Ministry of Health and Family Welfare has issued a Notification dated February 5, 2024, revoking an earlier Notification dated February 17, 2017 (“2017 Notification”) regarding the restricted sale of ‘Oseltamivir Phosphate’ and ‘Zanamivir’. With this, now, the sale of ‘Oseltamivir Phosphate’ and ‘Zanamivir’ is permitted to be done in the manner similar to drugs referred to in Schedule H1.
Background
Under the 2017 Notification, it was mandated that manufacturers seeking to sell, distribute, stock, exhibit, or offer for sale or distribution any preparation containing the drugs ‘Oseltamivir Phosphate’ or ‘Zanamivir’ must obtain prior written approval from the DCGI. Additionally, they were required to adhere to the conditions specified in the Drugs and Cosmetics Rules, 1945, regarding drugs listed under Schedule H1 while manufacturing ‘Oseltamivir Phosphate’ and ‘Zanamivir’ or any preparation based on them. Manufacturers were also obligated to submit a monthly statement to the DCGI, detailing the quantity of the specified drugs supplied to distributors, stockists, and dealers by the end of each month. Distributors, stockists, and dealers holding stocks of ‘Oseltamivir Phosphate’ and ‘Zanamivir’ were required to submit a monthly statement to the respective State or Union territory, containing the quantity of the specified drugs available to them.
However, with the rescinding of the 2017 Notification, the earlier 2016 Notification, allowing the sale of ‘Oseltamivir Phosphate’ and ‘Zanamivir’ similar to drugs in Schedule H1, will be reinstated.
Copies of the Notifications are attached herewith for your ease of reference.
Source: Ministry of Health and Family Welfare
