Dabur India Ltd has approval from the Drug Controller General of India for conducting phase 1 clinical trials in India involving its maiden research molecule. Synthesised from natural sources, the anti-cancer molecule has been developed by the Dabur Research Foundation.

The molecule has cleared the pre-clinical trials stage, in which it successfully underwent efficacy and toxicity tests on animals. Dabur intends to carry out all three phases of clinical trials in India for its anti-cancer molecule. However, the company is tight-lipped about when it would actually start phase 1 studies, and on the duration of the trial.

The successful completion of the initial phase is likely to be followed by a licensing deal involving a foreign partner for further development and marketing, as is the case with a number of emerging research-based Indian companies such as Dr Reddy’s (with Novo Nordisk) and Ranbaxy (talks are on with MNCs for licensing of Pravosin, its research molecule indicated for benign prostatic hyperplasia).

The increasing acceptance of data originating from clinical trials conducted in India by international regulatory agencies is proving beneficial to Indian companies. Indian companies can now conduct phase 1 and phase 2 trials in India at a significantly lower cost and license the molecule only for phase 3 trials. This would fetch them more milestone payments, as the risks are considerably lower for a foreign company undertaking a multi-centric phase 3 trial, says a market consultant based in Mumbai.

Dabur has identified oncology, or anti-cancer, as a key area of operations, following advice from McKinsey & Co on the group''s restructuring. Oncology is a core business for the company, contributing 25 per cent of its total pharmaceutical sales of Rs 72 crore. The company markets 15 anti-cancer products in India.

With a view to expanding its oncology business, Dabur is setting up a subsidiary in the UK – Axol Laboratories – for manufacturing and marketing of Dabur’s products in European countries and the US. The company is planning similar ventures in Russia and African countries.