Activists and experts raise concerns of overcharging and shortages of Remdesivir

The government has been urged to look into the overcharging and shortages of key COVID-19 therapy, Remdesivir across the country. Health activists and legal experts have urged the government to invoke public health safeguards under the Patents Act to improve the availability and affordability of the antiviral drug.

Activists believe Remdesivir’s availability and manufacturing can be expedited by just issuing a government use licence to companies, which will pave the entry of multiple generic firms.

KM Gopakumar, legal advisor of international health and development non-governmental organization – Third World Network, told ToI that since India does not have a system of patent linkage, the DCGI can provide emergency approval to additional generic manufacturers of Remdesivir without linking to patent status, or without the requirement of companies obtaining a voluntary license from the patentee (Gilead), given the emergency of the situation.

“This should be the preferred option to implement quickly, considering the situation in the country. Recently, the pharma industry body – IDMA had sought emergency approval from the government to manufacture the COVID-19 drug, while Maharashtra sought a compulsory licence from the Centre,” Kumar said. “There is no legal barrier even under the Drugs and Cosmetic Act for DCGI to grant emergency approval to additional manufacturers, who are not Gilead’s licensees.”

As such, activists have asked the government to revoke amendments to Para 32 of the DPCO, 2013 notified in January 2019, “as Remdesvir is a patented drug and outside price control. The amendments prevent the National Pharmaceutical Pricing Authority (NPPA) from regulating or setting price caps on patented medicines for five years from the date the patentee commences commercial marketing of its product. It has immense potential for abuse, as is evident from the failure of the NPPA to control the price of Remdesvir in the private market.”

Experts have been urging the government to impose price controls on the drug, to prevent its overcharging and black marketing across cities. The NPPA, on Saturday, announced that pharmaceutical companies manufacturing Remdesivir in India have voluntarily slashed prices following government intervention. The authority declared change in prices for seven brands of Remdesivir injections of potency 100 mg per vial.

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Moreover, as per an office memorandum by NPPA dated April 17 2021, the prices have been slashed in the range of Rs 1,000 to Rs 2,700. After the price cuts, Cadila Healthcare’s Remdac continues to be the cheapest Remdesivir injection at Rs 899, which was earlier being sold at Rs 2,800.