By Killugudi Jayaraman

Bangalore, Jan 18 (IANS): The health ministry's refusal to allow the use of a highly potent mosquito control agent developed by one of its own institutes and granting permission to an imported product, has kicked up a controversy. At stake is not only a Rs.1,000 crore (approx $220 million) market, but also the eradication of diseases like malaria, dengue and chikungunya.

At the centre of the controversy is a biological agent developed by the Vector Control Research Centre (VCRC) in Pondicherry that kills the larvae of all species of mosquitoes.

It was certified to be the best by the Pasteur Institute in Paris and by no less than Mir Mulla, the renowned entomologist at the University of California in the US. Use of this agent would have contributed to the management of vector-borne diseases like malaria, dengue and chikungunya.

Four years ago, the VCRC licensed its technology for producing this agent in large scale through the National Research Development Corporation (NRDC) to eight Indian entrepreneurs, which are mainly small time business houses. Each company spent around Rs.20 lakh for the license, field trials and finally for getting the marketing licence from the Central Insecticide Board (CIB) under the health ministry.

But these companies allege that their attempts to sell the product to the central and state governments and municipalities have failed because of refusal by the Technical Advisory Committee (TAC) headed by the director general of health services (DGHS) to give its approval for one reason or another.

R.K. Srivstava, the DGHS, was neither available on phone, nor did he reply to e-mails.

The denial of permission to utilise the homegrown product has led to a single company in New Delhi monopolising the entire market for this product worth at least Rs.10 billion (over $220 million) annually, it is alleged. The company - Biotech International Ltd - is the only company approved by the TAC to market its larvicidal agent, based on a Russian technology, for mosquito control programmes throughout India.

"I am afraid this is going to be another scam," said Palakkad Krishnaiyer Rajagopalan, who was VCRC director till 1995 when his scientists developed the technology.

"I am deeply upset that a bio-friendly mosquito control agent developed by the ministry's own scientists with painstaking efforts has been dumped in favour of a foreign product," he said.

Rajagopalan said that in the 1980s, VCRC scientists isolated an indigenous strain of a bacterium called Bacillus thuringiensis israelensis (or BTI) from the soil of a village near Pondicherry. "The organism was highly lethal to a variety of mosquitoes that transmit filariasis, malaria, dengue and other diseases."

During the next two decades, he said, scientists worked on all aspects such as bio-efficacy, safety to non-target insects such as honey bees and silk worms, as also on birds and mammals.

The VCRC subsequently developed cost effective production and formulation technologies so that the product could be affordable for poor countries, Rajagopalan said.

"The agent was tested in several distant geographical areas with different geoclimatic conditions for its efficacy, and shelf life and was found to be fit for an efficient mosquito control operation in all those areas."

Further, he said, the efficacy of this agent was tested independently by National Institute of Malaria Research in New Delhi, the Centre for Research in Medical Entomology at Madurai and the Calcutta School of Tropical Medicine in Kolkata.

"This product has met all the requirements necessary for obtaining the clearance by CIB and some of the companies have already gotten permanent CIB clearance," Rajagopalan said. "In spite of this, the product is not approved by the TAC for reasons best known to the health ministry. It appears that all this is happening in order to protect the interests of one firm."

The entrepreneurs who have been struggling to get the approval for their product are restive and feel cheated.

"We have taken up the issue at the highest level and are fighting," Ravi Kumar, manager of R.K. Biotech Product Private Ltd. in Chennai - one of the licensees of the VCRC technology - told IANS. "We have invested a lot of money and are not going to leave the matter."