Showing posts with label generic drugs. Show all posts

Wednesday, April 17, 2013

MHRA not to open Indian office but prefers sending expert inspectors: Gerald Heddell

from Pharmabiz.com http://www.pharmabiz.com/NewsDetails.aspx?aid=74806&sid=1

Nandita Vijay, Bengaluru
Tuesday, April 16, 2013, 08:00 Hrs [IST]

The UK based Medicines and Healthcare products Regulatory Agency (MHRA) has not considered setting up an Indian office on similar lines of US FDA which has an India centre at New Delhi. Instead, it has decided to interact with the Indian pharma industry who are seeking MHRA approvals through seminars and discussions, said Gerald Heddell, director of Inspection, Enforcement and Standards, MHRA.

India has 141 MHRA approved plants which is around 20 short of the US FDA certified facilities. “We decided not to open an Indian office because almost every week of the year barring the monsoons phase, MHRA inspectors are in this country. Although, we have a presence, maintaining a small team in India with the necessary breadth of expertise across a broad range of activities would not be easy. However, MHRA prefers to send in its expert inspectors and also often engage in meetings rather than open an India office, Heddell told Pharmabiz.

“Indian pharmaceutical industry has a strong foundation in supply of generic drugs. But the industry may consider moving forward into biosimilars and ultimately into developing more innovative drugs. There are already a number of ongoing clinical trials in phase II and III which is a move in the right direction. The future of India does not lie in generics alone but biologicals and innovative products, he said.

In order to strengthen the relationship with India, the Drugs Control General of India (DCGI) office and the MHRA are in the process of inking a memorandum of understanding. This will bring in a better understanding between the regulators in India and the UK and enable working together.

Recently, the MHRA also brought in the National Institute for Biological Standards and Control and the Clinical Practice Research Data under its umbrella, he said.

Commenting on the recent moves of MHRA including the Innovation Centre, Heddell said that the initiative would help to work closely with the industry and share new approaches to licensing and manufacture ensuing safe and high quality drugs for the benefit of patients.

“The falsified medicine directive to be implemented for APIs from July 1, 2013 is a major piece of European legislation. There are many aspects of it like product security, regulation of some people who broker products and importation of active ingredients with the requirement for a written statement from the regulatory of the country of origin. An official from the DCGI office has assured that, India would be able to provide the written confirmations to this effect,” he said.

“All our audits are triggered by a Marketing Authorisation in Europe or UK. The approval of a Marketing Authorisation in the European system works to a fixed time scale of 210 days from validation of application to agreement. The inspection schedules fit in with those applications. However, it would be vital for a prospective Indian company seeking certification to discuss in advance their intention for our audit. There are no plans to decrease the time frame for application and approval of Marketing Authorisation as it is dictated by the European Commission,” he said.

On the presence of two regulators in the EU: European Medicine Agency (EMA) and MHRA, Heddell said that the MHRA is seen as an ideal and efficient route to enter Europe. “We do more work on behalf of Europe than any of the 27 EU countries. We are the leading agency and so contact with the MHRA is a best way to start to apply for drug licenses in the EU.”

Sunday, April 7, 2013

Just because companies make drugs, should they aspire to less profits than a firm that makes trendy electronic goods?

by Narayan Ramachandran for Live Mint
For complete article, click here: http://www.livemint.com/Opinion/zqnV2T5dz0XaGITEmSHfqI/Patently-unfair.html

The story of the Supreme Court turning down Novartis’s patent petition for a new and improved Glivec is well known. Less known is that the decision, made on the basis of Section 3(d) of the Indian patent law, is really a technical ruling rejecting the new and improved idea. A patient sympathizer would say the improved notion was merely an attempt by the company to evergreen the drug by extending the patent regime and keeping out generics for longer. A patent sympathizer would say the improved version was truly a more efficacious drug; how is a company to innovate if it cannot protect its innovation? Precisely how a court of law was able to adjudicate on such a technical matter (reasonable experts may well differ) is not clear, but the ruling is binding.

The fight is really about the future. It is about how different the future of the pharmaceutical industry will be from its past. It is about the pricing of drugs. It is about how governments will go about balancing patent and patient in a world in which the gap between rich and poor is wide (both within a country and internationally). Could we have a different price for inner city Washington DC, Kenya and India from that in the developed markets? Should the full impact of that differential be borne by the pharmaceutical company or also by the chain of stakeholders—rich consumers, insurance companies and governments?

Wednesday, April 3, 2013

Western Drugmakers Expected To Practice Caution After Patent Defeat In India.

Reuters (4/3, Hirschler, Kulkarni) reports on Western drugmakers' reaction to a landmark patent defeat in India. Amit Backliwal, who heads South Asian operations for IMS Health, remarked, "India is too big to ignore. Companies will definitely get cautious, and it definitely means a change in their business model, but I don't think they will pull out." Raghunath Mashelkar, former director general of the Council for Scientific and Industrial Research and an architect of India's IP policies, added, "Drugmakers will have to work out strategies for the lower sections, to give affordable access to medicines and make money by large volumes and smaller margins. And then they will look at the middle and the upper sections and make money through smaller volumes but higher margins."

US Business Reacts To Ruling.Reuters (4/3, Palmer) reports that the US Trade Representative's office is considering its response to the ruling, while the US-India Business Council and other business groups have criticized it.

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Tuesday, April 2, 2013

India's Supreme Court Allows Continued Low-Cost Generics.

