'Pharma, The White Knight of the Pandemic'

“Pharma going to be the White Knight as we go ahead”- Ranjit Shahani

Anticipating a flood of causalities in the coming campaigns, President Franklin D. Roosevelt very early on during World War 2 called upon pharmaceutical companies to produce a “miracle drug” that would save wounded GIs. Nineteen companies volunteered but it was Pfizer whose fermentation process to create penicillin was finally approved.  Pfizer was to ship close to 90% of the penicillin used during that war.

Today, a similar race for a vaccine is being witnessed. It is reported that 159 vaccines are in the development stage.  Of these, two are in Phase 2 trials (dose-testing in humans), five in Phase 1 to 2 (safety and efficacy trials) and four in Phase 1.

As regards an antiviral drug specifically to tackle COVID 19, around 69 drug candidates have been shortlisted, of which 41 are either already approved by the U.S. Food and Drug Administration or are currently in clinical trials for other uses. So far, Gilead’s Remdesivir, a broad-spectrum antiviral medication is the frontrunner and is already in use on patients with severe symptoms in the U.S. and Japan.

TAKING A PROACTIVE STAND 

Pharmaceutical companies have been extending a helping hand to consumers facing economic difficulties in accessing critical medication.  Eli Lilly, a U.S. company, has offered support to many insulin-dependent diabetics whose loss of income has left them unable to access life-saving medication. 

The Indian government took proactive measures to avoid supply-chain disruptions in the pharma industry. To monitor transportation and delivery of essential commodities in real-time, the Department for Promotion of Industry and Internal Trade (DPIIT) set up a  control room with the respective state drug controllers providing operational data on a daily basis. “There’s a lot going on in this space [pharma], which will hopefully give some succour. Indian companies have upscaled their manufacturing for HCQ, clinical trials for which are still going on to see its usefulness; there are companies which are producing re-purposing medicines to see whether they can help in COVID. There’s a lot of creative work going on,” say Shahani.

THE MANY LAYERS OF DRUG MARKETING

One major issue is the licensing protocol for newly introduced drugs.  Recently, Gilead’s Remdesivir was sanctioned the ‘orphan drug’ status by the U.S. Food and Drug Administration, which was quickly revoked due to severe criticism. The ‘orphan drug’ designation is granted in situations where the disease affects fewer than 2,00,000 patients whereas in the U.S. far more people have been infected by this virus. This status comes with seven-year market exclusivity to the company, which means Gilead would have had an exclusive right to manufacture and market the drug, giving it a monopoly.

'Doctors Without Borders' has urged global leaders to accord patents to privately developed COVID treatments to “ensure availability, reduce prices, and save more lives.”

Creating a vaccine for a virulent virus like COVID-19 is extremely hard work, and ensuring it is accessible to all will be even harder.  Shahani succinctly explains the dilemma. “Access has more than one dimension. People focus on it only in relation to price. Access also relates to availability and quality. You may have the product but not the right quality, then that's poor access. Now, either the government does the research, and a pharma company does the manufacturing to distribute it. But if you are a listed company, and you are my shareholder, then you'll want a reasonable return on the investment. This is always the challenge. Americans pay the highest amount for innovative products, followed by the Europeans where the pricing is 20-30% less than the U.S., followed by Asia where the price drops by around 50%. When it comes to India, it is one-fifth of the pricing sold globally. Yet, we have six hundred million people here who have an income of about two dollars a day or less. Now, that's the challenge. One way is to distribute these through government outlets, like ration shops. The government can buy these in bulk and sell it to them or give it for free.”

THE API CONUNDRUM 

Sourcing of active pharmaceutical ingredients (APIs) for drug manufacturing became a serious issue once the supply chains from China collapsed suddenly. The Indian pharma industry has a dependency of over 70% for API from Chinese suppliers. The prices of most of the APIs have risen sharply.

In March, the Joint Drugs Controller of the Central Drugs Standard Control Organisation (CDSCO) had to step in with a package to replenish the API industry.  In fact, in 2014 the present National Security Adviser Ajit Doval had warned that India’s dependence on China for APIs could be a national security threat.

Shahani cites the example of Switzerland, which follows a rule of maintaining a two-year stock of critical supplies. “79% dependency on one country, China, is just not on,” he says. In sum, Shahani feels that there is great opportunity for the pharma industry in coming times. He says,  “Pharma is going to be the White Knight as we go ahead”.