So far preclinical research has been limited in India because experience, including primate and toxicology studies, in the country is generally still underdeveloped. In addition, first-in-man trials of 'foreign made' new drugs are not permitted in India, while other Phase I studies of foreign made drugs are only allowed once the drug has completed phase I and moved to phase II in other countries. However, preclinical and early phase research in India is "rapidly evolving," Dr Satyanarayana Chava, CEO of Indian firm Laurus Labs, and Aptuit CEO, Michael Griffith, told Outsourcing-Pharma.com in a joint interview during last week's US Drug Information Association (DIA) meeting in Altanta. "This is evident by the number of preclinical and early phase facilities that are being constructed in the country," said Chava.
It is also expected that within the next 18 months the Indian drug regulatory authority will have new guidelines in place for the conducting of Phase I studies on foreign drug compounds which will open the doors to much more of this type of research in the country, he said. It was at the show that Laurus and US-based CRO Aptuit announced their new partnership, along with a more than $100m (€75m) investment from Aptuit in order to fulfil their expansion plans. As part of this, they will invest in beefing up their preclinical and early-stage drug development capabilities in India as a result of the growth opportunity they have identified in this area, the two CEOs said. Aptuit currently specialises in formulation development, preclinical testing, clinical packaging and informatics in US and Europe although Laurus currently has no such capabilities in India.
"There are hundreds of clients already doing preclinical testing and analysis in India who want to be able to use one company to bring their product from discovery through the various clinical development stages," said Griffith. "We want to be established in this growing area so that we can pick up projects at an early stage and carry them right through." So, as part of the large investment Aptuit is making, a new small-scale formulation and development facility will be built that can do formulation development for oral dosage forms, as well as manufacturing, packaging and labelling of clinical supplies of between one and three billion units per year. Production will begin for this facility within 12 to 18 months although the site location is yet to be decided, said Griffith. It won't be at Hyderabad, he added, but will be somewhere that a bundle of other preclinical service suppliers are located, possibly Bangalore, although "as this field is still emerging in India, we will have to watch and wait."
Other expansion plans the two firms have for India further down the line will likely involve the formulation and filling of lyophilised drugs on a pilot scale. "There is an immediate demand for this service in India," said Griffith. Meanwhile, through the joint venture, Laurus has given Aptuit access to the Indian market and also brings new large-scale active pharmaceutical ingredient (API) development and scale-up capabilities. Aptuit has one small scale API facility in US and is now also looking to acquire one in Europe, although has been searching for the past three years and is yet to find something suitable.
"The ones we have seen so far have been typically old, underinvested and lacking in technology," said Griffith. He also indicated the plant would ideally have capabilities for biologic drugs.