According to two people who are familiar with this matter, Indian designs include the offer of low -cost complex generic drugs at sharply reduced costs, patent reforms that allow earlier generics in US, increased American production of Indian pharmaceutical companies active pharmaceuticals (APIs) and tariffs (FDF) Lifetime formats from life formats from Indian forms.
The API is the main component of the drug (Think Paracetamol), while FDF is a combination of two or more APIs in one drug, such as a tablet that contains both paracetamol and ibuprofen.
India’s offer comes against the alleged desire of the US administration sharply to reduce the prices of local drugs and gains importance with regard to every second regulation in the US has a generic drug created by the Indian company.
In the middle of US pressure to bring drugs to its mutual tariff regime, India suggested supplying comprehensive generic drugs to 20-25% of current branded prices in the first three years after the patent expired. Over the next seven years, there will be another 10-15% reduction in costs, people said the above on condition of anonymity.
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“Together with the price commitment of India, it has proposed to allow the final phase of the medicine-including the initial and completed dose forms-be performed in the US under the pressure of” make in America “Trump administration, said the first person cited above.
Other countries are reluctant to invest in the production of cheap generics based in the US, unless the products are highly valuable or there is no gap in delivery. “India has effectively managed this space,” this person said.
The other person stated that in patent reforms, Indian negotiators suggested the end of “evergreen” by American pharmaceutical companies and a reduction in the exclusivity of the patent from the end of India – steps that claim to significantly reduce drug costs.
The patent “Evergreening” is an alleged practice of serving new patents with secondary traits of pharmaceutical, as the earlier patents expire, extending the effective exclusivity of the patent after the original 20 -year period.
Currently, the Indian Patent Act – under Section 3 (a). D) of the Act on Patents – already establishing restrictions on evergreen, but India has now proposed tightening these provisions and at the same time shorten the duration or extent of exclusivity provided to new drug patents to speed up the availability of generics.
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“India also proposed tariffs exceptions for saving life and critical drugs with thin margins and called for greater transparency and public approach to American exports-Import data,” the other person said.
Certainly, the Indian delegation at a high level led by the main negotiator Rajesh Agarwal, another secretary of the Ministry of Commerce, returned from Washington on Sunday evening after the officials described as a positive round of interviews. According to Mint 16th May, the first trancho of the bilateral trade agreement (BTA) is expected to be completed to the 8th July-Data, which means the end of the 90-day pause on the reciprocal tariffs of US President Donald Trump.
Questions sent to the Pharmexcil Business and Industrial Association remained unanswered until the press period. The US Embassy spokesman said, “We do not comment on the ongoing bilateral negotiations.”
Depicting experts
The Indian offer comes in the middle of US President Donald Trump’s efforts to consolidate drug prices. On May 21st, Trump signed an executive order to reduce prescription prices by up to 80% according to the “most popular nation” rule, which followed US drug prices to the lowest worldwide.
“Although it can be beneficial to American patients, it could cause global prices and pressure countries like India to increase prices by tightening patent laws through commercial agreements,” said Ajay Srivastava, co -founder of a business tank Global Trade Research Initiative (Gtri) initiative.
“India has long resisted foreign pressure to change its patent laws, but India – UK FTA meant a shift, including provisions that exceed the ways. This could lead to other concessions in the EU and the US, which risked delayed generations and more expensive drugs in the global south,” Srivastava said.
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The Trips concerns an agreement on the aspects of intellectual property rights related to trade, the WTO pact, which sets minimum standards for intellectual property protection, including patents, trademarks and copyrights, across Member States.
“India must defend its patent regime, which ensures available approach, prevents monopoly expansion and protects public health. The world depends on the generations of India. The maintenance of this model is national and global imperative,” Srivastava added.
Biswayit Dhar, economist and business expert from Tank based in Delhi, the Social Development Council said that with President Trump dowrying about American societies, he would come down for the sale of high pricing medicines.
“Indian companies have to make the most of this opportunity,” Dhar said. “The PLI scheme must make full use of the production of pharmaceutical products. Together with Indian companies, they must ensure that their products fully meet strict American FDA quality requirements.”
Daara Patel, General Secretary of the Indian Drug Manufacturers Association (IDMS), said the US may not need generic plants immediately, but looking for API units. “The cost is very high to set up a units in the US; they also want to save money,” Patel said. “There is an incorrect idea that they have a system of insurance. Insurance also has restrictions. They want goods at available prices from India or our support to produce in the US itself.”
Generics Powerhouse
India is a key supplier of generic drugs for the US, with $ 10,52 billion worth exporting to the USA at FY25, according to Pharmexcil. Indian companies supply almost 47% of generics used in the US and underline their key role in the US health care system.
Data on the Ministry of the Ministry of Trade show that the segment has been constantly growing, exporting from $ 7.08 billion in FY22 to $ 7.55 billion in FY23, then sharply to $ 8.73 billion in FY24 and $ 10.52 billion in FY25.
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The US pharmaceutical market was awarded $ 634.3 billion in 2024. The Indian contribution of $ 10 billion in Generals helps the US to save around $ 216 billion per year by potentially replacing expensive patented drugs, according to Indian Brand Equity Foundation (IBEF), points of the Ministry of Commerce.
This means that there is still a huge market opportunity of $ 624 billion for India. If the US decides to stop the evergreen patents, many patented drugs will fall into generics. If $ 400 billion is translated from a patent to the general of $ 634 billion, it will add to the generic drug segment.
(Tagstotranslate) US tariffs
