The Central Drug Research Institute, Lucknow has decided to seek the marketing nod from the Drug Controller General of India for a unique male contraceptive, Concept Cream. CDRI, the inventor of the product, has successfully trailed the product on humans with the Phase 3 having been just concluded, according to senior scientist Zaka Imam. The results of the trials are being complied for submission to the DCGI. The application for marketing approval will be filed within two weeks.
CDRI has also concluded the phase 2 human trials on the hepato-protective Picrolive, a plant-driven drug. The application for the commencement of the phase 3 would be filed shortly.
The institute is currently holding talks with leading drug companies to evaluate the option of licensing the two drugs to them. CDRI is keen on giving thrust on collaborative drug development with the private sector as well as on licensing the clinically trailed compounds and other leads to drug industry for their further development.
He however did not divulge the names of the companies the CDRI is talking to, regarding Picrolive and the contraceptive product.
CDRI-developed plant driven drug for multi-drug resistant P.falciparum malaria is now being manufactured by Mumbai Themis Chemicals. The drug is supplied in bulk to hospitals and nursing homes and not retailed. Nicholas Piramal has recently launched another breakthrough anti-malarial (AT-53 for P-vivax) from its collaborative pact with CDRI. Branded Aablaquin, this synthetic product to treat relapse malaria is reckoned as a money-spinner for NPIL.
CDRI's focus on inventing anti-malarials might yield more results in the future, sources said. Another lead molecule for MDR malaria is in the pipeline, though it has not reached the human trials sage of development. The CSIR laboratory is also working on diabetes segment with a collaborative project with Danish major NovoNordisk.