase 3 study with Respiratory Syncytial Virus (RSV) Maternal (RSVPreF3) vaccine in India.