Apothecaries' Brijesh Regal (centre) with co-promoters C.P. Popli (left) Madhulika Kaushal: Clinical research apart, the firm has made tentative strides into an emerging area---training

Vidur Kaushik, the 49-year-old chief Executive Officer of SRL Ranbaxy, was not quite expecting a standing ovation when he went on a routine client visit to one of the largest drug companies in the US last year along with his colleague Dr. Sumedha Sahni, Director (Operations and Clinical Trials). But that is what the surprised duo got for supporting trials of a new drug out of India that saved the multinational three years in time and millions of dollars in costs. But Kaushik does not have time to fill in the details of the story because he is just about to leave for what promises to be an interesting trip to Britain. Barely managing to hide his excitement, he says in a hushed tone: "We have been approached by some international companies for providing diagnostic services in India."

That's not just a first for an Indian network of labs, but also proof of the world pharma industry waking up to an entirely new potential of India: As a huge market for testing of new generation drugs, or clinical trials in the industry parlance. What happened to all the concerns about India being a logistics and bureaucratic nightmare? Well, the concerns have been wiped away by the sheer beauty of economics. Consider this: In the world pharma industry, it takes about $900 million (Rs 4,140 crore) and 10-15 years to get a new drug to market. About two-thirds of this amount, or about Rs 2,700 crore, is spent on testing the drug to prove its efficacy and safety through an elaborate process of clinical trials (See Clinical Trials For Dummies). Bring the test drug to India and, voila!, a company can halve the cost and time. "The USP for the country is world-class services at Indian prices," says Kaushik.

Small wonder then, a bevy of drug giants including Pfizer, Aventis, Glaxosmithkline, Novartis, and Eli Lilly is making a beeline to India. While specific numbers are hard to come by, almost everybody agrees that the number of trials in India is increasing with each year. Currently, there are 80 trial sites across the country, and more than one trial could be happening at each of these sites. "The most exciting thing going for India is the large pool of patients who have never used any drug (referred to as treatment-naïve in medicalese)," says Brijesh Regal, Managing Director of Apothecaries Ltd, a contract research organisation (CRO).

WHY INDIA? A host of reasons makes Inida an attractive market for clinical trials.

ECONOMY Clinical trials in India cost half or a third of a developed country's and take as little time to complete SUPPLY India has a large population that has not received any medication or, in industry lingo, is treatment naïve SKILLS India has a large pool of qualified, but inexpensive technicians required to carry out clinical trials REGULATION Norms are to be eased, besides which product patent starting 2005 ensures greater security of data TECHNOLOGY An increasing role of software in clinical trials further helps strengthen the India advantage

Regal's firm operates in both the main facets of contract research: a data intensive and logistics part (patient recruitment, data capture, data organisation and its submission to the regulatory authorities) and one that focuses on chemical analysis (of the kind provided by SRL Ranbaxy). The company has made tentative strides into a third emerging area: training. Doctors, nurses, research managers, and medical writers associated with clinical trials need to be trained in good clinical practices (GCP) to meet the norms required by the international drug regulators.

In fact, the mantra for success in the business is a high-flying GCP flag. Since the clinical trial data needs to be submitted to drug authorities in Europe and the US (the US Food and Drug Administration, for example), there are impromptu audits by their representatives and also by the companies that have outsourced the trials. SRL Ranbaxy, for example, is certified by the College of American Pathologists, the Indian government's National Accreditation Board for Testing and Calibration Laboratories and has been audited by clinical study sponsors like Pfizer, Smithkline Beecham, and Eli Lilly. It is expecting a direct audit from the US FDA soon.

A Game Of Precision

While the typical investment required to set up a full-fledged CRO is not too high at $2-2.5 million, or Rs 9.2-11.5 crore, (Ernst & Young estimates), a clinical trial is a game of precision and the cost of one blip in administering the drug or documenting the impact can be very severe. In fact, it could nullify the entire trial. "It is not a back office function. It is state of the art. There cannot be any differences in clinical trial done at Detroit or Delhi. Both are similar in nature, complexity or position in the value chain," emphasises the president of Neeman Medical International, Dr. Vijai Kumar. A division of Max India set up in technical collaboration with Harvard Medical International, Neeman has seen a five-fold jump in patient trials over the last two years. It is currently managing clinical trials at over 30 medical institutions around the country for multinational pharmaceutical companies in the fields of ophthalmology, infectious diseases, and gastroenterology.

The upside for the country is that there are enough patients here for diseases that are top of the concern list in the developed countries like HIV/AIDS and cancer. India is home to 25 million diabetic (type II) patients, which is 20 per cent of the world's diabetic population. The pediatric population is over 15 million. Says Rabo India in its latest research on the Indian pharmaceutical industry: "We believe cost savings arising due to faster patient accrual will be a bigger factor than lower operating costs."

Pfizer, the world's biggest drug company, is currently involved in about 20 studies in India and has an in-house team of more than 100 clinical research professionals. "We believe that this number reflects the current potential that India has in clinical R&D," says Shekhar Potkar, Director (Clinical Research) at Pfizer India.

Pfizer alone spends a staggering $7 billion (Rs 32,200 crore) on R&D, and of that 70 per cent is spent on clinical trials. The number of studies is expected to spike sharply over the next one to two years-product patent comes into force in 2005-as enablers such as IPR and data protection, training and accreditation of investigators and labs and upgradation of hospital infrastructure kick in.

The estimates of the addressable opportunity globally for India vary from $10 billion (Rs 46,000 crore) to multiples of that. "It is widely believed that by 2008 India can annually capture about $1 billion of the global contract research opportunity," says Utkarsh M. Palnitkar, Partner and head of the life sciences practice at Ernst & Young. Indeed. Of the eight million patients involved with 80,000 clinical trials conducted world over last year, less than a thousand are estimated to be from India.

CROs that have set up shop in the country include the world's largest, the $2-billion Quintiles, which has ramped up to 450 employees since it ventured into the country six years ago. It plans to expand substantially over the next 24 months. "There is a rather ambitious plan in place," says President of Quintiles Narges Mahaluxmivala. It has about 20 clinical trials active as on date.

Another large international player, Covance, tied up with India's siro Clinpharm earlier this year. Clingene (part of Biocon group), Wellquest, Lambda, Lotus Labs, Synchron...the list is expanding. Today clinical trials in India are on for cancer, diabetes, Parkinson's, cardiac ailments, vaccines, anti-infectives, psychiatric problems, and a host of other therapeutic areas.

To make India better prepared for the outsourcing run, the government is slated to allow easing of the norms for clinical trials. Go ahead. Give it a try. You have nothing to lose but your ailment.