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India – The Delay In Generic Drug Approvals By The US FDA Likely To Hurt Indian Pharma.

20 November, 2014

 

Legal News & Analysis – Asia Pacific  India – Intellectual Property

 

Indian Pharmaceutical companies expect a slowdown in new generic drug approvals  by the United States Food and Drug Administration (USFDA) to diminish sales in their  largest market for at least two more quarters.

 

The slowdown has been the result of an ongoing overhaul of the review process in the FDA which has been necessitated by the rise in the number of filings for approvals of new generic drugs manufactured in US and elsewhere. Also the FDA has stepped up inspections of production facilities before giving final approval for the drugs which is putting pressure on FDA resources adding to the backlog. 


The FDA implemented the Generic Drug User Fee Act (GDUFA) programme in October 2012, giving the agency the right to collect fees from manufacturers to expedite the approval for sale of generic drugs. However, the agency has not made as much progress with clearing the existing backlog of applications as some domestic manufacturers had hoped. While the regulatory agency is hiring more sta and looking to speed up the process, executives of the domestic pharmaceutical industry say the pace of approvals is unlikely to pick up until 2016.


The Indian pharmaceutical industry, which supplies about 40 per cent of generic and over-the-counter drugs to the United States, has been hit by a spate of regulatory sanctions in the past by the FDA due to concerns about its production processes. 


While, many in the domestic pharma sector see this as FDA’s bid to support global innovator companies whose business is clearly threatened by the increasing exports of low-cost quality drugs from India, compliance with regulations is a key requirement for Indian pharmaceutical companies to realise their growth potential. Failure on this front would seriously hurt credit worthiness. 


It could lead to disruptions in production, import bans, remediation costs, and above all reputational and litigation risks

 

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