In the wake of shortage of critical drugs used to treat Covid patients, the Centre has stepped up pressure on pharmaceutical companies to ramp up production of injectables like remdesivir.
According to sources, 365,000 doses of remdesivir are scheduled for supply in July. In August, the makers have committed to supply 815,000 doses.
Remdesivir is a Gilead Sciences, Inc. drug being made by Indian players under license agreements with the innovator. The drug, originally developed for Ebola, has been repurposed for Covid-19, and is being given to patients under the compassionate-use programme.
Leading pharmaceutical players like Cipla, Hetero Drugs, Jubilant Life Sciences, Mylan, Dr Reddy’s Laboratories, and Cadila Healthcare have tied up with Gilead for making and marketing the antiviral drug here along with other countries. So far, Hetero, Mylan, and Cipla have launched their respective brands of remdesivir priced between ~4,000 per vial and ~5,400 per vial.
The drug has been selling at six to seven times its maximum retail price as it was also in short supply in the black market. The Department of Pharmaceuticals held meetings with manufacturers and has asked them to scale up production. The process of production is not simple — it involves 14 active pharmaceutical ingredients and over 20 different steps to make the injectable drug. This makes manufacturing time-consuming as well as expensive.
Makers, too, are fighting shy of making the drug in bulk as it has a three-month shelf life. “We are steadily ramping up supplies. Since the drug got emergency authorisation from the drug regulator in the wake of the pandemic, it has been granted three-month shelf life until further data is submitted. Making huge volumes in one go is fraught with risk,” said one drugmaker.
The government, however, has held multiple meetings with the makers and is taking action to clamp down on black-market activities. “This drug is also being prescribed indiscriminately by many clinicians. Private hospitals, nursing homes, and a clutch of doctors have found this to be a lucrative business. The affluent also stock it, fearing shortage,” said a senior government official, adding the government has been collating data on profiteering.
He asked, “What is the point of stocking a drug with a three-month shelf life?”
The official further explained that the supplies scheduled in July are 365,000 doses. “Considering each patient gets six doses, this should ideally cater to 50,000 patients. Are there 50,000 people in ICUs now?” he asked.
In August, the official added that manufacturers have promised around 815,000 doses and this would take care of the demand in the market. He clarified that the July supplies do not include Jubilant’s numbers as the integrated global pharmaceutical recently got the nod.
The prices of remdesivir, too, are expected to come down further. While Hetero launched it for ~5,400 per vial, Cipla has launched it for ~4,000 per vial. Cadila Healthcare and Dr Reddy’s are expected to price their brands competitively after the Drug Controller General of India’s go-ahead.