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Nandita Vijayasimha, Bengaluru January 23 , 2025
Indian pharmaceutical industry is hopeful that under the new President Donald Trump’s regime Indian pharma companies can expand their presence in the US market and will continue to iron out various issues such as drug supply shortages and lower price erosion. There are only a handful of medicine manufacturing plants in the US and so dependence of India over China is imminent.
 
Every third prescription in the US is a drug from India. As the situation evolves with escalating production costs, patent exclusivity challenges, and the rising complexity of healthcare insurance systems, the preference for Indian pharma is likely to continue growing. India is the Pharmacy of the World and home to the highest number of US FDA audited pharma production plants pegged at 741 facilities.

According to Kaushik Desai, a pharma consultant, there are several factors like demand of generics and supply at low cost as compared to US manufacturing companies which is a preference by every insurance company in the US. There could be a temporary setback but in the long run, Indian pharma companies will benefit. India has much more capacity to produce and supply compared to US-based pharma manufacturing companies and will take care of the medicine shortages with stronger trade ties between the two countries.

Amid higher unemployment, visible signs of escalating costs of healthcare in the US, including insurance premiums and out-of-pocket expenses, are pushing patients and healthcare providers toward more affordable drug options. Indian pharmaceutical companies have always stepped in to fill the gaps, providing much-needed medications to meet demand, Desai noted.

According to Chakravarthi AVPS, chairman, Federation of Pharma Entrepreneurs (AP & Telangana), “The new regime of President Trump could bring both opportunities and challenges for Indian pharma. On the positive side, his push to reduce US reliance on China could position Indian pharma as a key supplier of APIs and generics.”

President Trump’s focus on lowering drug prices aligns well with India’s strength in producing affordable medicines, and create more opportunities for exports. He might also negotiate better trade agreements, offering favourable terms for Indian pharma. Additionally, there could be more collaboration between India and US in innovative areas like biologics and biosimilars. Indian firms setting up manufacturing in the US might benefit from policies that support local production, he added.

However, challenges remain. President Trump’s protectionist approach could lead to higher tariffs or stricter import rules, impacting Indian pharma exports. Stricter US FDA regulations might increase compliance costs. While affordable drugs are in demand, aggressive price reductions could hurt profit margins. India’s heavy reliance on China for APIs could pose risks if US-China tensions rise, affecting supply chains. Furthermore, Trump’s push for local manufacturing could increase competition for Indian generics in the US, said Chakravarthi.

To navigate these challenges, Indian pharma needs to invest in quality and compliance, reduce dependence on Chinese APIs by boosting local production and focus on innovation to explore new partnerships. While Trump’s return could open new doors, it will require strategic planning to overcome potential obstacles, said Chakravarthi.

Suresh Khanna, designated partner, Dossier Solutions & Services LLP, pointed out that in contract research and manufacture services (CRAMS), India stands to gain. Our industry’s mainstay in CRAMS product development, regulatory protocol adherence, and dossiers submissions in the required CTD (Common Technical Document) format are big growth opportunities. Scope for export of pharma services is going to be the key opportunity. The segment of CRAMS has proven its reliability in terms of turnaround. India also is home to a huge talent pool armed with skills of clinical studies, clinical data management, technical data writing, medical writing and coding which requires ample skill sets in information technology which propels CRAMS, stated Khanna.

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