MUMBAI (Reuters) - A panel of advisors to the government has recommended that late-stage clinical trials be waived under certain conditions for some new drugs already being sold on international markets.
Indian law requires all medicines to be tested in late-stage clinical trials before being approved for sale. The requirements can be shortened, deferred, or omitted in certain cases, such as life-threatening diseases.
The recommendations were made last month at a meeting of the Drugs Technical Advisory Board, which advises the central and state governments on technical matters related to drug regulations.
The 19-member panel agreed that clinical trials for new drugs already selling in a "well regulated country" may be waived, if the safety and efficacy of the drug is found to be "favourable", according to minutes of the meeting.
The evaluation of such new drugs should be made in consultation with experts on specific therapeutic areas, the panel advised.
A waiver to late-stage trials would significantly speed up the approvals process for new drugs and will likely be cheered, chiefly by foreign drugmakers who have decried India's strict rules and red tape around clinical trial approvals.
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The recommendations were posted on the drugs regulator Central Drugs Standard Control Organisation's website last week.
They will now go to the health ministry for approval before new rules can be implmented, three members of the panel said on the condition of anonymity as the details are not public yet.
"The waivers will be granted in very rare circumstances, and the global clinical trials of the drug will also be closely looked at to ensure ethnic differences do not affect the efficacy or safety of the drug," one of the members said.
(Reporting by Zeba Siddiqui; editing by David Clarke)