India
2024 saw important regulatory changes in India including in areas such as GMP, clinical trials and efforts to rein in unethical marketing practices. Further action is expected to play out in the new year as well.
India continues to reform biopharma regulatory processes and widen digitization efforts. The regulator will curb "re-deliberations" at subject expert committee meetings unless applicants furnish new data.
US President-elect Donald Trump’s second term is seen in general as “bad news” for Asia, especially China, by some analysts. But the outlook for India pharma appears upbeat, says a cross-section of experts.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to cause a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the companies that have been part of pricing discussions.
Contract research organizations in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
A senior McKinsey executive discusses trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The deadline is nearing for pharmacopoeias to express their interest in joining the decades-old discussion group that works to harmonize excipient monographs and general chapters and reduce the burden on manufacturers to perform analytical procedures in different ways depending on the jurisdiction.
India prohibits the manufacture and sale of over 150 fixed-dose combinations (FDCs) that lack therapeutic justification and pose potential health risks, though all eyes are on how effectively the regulatory apparatus enforces the ban, not the first in the area, amid legal action. One firm has secured an ad interim ruling for its combination drug.
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.
US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.
More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance warding off a local drug maker in the Evrysdi patent infringement case.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
India’s revised code for marketing practices includes US Sunshine Act-like requirements converging with tax laws and puts the spotlight on continuing medical education initiatives, where pharma will need to display funding/expenditure data on their website. The Pink Sheet talks to experts on the implications and also new requirements on brand reminders and drug samples.
Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative.” The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.
India’s National Cancer Grid pilots pooled procurement for 40 drugs including trastuzumab, imatinib, and pemetrexed, delivering median savings of over 80%. Experts discuss with Scrip the prospects of scaling the initiative and what it may mean for pharma’s margins and go-to-market strategy.
The contentious issue of data exclusivity came to the fore during the European Free Trade Association's negotiations with India for a Free Trade Agreement. What are the arguments in support and against, including impact on compulsory and voluntary licensing?