Firms may be curbed on flu drug production

Drug manufacturers are keeping their fingers crossed over the government’s plan to allow private sale of the swine flu drug.

Going by the way the flu is spreading and the panic it has caused, drug companies have been eyeing the opportunity of selling the medicine in the open market.

But, the way the government is contemplating to channel the drug into the market is not giving any scope for the companies to celebrate.

According to sources in the industry, the government authorities, including the central health ministry, held a meeting recently with drug manufacturers over the possibility of opening up the market and allowing private drug companies to sell the medicine in the open market.

One of the proposals for opening up the market is to include the swine flu drug (oseltamivir) in Schedule X category. Under this schedule, the regulations allow the sales of narcotics. The spirit of the schedule is to check the indiscriminate use of the drug included in this category. For this, the druggists will have to maintain a complete documentation of the sale, including the details of the buyer. It will be sold only on prescription.

“It is not easy either for the companies or for drug stores to sell the medicine under Schedule X. It is definitely a pains-taking process to comply with the requirements of the schedule,” a source said.

In addition, the government is also working on a plan to bring the drug under the National Pharma Pricing Authority (NPPA). “This automatically brings the drug under the price regulation mechanism. Though the objective of the authority is to look at the immediacy of delivering the medicine at affordable prices, the drug companies will end up making all the efforts for wafer-thin margins,” the source explained.

In addition, the government has also reportedly made it clear to drug manufacturers that the entire operation — from manufacturing to delivery of the drug to the needy — would be monitored. In fact, the entire operation is being currently operated under a controlled environment.

The government is directly sourcing the drug from the selected manufacturer - Hetero Drugs - for now. The testing of swine flu suspects too is being done by the government agencies without giving any scope for the private participants. With the drug being made available only through the government channels under strict auditing norms, the private hospitals have not been accepting any swine flu suspects.

However, with the number of suspects increasing by the day and the two government labs - the National Institute of Communicable Diseases (NICD), Delhi and the National Institute of Virology (NIV), Pune - having their hands full, the government has decided to allow private hospitals and pathology labs to handle the treatment process. This automatically extends to allowing private sales of the drug.

The government has been under pressure to open up the market to meet the demand that is likely to come up in the days to come. The WHO has cautioned that the number of infected people is likely to go up in the days to come.