Cipla’s generic oseltamivir pill in WHO list

Indian generic maker Cipla Ltd’s  version of Roche’s oseltamivir (Tamiflu) has been included in WHO’s prequalification list.

Clpla said its oseltamivir pills with a strength 75 mg has shown to be effective against the H1N1 flu virus, had been included in the World Health Organisation’s list of pre-qualified medicinal products.

Oseltamivir one of only two approved drugs to which the H1N1 strain of influenza has been found to be susceptible. The other being GlaxoSmithKline’s Relenza (zanamivir).

WHO’s Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. WHO achieves this through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

WHO’s strategy for pre-qualified drugs includes: applying unified standards of acceptable quality, safety and efficacy; evaluating the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites; prequalifying quality control laboratories of pharmaceuticals and build the capacity of staff from national regulatory authorities, quality control laboratories, and from manufacturers or other private companies, to ensure medicines quality.

WHO’s list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health produced by the Programme is used principally by United Nations agencies — including UNAIDS and UNICEF — to guide their procurement decisions.

WHO’s prequalified medicines list has become a vital tool for any agency or organization involved in bulk purchasing of medicines, be this at country level, or at international level, as demonstrated by the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Inclusion of Cipla’s generic oseltamivir in WHO’s prequalification list of medicines is likely to boost the sale of the drug at a time when countries across the world are increasingly stockpiling Tamiflu pills.

Originated in Mexico, Swine flu has infected 5,251 people in 30 countries so far, killing 61, according to WHO data.

Oseltamivir is being stockpiled in India as well. India is planning to reserve nearly 10 million doses of oseltamivir as a precaution against a possible outbreak of swine flu in the country. 

Recently, Cipla Ltd announced that it has the capacity to supply upto 1.5 million doses generic oseltamivir (Tamiflu) drug.

India’s Cipla is one of very few companies in the world which has achieved capabilities for producing oseltamivir, the generic version of Gilead’s patented drug Tamiflu.

Cipla has already received proposals from people on behalf of countries in Latin America, Mexico and Israel. However, no approach had yet been made by either the World Health Organisation (WHO) or the Indian government, he added.

Indian Patent Office denied Gilead Science Inc. patent rights for its anti-influenza drug oseltamivir phosphate marketed as Tamiflu, in India, last month.

Cipla had earlier opposed granting of patents rights to Gilead’s Tamiflu did not have inventive step – a pre-requisite for products to gain patents in India.

Cipla had received marketing approval from the drug controller-general of India in January 2006.

Patent laws allow governments to authorise supply from generic companies, subject to remuneration to patent owners to address public health problems, including emergencies.

Cipla’s version of oseltamivir is priced at about Rs 1,000 ($ 20) per strip of ten 75 mg tablets. It is  less than half the current Tamiflu market price of $60.

Now Cipla claims that it can legally sell oseltamivir to India and 49 other developing countries.

However, Cipla is yet to be contacted by the Indian health ministry for procuring the drug for India’s stock pile.