Indus Biotech is awaiting clearance from the Drugs Controller General of India for its H1N1 drug that is ready for clinical trials. The company has submitted IND (Investigational New Drug) dossiers in September.

“The dossier is under review and we are hopeful it should be approved at the earliest. We are looking at multi-centric human studies spanning for two weeks. The outcome of the trial is crucial as it will also be considered to treat malaria, dengue and Japanese Encephalitis as these are also RNA driven viruses like H1N1,” Rajan Srinivasan, executive director, Indus Biotech Private Limited said at a press conclave.

The drug which is from a botanical source. The company has capitalized on the plant bio diversity of India. However the biggest challenge in the country is the lack of regulations in botanical drugs. Currently, it is only US FDA which has released a set of guidelines in 2004 for this segment, he added.

“The research has proved that the drug can handle the strains that are sensitive and resistant to Tamiflu drug which is currently the only therapy being administered to control the condition. The company has also carried out studies in a Bio-safety III P3 containment facility at Taiwan. This H1N1 drug will come under the category of influenza A drugs going by its potency to treat a variety of flus,” said Sunil Bhaskaran, managing director, research Indus Biotech .

The company has received the IND clearance from US FDA to carry out clinical trials for its HIV drug ‘IND02’ in the US. In fact, Indus is the first company in the country to have the distinction to receive the IND approval. Since this is an expensive proposition for a nascent botanical outfit, Indus will now talk to the US regulatory authorities to seek permission for human studies to be carried out only in India. The company has already carried out human studies and the drug has demonstrated promise, stated Bhaskaran.

The year- and-half-decade-old company which is in the drug discovery space will refrain from manufacture and marketing of drugs. Once the drug safety and efficacy are proved it will enter into a dialogue with potential global and Indian pharma-biotech majors for out-licensing or out right sale of the drug candidate.

“As part of our short-term monetization strategy, we are focusing on anti infective drugs. However our expertise spans over therapies for diabetes, rheumatoid arthritis and auto immune conditions. It has a pipeline of seven new chemical entities (NCEs) in 12 therapeutic area s including CNS and oncology,” said Srinivasan.