India
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Parexel’s CEO Peyton Howell and India chief Sanjay Vyas talk to the Pink Sheet about clinical trials amid global turmoil, the slowdown in big pharma decision-making and pivot in some cases to the FSP outsourcing model, evolving DCT definitions and India opportunities.
India’s proposal to speed up multicenter research through a single ethics review system is drawing strong interest from the research community.
A regulatory sandbox and greater global harmonization will not only improve pathways for Indian cell and gene and other advanced therapies to reach the UK’s National Health Service but also speed up approvals in India
From enforcing new GMP norms to risk-based inspections and 850 CAPA notices, India’s drugs regulator is moving to tighten compliance across domestic pharma units. A striking step up in the regulator’s internal scientific cadre and more regulatory rationalization are also on the cards.
The US-India dance around pharma goes on as they announce a trade deal framework that continues to exempt generics from the reduced 18% tariffs till a “negotiated outcome” is reached post a Sec. 232 investigation. However, oil imports from US could increase costs for Indian pharma makers
A new report identifies opportunities to implement the 3Rs principle in India, calling for a waiver of redundant animal testing for generics and NCEs/NBEs and alignment with global regulatory frameworks. Will India shift gears to adopt harmonized NAM-first policies?
An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?
Regulatory streamlining including in areas such as test licenses and cell/gene therapy, and policy support/incentives to propel innovation, were among the key themes that played out in India in 2025. More action is anticipated in this year, including in the biosimilars segment.
India’s moves on digital data protection don’t pose a hurdle to patient recruitment, but on the wish list of global innovators is permission for first-in-human (FIH) trials and removal of certain commercialization requirements, says Parexel’s India head
India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.
Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds
India rolls out amended R&D financial assistance plan targeting certain ‘priority areas’ and calls for proposals from industry and startups. While the corpus is modest, the scheme hopes to enable the ‘Innovate in India’ ecosystem and includes a co-funding provision.
As US Secretary of State Marco Rubio hints at reconsideration of a punitive Russian oil tariff, Trump adds an H-1B visa brick to his trade wall and India lowers GST on cancer and rare disease drugs, the Pink Sheet considers the impact.
Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?
Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.