# India’s Pharmaceutical Exports: Upcoming Challenges Ahead

- Link: https://www.thailand-business-news.com/india/226004-indias-pharmaceutical-exports-upcoming-challenges-ahead
- Published: 2025-06-15T22:44:05+07:00
- Author: News Desk

**India’s pharmaceutical industry faces scrutiny over quality control issues, with
stricter US FDA inspections planned. Several companies, including Orchid Pharma 
and Glenmark, have faced recalls due to safety concerns.**

**Key View**

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 * India’s domestic pharmaceutical industry will remain under increased scrutiny
   due to persistent quality control issues across domestic manufacturers.
 * Regulators will face challenges implementing stricter controls across the pharmaceutical
   manufacturing sector.
 * While India’s generic drugmakers face tariff risks, India-based companies will
   continue to dominate new generic drug approvals.

**India’s domestic pharmaceutical industry will remain under increased scrutiny 
due to persistent quality control issues across domestic manufacturers. **On May
6 2025, the US FDA announced plans to increase unannounced inspections at foreign
manufacturing facilities producing medical products for the US market. This initiative
aims to ensure compliance with strict quality standards and regulatory requirements,
moving away from the previous model of scheduled inspections. FDA inspectors will
now conduct surprise visits to overseas factories, including those in India, to 
enhance oversight of global drug production. This change addresses rising concerns
about product quality and safety in international supply chains. For example, in
February 2025, India-based Orchid Pharma received seven observations after an unexpected
US FDA inspection at its active pharmaceutical ingredient (API) facility. In March
2025, India-based Glenmark Pharmaceuticals recalled bottles of a generic ADHD medication
in the US due to impurities. More recently, in July 2025, drug samples from India-
based I Heal Pharmaceuticals and Quixotic Pharma were found substandard following
US FDA inspections. Moreover, between February and April 2025, drugs manufactured
by India-based Sun Pharmaceuticals and Zydus Lifesciences were recalled due to impurity
and dissolution problems, and Dr. Reddy’s products were recalled because of incorrect
labelling instructions.

India’s pharmaceutical industry is a global powerhouse, supplying a significant 
share of generic medicines worldwide. However, the sector is encountering increasing
challenges that could hinder its growth. Factors such as stringent regulatory scrutiny
in international markets, particularly from the U.S. Food and Drug Administration(
FDA), pose a significant barrier. Companies must navigate complex compliance requirements,
which can be both time-consuming and costly, potentially affecting their global 
competitiveness.

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Additionally, rising production costs, driven by fluctuations in raw material prices
and reliance on imports, are straining profit margins. The recent disruptions in
supply chains, exacerbated by geopolitical tensions and the ongoing impact of the
COVID-19 pandemic, further complicate the landscape. As a result, Indian pharmaceutical
manufacturers are under pressure to innovate while maintaining quality, a delicate
balance that could be challenging to achieve amid these pressures.

Moreover, increasing competition from emerging markets and the evolving landscape
of intellectual property rights add further complications. To sustain their position,
Indian pharmaceutical companies must invest in research and development, explore
new markets, and strengthen supply chain resilience. The future remains uncertain,
but proactive measures are crucial to overcoming these hurdles and ensuring continued
success in the global arena.
[Read More](https://www.fitchsolutions.com/bmi/pharmaceuticals/indias-pharmaceutical-exports-will-continue-face-growing-challenges-11-06-2025)