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US Statement: Enforcement Of IPR Administration A Main Concern


Posted By Admin on 03 Sep 2015

Across the global market, Indian pharmaceutical segment is at a turning point, in the global economy. This is the time when this industry is all prepared for a launch; the area is loaded with regulatory concerns for active pharmaceutical ingredients (APIs) whilst there are quality issues taking a toll on ‘brand India’ in the global market.

Indian pharmaceutical industry is in and facing a couple of immediate challenges

The US Trade Representative (USTR) reports allege insufficient fortification and enforcement of the IPR regime. The clearer picture regarding the same between India and the US will come to a limelight when Prime Minister Narendra Modi visits the US. The US has put India on the priority watch list.
Though, India has its innate strength with the highest USFDA-approved plants going along with right pricing. It is high time for the world to find out that India is a producer of highest quality drugs at one fourth the pricing of branded pharmaceuticals.
The home commerce is at present facing major tests, one the most important of which are the patent issues. The chief dispute is to make the Indian government aware of the agenda of the developed countries to shut off reasonably priced medicines from India.

On the domestic front, we need to reorganise the process of regulation. When issues arise in medical experiment, companies look for alternatives and start doing the trials outside, and at a much higher cost. This affects the local. Hence, the pricing should focus on complete procession and maintain the prices consequently.

The issues that arise from the manufacturing side’s cost competitiveness. There have been requests to the government to set up manufacturing bunch that will be able to provide infrastructure, utilities, etc all under one roof and give a boost to manufacturing.

Growth in drug exports from India fell to 2.6% in FY14 to about $13 billion due to quality issues. Approximately two years back , there was a 23% rise in drug export value, this year again, it is approximated to be even. However, it is almost a surety that pharma exports from India will be more than the size of the domestic sales by FY15. Moreover, the government plans to create a special entity in partnership with private firms for a ‘Brand India Pharma’ campaign with the aim of improving the image of drug exporters.

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