Impact of Controversy on India's Pharma Exports

Recent comments by President Donald Trump have sparked controversy by linking the use of Tylenol and related paracetamol products by pregnant women to autism in children. However, experts believe that India’s pharmaceutical exports to the US will remain largely unaffected.

Insights from Industry Experts

• Nikkhil Masurkar, CEO at Entod Pharmaceuticals, indicated that paracetamol constitutes a minor portion of India's pharma exports to the US.
• The recent advisory by the US Food and Drug Administration (FDA) is unlikely to significantly diminish US demand for paracetamol.
• He noted that any pressure would more likely affect smaller companies regarding procurement and compliance.
• US supply chains for paracetamol's active pharmaceutical ingredients (APIs) rely heavily on non-Indian sources, particularly China, minimizing potential disruptions from India.

Statements and Data from Indian Authorities

• Namit Joshi, chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), emphasized that the impact depends on American physicians' responses to the FDA advisory.
• He mentioned that there is no established link between paracetamol and autism, leaving physicians as the final authority.
• Paracetamol accounts for about 0.56% of India's API exports to the US, valued at approximately $2.77 million in FY25.
• India exported $182.31 million worth of paracetamol products in FY24, with $21.98 million going to the US.

Scientific and Regulatory Insights

• A review of 46 studies suggested a potential link between Tylenol usage during pregnancy and neurodevelopmental disorders like autism and ADHD.
• The FDA plans to revise acetaminophen’s pregnancy safety classification following these findings.
• Despite this, the FDA acknowledges no clear causal evidence and continues to monitor ongoing research.

Medical Perspective

• Tripti Raheja, a director at CK Birla Hospital, emphasized that studies show associations but do not establish causality between acetaminophen and autism.
• Current medical guidelines uphold acetaminophen as the safest option for managing pain and fever during pregnancy, as opposed to alternatives like ibuprofen or combiflam.