India made generics got support from USFDA chief


Indian government keep on promoting the use of generics drugs and with the support from Scott Gottlieb, USFDA chief the generics drug market will be increased definitely. Generics manufacturers in India are finally seeing a recovery as most of their manufacturing factories being approved by the US watchdog.

Indian pharmaceuticals manufacturers especially generic drug producers have got a shot in the arm with the support they got from US Food and Drug Administration (USFDA) chief. As per his statement, generics made in India are safe to use and the US to dispel fears over such medicines.

Three decades ago, the generic market was only 33% of the US drug market but now its 90% of the US drug market. Supportive statement from FDA commissioner Scott Gottlieb in the favor of Indian generics also boosted the S&P BSE Healthcare index, which is gained by 0.7%.

Many of the Indian drug manufacturers are getting the major business outcome from the sale of generics in the US market. USFDA chief supportive statement has given a respite from the poor perception of generics as well as Indian-made drugs and made producers happy.

Gottlieb wrote in a newsletter that generic drugs are equally safe and effective as their branded drug counterparts. A generic drug contains the same active ingredients as branded medicines and works the same way, so they have the same risks and benefits. He also added that the regulator’s rigorous standards and inspections apply equally to both generic and branded drugs — whether the medicines are being manufactured in Shandong, India, or in Indiana, USA.

323 sample products collected from around the world were tested by the US FDA in FY2017-18, which were including more than 100 from India, to determine if foreign producers had a higher incidence of product failure. All samples met the US market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications, the regulator said. According to Gottlieb statement, though the inspections by the USFDA declined slightly in China from 2017-18, inspections in India have increased substantially.

Finally, the Indian drug makers, seeing a recovery with most of their factories being cleared by the US watchdog.


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