Report: India needs to clean up its regulatory act

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The market for clinical trials in India is worth about $1.5 billion and predicted to grow hand-over-fist, but if the country doesn't set straight its regulatory policies, it stands to lose ground to other emerging players, The Times of India opines.

Over the next 5 years, analysts figure the Indian CRO industry will bring in $20 billion a year, snagging between 5% and 10% of the global market for clinical trials, the paper reports, but mounting concerns about trial safety and transparency could well scare off drugmakers and regulators in the West, funneling business to on-the-come-up trial sites like South Korea and Eastern Europe.

The Times highlights some improprieties in Indian policy that, if reformed, could help keep trial participants safe and make the Indian market even more attractive to outsourcers worldwide:

  • As we've covered before, the country has no standardized system for paying compensatory sums to the families of patients killed in trials. The government mandates the payment, but the amounts are dictated by trial-runners, leading to short-changing that has alarmed many observers. India's Central Drugs Standard Control Organization is lobbying for a regulated disbursement system and has found a few allies in the process.
  • The consent forms given to trial participants are heavy with medical jargon, the Times says, and many of the people who sign on for studies have little knowledge of what they're getting into. Furthermore, some patients are asked to sign forms that waive their right to compensation in the case of injury or death, which is illegal.
  • Currently, there are no minimum clinical standards for trials in India, and the only requirement is medical supervision, meaning any doctor can administer a legal trial in a private clinic. That opens the door for fly-by-night outfits conducting high-risk trials at sites ill-equipped to handle serious adverse events, the paper reports.

While there's broad support for such reforms among Indian regulators and the Supreme Court, many in the industry say ramping up the country's trial scrutiny will drive up insurance costs for CROs and drugmakers, pricing out mid-size local firms and making the country affordable only for multinational drug giants. 

- read the Times story

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