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India simplifies clinical trial regulatory process
By Kirsty Barnes, 30-Nov-2006
Related topics: Regulatory affairs, Clinical Development
The Drugs Controller General of India (DCGI) has just simplified the process for gaining regulatory approval for global clinical trials.
The new changes, set to come into effect as of December 1, are aimed at stamping out a lot of the delays faced when international firms conduct clinical research in India, in order to drive this burgeoning industry forward faster.
"I am sure this will further win confidence of global research & development fraternity and attract a lot of clinical trial business in Asia Pacific region," Dr Umakanta Sahoo, managing director of Chiltern International in India told Outsourcing-Pharma.com.
India is holding the lion's share of the world's contract research business as activity in the pharma market continues to explode in this region, and holds nearly double the business of its nearest rival.
However, while the industry in India is quickly gaining momentum, it still has a lot of ground to cover.
"If India wants to achieve the dream, it needs capacity building on every level, from regulatory authorities, ethics committees, hospitals and research facilities and staff training," Dr Vasudeo Ginde, president and managing director of iGATE Clinical Research, told Outsourcing-Pharma.com in a recent interview.
It seems these new regulatory efforts are a big step in the right direction.
Specifically, DCGI agreed in a recent meeting at Indian Drug Manufacturers' Association (IDMA) that "For the purpose of granting permission, the clinical trials are classified into Category A and Category B, and Category A will include those clinical trials whose protocols are already approved by some of the recognised and developed countries.
India will accept the protocols of these Category A trials on the basis that they have already been approved in the recognised countries, reducing the approval time to two to four weeks, based on the current load of 20 applications per month.
Recognised countries include USA, UK, Switzerland, Australia, Canada, Germany, South Africa, Japan and countries in the EMEA.
All other trials not covered under Category A will fall under category B, said DCGI, and will need to undergo the regular protocol verification process - taking eight to twelve weeks to approve.
The full list of amendments can be viewed >here and >here .
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