India’s interim budget 2024 hikes allocation for production-linked incentive schemes in pharmaceuticals, supports biotech start-ups - particularly green ones- and sets the right note for inclusion of HPV vaccination in the country’s Universal Immunization Program, one of the world's largest public health programs. How does it help?
India’s interim budget 2024 furthers the government’s push for self-reliance with a hike in the allocation for production-linked incentive (PLI) schemes related to pharmaceuticals, support for green bio-production processes and innovation, as well as growth of medical colleges.
In continuation of a focus on specific diseases, like on sickle cell anemia in the fiscal year 2023-24 budget, this...
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.
