India's Pharma Sector Faces Heightened FDA Scrutiny on Quality

• US FDA to increase unannounced inspections at overseas pharma facilities
• Indian firms like Orchid Pharma, Sun Pharma, and Zydus face quality-related actions
• Stricter oversight could affect drug approvals and export sales from India

India's domestic pharmaceutical industry will be subject to heightened scrutiny in light of ongoing quality control issues among domestic manufacturers, a reported by BMI stated.

On 6 May, the US Food and Drug Administration (FDA) announced plans to increase unannounced inspections of foreign manufacturing sites producing medical products for the US market. 

Also Read: Building a Successful Pharma Brand in India: The Role of Scientific Communication

 “The recent FDA announcement will present risks for India's pharmaceutical export sector, which is a major supplier of generic drugs and APIs to the US,” the report said.

“For example, in February, India-based Orchid Pharma received seven observations after an unexpected US FDA inspection at its active pharmaceutical ingredient (API) facility,” it added.

At the same time, drugs manufactured by Sun Pharmaceuticals and Zydus Lifesciences were recalled due to impurity and dissolution issues during the period of February and April.

Scrutiny is not only likely to affect the approval rate of medicines from the country but also affect medicine sales for major drugmakers if facilities are sanctioned.