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India plans drug regulatory overhaul and immediate licence suspensions for substandard manufacturers
The changes could make India more attractive for global drug development while tightening oversight of manufacturers, affecting drugmakers and investors.
What happened
India is planning a major overhaul of its pharmaceutical regulatory framework to bring its drug oversight system in line with global practices. The Economic Times One key option under discussion is to cautiously allow multinational companies to conduct first-in-human Phase I clinical trials in the country. The Economic Times The regulator has already held informal discussions on allowing multinational pharmaceutical companies to conduct early-stage clinical trials in India. The Economic Times Separately, the government has proposed immediately suspending the manufacturing licence of any company producing a drug that is not of standard quality. raps.org Under the planned change to the Drugs Rules, 1945, licences would stay suspended until the manufacturer completes an effective root cause analysis and implements a corrective and preventive action plan to the licensing authority's satisfaction. raps.org
Around it
India has significantly strengthened its manufacturing compliance over the last two years and is looking to bolster its specialist regulatory capacity, according to multiple government and industry sources. The Economic Times The proposals would empower central licensing authorities to seek details of root cause analyses, corrective plans, investigational reports and final actions taken by manufacturers. raps.org
Sources
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