Regulatory hurdles eclipse tariff worries for pharma CXOs: Deloitte survey

Industry seeks AI-based submission tools and unified digital portals to accelerate approvals and compliance tracking

Regulatory scrutiny and delays in securing product approvals are expected to pose a greater challenge to large Indian pharmaceutical companies than tariff uncertainty, geopolitical tensions or dependence on China in 2026-27 (FY27), according to a Deloitte survey.

 

The survey found that 57 per cent of pharma CXOs expected increased regulatory scrutiny in domestic and export markets to have a significant impact on their businesses. An equal proportion identified delayed product approvals and complexities surrounding clinical trials as a significant headwind.

 

By comparison, 43 per cent classified trade and tariff wars as having a significant impact, while 52 per cent expected their impact to be moderate. Geopolitical tensions received an identical response. Import dependence on China was considered a significant risk by 33 per cent of respondents and a moderate risk by 43 per cent.

   

“Regulatory scrutiny is seen as more immediate because it has a direct bearing on approvals, launches, plant operations and customer confidence. It is a risk that management teams continually deal with,” said Joydeep Ghosh, partner and leader, life sciences and health care, Deloitte South Asia.

 

The Indian Pharmaceutical Industry Survey: FY27 Outlook was conducted in the first half of 2026 among CXOs of Indian pharmaceutical companies with annual turnover exceeding ₹10,000 crore. Deloitte has not disclosed the number of respondents.  

 

  Ghosh said recent developments surrounding tariffs and geopolitics had not fundamentally altered the industry’s priorities but had made concerns around resilience more pressing. “While the survey already flagged concerns about geopolitics and trade, recent shifts have not really changed the core outlook. They have just made those concerns more pressing,” he told Business Standard.

 

As regulatory requirements become more complex, pharma executives are seeking greater use of technology to speed up approvals and strengthen compliance. Around 76 per cent of respondents identified artificial intelligence-based tools for regulatory submissions and audits as a key requirement, while 67 per cent favoured digital portals for faster approvals and compliance tracking.

 

Indian companies handle multiple filings across jurisdictions, including abbreviated new drug applications in the US and certificates of suitability in Europe. AI-based systems could help compile dossiers, identify compliance gaps and reduce duplication and manual errors, the report said.

 

Around 62 per cent of respondents also sought faster and more transparent approval mechanisms from the government, while 48 per cent called for access to digital compliance tools. Only 14 per cent prioritised training programmes for regulatory teams, indicating that companies perceived system-level bottlenecks as more pressing than internal skill shortages.

 

Companies also want a more direct role in shaping regulation. Fifty-seven per cent preferred industry-government task forces for policy design, while 40 per cent backed cross-border regulatory harmonisation initiatives.

 

For exports, 71 per cent identified mutual-recognition agreements with major markets such as the US and the European Union as the leading regulatory reform. Such agreements could reduce duplication, shorten approval timelines and lower the cost of entering regulated markets, the survey said.