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04-27-2012, 08:23 AM #1
Ranbaxy launches homegrown malaria drug
Ranbaxy has launched an anti-malarial drug billed by CEO Arun Sawhney as "India's first new chemical entity developed through clinical trials and commercialization in India".
Synriam, priced at Rs. 130 for three tablets, is a three-day course. The three-tablet module sets it apart from alternative therapies which require a 2-4 tablet dosage per day.
Addressing the issue of price compared to competitors in the same category, Sawhney said that the drug is "the most economic therapy for malaria from the available options...there are some drugs that are priced at Rs.250 so compared to that this will be half of that."
This new drug, partially financed by the Department of Science and Technology of the Government of India, has been approved for marketing by the Drug Controller General of India (DGCI). According to the press release, it "conforms to the recommendations of the World Health Organization (WHO)".
An estimated $30 million was invested in the research and development of this drug and so far the DST has put Rs. 5 crore into the project.
"We have so far developed this drug only for India...there are several clinical trials going on in countries in Africa once those trials are completed we'll go in for registration in those countries as well," said Sawhney.
The drug is for treatment of uncomplicated Plasmodium falciparum (in adults), which accounts for 50 per cent of malaria cases in India.
"This is not so much a revenue drug as it is a CSR drug. It might take years for Ranbaxy to recover the cost of producing this drug," said Sawhney.
Malvinder Mohan Singh, group executive chairman, Fortis Healthcare, who was at the helm at Ranbaxy when this drug was being developed, told BT last year, "It is absolutely fantastic. It is a new cure for malaria and is going to be the first NCE [new chemical entity] out of India that is actually developed and worked upon by an Indian company."
As BT reported in a story late last year, Ranbaxy didn't initiate work on the drug, but its achievement in developing it and bringing it to market is certainly a landmark. Typically, around 80 per cent of new drugs may be brought to market by the big global majors but only 35 per cent of such drugs have been developed by them from the earliest stage.
Ranbaxy acquired the molecule that would become Synriam from global pharma major Roche under a project called the Medicines for Malaria Venture.
According to Ranbaxy, "India accounts for over 75 per cent of the 2.5 million reported cases of malaria in South East Asia. More than two-thirds of the Indian population live in malaria-affected parts of the country.''
According to the World Health Organisation (WHO), 15,000 people die annually due to malaria in India. The Lancet, one of the world's leading medical journals, points out that 205,000 people die of malaria annually in India. In India around 117 districts are resistant to Chloroquine, a common treatment. SynriamTM has been shown to be effective in these geographical regions also.
Over the past ten years, India, Indonesia and Myanmar contributed more than 90 per cent of the reported malaria cases and deaths in the South East Asia Region, according to WHO.
The Minister of Health and Family Welfare, Ghulam Nabi Azad, and the Minister of Science and Technology and Earth Sciences, Vilasrao Deshmukh, were present at the Synriam launch function.
The health minister expressed his hope that the drug major would keep the drug at an affordable price and also stressed the importance of state government involvement in the development process in this industry.