Production capacity of Remdesivir ramped up by more than 3-times

Production capacity of key antiviral injectable drug Remdesivir used to treat Covid-19 has been ramped up by more than three-times in the last few months to 12.249 million vials per month by June. The Centre is also trying to build an inventory or a buffer stock of this injectable before a third wave hits.

The drug was in short supply in April and May when the country was witnessing a massive second wave of infections, and manufacturers were in the middle of ramping up capacities.

In a response given in the Rajya Sabha, Health Minister Mansukh Mandaviya said that the Drugs Controller General (India) granted ‘expeditious approval’ to 40 new manufacturing sites of the licensed manufactures of remdesivir. “This led to an increase in the number of remdesivir manufacturing sites from 22 in mid-April, 2021 to 62 at present. The domestic production capacity of Remdesivir increased from 3.88 million vials per month in mid-April to 12.249 million vials per month in June, 2021,” the minister said.

Further, in order to supplement the domestic availability of remdesivir manufactured in the country, the export of Remdesivir Injection and remdesivir API (Active Pharmaceutical Ingredient) was prohibited from April 11, the health ministry said in the Rajya Sabha. The Department of Pharmaceuticals (DoP) and Ministry of Health and Family Welfare (MoHFW) jointly undertook an exercise for allocation of available stocks of remdesivir to all the States and UTs of the country.

Mandaviya added that of the 9,887,000 vials of Remdesivir injections allocated to states, 9,703,393 vials have been supplied till July 18. In addition to the above, allocation of commercial supplies to states, the MoHFW has also supplied around 2.9 mn remdesivir vials, free of cost, to the states, the health minister noted.

Ahead of the anticipated third wave, India is trying to build a buffer stock or inventory of essential Covid-19 medicines like Remdesivir, Favipiravir apart from common medicines like paracetamol, antibiotics and vitamins etc to ensure no shortage once cases spike. Industry sources indicate that for key drugs like remdesivir, which have seen shortages in the past, the plan is to build an inventory for 30-days at least.

The Centre is planning to procure 5 mn vials of remdesivir ahead of the third wave. What’s best is this time, they are also paying us in advance,” said a Mumbai-based pharma player who makes remdesivir. The senior official at the firm added: “During the second wave, when we were asked to scale up our capacities by two-three folds, we had asked what will happen to these excess capacities in the future unless there was an assurance of offtake. This time, the government has not only placed orders for large volumes, but is also paying us in advance.”

The official added that roughly India now has a capacity to make 10 mn Remdesivir vials a month. The drug had seen prices jump manifold in the blackmarket, and patients were scrambling to procure their stock of medicines during the second wave. Each patient typically needs 6 vials.

“Typically, a batch of Remdesivir takes 15 days to make. This includes sterility testing requirements. If a manufacturer is using a certain type of sterile equipment in manufacturing, this testing requirement can be bypassed for now. This can halve the time required to make one batch,” said a government official. Business Standard