ImageParallel to the growth of clinical trial industry in India, a huge opportunity for clinical supplies manufacturing is opening up for the country's contract manufacturing companies.

At least two companies have already set up their manufacturing facilities in the country to outsource small volume products for clinical trial execution even as many other companies are analysing the potential of the service, according to industry sources.

The well established capability of Indian pharma companies in outsourcing research and quality manufacturing services, success of various domestic companies in service providing and the ability to provide adequate phase to phase supply with speed are the key factors supporting the Indian companies in this business.

The Mumbai-based Rubicon Research Pvt Ltd and Hyderabad-based Suven Nishtaa Pharma Pvt Ltd have set up their facilities offering the clinical supply manufacturing services in 2008. The Pune-based Bilcare Ltd is the first Indian company to initiate clinical supply manufacturing, but the company's facility is situated in US.

The model offers a wide range of services from manufacturing for innovators' samples, placebos and small volume manufacturing for clinical trial needs of generic drugs. However, the potential of the service model in India is yet to be gauged, as the business is in infant stage at present, averred sources.

"There is indeed a huge opportunity for Indian companies in clinical supply manufacturing services. But it is in a nascent stage and we cannot comment on the potential of the business model," said B V Srinivasa Rao, head – Business Coordination, Suven Nishtaa Pharma Pvt Ltd. The company has commissioned its facility in the end of 2008 near Hyderabad to provide services ranging from formulation development to packaging of clinical supply products on contract basis.

The possibility of outsourcing business in clinical supply manufacturing is immense in the country, asserted Sudhir D Pilgaonkar, chief commercial officer, Rubicon Research Pvt Ltd. The company commissioned its dedicated facility for clinical trial supply manufacturing in Mumbai in the middle of 2008. The facility, set up with an investment of around USD 400 million has received approval from the Drug Controller General of India (DCGI) and will start operation with a fresh set of projects, he added.

Meanwhile, the model is in a very nascent stage in India and hence has to face a series of challenges, informed sources. Rao highlighted that the Indian companies has to build up trust in the clients on confidentiality in data for the products manufactured for clinical trail usage. Keeping accuracy in date of delivery of products should also be considered as important to satisfy the customer, he added.

"Having adequate infrastructure to manufacture various forms of medicines in small volume is essential and India has to gather momentum in infrastructure development to grab the market. Though we are known to be rich in skilled manpower in formulation development, we have to develop expertise in formulation development in this niche segment," explained Pilgaonkar.

Further, speedy approval for trials from drug regulator and adequate support from the regulatory body are essential in growth of the business model. Hopefully, the current changes in the drug regulatory system will add momentum to the growth of the model, added the sources.