Changes in the pharma world during the COVID-19 pandemic
Changes in the pharma world during the COVID-19 pandemic
As sectors of the economy are struggling with Covid-19's effects, companies are undergoing loss, employees are jobless and so many faces the prospect of a complete lifestyle upheaval. Throughout these unpredictable days, drug manufacturers are reacting to the quick obstacles raised by distribution networks disruptions and the need to adjust workflows. The pharma industry is continually subject to transition. If the present COVID-19 epidemic persists for a prolonged period of time, it might just affect the availability of active product and ingredients (mainly from China), as well as pharmaceutical imports and exports. In the last few years, in particular the processing of active substances and raw materials has been gradually moved to countries where manufacturing can be more cost-effectively carried out. "Contract Manufacturing Organizations" (CMO) outsourcing has become extremely common. Though, the globalization of supply chains and increasing dependency on third parties has indeed contributed to severe slowdowns in the supply of drugs in individual situations particularly for life-saving drugs which are important. The world's current COVID-19 outbreak could also contribute to higher restrictions or perhaps even supply drug bottlenecks. However, this move of CMOs outsourcing may be reversed in order to maintain the availability of essential drugs. COVID-19 has impacted the pharma in various aspects such as:
Cost of active ingredients and drugs
The Covid-19 effect which developed in China has now led to the shutdown in various countries like the U.S and India. This increases the possibility of shooting up in the raw materials and drugs prices. Some of the examples are:
The paracetamol price has increased from 250-300 Rs/Kg to 400-450 Rs/Kg in India. Similarly, the penicillin and vitamins price has been escalated by 40-50 percent.
If the present situation tends to persist, the price of prescription drugs in the other countries may also escalate.
The pharmaceutical distribution network is vulnerable and Covid-19's effect has yet again exposed it to the spotlight. Branded drugs are the goods which are secured by a stable supply chain and which are profitable for producer’s while generic products have very low profit and has lean supply chain. As of now, china and india is leading the market of active products ingredients. But the inventory of these ingredients is very small due to which this challenge can induce drugs shortfall at any point with the median drug scarcity continuing for 14 months. Medications that are particularly affected by shortages are pain relief medications, anaesthesia and emergency medicine. The current scenario may result in a shortfall and a rise in the requirements of some drugs such as chloroquine and hydroxychloroquine, most discussed throughout these outbreak times. This is suspected that the shortfall will not arise for now because businesses are holding inventory for at least the next five months.
Policies of FDA
The effect of the Covid, the drugs demand and the shutdown in different nations could compel the FDA to relax conditions in a few ways. Generic Drug's approval process is extensive, the requirement and scarcity produced in the present condition may also allow some minor modifications. The federal legislation allows companies to inform the FDA of scarcity whenever the situation occurs. However, the law is not applicable to medical devices, because they are produced in several plants. Shortages during the outbreak could compel the FDA to reconsider product regulations. To maximize the respirators numbers thar are readily accessible, the CDC and FDA announced last month that some CDC-regulated respirators, but not the FDA, may be used as well.
Analytics and Data
Pharmaceutical industry possesses a volume of data, but also poses multiple challenges such as social listening, privacy of data, clinical trial advance in-sighting, unstructured data leveraging, combining siloed data and deriving insights technology to harness the big data power. The cost of producing drugs is ballooning, and the time it takes to launch a product is also significant. For years the sector is using data, but the obstacle is to capitalize on its maximum potential. A vast number of experimental and biological available data across the years will lead to predictive analysis that can be used to improve the cycle of development of drug and clinical trials. Companies exploit analytics data, but the situation today may require them to make even more effective use of data for marketing, forecasts and clinical trials. Big-data and social communication technology would also play a crucial role.
Data of real world
The projected cost of producing new medicines is $2.6 billion, rising from $1 billion in 2013. The time required for production & clinical trials, in addition to the expenses involved, could bring more attention to data of real world. About 95 per cent of businesses use or will use data of real world by 2021. Accessibility of data and security concerns are some of the difficulties of using data of real world, but it can be resolved and this will attract further acceptance as businesses and regulatory authorities from now on may look to put innovative initiatives into clinical trials. Clinical studies are pharmaceutical gold dust but over the past there are instances where the products were taken out of the markets even after FDA approval. The biggest issue with clinical trials is that they are looking at a homogenous group. To counter this, FDA may loosen data of real-world regulations.
Telehealth / video calls, healthcare-related videos and devices are reaching a wider audience; thus, digital health could be the next big thing. Online services investment that support the connection between doctor and patient will increase. Some of the examples are:
Well mind health (services online courses for conscientiousness-based cognitive therapy) has seen a new rise in buying and inquiries. Because of the situation of pandemic, UK hospitals have been urged by NHS England to raise video consultations, telemedicine and therapy apps headspace and calm have launched free digital services to help people deal with anxiety and panic.
Also, there is the possibility for negative consequences on R&D and manufacturing operations of a medium-and higher-term type along with delays on developments / initiatives not relevant to the core production chain / database management activities. While the full impact of the global epidemic is still uncertain, pharmaceutical companies need to adapt, recover and survive.