Journal of Generic Medicine – Editorial March 2022

Predictions for 2022 continue. Many pharmaceutical companies have upgraded their earnings forecasts with bullish tentative expectations for 2022. Complex injectable manufacturers seem to do particularly well. UNICEF is projecting that the global production capacity of vaccines will expand to 40 billion doses in 2022 from 8 billion in 2021. Quite an increase. Capacities are rising in a range of countries including Senegal, Egypt, South Africa, Morocco and India. On the adverse side, shipping costs continue to increase alongside raw materials and APIs. In 2022, Perrigo has waved goodbye to its generic prescription business whilst J&J, Pfizer, GSK, Merck and Sanofi have all decided to spin off their consumer businesses. Vertical integration seems to be a major strategy at Amazon as seen in the recent purchase ofMGM studios to assist in the production of original Prime video. Some observers believe this approach may carry Amazon into the generic pharmaceutical industry in the future. In addition, Amazon already owns Pillpack which could evolve into a new distribution arm as well as synergising with a large generic pharmaceutical acquisition. Indeed, there are a couple of large Western generic companies having a challenging time at present which come to mind. In the USA, the FDA has now paused all domestic USA nonmission-critical inspections. This slowdown has been brought into force to ensure the safety of FDA employees and the companies it regulates in the light of the rise of omicron COVID-19 cases. This pause will increase the agency’s backlog of worldwide inspections. In spite of this news, some Indian facilities have still received warning letters in recent times following 2021 inspections. Interestingly, the FDA has advised API manufacturers to consider using alternative excipients such as sodium carbonate and ascorbic acid in order to inhibit the formation of nitrosamines which have caused so much trouble in the API industry in the last couple of years. In India, 55 manufacturers have benefitted from the new production-linked incentive (PLI) scheme introduced by the Indian Government. The PLI scheme offers financial incentives on sales increases over the next 6 years. The total cost of the scheme is quoted at over $1.5 billion. There were reported to be 278 applicants spread across three different categories which are defined by business sales and manufacturing focus. As Indian pharmaceutical companies expand into the Chinese marketplace, there are a growing number of alliances being established between Indian pharmaceutical companies and Chinese generic companies. In Europe, the European Commission seems more focussed on the generic industry these days compared to the past, and a recent report has identified that biosimilars saved European countries over $5 billion in 2021. Healthcare costs are rising, and the UK now spends 13% by value of its economic output on healthcare which makes it one of the highest in Europe. In this issue, we continue with our global footprint of manuscripts with contributions from Canada, Italy, Bulgaria, France, India and the USA.