The Delhi High Court’s verdict allowing Cipla Ltd to manufacture and sell the generic version of Hoffman-La Roche’s lung cancer drug, Tarceva, is a shot in the arm for Indian generic drug makers. In a ruling on Wednesday, the court stated that the “huge difference in prices of the two products” made the generic version much more affordable to people. This is great news for tens of thousands in India who are diagnosed with cancer of the lungs and bronchitis each year. For the generic drug costs a third of the price charged by Roche. The Swiss drug major received a patent for Tarceva in India last year, but subsequently faced stiff opposition from Cipla and other companies that are keen on marketing the desi version of the tablet.
The frequency of such courtroom battles between domestic drug makers and big pharma MNCs will only increase as India’s generic drug industry grows at a fast clip. With foreign drug companies ever so eager to set up shop here and protect their patent rights, judicial decisions like this are probably the only hope for domestic drug makers with their limited resources. Although technically, the Swiss company can still appeal to the Supreme Court, the issue is much larger than that of being merely a question of legal interpretation, given the enormous stakes involved for India. Any drug, once patented, can push the cost of medical treatment out of control for many patients suffering from diseases like cancer. This strengthens the case of domestic pharma companies that clamour for a more liberal interpretation of the Indian patent laws. These companies are at the forefront of India’s science-based industries and have unmistakable potential in the complex field of drug manufacture and technology. Small wonder almost every type of medicine is now made indigenously — from simple headache pills to sophisticated antibiotics and complex cardiac compounds.
The opportunities for drug discovery in India are tremendous, given the low cost of clinical development — unlike the rising R&D budgets in developed countries. The Achilles heel of Indian pharma, however, is obviously R&D, which invariably gets relegated to the back seat. We can no longer afford to let dismally low levels of investment in R&D keep Indian companies from becoming serious players in the global market.