Indian pharma under USFDA lens
India holds a major stake in the US market. Hence US Food Drug Administration (FDA) has imposed stringent regulations to meet the international regulatory requirement which further boosts number of inspections carried out at various facilities on Indian pharmaceutical companies. With the booming generics business, USFDA is keeping a stern watch over the Indian pharma companies to safeguard the health interest of its population. The government of India has been adopting to stringent mechanisms to ensure the quality of drugs into the market. The Ministry of Health has been imposing a mandatory BA/BE studies for all the pharmaceutical manufacturing permissions. Government’s “Make in India” initiative is expected to deliver more safe, efficient and quality drugs into the market. With these and many more initiatives India will continue to be the powerhouse of pharmaceutical industry in coming years.
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