HONG KONG – The Drug Controller General of India (DCGI) has approved Mylan NV’s remdesivir 100-mg vial for restricted emergency use in COVID-19 cases.

The drug received an accelerated approval for the treatment of COVID-19 in adults and children hospitalized with severe presentations of the disease. It will be released in India under the brand name Desrem, and be available to patients at a price of INR4,800 (US$64.34) this month.

Mylan claims its price for the India market is more than 80% less than the price at which the branded version of remdesivir will be available to governments in the developed world. Its remdesivir will be manufactured in India at its injectables facilities there.

Mylan is one of the six Indian pharma companies that have received nonexclusive licenses from Gilead Sciences Inc. to manufacture and distribute generic remdesivir in 127 low- and middle-income countries. The approval from the DCGI in India represents the first for Mylan in those 127 markets.

Gilead has priced its remdesivir at USD2,340 for patients in wealthier countries, with the U.S. being the biggest buyer with a recent purchase of 500,000 doses.

“Mylan and Gilead Sciences have partnered for many years to make high-quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world,” said Rajiv Malik, the president of Mylan.

“We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India.” He hailed the approval as a significant milestone for Mylan, the global public health community, and for patients who are battling this pandemic.

“The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health,” said Rakesh Bamzai, Mylan’s president of India and emerging markets. “Mylan is cognizant of its responsibility in fighting this pandemic and will leverage its global resources and capabilities, including R&D, regulatory knowledge, and its manufacturing and supply chain, while engaging with key stakeholders across the licensed territories to serve the patients in need and further its mission of creating better health for a better world.”

Many are excited about the new supply, as previously patients in India could get access to remdesivir only through alternative methods such as importation or on compassionate grounds.

"The approval will facilitate the direct availability of remdesivir for patients in India with moderate to severe COVID-19 who face higher risks of mortality,” said Sasmitha Sahu, a pharma analyst at Globaldata. “Currently, the supply is restricted only to government channels or hospitals or institutions and not through retail channels.

"The accelerated approval of remdesivir by multiple manufacturers in India will not only ensure prompt and steady supply but also mean a reduction in the overall price in the longer run,” Sahu added.

Mylan’s approval follows Cipla Ltd. and Hetero Labs Ltd.’s approvals from the DGCI. Cipla and Hetero will launch their generic versions of remdesivir for COVID-19 treatment under the brand names Cipremi (expected price of around INR5,000) and Covifor (INR5,400), respectively.

Daman, India-based Sovereign Pharma Pvt. Ltd. said it has just delivered the first batch of remdesivir it manufactures for Cipla, which is expected to launch in the next few days. The company estimates it can supply 50,000 to 95,000 injectable doses per month.

"In addition, Jubilant, Mylan, Dr. Reddy's, Zydus, Cadila and BDR Pharmaceuticals are in the process of seeking approval for generic remdesivir in India,” Sahu said. “Gilead is yet to launch remdesivir in India despite being the first company to receive approval in the country for import and launch.”

The pandemic has made countries take a closer look at their pharma supply chains.

“The COVID-19 crisis has created supply chain disruptions and a shortage of medical personal protective equipment in many countries and has since prompted more awareness about the importance of India’s self-sustainability in essential goods,” Sakshi Sikka, senior pharmaceuticals and health care analyst at Fitch Solutions, told BioWorld. “We believe that India is likely to put in place domestic manufacturing of essential medical supplies, or at least build a larger emergency stockpile.”

Rising China-India political tensions have also caused consignments from China to be subject to more scrutiny at ports and airports, leading to delays in the clearance of goods ranging from electronics to pharmaceuticals. That could be further motivation for India to approve and support more domestic manufacturers of much-needed medicines like remdesivir.

No Comments