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 Reddys (with Novo Nordisk) and Ranbaxy (talks are on with MNCs
for licensing of Pravosin, its research molecule indicated for benign prostatic
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 Daburs products in European countries and
the US. The company is planning similar ventures in Russia and African countries.