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9
3 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
N/A
进行中（未招募）
3
33.3%
已完成
5
55.6%
终止
1
11.1%
暂无批准数据
- India's CGPDTM published Draft Guidelines for examination of pharmaceutical patent applications on September 4, 2026, inviting public comments before finalisation. - The draft rebuilds the examiner's framework around roughly two dozen judicial decisions, including the 2013 Novartis ruling and Delhi High Court judgments from 2024–2026. - Section 3(d) efficacy analysis is reinforced as a data-driven inquiry, with bioavailability clarified as a pharmacokinetic parameter rather than a direct measure of therapeutic efficacy. - New structured tests for novelty ("Seven Stambha") and inventive step, plus dedicated treatment of Markush and product-by-process claims, signal stricter prosecution standards.
