ABU DHABI // A pharmaceutical firm in the UAE has been given the go-ahead to produce a generic version of Tamiflu, the antiviral drug used to treat swine flu. The Ministry of Health announced that it had agreed to let a local drug company manufacture the tablets after a meeting of the higher committee for registration and drug pricing.
Although the ministry declined to name the company, Dr Bavaguthu Raghuram Shetty, managing director and chief executive of the NMC Group, confirmed it was NMC's Neopharma plant in Abu Dhabi. He said it had the capacity to produce 20 million capsules of Oseltamivir BR Flu a month and had enough materials to do so for the next six months. Oseltamivir is the active ingredient in Tamiflu, which fights the H1N1 A type virus that causes swine flu.
"We are very pleased to be making the medicine for swine flu," Dr Shetty said. "It is very good for the UAE market. We were given the licence last week and are already ready. This is something we really wanted to do, so we are pleased that the Ministry of Health have allowed us to start helping in this epidemic." He said that as a "leading manufacturer of life-saving drugs" it was the company's responsibility to help during this critical time.
In a statement released yesterday, he said: "We are confident the approval for Oseltamivir will significantly facilitate medical professionals and the wider community to effectively tackle the lethal H1N1 virus in the region." Neopharma, which was set up in 2003, supplies drugs to 22 nations, mostly in the Middle East and North Africa. Dr Shetty said the plant had been given the licence to produce Tamiflu by a firm in India ? Hetero Drugs ? which has strong links with Roche, holder of the Tamiflu patent, after the plant was inspected. The firm will import all the raw materials from the Indian company then produce the capsules and powder here.
"We have already received orders for the medicine from Oman, Bahrain, Saudi Arabia, Yemen and a few other countries in the region," Dr Shetty said. "We were inspected and they were impressed with the factory; it is something we are very proud of. This shows how important local manufacturing is." He said manufacturing had already begun. No details of the cost were available. Throughout the H1N1 epidemic the Ministry of Health has maintained that the country has sufficient supplies of Tamiflu. However, along with the Health Authority- Abu Dhabi and the Dubai Health Authority, it has always declined to release stock figures. Most of the stocks were left over from the avian flu scare in 2006.
"This provides a way for us to supply the demand in the UAE and the region," Dr Shetty said. Khaled Hamza, operations manager of the Dubai pharmaceutical distributor Medysinal, said: "If they are able to produce a drug with the same efficacy, at a smaller cost and in sufficient qualities, then it is a good step." This year local pharmaceutical companies and distributors, including Neopharma, called for more government stimulus and support to help boost the UAE industry.
They warned that because around 90 per cent of the pharmaceutical industry - including medications - relied on imports, there was a risk that in serious epidemics the UAE would not be well stocked. Prices were higher than they needed to be, they maintained. In times of peak demand, such as during pandemics or epidemics, they said, manufacturers were likely to target bigger markets and less likely to offer discounts to smaller countries like the UAE.
The World Health Organisation's 2008 annual statistical report, published this year, indicated that people in the UAE were paying up to 23.52 times an international guide price for branded drugs because of a heavy reliance on imports. When drugs are imported it is the Ministry of Health that decides import costs and sets the percentage by which drug distributors and pharmacies can mark up prices. With a population of only four million, the UAE has comparatively little bargaining power when negotiating import prices with international drug companies.
In a statement released by the ministry on the decision to allow local manufacturing of Oseltamivir, Dr Amin al Amiri, the executive director of medical practices and licensing, said it had been taken after the ministry examined the company's bid and ensured the proposed medicine was compliant with international standards. "The company has been granted approval to make tablets similar to Tamiflu with a 75mg concentration as well as produce a duplicate of Tamiflu powder for children with a 15mg concentration," Dr al Amiri said.
He added that the UAE was one of the first countries to be granted approval by the "mother company" that owns the patent and intellectual property rights to manufacture this pharmaceutical category. The committee for registration and drug pricing, which includes members of the HAAD and the DHA, warned the public not to stock up on certain medicines out of fear they would run out. There was no reason to panic, it said.
The vaccine for the H1N1 swine flu virus is expected to be ready by the end of this year. The WHO released an update last week saying that initial estimations of worldwide production capacity had been higher than is now expected. The current yearly estimate is three billion doses per year. A WHO statement said: "These supplies will still be inadequate to cover a world population of 6.8 billion people in which virtually everyone is susceptible to infection by a new and readily contagious virus. Global manufacturing capacity for influenza vaccines is limited, inadequate and not readily augmented."
@Email:email@example.com * With additional reporting by Vesela Todorova