PESHAWAR: The government has decided to provide Remdesivir injection for the treatment of serious Covid-19 patients initially to the hospitals only as Ferozsons Laboratories is ready to start supply of the drug from July 28 to the market, according to officials.
Officials at Drug Regulatory Authority of Pakistan (DRAP) told Dawn that Remdesivir injection for Covid-19, manufactured by BF Biosciences Lahore under agreement with Gilead sciences USA, would be available in the end of current month with brand name Remedia both in lyuphized powder for infusion and in liquid form.
“We are going to supply 25,000 injections to the market that are presently undergoing sterility tests after which these will be tested at Central Drug Testing Laboratory, Karachi before making them available for patients,” they said.
On June 8, DRAP allowed 12 firms to manufacture or import Remdesivir in liquid and powder form for the treatment of Covid-19 patients in the country. Another firm has imported the drug from Bangladesh but Ferozsons is manufacturing the injections in Lahore in collaboration with Gilead Sciences USA, which has originally developed it.
“The government and the companies have signed agreements that the drug would not made available over-the-counter but will be supplied to the hospitals directly where Covid-19 patients are treated,” said the officials. The measure are meant to
Officials say Remdesivir will not be available over the counter to prevent hoarding
put brakes on black-marketing of the injection given the experience of the past few months, which saw skyrocketing prices of some anti-inflammatory drugs used for the treatment of Covid-19 patients.
Officials said that trial and commercials batches had satisfactory results and were ready for use but as precaution they were waiting for sterility tests. The price of per injection will be Rs10,800 or Rs12,800 and the patients would require six injections.
They will need two injections on the first day, followed by one injection daily for four days. In more severe cases 11 injections will be needed, depending on the advice of physicians.
The approval regarding powder came in emergency for the companies that had lyophilisation facility and could store the product at below 24 degree centigrade, the officials said.
They added that for liquid injection, the factories having cool chain facilities of 2-degree centigrade to 8-degree centigrade were allowed.
Officials said that Remdesivir was available worldwide in 20 ml liquid injection vials as well as in freeze-dried form, to be reconstituted for injection after mixing of distilled water. They said both forms were allowed by DRAP.
They said that hospitals would send demand to the company that would supply the drug on the basis of needs. They added that the manufacturer got raw material for 100,000 injections and it could be imported once situation regarding demand in the country became clear.
There has been rising demand for the medicine owing to the severity of the pandemic as each and every country requires the injections approved by the US Food and Drug Administration as well as European countries.
“In view of the shortages of anti-Covid-19 drugs, the government has bound all the manufacturers to restrict sale to the hospitals only to discourage hoarding and sale in open market,” said the officials.
They said that sale over-the-counter could not be allowed because the drug would be required by the serious patients, who remained on ventilators. Serious patients on ventilator could only be in hospitals, therefore, it was decided to sell the stuff to hospitals only, they added.
Published in Dawn, July 17th, 2020
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