Cipla will be supplying 5000 bottles of Oseltamivir syrup to the Gujarat government based on the much awaited product license clearance from Goa Food and Drug Administration (FDA) to tide over the shortage of swine flu drug. Meanwhile, the government is also planning to replenish the stocks in retail trade to avert any stock out in the near future.
Gujarat government had written to the Goa FDA to fast track the clearance and is expected to get the supplies anytime around next week. This will be huge relief to the patients who are in urgent need of medicines which according to experts can bring down mortality rates significantly in the state.
It has been learnt that there has been 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.
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 had to wait for approvals of fresh manufacturing licenses leading to inconsistent supply of the drug.
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The Union health ministry rescinded its notification dated September 15, 2009 restricting the sale of antiviral drugs oseltamivir phosphate and zanamivir drugs as specified under Schedule X to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 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.
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. – Medical Buyer Bureau