Govt issues draft notification for inclusion of Oseltamivir and Zanamivir in Schedule H1

Download GSR 686(E) Dt 25-09-2023: The draft notification will be open for public consideration for a period of 30 days from the date of notification

The Health Master

September 28, 2023

203

Govt of India Gazette of India Notification — Gazette of India

Table of Contents

Last Updated on January 6, 2024 by The Health Master

Draft notification

Download the draft notification; the link is given below: In a significant move towards enhancing public health measures, the Union health ministry has recently issued a draft notification proposing the inclusion of antiviral drugs, oseltamivir and zanamivir, into Schedule H1 of the Drug Rules, 1945 vide notification No. GSR 686(E) Dt 25-09-2023.

Download GSR 686(E) Dt 25-09-2023 Draft Notification Inclusion of Oseltamivir and Zanamivir in Schedule H1

This amendment aims to allow retailers to stock and sell these drugs without prescription, provided they maintain a separate record for the details of each sale.

This development follows the removal of these drugs from Schedule X in 2017, with the intent of integrating them into Schedule H1, which was introduced in 2013.

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Key Changes in the Notification

The draft notification, released on September 25, 2023, outlines the following key changes:

Serial Numbers: Oseltamivir will be listed as serial number 49, and zanamivir as 50 in the Schedule H1 drugs.
Implementation Timeline: These amendments will come into force upon their final publication in the Official Gazette, unless otherwise specified.
Public Feedback: The draft notification will be open for public consideration for a period of 30 days from the date of notification. The Ministry has emphasized that any objections or suggestions received during this period will be carefully reviewed by the Central Government.

Insight into Schedule H1

Schedule H1 was introduced by the government on August 30, 2013.

This schedule comprises a range of 3rd and 4th generation antibiotics, certain habit-forming drugs, and anti-TB medications.

The sale of drugs listed under Schedule H1 is subject to specific conditions, including the mandatory recording of details at the time of supply.

These records should include the prescriber’s name and address, the patient’s name, the drug name, and the quantity supplied.

Furthermore, these records must be maintained for a period of three years and be accessible for inspection.

Labeling and Prescription Guidelines

The drugs specified in Schedule H1 must bear the symbol Rx, prominently displayed in red at the top left corner of the label.

Moreover, they should be labeled with a warning stating that their consumption is potentially hazardous unless done in accordance with medical advice.

These drugs may only be sold by retail upon presentation of a prescription from a registered medical practitioner.

Historical Context

In a gazette notification dated September 15, 2009, the health ministry imposed restrictions on the manufacturing and sale of these drugs, aligning them with the conditions specified for Schedule X of the Drugs and Cosmetics Rules, 1945.

This notification also mandated prior permission from the Central Government for the export of these drugs.

However, in a pivotal move in June 2017, the Drug Controller General (India), Dr. G.N. Singh, announced the removal of oseltamivir and zanamivir from Schedule X, permitting their sale under the regulations of Schedule H1.

Recommendations and Rationale

The decision to include these drugs in Schedule H1 was propelled by the recommendations of the Drugs Technical Advisory Board (DTAB) in November 2016.

The DTAB proposed that both oseltamivir and zanamivir be incorporated into Schedule H1, contingent upon manufacturers regularly submitting details of production and sale to the DCG(I).

This move was seen as crucial in ensuring stringent monitoring of manufacturing and sale activities.

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