Gujarat government has replenished stocks of swine flu drug from the earlier stock of 20,000 capsules to 65,000 capsules as a step towards maintaining consistent supply of medicines to the patients.
Oseltamivir, which is used to treat swine flu (H1N1), was taken off the Schedule X list of drugs and placed under Schedule H1 of the Drugs and Cosmetics Rules a month ago to make it easily accessible to patients. Schedule X drugs can only be sold if the buyer has a doctor’s prescription, not over the counter.
The anti-viral drug was in short supply due to the fact that manufacturers were not getting speedy approvals for issuance of fresh manufacturing licenses, which had stopped production after the drug was removed from the Schedule X list.
It has been learnt that 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The Union health ministry rescinded its notification dated September 15, 2009 restricting the sale of antiviral drugs oseltamivir phosphate and zanamivir drugs as specified under Schedule X to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.
In the wake of spread of antiviral diseases, especially swine flu, in the country, 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.
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.
Unlike this, to sell drugs included under Schedule X, the chemists need a special licence, besides maintaining records of every unit sold for at least two years. The retailers are given special licence 20 (F) to stock and sell Schedule X category drugs, the wholesalers get 20 (G) licence and the manufacturers require 25 (F) licence to manufacture these products.