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Antiviral drugs oseltamivir phosphate & zanamivir removed from Sch X to overcome restrictive sales
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Ramesh Shankar, Mumbai
June 29 , 2017
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In the wake of spread of antiviral diseases, especially swine flu, in
the country, the Union Health Ministry has withdrawn the antiviral drugs
oseltamivir phosphate and zanamivir from Schedule X and placed them
under Schedule H1 of the Drugs and Cosmetics Rules to remove the
restrictions for stock and sale of these formulations. The ministry has
now rescinded its notification dated September 15, 2009 restricting the
sale of these drugs as specified under Schedule X to enhance the
availability of these drugs in the country.
The Health
ministry's gazette notification issued on September 15, 2009 had imposed
restriction for stock and sale of oseltamivir phosphate and zanamivir
formulations as a Schedule X Drug.
Now, the ministry has
included these drugs under Schedule H1 category which was introduced in
the drug law in 2013 to combat concerns of antibiotic resistance. The
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.
Unlike this,
to sell drugs included under Schedule X, the chemists need a special
licence, besides maintaining records of every unit sold for at least two
years. The retailers are given special licence 20 (F) to stock and sell
Schedule X category drugs, the wholesalers get 20 (G) licence and the
manufacturers require 25 (F) licence to manufacture these products.
“In
view of the recommendations of Joint Monitoring group in its meeting
held on 31/05/2017, it is brought to the notice of all stakeholders that
vide Gazette Notification G.S.R. No. 144(E) dated 17th February, 2017
Oseltamivir and Zanamivir are withdrawn from the list of Schedule X
drugs and are now permitted for sale as similar to drugs under Schedule
H1 of Drugs & Cosmetics Act and rules”, Drug Controller General of
India (DCGI) Dr GN Singh said.
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