Pharmaceutical research outsourcing is all set to grow leaps and bounds. Compliance with TRIPS and subsequent legislations have given an edge to India as a potential destination where global partners in research can tread without much fear on losing intellectual property rights.
With unparalleled skills in reverse engineering or process Chemistry, the rich pool of Indian scientific community has several cost -effective solutions to offer to the Big Pharma of the world which is reeling under ever-mounting drug research and development costs.
Traditionally, the country has been a source-point for generics, active pharmaceutical ingredients and formulations to the regulated and less regulated global markets. It has also been proved for sometime now that, India can well be a major centre for contract research, custom synthesis and clinical research. Apart from this, new drug discovery research, a domain which has been lying rather low so far, has been propelled onto the fore with increased possibilities now.
Amongst, the various research and support services that the MNCs are seeking to outsource from India, clinical research occupies the prime position. The clinical research organizations (CROs) market, which was somewhere around $35 million in the year 2003 is expected to touch $1- 1.5 billion in the next five years. Despite the predictions of drying pipelines of global majors, the market is expected to grow 50-55% in the coming year.
Several provisions of Schedule Y of the Drugs & Cosmetics Act have been amended recently, for example, to conduct of trials in a concurrent phase with those carried out in centres abroad to remove phase lag, legal support to GCP, definition of responsibilities of all stake holders, formats for ethics committee, consent form, clinical trial report etc , keeping in mind that India can become a hot centre for clinical research outsourcing.
Besides the proven strengths in chemical technology to develop innovative processes, custom production of synthetic drugs involving highly sophisticated technologies and clinical research, the country has vast reserve of genetically diverse population which is drug-naïve, skilled clinicians, adequate documentation and analytical systems are the other advantages India offers.
Other than reduced time-lines, the biggest advantage to outsourcing clinical research to India is surprisingly low costs. Currently, the costs for developing and commercializing a new drug has been estimated to be somewhere in between $ 890 million to $ 1.7 billion. And companies are under tremendous pressure to reduce high costs. Such costs could be lowered at least to half when clinical research activities are outsourced from low cost economies such as India, experts say.
Several of the globally operating CROs like Quintiles, Neeman Medical International etc have successfully tested Indian waters. And many of the multinational pharma giants are also drawing up plans to foray India as part of their plans to cut-short time and costs in developing new drugs.
However, the multinational firms are a bit wary to scale-up their operations other than the current exploratory and supportive clinical studies because of their apprehensions on data protection. Since India is yet to fully agree on the Data Exclusivity clause in the TRIPS agreement, MNCs fear that the data generated through clinical studies would be copied and used by other firms. For those overseas firms who are yet to enter India are concerned about lack of adequate infrastructure in many areas of R&D, imprecise documentation systems and low track record in the implementation of global regulatory and intellectual property protection standards.
Experts feel that considering the bigger advantages of outsourcing research services from India, these issues related to perception could be overcome over a period of time.
Indian CROs, taking a cue, are striving to achieve these goals. Increasingly they are becoming competent in all relevant fields through incorporating global standards like GCP and GLP in the truest sense of the term. They are, after all, in firm belief that even if they can get even a 10% market share out of the $ 175 billion estimated global outsourcing market by 2010, it will still be double of the current turnover of the entire Indian pharmaceutical industry, in value terms, aver experts.