Health ministry issues notification to include antiviral drugs oseltamivir & zanamivir into Schedule H1
The Union health ministry has issued a draft notification to include antiviral drugs oseltamivir and zanamivir into the Schedule H1 of the Drug Rules, 1945, allowing the retailers to store and sell the drug against prescription by maintaining a separate record for the details of the particular sales. These drugs were removed from the Schedule X in the Rules, in 2017 with an intention to add them to the Schedule H1, which was introduced in the year 2013.
In a draft notification issued on September 25, the Ministry said that the amendment, which shall come into force on the date of their final publication in the Official Gazette unless otherwise specified, proposes to include oseltamivir as the serial number 49 and zanamivir as 50 in the list of Schedule H1 drugs.
The draft rules shall be taken into consideration on or after 30 days from the date of the draft notification made available to the public and the ministry said that objections and suggestions received within the period will be considered by the Central government.
Schedule H1 was introduced by the government through a notification on August 30, 2013, which contains certain 3rd and 4th generation antibiotics, certain habit forming drugs and anti-TB drugs. These drugs are required to be sold in the country with certain conditions including that the supply of a drug specified in Schedule shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied. Such records shall be maintained for three years and be open for inspection.
The drug specified in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label and shall be labelled with the warning that it is dangerous to take the preparation except in accordance with the medical advice and it should be sold by retail without the prescription of a registered medical practitioner.
The health ministry’s gazette notification issued on September 15, 2009 had imposed restrictions on the manufacturing and sale of these drugs so that it should follow the conditions as specified for Schedule X of the Drugs and Cosmetics Rules, 1945. It added that it requires permission from the Central Government each time for the export of these drugs. In a notice on June 22, 2017, the then Drug Controller General (India) Dr G N Singh informed that in February, 2017, the government through a gazette notification withdrew oseltamivir and zanamivir from the list of Schedule X drugs and permitted for sale as similar to drugs under Schedule H1.
The notification was issued following the recommendation of the Drugs Technical Advisory Board (DTAB) in a meeting held on November, 2016, that both the drugs should be included in Schedule H1 subject to the condition that details of the manufacture and sale of the drugs should be submitted by the manufactures to the DCG(I) at regular interval and the DCGI should direct his enforcement officials to keep strong vigil on manufacture, sale of these drugs.
Infact, the DTAB has considered the proposal to include these two drugs under the Schedule H in February 2015 itself, observing that oseltamivir phosphate and zanamivir belonging to Schedule X had impacted the sale of the drug in the country, in the wake of a rise in the incidence of swine flu and large numbers of deaths reported during the time. The Board during then observed that there is an urgent need for oseltamivir formulations to be made freely available putting an end to the toll caused by the ailment and an indigenous H1N1 vaccine has been developed in the country and permitted to be sold without such restrictions.
“The above restrictions were imposed in 2009 when it was felt that oseltamivir is the only drug available for treatment of H1N1 virus influenza in humans and it is not desirable to allow indiscriminate and unregulated access to this drug as inappropriate use would lead to the H1N1 virus developing resistance to the drug, thereby rendering it ineffective,” it said, adding that in view of the situation prevailed in 2015 the notification may be rescinded and fresh notification for the sale of the drug as Schedule H1 drug may be issued which would make increased availability of the drug in the country.
The Board, during the time said that its members were of the view that the drug has been in use in many countries and there are no reports of resistance being developed with the use of the drug. It also recommended that the 2009 notification may be withdrawn and Schedule H1 may be amended to allow sale of the drugs applying the relevant conditions.
The Drugs Consultative Committee (DCC), in a meeting in July, 2020, recommended revoking of the notification issued on February, 2017 which mandated permission from the Central Government to be given each time for the export of these drugs, and recommended that the drugs should be notified under Schedule H1. Following this, the drug regulator decided to remove the export restrictions on oseltamivir and zanamivir.
It may be noted oseltamivir is sold by Swiss pharma major Roche under the brand name Tamiflu and by various Indian manufacturers under different brand names, while zanamivir has been sold by GlaxoSmithKline under the brand name Relenza, and by various Indian manufacturers under different brand names.
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