New Delhi: India has decided to allow restricted retail sale of the antiviral drug Oseltamivir—Roche’s Tamiflu and its generic versions—from the second week of September even as the country braces for a fresh wave of swine flu or H1N1 infections with the onset of winter.
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The rapid spread of the disease, which has thus far resulted in 88 deaths in India, has created panic in the country and increased sales of antiviral Oseltamivir, controlled by the government, in the unauthorized or so-called black market.
On Wednesday, health minister Ghulam Nabi Azad approved stringent guidelines for the retail sale of the drug and the government readied a gazette notification—required for any government order before it can be implemented. The government buys the drug at around Rs270 for 10 tablets from Hetero Drugs Ltd. Black market rates soared as high as Rs4,000 for 10 tablets at the height of the panic last fortnight. Hetero is expected to retail its offering at Rs450 for 10 tablets.
The government’s move will allow people to buy Oseltamivir from designated chemists and other distribution channels if they have a prescription. Until now, Oseltamivir was made available only through government channels and its retail sale was banned.
Zanamivir, the second drug recommended by the World Health Organization, which is inhaled, is being sold in the market by Cipla Ltd under the brand name Virenza. The original drug, Relenza, is made by GlaxoSmithKline Plc. (GSK). The government now plans to curb its retail sale also.
The Centre already has a stockpile of 20 million tablets of Oseltamivir and is waiting to get an additional 10 million. The retail sales will begin once it procures the additional stock. “So, the retail sale of Oseltamivir should be notified and started around 7-8 September,” a senior government official involved in the process said, speaking on condition of anonymity.
However, the government, which has been worried over allowing retail sale of the drug out of fear that this will encourage hoarding or, worse still, unprescribed use resulting in development of drug resistance, has drafted and approved strict guidelines for its sale.
It has invoked, for the first time, a new rule under the Drugs and Cosmetics (Amendment) Act, 2008, which gives the Union government overriding powers to “regulate or restrict the manufacture, sale or distribution of a drug if it is essential to meet the requirements of an emergency arising due to epidemic or natural calamities”.
Citing this rule, the Union government is withdrawing powers from state drug licensing authorities to issue manufacturing licenses for both drugs—Oseltamivir and Zanamivir. The licence will be issued only by the Drugs Controller General of India.
The official said that both drugs will be labelled under Schedule X.
“Under Schedule X, the patient will have to produce two prescriptions issued by the same doctor at the time of purchase. The chemist will have to keep one copy of the prescription for two years,” said the official. The doctor, too, will have to clearly provide all his contact details on the prescription.
This will bring both the chemist and the doctor under the scanner.
Underlining its cautionary approach, the government has an additional rider, which says that distributors and chemists must have a separate licence to distribute or sell Schedule X drugs. In India, only 60 distributors and about 300 chemists have this licence that allows them to sell drugs falling under Schedule X.
The official added that under the government’s guidelines for sale, the manufacturer, the stockist and the dealer will also have to submit a monthly statement of record of sale and remaining quantity of Oseltamivir and Zanamivir.
C.M. Gulhati, editor of Monthly Index of Medical Specialities, said this is a good move by the government since under Schedule X, the details of doctors and chemists will be with the government and can be traced back.
“This is the only solution because if, on the one side you allow private laboratories to test samples (for swine flu), then you have to allow private sale also. Also, people will be very careful in selling this drug since Schedule X is basically for narcotics and so prosecution comes under the narcotics commissioner,” he said.
Meanwhile, large manufacturers such as Hetero, Cipla and Strides Acrolab Ltd are prepared for the retail launch of their versions of the drug and have already labelled batches as Schedule X.
Cipla’s joint managing director Amar Lulla said that the company has stock labelled Schedule X for retail sale and termed the government’s move to make the drug available in a controlled manner “good”.
Hyderabad-based Hetero has five million tablets labelled Schedule X and ready for distribution, confirmed Srinivas Reddy, director (marketing) at the company. The company has a capacity of making 100 million tablets per month.
“With Schedule X drugs, we are accountable for what we do. So, based on how much (stock) can be made available at one time, keeping in mind the accountability, we will distribute the drug to the stockists. We do not want hoarding,” he added.
Meanwhile, GSK is talking to the government to launch Relenza (Zanamivir) in India and already has marketing approval for it, according to Hasit B. Joshipura, managing director of GlaxoSmithKline Pharmaceuticals Ltd.
According to the government official, Zanamivir will be advised for use only in cases where there is resistance to Oseltamivir.