Last Updated on December 7, 2020 by The Health Master
The Union health ministry may revoke notification dated February 17, 2017 to allow export of drugs oseltamivir phosphate and zanamivir and these drugs will be included under Schedule H1 of the Drugs and Cosmetics (D&C) Rules, 1945 based on Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) recommendations.
Oseltamivir and zanamivir, two extensively used clinically effective anti-influenza drugs, are viral sialidase (also known as neuraminidase) inhibitors that prevent the release of progeny virions and thereby limit the spread of infection.
Schedule H1 list contains third and fourth generation antibiotics, select habit forming drugs and anti-TB medicines. This special category mandates the chemists to not only sell it against a prescription but preserve details like name and address of the prescriber, name of the patient, name of the drug and the quantity supplied for three years.
The Drugs Controller General of India (DCGI) had earlier issued the gazette notification stating that oseltamivir has been removed from the Schedule X list and manufacturers therefore have to take an NOC from the government. The pharmaceutical companies that already had the permission to manufacture the drugs had to apply again for the requisite permissions for consistent supply of medicines.
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DTAB and DCC were apprised that the Union Health Ministry had published the Gazette notification vide G.S.R. 144(E) dated February 17, 2017 under the D&C Act, 1940. The Gazette Notification G.S.R. 144(E) inter-alia mandates that: “… no person shall manufacture for sale or distribution or sale or stock or exhibit or offer for sale or distribute any preparation containing the drug “Oseltamivir Phosphate” and “Zanamivir” except in the following manner: “(b) the conditions specified in the D&C Rules, 1945 in respect of the drugs specified under Schedule H1 to that rules shall apply to the drugs “Oseltamivir Phosphate” and “Zanamivir” or any preparation based thereon.
To download the notification, click here
Provided that the Drugs Controller General India (DCGI) may allow export of the drug “Oseltamivir Phosphate” and “Zanamivir” or any preparation based thereon for reasons to be recorded in writing and in consultation with the Central Government.
Thus, permission by the Central Government is required to be given each time for the export of these drugs as per the above notification.
DCC in its 58th meeting held on July 14, 2020 deliberated the matter and recommended revoking the Notification G.S.R. 144(E) dated February 17, 2017 by considering the aspect in the current context.
However, the DTAB also recommended that simultaneously, these drugs should be notified under Schedule H1 of the Drugs and Cosmetics Rules, 1945 for the regulation of their sale in the country.
The DTAB after detailed deliberation recommended for revocation of the G.S.R. 144(E) dated February 17, 2017 and inclusion of these drugs in Schedule H1 of the D&C Rules, 1945.
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