Dr. Guru Prasad Mohanta
Reports speak of shortage in and black-marketing of the most-promising Covid–19 medicine, Remdesivir, in the open market. The black-market prices are substantially higher, making the medicines unaffordable. The police have registered cases against the black-marketers. Realising the potential of this experimental drug, the Trump administration has booked enough of supply to meet its requirements for the next three months, leaving little or nothing available for others. The Indian situation is different.
Remdesivir, developed by American company Gilead for Ebola treatment is now repurposed for Covid-19. Though the company has obtained patent in India, it has signed a licence agreement with some Indian pharmaceutical companies, like Cipla, Hetero, Mylan, Jubilant etc, permitting them to manufacture and sell the drug in 127 low and middle income countries. This is subject to regulatory approval.
India’s drug regulator, the Drugs Controller General (India), has permitted the above companies to manufacture and sell the drug. Under the non-exclusive licencing agreement, Gilead provides technology transfer for manufacturing Remdesivir which would enable the Indian companies to scale up. The companies are given the liberty to fix their own prices for the generic products. In a goodwill gesture, Gilead decided not to receive any royalty on sales volume until one of two conditions are met: either World Health Organization declares Covid-19 as a public health epidemic globally, or vaccine or medicine is made available to treat it.
The Union Government has approved use of the drug under emergency authorisation and this is recommended for patients with moderate disease (those on oxygen support), but with a rider. The drug is not to be used for pregnant or lactating mothers or children below age 12. The drug is not recommended for patients with liver and renal impairment.
The drug should be used prudently by adhering to government advisory. Three pharmaceutical companies have announced their prices: Hetero pharma’s Covifor costs Rs 5,400; Mylan’s Desrem costs Rs 4,800 and Cipla’s Cipremi costs at Rs 4,000 per vial. Typically for a five-day course, the drug cost varies from Rs 24,000 to Rs 32,400. Gilead’s product in US costs substantially higher, for a course of five days, at the lowest price of $ 2,340 — equivalent to Rs 175,500. The price of Remdesivir in India is low compared to the US price, but there is a large inter-brand variation. The price variation between the lowest priced and highest priced product is of 35 per cent.
Remdesivir is an injectable product to be given as infusion. This is to be used only in hospital; means there are added costs. Here is a tricky situation. Which of the three products that are currently available will be used by hospitals? Will there be patients’ interest to choose the lowest-cost one or the one which gives maximum profit to the hospitals? Medicines are different commodities. The real buyer, the patient, has no choice but to pay, while the one who makes choice is paid.
Remdesivir not only looks promising but is cost-effective too. The study has shown that the use of Remdesivir reduces the recovery time by 31 per cent. The patients with Remdesivir will recover in 11 days against the standard care which takes 15 days. In Covid-19 treatment especially in private sector, the bed cost and professional charge dominate. A savings of four days’ hospital cost would benefit the patient.
The simple marketing force alone is not the determining factor of the medicine price. Pharmaceutical marketing is a complex process and the government is advised to enforce pharmaceutical marketing code. The stepping up of production and improved logistics may improve availability of drugs but the affordability remains a concern! The Drugs Price Control Order provides immunity from price ceiling for new patented medicines for five years. Remdesivir falls under the category. But in public interest, the government’s intervention is needed to rationalise price and keep a tab on maximum retail price.
The writer is a retired pharmacy professor with Annamalai University.