Swine flu toll in Mumbai now 7, drugs in short supply
The disease has affected 3,724 people and killed 376 this year (till August 4) in Maharashtramumbai Updated: Aug 06, 2017 23:53 IST
A month after antiviral drug Oseltamivir, which is used to treat swine flu (H1N1), was taken off the Schedule X list of drugs to make it easily accessible, it is in short supply in Mumbai. Schedule X drugs can only be sold if the buyer has a doctor’s prescription, not over the counter.
The disease has affected 3,724 people and killed 376 this year (till August 4) in Maharashtra. In Mumbai, seven people have died and 413 people have been treated for the disease in July. Mumbai reported one case in July 2016, but no deaths.
The primary reason for the delay is the Drug Controller General of India (DCGI)’s failure to provide fresh permissions to one of the two pharmaceutical companies, which had to stop production after the drug was removed from the Schedule X list, to start manufacturing the drug again.
Chemists said the drug is in short supply at most of the 6,000 pharmacy stores in the city. A chemist near Sir JJ Hospital said the shortage began last month and availability has been a problem for 10-15 days. “A major issue was the liquid and one of the brands of Oseltamivir, which is scarcely available. Initially we didn’t know we could stock medicines because we don’t have the licence to stock schedule X drugs,” said the pharmacist.
Prasad Danve, a Dahisar-based chemist, said they were aware about the changes in the drug’s status, but the problem was from the manufacturer’s side. “We all were told we can stock the medicines but it’s not available in the market. The problem has persisted since last month and we have informed the manufacturers,” said Danve.
Officials from the state health department said DCGI Delhi has not issued a Non Objection Certificate (NOC) to the Goa-based manufacturers of Oseltamivir syrup (for children diagnosed with H1N1) and pills (for adults). “The notification that said Oseltamivir has been removed from the schedule X list, added that manufacturers need to take a NOC from the government. The pharmaceutical companies that already had the permission to manufacture the drugs had to apply again and that application has been gathering dust in Delhi,” said an official.
Food and Drugs Administration (FDA), Maharashtra, is a state body that implements the norms laid down by DCGI for standard and quality of manufacturing, selling, import and distribution of drugs in the state.Sources said since the manufacturing unit is in Goa, it does not fall under the ambit of the (FDA) Maharashtra, and the issue has to be communicated through Drug Controller Goa.
Pallavi Darade, FDA commissioner, Maharashtra, said they have written to the FDA, Goa, which has the authority to avail necessary permissions from the DCGI. “As it doesn’t fall under our jurisdiction, as a colleague officer we have requested our counterparts in Goa to grant permission. There is nothing FDA Maharashtra can directly do in the matter,” said Darade.
Vinita Thomas, joint commissioner (Drugs), FDA, said. “Non-availability of the syrup which is used for children was serious so we asked Noble Medicines and Wellness Medicines to stock Oseltamivir immediately. It’s not an attempt to promote a certain chain of pharmacies, but since the two are largest retail chemist chains in Mumbai it’s easier to make the stock available through them. Apart from that, all the chemists attached to government and private hospitals are asked to ensure that the drugs are available,” said Thomas.