Indian pharma cos upbeat over US govt move to import select set of pharmaceuticals to check price there

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Indian pharmaceutical manufacturers are upbeat over a move by Washington to explore ways to safely import a select set of drugs from foreign countries to lower the price of prescription medicine. The measure could provide some relief for the domestic drug manufacturers who are battered by the recent price erosion in the US market.

According to industry estimates, price erosion in the fourth quarter of the last fiscal in the US market was around 8-10 per cent and this is expected to continue in the current financial year.

“Since India has the highest number of Food and Drug Administration (FDA) approved drug manufacturing plants outside the US, the Trump administration’s plan will open the door to new opportunities for domestic drug manufacturers. Our generic companies have established a strong logistic network and also sell lot of off-patent drugs as well as biosimilars in India. If this plan becomes a reality, Indian companies can definitely reap benefits,” an industry lobby group representative opined.

The US Department of Health and Human Services said in a statement that the FDA was forming a working group to examine how the US could import medications from abroad in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities. The US media reported that Turing Pharmaceuticals, a US-based manufacturer, had hiked the price of its tablet for parasitic infection, Daraprim, from USD 13.50 to USD 750. The price hike came into effect after the company acquired Daraprim recently.

Washington has already released a blueprint to lower prices, and officials are looking to draw recommendations from the industry. Critics of the outline have said it is light on specifics.

However, the Pharmaceutical Research and Manufacturers of America said importing drugs, even in the very specific and narrow instances outlined by FDA, is not the answer. “Drug importation schemes circumvent the robust safety requirements we have in United States, posing a serious public health risk and jeopardizing our secure medicine system,” the industry group said in a statement. Instead, it said FDA should continue focusing efforts on increasing patient access to generic drugs.

Indian pharmaceutical companies have been adopting a slew of measures to tide over the pricing pressure in the US market. Dr Reddy’s has already announced plans to step up launches of value added products and some others such as Aurobindo are getting ready to diversify market presence beyond the US.

The Pharmaceuticals Export Promotion Council (Pharmexcil) data shows that exports are witnessing a turnaround. Though the cumulative data for 2017-18 shows a modest 2.91 per cent growth to USD 17.27 billion against USD 16.78 billion in 2016-17, the annualised shipments have shown a sharper increase of 7-14 per cent since November 2017.

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