Ranbaxy SP Medicamentos, Brazil, a 55 per cent subsidiary of Ranbaxy Laboratories Ltd, has received approval of the Brazilian regulatory authority, ANVS, for its anti-AIDS drug, Lamivudine.
This is the first bio-equivalent generic approval in Brazil in the anti-AIDS segment.
According to Ranbaxy sources, this could result in an annual income of $20 million for the company.
The product is slated for launch in September, in time to bid for the government tender for the anti-AIDS drug. If the company gets an order, supplies would begin early next year.
The Brazilian government is targeting to distribute 22 million Lamivudine dosages to the HIV-infected patients in the country.
According to sources, the ministry of health in the Brazilian government purchases some $500 million worth of drugs every year for free distribution in the country, almost 70 per cent of which goes for anti-AIDS drugs.
The original product Epivir is from Glaxo SmithKline. Ranbaxy executives expect its drug to be almost 40 per cent cheaper than Epivir. Epivir too is a part of the cocktail of medicines distributed free by the ministry of health.
Lamivudine is a synthetic nucleoside with activity against HIV 1. It is commonly prescribed as a part of high active anti-rectroviral regimen in combination with other anti-rectrovirals.
Ranbaxy SP medicamentos began operations in November 2000, and is present in the branded as well as generic segments.
In spite of its operations kicking off late in the year, the company clocked a turnover of $1.9 million during financial year 2000 and a profit after tax of $0.2 million.
This is only the second time that an Indian company has come out with a cheap anti-AIDS drug. Cipla shocked global drug majors in February by offering an AIDS triple drug cocktail for less than a dollar a day to international charities.
Indian law allows only for the patenting of processes by which drugs are made, not the drugs themselves.
That allows companies to copy drugs under patent in the west by using a process that differs from the original.
This approach means Indian drugmakers spend little on research, reducing the costs significantly. Also, their manpower and production costs are very low, allowing them to supply drugs more cheaply.
