Bhubaneswar: The Directorate of Drugs Control, Odisha on Saturday set certain conditions as per the directives of the Drugs Controller General India (DCGI) for retail sale of the COVID drugs.
The Fevipiravir tablets and Remdesivir injectable formulation will be sold under the prescription of medical specialists only, as per the conditions. Besides, informed consent of the patient or his/her representative in the prescribed form is mandatory before initiating the treatment.
The Directorate has also set the following conditions:
—The drug will be made available to the patient/his representative only through in-house retail chemists attached to hospitals/ nursing homes having valid drug licenses. Where there is no in-house retail chemist shop in the hospital/nursing home, the local Drugs Inspector will identify one or more retail chemist shops through whom the drugs will be made available.
—The retail chemist shop will mandatorily retain a photocopy of the prescription, photocopy of written consent of the patient or his/her representative, residential proof of the purchaser and his/her contact details before the supply of the medicines as a record for verification in addition to fulfillment of other conditions under the Drugs and Cosmetics Rules.
—Remdesivir formulations are required to be supplied for use only to the hospitals/institutions to ensure proper use of the drug under the restricted emergency use. In no case, Remdesivir formulation is to be sold to any patient/his representative directly.
—The retail chemist shall furnish details of purchase/sell of the above drugs to the respective range Drugs Inspector on a weekly basis.
Besides, the Directorate has asked the Drugs Inspectors to identify one or more stand-alone stockists and retail chemists to facilitate the supply of the drugs and ensure that they have valid drug licenses with a good track record under the provision of the Drugs and Cosmetics Act and Rules.
The Drugs Inspectors are to verify purchase and sale details of the stockists/retail chemists from time to time to weed out possible hoarding or black marketing and report compliance, it said.
Favipiravir has received the authorisation from the DCGI for emergency use.
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