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Amit Mitra

Pharma industry analysts say that the present trend reflects global CRO majors joining forces with the Indian CROs for undertaking a range of clinical trials.

Mumbai , Oct. 17

THE fact that India has a huge population, especially in the rural areas, that has had no access to modern medical services may be spreading ripples of concern amongst the country's medical fraternity, as it mirrors the poor penetration of drugs in India. But for global pharma majors, this represents a potential market for clinical trials of a wide range of untested drugs.

The reason - certain protocols for clinical trials require certain drugs to be tested on such `uncontaminated' patients, or people who have not been subjected to any drugs.

This, coupled with the existence of a spreading pool of patients with urban lifestyle diseases and tropical diseases, who can be roped in relatively easily for clinical trials and the lower costs involved, is increasingly attracting global clinical research organisations (CROs) to India.

Statistics compiled by the Organisation of Pharmaceutical Producers of India (OPPI) indicate that the clinical trial sector in India has burgeoned into a $70 million market, which is growing at a brisk pace.

Pharma industry analysts say that the present trend reflects global CRO majors joining forces with the Indian CROs for undertaking a range of clinical trials.

The recent alliance between SIRO, a domestic player, and global CRO major, Covance, may well accelerate the trend in the coming months, as MNCs are increasingly turning to India for clinical trials.

Market sources say that some of the Indian CROs, especially Lotus Labs, are looking out for such alliances with global majors for undertaking clinical trials in India.

Says Mr Alok Gupta, Director-Head of Rabo India's Life Sciences and Biotechnology division: "I foresee a few more such alliances in the coming months. Indian CROs have conducted clinical trials for big MNCs and the products are in the process of being registered in Europe and US. Already MNCs like Novartis, Pfizer, Eli-Lilly have established data management and statistical data analysis centres in India."

What makes India actually a potential laboratory for clinical trials? Firstly, India has a direct cost advantage in the realm of contract research and clinical trials.

For example, a study by Rabo India recently has pointed out that the cost of trials in India is 50 per cent lower than the $20 million required in the US for the phase I study and 60 per cent lower than the $50 million required for the phase II study. Also, India has a lower cost of hiring investigators, nurses, computer operators and recruiting patients.

Further, industry experts indicate that cost of patient recruitment in the US could range from $4,000 to $10,000 per patient while in India these costs are estimated to be lower by 50 per cent.

Secondly, India's advantage lies in the huge population of `uncontaminated' or naïve patients, who are required for testing of certain drugs.

This is because of the low penetration of drugs in India, which is reflected by the fact that India has one of the lowest per capita expenditure on drugs. Recent studies have shown that India's per capita spend on drugs is at a measly level of $3, compared with $97 in UK and $412 in Japan.

Another advantage India has is its biodiversity of population, involving a wide and varied gene pool that can provide a wealth of information for target identification. Said Mr Gupta: "It has been calculated that all of the currently known drugs act against only 500 different molecular targets in the body. It has however been estimated that between 5,000 and 10,000 targets actually exist. I think that genomics will play a greater role in increasing the identification of newer targets."

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