India's Maharashtra government is going to import Gilead's antiviral drug Remdesivir from Bangladeshi drug maker Eskayef Pharmaceuticals and it has taken the Indian pharmaceutical industry by surprise.
Yet analysts and legal experts have found out that if the drug is not for commercial use it is completely safe to import it.
On June 6, Maharashtra Health Minister Rajesh Tope said the state will buy Rs 12,000 per vial for 10,000 doses of remdesivir from Dhaka-based Eskayef Pharma, reports Moneycontrol.
Gilead told Moneycontrol it has not given a license to manufacture remdesivir to Eskayef Pharmaceuticals or any other business in Bangladesh.
"Gilead cannot comment on or verify the authenticity or effectiveness of this product as it is not manufactured by Gilead or one of our licensed partners," it said.
The announcement of Maharashtra came even as three Indian companies-Cipla, Hetero and Jubilant Life Sciences-are awaiting approvals from the Indian drug regulator for marketing authorisation. The three firms hold Gilead licenses to manufacture and sell the medication in 127 low- and middle-income (LMICS) countries.
Maharastra reported 82,968 cases, and 2,969 deaths due to Covid-19, India's highest. Remdesivir is one alternative on the table that has been approved for treating Covid-19 in India but is yet to be released. This prompted the state government to go for Eskayef's Remdesivir.
"We should not have any concern (on any IP infringement). DCGI is conversant with the IP provisions, and has acted promptly in granting the import (to Bangladesh company)" said Dr Gopakumar Nair, Gopakumar Nair Associates, a Mumbai-based consultant for Intellectual Property (IP) related matters.
Nair said Section 107A of the Patents Act, 1970, provides for the importation of the drug if the company is duly authorised to produce and sell or distribute the product under the law. Nair also quoted Section 100 of the Patent Act, which specifies that a proprietary invention should be used for 'for purposes of Government'.
Nair is a consultant with Beximco Pharma, another drug-maker from Bangladesh who produces remdesivir.
Two Bangladesh companies - Eskayef Pharmaceuticals and Beximco Pharma - have started making and distributing remdesivir without Gilead's approvals. These companies have been quick to take advantage of international trade rules that allow nations defined by the United Nations as least-developed countries to ignore patents and produce affordable drugs. Bangladesh comes under least-developed country.
They are also exporting remdesivir to other countries, putting them directly in race with Indian drugmakers.
Another analyst told that remdesivir made in Bangladesh is not inferior and made in USFDA compliant facilities.
"Many Indian technical and legal consultants have helped Bangladesh companies. Bangladesh has aspirations to become powerhouse of generic drug manufacturing. It has decent technical expertise and has built many USFDA compliant facilities. Given its status as least-developed country, it can easily copy patented drugs. Covid-19 gave them perfect opportunity to put those skills to use," said a partner at one of the big four consulting firms on condition of anonymity.
Wait for Indian-made remdesivir continues
An executive of a drug maker who has a license from Gilead for remdesivir and whose application for marketing authorisation in pending with Drug Controller General of India (DCGI) told Moneycontrol that the regulator has sought data on animal toxicology studies.
"We are in the process of submitting the data," the executive said. The Indian regulator had given clinical trial waiver for the drug.
The executive declined to comment on the Eskayef drug, but said his company would price the drug at an affordable rate.
As per the agreement with Gilead India, companies are free to price the drug. Gilead is yet to fix the price for US market.
The Institute for Clinical and Economic Review (ICER), the Boston-based independent nonprofit organisation, which has done cost benefit modelling has estimated the price of the drug at $4460 (Rs 3,36,779) for a full course of treatment in US .
In terms of pricing, Bangladesh companies are selling Remdesivir in local market at 7000 takas per vial, which puts the five-day treatment cost at 35,000 takas (Rs 31,000), that's one-tenth of the price.