Regulatory Compliance Tops Pharma Concerns Over Tariffs in FY27: Deloitte Survey

India’s large pharmaceutical companies expect regulatory challenges to have a greater impact on their businesses than tariffs or geopolitical uncertainties in FY27, according to Deloitte’s latest industry survey.

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The survey, conducted among CXOs of Indian pharmaceutical companies with annual revenue exceeding ₹10,000 crore, found that 57% of respondents identified tighter regulatory scrutiny in domestic and overseas markets as a major business challenge. An equal proportion also pointed to delays in product approvals and the complexity of clinical trial requirements as significant concerns.

Regulatory Issues Rank Above Trade Risks

Trade and tariff-related issues were viewed as a significant challenge by 43% of respondents, while another 52% considered them a moderate concern. Geopolitical developments received a similar assessment. Dependence on imports from China ranked lower, with 33% describing it as a significant risk and 43% categorising it as a moderate one.

Speaking to Business Standard, Joydeep Ghosh, Partner and Leader, Life Sciences and Health Care at Deloitte South Asia, said regulatory oversight remains an immediate concern because it directly affects product approvals, launches, manufacturing operations and customer confidence. He added that recent developments related to tariffs and geopolitical tensions have reinforced the need for resilience but have not fundamentally changed the industry’s priorities.

Companies Seek Technology-Driven Compliance

The survey indicated growing interest in technology-led regulatory processes. Around 76% of respondents said artificial intelligence-based tools for regulatory submissions and audits would help strengthen compliance and improve efficiency. The other 67% of the people were in favor of using digital platforms that would help speed up the process and also make compliance tracking easier.

According to the survey, Indian pharmaceutical companies manage multiple regulatory filings across global markets, including abbreviated new drug applications in the U.S. and certificates of suitability in Europe. Deloitte said AI-enabled systems can assist in preparing regulatory dossiers, identifying compliance gaps and reducing manual errors during submissions.

Demand For Faster Approval Mechanisms

Procedural reform was another important topic mentioned by many participants, as 62% of them wanted faster and more transparent approval processes from the government agencies, and 48% required access to digital compliance infrastructure. Only 14% of the respondents thought of providing further training to regulatory staff, which implies that procedural problems are considered more important than the skill levels of the personnel.

Furthermore, 57% of the respondents would like the creation of industry-government task forces for regulatory policy development, and 40% would support initiatives on regulatory harmonization in international markets. 

As far as pharmaceutical exports go, regulatory convergence is extremely important for drug manufacturers based in India. In particular, about 71% of the respondents stated that the mutual-recognition agreement with key markets such as the USA and the EU was the most important regulatory reform. 

According to the survey results, it could eliminate duplicate regulation and accelerate approval process as well as reduce compliance costs for Indian companies operating in the regulated foreign markets.