India

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.

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?

Absent agency said to have a plan to overcome vacancies and clear inspection backlog; subcommittee has other plans.

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 revised GMP rules up the bar and lay out specifics for pharmaceutical quality systems, handling of product complaints and supplier audits, among other areas. While risk-based inspections are already being deployed, it will take unflinching enforcement to separate the wheat from the chaff across 10,000 manufacturing sites in the country.

AI initiatives in a country known for its software prowess, along with startup support, clinical trial rule changes, crunched approval timelines, unified digital regulatory interfaces and a R&D policy laying out $600m in funds, are all meant to build something greater than the sum of its parts. In a bottom-up approach, India is building an innovation ecosystem

Incoming director general of the Organisation of Pharmaceutical Producers of India discusses the evolving policy and regulatory landscape in India in areas such as R&D and quality. Stricter adherence to ethical marketing practices could be focus in the coming year, Anil Matai adds.

Intas – the the troubled Indian firm at the center of the cisplatin shortage – may have punished workers for their visual-inspection subterfuge, but it also should have gone after managers, the FDA asserted in a second data integrity warning letter in four months.

Could Cipla dissuade the FDA from issuing a warning letter by defending the dismissal of thousands of complaints from asthma sufferers about jammed albuterol inhalers that came to light during a site inspection? The agency’s answer came in a warning letter.

An updated National Pharmaceutical Policy aimed at enhancing India’s self-reliance and global competitiveness is on the cards. A focus on private-public partnering and academia-industry linkages means much of its success will depend on the ability of various parties to deliver within the constraints they operate in