Indian researchers are testing Cedrus deodara, native to the Himalayas, against 20 diseases.

India has embarked on a fast-track program to discover new drugs by building on traditional medicines and screening the country's diverse plant and microbial resources. The five-year project has already uncovered more than 40 leads, and two potential blockbuster drugs are expected to enter human trials within a year.

The unique project was prompted by the realization that after January 2005—when new intellectual property regulations come into force—Indian companies can no longer copy drugs, but must develop them on their own. Few Indian companies have the money or the resources to compete with multinational drug firms, however.

“The only way out is to use our traditional medical knowledge and biodiversity as a springboard,” says Raghunath Anant Mashelkar, director general of the Council of Scientific and Industrial Research (CSIR), and the project's chief executive. “By fusing ancient wisdom and modern science, India can create world-class products, and that is what this program is all about.”

After a two-year pilot phase, the full-fledged Drug Discovery Programme (DDP) began in 2000. Using both conventional and modern tools, researchers subject plant and microbial extracts and traditional medicines already on the market to an elaborate screening process. The project now involves 900 researchers from 20 CSIR laboratories, 12 universities and several research institutions. Each year, the researchers screen extracts of 1,000 plants, 1,500 microbial strains and 25 traditional drugs, but the capacity is to double in 2005, officials say.

The CSIR spent nearly $10 million on equipment, in vitro and animal testing facilities and modeling workstations. In the next five years, the project is expected to cost another $30 million.

“In terms of its size, diversity and access to talent and resources, [the] DDP is not only the world's largest project of its kind but [it is] also unique,” says Kondapuram Vijaya Raghavan, director of the Hyderabad-based Indian Institute of Chemical Technology, one of the participating laboratories.

Researchers are screening all products for each of 20 diseases, regardless of previously reported effects. This approach, Raghavan says, “has helped to unravel the unknown strengths of traditional drugs in terms of their multiple activities.”

In the last five years, the DDP has screened 78,000 samples and obtained 150 in vitro and in vivo 'actives'. Out of those, 44 have been identified as potential Investigational New Drugs. They include new herbal formulations with antigastric activity, a new combination of chemical entities with proven anticancer activity, an herbal preparation with memory-enhancing abilities and a number of single-molecule compounds. The project saves time and money by focusing on naturally available molecules instead of synthesizing them from scratch, Raghavan says.

Although the project is commercial in intent, there is some need for basic research, says Raghavan. Because herbal drugs are complex mixtures, “the synergy effects in herbal drugs provide one of the most outstanding challenges in designing them,” he says. “This calls for basic research to understand this phenomenon at cellular or molecular levels.”