3 agencies to develop drugs based on ancient texts

Three Indian science research agencies have joined hands to develop drugs on the basis of ancient Indian knowledge with the underlying objective of making such medicines acceptable to doctors.

At the moment, the practitioners of modern medicine don't prescribe these drugs because they don't come through the rigorous, scientific drug development process— a reality that may change with the new linkage between CSIR, ICMR and the Department of Biotechnology (DBT).

On the table are seven drug candidates— four from the Council of Scientific and Industrial Research (CSIR), two from Indian Council of Medical Research (ICMR) and one from a DBT-funded institute in Imphal— which would be evaluated though the standard drug development route of pre-clinical and clinical trials.

These molecules have shown promise in laboratory studies on pain management, paediatric epilepsy, rheumatoid arthritis, gastric ulcer, neurodegenerative brain diseases, diabetes and cognitive dysfunction.

The source plants range from cannabis to brahmi and ashwgandha.

“The CSIR will come out with the R&D breakthrough and do the pre-clinical studies, while DBT will fund part of the research as well as to prepare the Investigational New Drug dossier that needs to be presented to the Drugs Controller General of India (DCGI). ICMR will fund and conduct the clinical trials,” Ram Vishwarka, who heads CSIR's Indian Institute of Integrative Medicine, Jammu, told DH.

Four out of the seven leads to be taken up under this programme came from the CSIR's Jammu institute.

The new association comes three years after DCGI recognised phyto-pharmaceuticals as a new class of drugs besides chemical entities and biologicals.

They are plant-based medicines which will be approved by the DCGI after scientific studies and clinical trials unlike the herbal drugs that are approved by the AYUSH regulators on the basis of a very limited evaluation procedure.

The United States Food and Drug Administration approved phyto-pharmaceuticals as a new class of drugs in 2005 and three new molecule in the last 13 years.

So far, DCGI has not approved any such medicine for the Indian market.

While CSIR had launched the phyto-pharmaceutical mission about a year back, the agreement between the three agencies was signed on Monday.

“This approach, being tried in the country for the first time, would lead to taking up of the identified activities in the mission mode through best of the institutions,” CSIR said in a press statement.