COVID-19 Impact on Generic Drugs in Pharmaceutical Industry
OVERVIEW
In early 2020, a new virus began to make headlines around the world due to an unprecedented rate of infection. Its origins can be traced to the food market in Wuhan, China in December 2019. Coronavirus (COVID-19) is a contagious disease caused by newly discovered coronavirus. The United States is the most affected country. The disease caused by SARS-CoV-2 infection is called COVID-19, which stands for coronavirus disease 2019. As the final treatment for confirmed COVID-19 has not yet been identified, there is considerable interest in repeating existing generic drugs for use against COVID-19.
Generics can easily be produced without fear of intellectual property protection infringement, they have created protection profiles and as the results are more likely to get approval from the Food and Drug Administration and they can come directly to market by avoiding the early stages of testing in stage 3 clinical trials. Republished generics also provide the possibility of lower prices after development, increasing limited budget payers and access to patients worldwide.
IMPACT ON PRICE
A large number of challenges are being faced by the various market players due to the emerging of the novel coronavirus, one such issue is the uncertainty surrounding the impact of COVID-19 on generic drugs demands. Due to the increased demand of generic drugs for coronavirus treatment and increased travel and transportation costs the price of generic drugs has increased.
According to Association for Accessible Medicines (AAM), the cost of shipping drugs to the United States has risen sharply due to the global epidemic of pandemics, according to a new survey by generic drug manufacturers conducted by the Association of Accessible Medicines (AAM). A survey of generic and biological pharmaceutical manufacturers AAM found that travel and transportation costs rose by an average of 224%, while at least one manufacturer reported a 413% increase in transportation costs compared to the same pre-crisis costs. Generic drugs are 90% of all prescriptions issued in the United States. With the increasing demand and transportation costs of generic drugs have led to the increase of the generic drugs price.
IMPACT ON DEMAND
The corona virus zone is the result of various markets around the world. This is the cause of the widespread closures and isolation that are affecting world economic activity.
COVID-19 has led to the increased demand for APIs and drugs; those used against malaria are most in the demand and then bronchodilators, antibiotics and antivirals. A second wave of deficiency is observed among sedatives, analgesics, anesthetics and muscle relaxants needed to care for patients on ventilators. This persistent shortage has increased the need for generic drugs, which has led to the accelerated FDA approval and the abolition of existing import warnings. About 48 percent of the world's pharmaceuticals used to make generic medicines come from India and China.
As the pandemic of COVID-19 progresses, manufacturers of generic and biologic drugs work around the clock to ensure American patients have access to the drugs they need. Despite global drug chain companies straining under unparalleled pressure and demand, 9 out of 10 prescriptions filled in the United States are meeting the challenge.
The impact of COVID-19 has created an opportunity for the number of patients as there is high chance of adverse health effects of COVID-19 on the people.
IMPACT ON SUPPLY
As the epidemic intensifies, supply chains can be at significant risk due to locations that are over-located and potentially disrupted. The supply chain of drugs has been disrupted. The spread of COVID-19 makes it difficult for governments to use these drugs; the availability of these systems faces constant challenges due to their used parts as well as limited initial needs.
The majority of active pharmaceutical ingredients (APIs) worldwide are sourced from India, which also provides approximately 30 percent of the generic active pharmaceutical ingredients (APIs) used in the United States. Indian manufacturers, however, rely heavily on China's APIs to manufacture their pharmaceuticals and obtain about 70 percent from China, the world's largest manufacturer and exporter of APIs by volume. India provides affordable and inexpensive generic drugs to millions of people around the world and operates more than 250 US Food and Drug Administration (FDA) and medical and healthcare institutions (MHRA) in the UK.
