British multinational Glaxo has registered lamivudine (also known as 3-TC), with the Drugs Controller General of India (DCGI) but says that it plans to start stocking the product for local sale before the year end.

Cipla director Amar Lulla told The Financial Express that the drug branded Lamivir (150mg) is priced at Rs 50 per tablet, against the international prices ranging between Rs 120 and Rs 250 per tablet. The company has also exported 30 kilograms of the drug to certain overseas markets at approximately $8,000 per kg.

"We have already exported roughly 30 kg of lamivudine to South America and another 25 kg is expected to leave the Indian shores shortly.Lamivudine is the third anti-Aids drug after zidovudine and stavudine manufactured from the basic stage by Cipla," Lulla added.

The bulk drug for Lamivir is made at the company's Kurkumbh facility near Pune while the formulation is done at the Mumbai Central unit in Mumbai.

Lamivudine is a synthetic antiretroviral agent and acts by interfering with reverse transcriptase, an enzyme needed by the human immunodeficiency virus (HIV) to multiply. A major worrying feature of the HIV virus is its ability to mutate, thus rapidly developing resistance against single doses.

Lamivudine is, hence, vital to the combination therapy approach now widely used to combat HIV and is a preferred component due to its synergistic effect and better efficacy and safety profile. Trials have shown that the addition of lamivudine to zidovudine containing regimens significantly slowed the progression of the HIV disease and improved survival. India is estimated to have an HIV-infected population of around four million.

Meanwhile,even as analysts estimate the Indian lamivudine market to be worth roughly Rs 100 crore, Lulla is confident of accounting for the `chunk' of the market given Lamivir's reasonable pricing strategy.

Analysts said, "Given Cipla's agressive pricing strategy and process improvement expertise, Glaxo's lamivudine will surely feel the heat. Moreover, the Indian company's 55 kg export order will vouch for the international acceptability of Cipla's product."

Significantly, Glaxo's lamivudine is also undergoing clinical trials at present in several countries for the treatment of hepatitis B, although it had not yet been registered for that use in western nations. Only after these trials will the DCGI entertain an application for registering the indication in India. Several doctors in the country have, however, on their own, after reading medical reports of the efficacy of lamivudine, tried using it for the treatment in hepatitis B virus infection.