BackCreate regulator for human trials: Aptuit
Create regulator for human trials: Aptuit
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Aptuit Inc., a $300 million (Rs1,230 crore) global drug development services firm that earlier this week acquired a majority stake in Hyderabad-based Laurus Labs Ltd and plans to offer clinical trial services from India, has mooted for an independent regulator for human trials in India.
Echoing growing concerns over Indian subjects used as human lab rats in a loosely regulated market, Aptuit’s vice chairman and co-founder Frank J. Wright said, “It is a social problem the world over and South Africa and countries in former Eastern block of Europe and South America have already worked out models to protect the interests of human volunteers in their countries. I think India should also adopt a similar model."
The level of poverty in developing and underdeveloped countries drives human volunteers for clinical trials with little concerns for safety, Wright said, but laws are needed to protect this vulnerable section.
India does not have a law to check drug testing leading to blatant flouting of ethical norms in the business. But earlier this month, the Union government ordered on-site checks and audits at drug testing facilities in an attempt to protect the hundreds of trial subjects at drug testing facilities and hospitals in India.
The new Indian entity of Aptuit – Aptuit Laurus – plans to offer early-stage clinical trials to global drug firms. It plans to invest over $100 million in its Indian operations over the next four years to offer a complete suite of development services including expanded manufacturing and informatics facilities in Visakhapatnam and Bangalore.
The company would initially provide services to clients in early-stage drug discovery, medicinal chemistry, process development, safety and hazard assessment, formulation development and analytical chemistry.
At present, Laurus employs over 200 scientific personnel and has a large-scale drug ingredients manufacturing plant being built near Visakhapatnam in Andhra Pradesh. Aptuit Laurus would also expand its pharmaceuticals ingredients facility at Visakhapatnam from the existing reactor capacity of 200,000 litres to 1 million litres, the local company’s chief executive officer Satyanarayana Chava said.
Stating that privately-held Aptuit might not be keen on growth further led by acquisitions in India, Wright said it plans to set up a large-scale cortico-steroids facility in India and would shortly firm up the investment size and its location.
Wright said there is no pressure at present on Aptuit to go public from its private equity backers -- led by Temasek Holdings Ltd and Welsh, Carson, Anderson & Stowe -- who pumped in $750 million funds into the company. “Neither we are in a rush to spend the money raised from PE investors. We will consider going public only when the market is right and when the company is in a right shape to do," he said.
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