During COVID 19, Chinese active pharmaceutical ingredient (API) production is not only impacting the local market, it could cause supply chain disruption around the world. According to various sources, more than 60% of active pharmaceutical ingredients (APIs) of pharmaceutical manufacturers in India depend on imports from China. As some active pharmaceutical ingredients (APIs) makers in China were unable to return to work due to COVID-19, some Indian generic drug companies were at risk of production disruption, which then had an impact additional on their export to the European and American markets.
Trade restrictions have chosen nothing more than to produce essential medicines domestically. During the pandemic, as the increase increases, counterfeiting and price increases of imported goods increase. This means that even during the COVID-19 pandemic, market participants are able to maintain the supply chain.
STRATEGIC DECISIONS OF GOVERNMENT AND MANUFACTURERS
As the coronavirus continues to spread to various countries, concerns are growing about disruptions in drug production and distribution. Collaborations, agreements, initiatives of market participants such as Zydus Cadila, Gilead Sciences, Inc. in the pharmaceutical market have helped them expand their market. This in turn will help to increase the demand for the product among the consumers and thus increase the future sales of the company.
Market players have already taken different initiatives to combat the corona virus. For instance,
- Cipla is the largest manufacturer and medicinal product manufacturer in India. It has been approved by the FDA for the general albuterol sulfate inhaler, due to the increased demand for this product to prevent the asthma symptoms of COVID-19 patients. Inhalers are also being used as a treatment instead of a spray. No shortage has been reported in India so far, but there is a possibility of a shortage if the number of cases in India increases. Cipla has exported 35,446 kg of albuterol to the United States since March 2020. China has reported neither shortages nor exports, with its domestic supply of finished products.
- In August 2020, Indian pharmaceutical company Lupin has announced that they will sell Generic COVID-19 Drug Favipiravir. Lupine's version of the drug, called Covihalt, will be priced at 49 rupees (65 cents) per 200 mg tablet. Sun Pharma on Tuesday launched its own version, at Rs 35, the cheapest in India to date.
- In July 2020, Mylan, N.V., declared that they will launch generic version of Gilead Sciences Inc.'s COVID-19 treatment remdesivir in India this month at Rs 4,800 (USD 64.31) per 100 mg vial, as infections rise in third worst-hit country in the world.
- In June 2020, Hetero Healthcare announced that it is expected to deliver 20,000 vials of its antiviral drug Covifor (remdesivir) across the country for the treatment of COVID-19, at a maximum retail price of 5,400 rupees per vial and the company delivered the first batch of 20,000 vials in two equal batches of 10,000 each, one of which was immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, said Hetero Healthcare in a press release.
With the increasing demand and increasing sale of generics drugs, are fueling the growth of generics drugs market in the near future.
As such, market participants are involved in the production of generics drugs expanding their business through a variety of programs, including collaboration, contracts, and pipeline development, collaboration, and market expansion. It is expected that the strategic decisions of these companies will provide significant opportunities for market participants operating in the generics market.
CONCLUSION
Remdesivir is a new antiviral drug developed by Gilead Sciences, originally for the treatment of Ebola virus and Marburg virus infections. Remdesivir has broad-spectrum efficacy against members of several viral families, including filoviruses Ebola) and coronary viruses such as, SARS-CoV and Middle East Respiratory Syndrome (MERSCoV), and has shown prophylactic and therapeutic efficacy in clinical trials of these chronic varicose veins. Intravenous treatment with remdesivir has shown significant improvement for the first case of COVID-19 in the United States, and since then a rapid study has been initiated for to assess the efficacy and safety of remdesivir in hospitalized patients with 2019-nCoV infection.
There is evidence to support the safety and tolerability of generics in short-term treatment. However, more evidence is needed to assess the effects of long-term treatment. Given the limitations of the evidence and the particular safety concerns that remain, the widespread use of generics against pandemic COVID-19 should be justified.
Various manufacturers have allowed their manufacturers to operate a small production of generics at various production sites in safe areas around the world, helping them to maintain a stable supply chain. In addition, increased demand for generics for the treatment of coronavirus has increased profits.
