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Tag search: "Generic Drugs"

Health systems

As drug prices drop, generics makers fight back with deals

Generic drug makers are turning to M&A to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices. One example is Impax, Perrigo and Alvogen who have all been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale to an outright sale of the units

July 27, 2017

FDA moves to prevent Pharma from 'gaming' generic drug system

The U.S. Food and Drug Administration moved to prevent pharmaceutical companies from "gaming" the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition. "We know that sometimes our regulatory rules might be `gamed` in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition," he said. "We are actively looking at ways our rules are being used and, in some cases, misused."

June 21, 2017

India proposes stricter quality checks for generic drug manufacturers

The Union Health Ministry’s proposed draft amendments to the Drugs and Cosmetics Act want generic-drug manufacturers to prove that the biological qualities of the new drug are equivalent to the original formulation

June 13, 2017
Hindustan Times

Japan government scraps proposals for drug-price cuts in policy guidelines

Japan has dropped proposals on price cuts for prescription drugs aimed at boosting the use of generic drugs, underscoring the government`s struggle to rein in bulging social security costs for a rapidly ageing nation, this step comes as Japan looks to boost the use of generics to 80 percent by September 2020 from about 56 percent now, thus saving the government hundreds of billions of yen every year. In an annual draft of policy guidelines that incorporated the change, the government floated the idea of lowering the prices of these prescription drugs to the levels of generic drugs. But the proposals were missing from the final version of the annual policy guidelines approved by Prime Minister Shinzo Abe`s cabinet

June 9, 2017

Lower Drug Costs Still ‘Absolute Priority’ for Trump, Price Says

Tackling the high price of prescriptions drugs in the US is still “an absolute priority,” Health and Human Services Secretary Tom Price told senators, and one way to lower costs is to enable more generics to come to the market. FDA Commissioner Scott Gottlieb said that the agency is looking at how to push applications to the front of the line in cases where there are fewer than three competing generic manufacturers. The FDA is seeking to eliminate within a year the backlog of 2,640 generic-drug applications, Gottlieb said

June 8, 2017

Cutting HIV and Aids treatments costs in South Africa

About 15% of India’s pharmaceutical exports arrive in Africa and in South Africa, in particular, with the availability of generic antiretrovirals from India leading to a significant drop in the cost of treatment for millions of people with HIV or Aids. The BBC’s Taurai Maduma reports on Africa Business Report for the BBC World Service

May 26, 2017

Narendra Modi’s generics drugs plan worries health experts, pharma sector

India’s plan to bring in a law to ensure doctors prescribe medicines only by their generic names risks proliferating the sale of substandard drugs in a country where regulation is already lax, doctors and pharmaceutical executives say

May 26, 2017
Live Mint

Japan to bring forward target for increased generic drug use: sources

Japan will bring forward a target to boost the use of generic drugs by six months to September 2020, two government sources with direct knowledge of the matter said. The rapidly aging nation is aiming to lift the use of generics to more than 80% from around 56% currently – a move that would save the government hundreds of billions of Yen, the sources said

May 22, 2017

Kerala Generic in pilot mode

To date, 111 molecules have been identified to be procured through leading branded companies and some ninety four of them have been bought Most of the drugs the generic company is planning to support will be for non-communicable diseases, so the biggest advantage will become price reduction For example, insulin which costs Rs145 in the marketplace would cost Kerala Generic Rs70. Six months into the pilot run drugs will be made available to the medical community, very likely through Neethi stores or at Supplyco outlets

May 21, 2017
The Hindu

Narendra Modi hints at rules for doctors to prescribe generic drugs

Indian PM Narendra Modi indicated that his government may bring a legal framework under which doctors will have to prescribe generic medicines, which are cheaper than equivalent branded drugs, to patients. Modi said his government had brought in a healthy policy after 15 years and capped the prices of medicines and stents, which has angered some pharmaceutical companies, and this new direction would be a possible next step

April 17, 2017
India.com, Hindu Business Line, Bangalore Mirror

India makes a long overdue move to ensure better drug safety

India has finally amended the law to make bioequivalence studies compulsory for certain classes of generic drugs manufactured in India. These studies establish that two medicines have the same biological equivalence, and they work the same way, to some extent and for the same purpose

April 12, 2017
Scroll India

Indian drugmakers face squeeze in U.S. healthcare market

India’s small and medium-sized generic drug makers say the threat of tougher rules and higher barriers for outsiders in the U.S. healthcare market will force many of them to find a niche, or focus their expansion efforts on other countries. India supplies just under a third of medicines sold in the U.S. and cut-price generics sold by Indian companies have been critical in bringing down prices

March 17, 2017

Trump Sends Pharma Stocks Down With New Tweet on Drug Prices

President Trump jumped back into the drug pricing debate, earlier in the week, sending pharmaceutical stocks downwards again with a tweet promising to lower medicine costs for American people. In the tweet Trump claimed to be ‘working on a new system where there will be competition in the drug industry’

March 7, 2017

Twenty U.S. states join generic drug price-fixing lawsuit

California, Illinois and 18 more states have joined a lawsuit, filed last year, alleging that six companies, including Mylan NV and Teva Pharmaceutical, conspired to push up prices of two generic drugs

March 1, 2017