Global generic drug approvals up in 2016: USFDA

The 2016 numbers were also the highest in its history, said the annual report of the Office of Generic Drugs, 2016


The USFDA said that it has achieved a year early the target set for 2017, to take action on 90% of the applications pending prior to the start of the Generic Drug User Fee Amendment Act (GDUFA) of 2012. Photo: Hemant Mishra/Mint
The USFDA said that it has achieved a year early the target set for 2017, to take action on 90% of the applications pending prior to the start of the Generic Drug User Fee Amendment Act (GDUFA) of 2012. Photo: Hemant Mishra/Mint

The US Food and Drug Administration (USFDA) has approved 630 drugs in 2016 and given tentative approvals to 183, higher than its 2015 figures of 580 final approvals and 146 in the previous year.

The 2016 numbers were also the highest in its history, said the annual report of the Office of Generic Drugs, 2016.


The FDA said that it has achieved a year early the target set for 2017, to take action on 90% of the applications pending prior to the start of the Generic Drug User Fee Amendment Act (GDUFA) of 2012.

The annual report also mentions that nearly 80% of generic drugs have a global aspect to their development or production, leading to the regulator working more with its international offices and foreign industry in countries such as India and China.

Although generic drug approvals may be up, many Indian companies saw slower drug approvals than they expected, partly because some of their production units did not pass muster.

India textile industry to more than double by 2021

India’s textiles industry, estimated at $108 billion in CY2015 (calendar year 2015), is expected to grow to $223 billion by CY2021, IDBI Capital said in a report.

Currently, Indian home textile companies are in a sweet spot, with the potential to increase sales in export market.

Also, over the past five years, there have been structural shifts in the dynamics of the industry where Indian companies have gained advantage over their Chinese counterparts, the report added.

Further, IDBI Capital foresees textile and apparel exports growing from $40 billion in CY2016 to $82 billion by CY2021.

The textiles sector is one of the largest contributors to the country’s exports, forming 11% of the total exports, and India’s overall textile exports during FY2016 (fiscal year 2016) stood at $40 billion.

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