Ahmedabad-based privately held pharma company Cadila Pharmaceuticals Ltd has decided to go slow on its plans to come up with a manufacturing plant at Rwanda in partnership with US based Holtzman Group.
I A Modi, chairman, Cadila Pharma said, "We are in a wait-and-watch mode regarding the Rwanda project. No work has started on ground. We will take a call at the appropriate time." Cadila had plans to set up a manufacturing facility in Rwanda in central Africa in partnership with US based Holtzman Group. The joint venture had planned to invest $65 million to set up the plant that would manufacture solids, tablets and capsules; liquids, gels, ointments, creams and syrups; biologicals, injectables and vaccines and active pharmaceutical ingredients (APIs). The facility was scheduled to be fully operational by 2015.
The company,however, declined to comment on the future of the joint venture with Holtzman Group. Cadila, however, has now decided to focus more on its vaccine manufacturing joint venture back home in India with another US based biopharmaceuticals player Novavax which has recently received a regulatory approval for conducting rabies vaccine toxicology studies in India and clinical study of influenza vaccine.
"We have also received nod to conduct clinical trials for the H1N1 or swine-flu vaccine. We are very bullish on getting the approvals for our vaccines soon. Rather we have also started trial production at our Dholka site. We are waiting for the validation of the facility which can come in anytime now", Modi said. Cadila holds 80 per cent equity in the joint venture. The company plans to launch vaccines in the market in 2013. The Dholka facility can produce 60 million doses of vaccine every year. It employs the single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, Maryland. The Dholka plant would initially produce clinical supplies of vaccine candidates to prevent influenza and rabies and will later go on to make the commercial product as well.
Meanwhile, the Rwandan government is trying to establish a strict regulatory framework to ensure the quality of drugs produced, sold and imported into the country. Currently, a bill to establish the Rwanda Food & Medicines Regulatory Authority is in the Parliament. Companies would wait until the regulatory regime becomes more clear. Rwanda now depends on imports to meet its requirement for pharmaceutical products. According to estimates, around 30 per cent of imports into Rwanda are counterfeit.
