Almost every industry got affected by a coronavirus. Coronavirus impact on the world financial graph is visible. The coronavirus affected the pharmaceutical industry too.
Drugs and Raw materials
Several countries are facing lockdown because of COVID-19. Due to lockdown, the chances of cost of the raw materials and drugs may increase.
The 13% of brand and generic manufacturers are based out of China According to the FDA, as of 2018, 24% of medicines and 31% of medical ingredients were imported from India.
Example
- The cost of Paracetamol in India has ramped up to Indian Rupees 400-450 per kilogram from Rupees 250- 300 per kilogram
- The price of vitamins and penicillin has increased by 40- 50 % in India
If the pandemic is not controlled and the lockdown will be imposed for a long period then the cost of essential drugs might increase in the US and other countries as well.
India Pharma’s world leader
Pharma industry in India is a world leader in generics both globally and domestic markets. India is contributing significantly to a large volume to the global demand.
The drugs Made-in-India drugs are known for their safety and quality. They are supplied to the developed economies such as the US, EU and Japan.
Supply Chain
The disruption in the supply chain will lead to a shortage of drugs. Some of the critical APIs for high-burden disease categories such as cardiovascular diseases, diabetes and tuberculosis are listed in the National List of Essential Medicines (NLEM).
Pharma supply chain is very delicate. The impact created by COVID-19 has brought it to limelight once again.
The recent survey shows that emergency care, anesthesia care, and pain management drugs will suffer a severe effect due to shortages.
The current situation amid COVID-19 might cause a shortage and an increase in the demands of certain medications. The Hydroxychloroquine and Chloroquine are most talked about during these pandemic times.
The shortage will not occur now as per the sources because companies have stocks at least for the next 5 months.
FDA may allow relaxation
The coronavirus impact may force the FDA to allow relaxation in a few areas:
- The review process of Generic medicine is lengthy. The demand and shortage created may also force minor changes.
- The Federal law requires that the manufacturers should notify the FDA about shortages when the circumstance arises. The rule does not apply to medical devices. The medical devices are manufactured at multiple plants. The shortage of devices during the pandemic might force the FDA to rethink on regulations on devices.
- FDA might also think over the number of inspections on the overseas manufacturing plants
Example- To increases the number of respirators available, FDA and CDC recently announced that certain respirators regulated by CDC, but not by the FDA, can also be used.
Real-World Data (RWD)
The development of each new drug cost around $2.6 billion. This cost is higher than that of 1 billion in 2013. Above all the cost involved, the time taken for development and clinical trials might bring in more focus towards RWD. Almost 95% of the companies are using Real World Data or will be using it by 2021.
Clinical trials are beneficial for pharma. But, there are cases in the past where the drugs were wiped out from the market even after FDA approval. The main problem with a clinical trial is it looks at a homogeneous population. To address this, the FDA might relax the regulations on RWD.
Digital Health
Digital health is the future of medical science. It is believed to be a level up in the medical field. It may be the next big thing as telemedicine/video consultations, health-related videos and apps are gaining popularity.
Online portals who offer doctor-patient consultations will gain popularity. The investment of such portals will also get increased.
Digital Health is a boon amid pandemic.
- Wellmind health, it provides online courses for mindfulness-based cognitive therapy. It has seen a recent uptrend in the purchase and enquires
- Due to the current pandemic situation, hospitals in the UK have been instructed by NHS England to increase telemedicine/video consultations
- Meditation apps Calm and Headspace have released free digital offerings to help people cope up with panic and anxiety
Reassessing the strategies
To tackle the shortages of the drug several companies will reassess their strategies on the primary and secondary market for manufacturing.