Thanks to lax regulations and legal loopholes, Indian regulators have little control over the conduct of CROs in the country, but the government is on the path to reforms that would help rein in "fly-by-night" trial operators, officials told Outsourcing-Pharma.
The largest barrier to policing trials in the country is that investigators are not legally required to register with authorities, so any doctor can administer a legal trial in a private clinic, opening the door for high-risk trials held at sites ill-equipped to handle serious adverse events.
However, the country has proposed changes to the law, mandating that CROs register and remain transparent, and Deputy Drug Controller S. Eshwar Reddy told Outsourcing-Pharma's Natalie Morrison that he expects the reforms to find broad support.
Secretary of Commerce S.R. Rao told Morrison that the majority of trial runners working in the country comply with ethics rules, but others take advantage of vaguely worded or incomplete legislation, and India needs to tighten its regulations to keep patients safe and protect compliant outfits.
"When 80% of industry--a significantly large number--follow the rules, there are a couple companies who come and sour the pitch: fly-by-night operators," he said. "We do not want to tax the industry, but we certainly do not want anyone to take advantage of loosely based regulations."
And those reforms might protect more than patients. Analysts figure the Indian CRO industry will be worth about $20 billion in the next 5 years, but mounting concerns about safety and transparency could well scare off potential outsourcers, and up-and-coming trial sites like South Korea and Taiwan would be more than happy to pick up the difference.
But not everyone is convinced that stricter laws will be good for the industry in the long term. Some in the Indian CRO world have said that ramping up scrutiny on trials will only increase costs, possibly pricing out local drugmakers and making the country's CRO market affordable only for multinational pharmas.
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