With India’s top drug regulator has given nod for market sale of Fevipiravir Tablet and Remdesivir injectable Formulation, State Drugs Controller has allowed its sale in Odisha.
As Drugs Controller General of India allowed the sale the Directorate of Drugs Control, Odisha has issued notification in this regard on 12 September.
This order empowers chemist shops to sale Fevipiravir Tablet and Remedesivir Injections under the prescription of Medical specialists only.
Informed consent of the patient or his representative in the prescribed form is mandatory before initiating the treatment.
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 shop, though 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 representative, residential proof of the purchaser and the contact details before supply of the medicines as record for verification in addition to fulfillment of other conditions under Drugs and Cosmetic Rules.
Remedesivir 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 Remedesivir formulation is to be sold to any patient or his representative directly.
The Retail Chemist shall furnish details of purchase and sale of the above drugs to the respective Range Drugs Inspector on a weekly basis.
Drugs Controller has directed all Drugs Inspectors in this regard to identify one or more stand alone stockist and retail chemist shop to facilitate supply of drugs.
They will ensure the stockist and retail chemist having valid drug license must have good track record under provision of Drugs and Cosmetics Act.
Drug Inspectors will verify purchase and sale details from stockists and retail chemists from time to time to weed out possible hoarding or black marketing, said the notification .