Hyderabad-based Hetero Healthcare Limited, the first pharma company in India to launch anti-H1N1 drug oseltamivir in retail market under the brand name Fluvir, will be supplying 14,000 bottles of oseltamivir syrup to replenish the stocks in retail trade in the state of Gujarat to avert any stock out in the near future. There are around 37,000 retail and wholesale licensees in the state of Gujarat for which consistent supplies are required.
The anti-viral drug was in short supply due to the fact that manufacturers had stopped production after the drug was removed from the Schedule X list and placed under Schedule H1 of the Drugs and Cosmetics Rules. The manufacturers had to wait for approvals of fresh manufacturing licenses leading to inconsistent supply of the drug.
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 Union health ministry withdrew antiviral drugs oseltamivir phosphate and zanamivir from Schedule X and placed them under Schedule H1 of the D&C Rules to remove the restrictions for stock and sale of these formulations in the wake of spread of antiviral diseases, especially swine flu, in the country.
This comes close on the heels of Cipla supplying the oseltamivir syrup to the Gujarat government based on product license clearance from Goa Food and Drug Administration (FDA) to tide over the shortage. There were significant delays in issuance of product licenses for swine flu drug oseltamivir, which was taken off the Schedule X list of drugs and placed under Schedule H1 of the Drugs and Cosmetics Rules a month ago.
Gujarat government had therefore requested Goa FDA to fast track the clearance which brought a huge relief to the patients in urgent need of medicines.
Drugs Controller General of India (DCGI) 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.
The Union health ministry rescinded its notification dated September 15, 2009 restricting the sale of antiviral drugs oseltamivir phosphate and zanamivir drugs as specified under Schedule X to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. The ministry recently included these drugs under Schedule H1 category which was introduced in the drug law in 2013 to combat concerns of antibiotic resistance.
Published on: August 16, 2017