India’s pharma industry to face ongoing scrutiny over quality issues

A recent FDA announcement presents risks for the country’s sector.

India's domestic pharmaceutical industry will continue to experience increased scrutiny amidst persistent quality control issues across domestic manufacturers, according to a BMI report.

The US Food and Drug Administration (FDA) announced on 6 May plans to increase unannounced inspections at foreign manufacturing facilities producing medical products for the US market.

“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.

Meanwhile, drugs manufactured by Sun Pharmaceuticals and Zydus Lifesciences were recalled due to impurity and dissolution problems between February and April.

The increased scrutiny will not only have potential implications on the approval rate of drugs sourced from the country but will also impact medicine sales for major drugmakers if facilities are sanctioned.