India’s draft policy to catalyze R&D and innovation seeks to create a “regulatory bias” towards innovation and aims to cut approval timelines sharply, among a raft of other proposals that include enabling differential pricing for “innovation with therapeutic benefits.” The Pink Sheet explores multiple nuances of the plan with industry experts.
India has put forth a draft policy plan to spur R&D and innovation in the biopharma and medtech segments, but effective implementation, political will to press ahead on some key proposals and seamless co-ordination between multiple agencies could be pivotal to ensure real gains.
The proposed policy is built around three core prongs – strengthening the regulatory framework, incentivizing private and public investment in...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.
Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