The New York Times (4/2, A1, Harris, Thomas, Subscription Publication) reports in a front-page story, "Production of the generic drugs in India, the world's biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court," meaning the populations of developing countries "will continue to have access to low-cost copycat versions of drugs for" HIV and cancer. The court ruled that a previous patent for Novartis' Gleevec prevented the company from taking out a new patent on the drug. According to the Times, "the debate over global drug pricing is one of the most contentious issues between developed countries and the developing world." Because the US allows companies to repatent a drug by altering its formula or changing its dosage, the country "pays the highest drug prices in the world." Now, "the United States government has become increasingly insistent in recent years that other countries adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States."

The Washington Post (4/1, Lakshmi) reports, "Many international drug companies have said that the Novartis trial was crucial to addressing the rapidly growing perception around the world that India's patent protection system for drugs is weak." Recently, "other Western pharmaceutical companies have been facing similar patent-related setbacks in India." While health activists and Indian drug companies argue "most Indians cannot afford expensive patented drugs," the ruling also "is a huge boost for India's $26 billion generic drug industry."

The New York Times (4/1, Gottipati) reports in its "India Ink" blog, "The case represents a high-stakes showdown between defenders of intellectual property rights, who say generic versions stifle innovation by drug makers, and Indian drug companies and international aid groups, who warned that a ruling in favor of Novartis could have dried up the global supply of inexpensive medicines to treat AIDS, cancer and other diseases."

The AP (4/2, George) reports, "Novartis called the ruling a 'setback for patients,' and said patent protection is crucial to fostering investment in research to develop new and better drugs. Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling 'will hinder medical progress for diseases without effective treatment options.'"

Another AP (4/1) story reports, "Major drugmakers such as Pfizer and Bayer AG on Monday declined to say what they might do regarding the ruling and other recent decisions by poor countries to let local drugmakers sell cheap generic versions for medicines that have monopolies under patents in Western countries. ... One thing is clear, though: Emerging markets are not the gold mine that optimistic pharmaceutical executives have been making them out to be."

The Los Angeles Times (4/1, Alpert) reports, "Despite its objections to the ruling, Novartis said it was unlikely to challenge the court decision." Meanwhile, Tahir Amin, co-founder of the Initiative for Medicines, Access and Knowledge, "said the next battleground for generic drugs will be a Pacific free trade agreement under negotiation among a long list of countries, including the U.S., Canada, Mexico, Vietnam and Malaysia."

Also reporting this story are the Wall Street Journal (4/2, Subscription Publication), Bloomberg News (4/1, Von Schaper, Patnaik), Reuters (4/2), another Reuters (4/2), The Hill (4/2, Viebeck) "Healthwatch" blog, Time (4/1), NPR (4/1) "The Two Way" blog, Forbes (4/1), and BBC News (4/2).

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Monday, April 1, 2013

Indian Supreme Court Denies New Patent For Cancer Treatment.

The AP (4/1, George) reports, "India's Supreme Court on Monday rejected drug maker Novartis AG's attempt to patent a new version of" cancer treatment Glivec (imatinib mesylate), "in a landmark decision that healthcare activists say ensures poor patients around the world will get continued access to cheap versions of lifesaving medicines." The case "has global implications since India's $26 billion generic drug industry supplies much of the cheap medicine used in the developing world." India's patent office didn't issue a fresh patent for the medicine "because it was not a new medicine but an amended version of its earlier product," citing "a legal provision in India's 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes," which is called "evergreening."

The New York Times (4/1, Harris, Subscription Publication) reports, "The court's ruling confirmed that India's criteria for the granting of such patents remain far higher than those in the United States, where patents are so easy to win that one was given in 1999 for a peanut butter-and-jelly sandwich." The Times adds, "In recent decades, the United States has become increasingly insistent that countries wishing to do business there adopt far more stringent patent protection rules, with the result that poorer patients often lose access to cheap generic copies of medicines when their governments undertake trade agreements with the United States."

Bloomberg News (4/1, Von Schaper, Patnaik) reports the decision was "watched by non-profit groups seeking to expand access to medicines and drugmakers concerned about India's position on intellectual property." This "may add to concern among Western pharmaceutical companies that India is allowing domestic generic-drug makers to profit from products that deserve patent protection." India also "angered pharmaceutical companies by allowing generic-drug makers to produce copies of patent-protected medicines to ensure they're available in the country at affordable prices."

The BBC News (4/1) reports a month of Glivec costs about $2,600, compared to $175 for the same amount of its generic equivalent in India. Reuters (4/1, Mohanty, Kulkarni) also covers this story.

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Monday, March 25, 2013

High Court To Consider Settlements That Slow Entry Into Generic Drug Market.

USA Today (3/25, Wolf) reports, "Consumers will have billions of dollars on the line today when the Supreme Court hears the government's case charging antitrust collusion between brand-name and generic drugmakers. What's in dispute, though, is whether the questionable deals cheat consumers - or whether they come out ahead." The Federal Trade Commission "has been on a decade-long crusade to stop settlements in which brand-name drugmakers pay generics to stay out of the $250 billion U.S. drug market for a specified number of years," but drug manufacturers "say that without such settlements, millions of dollars would be wasted in litigation, and when generics lose patent challenges, the lower-cost drugs would remain off the market even longer, until the patent expires."

The New York Times (3/25, Wyatt, Subscription Publication) reports, "The case, Federal Trade Commission v. Actavis, No. 12-416, centers on whether the maker of a brand-name drug can pay a generic-drug company to keep the generic version off the market. Based on antitrust law, the obvious answer would seem to be no, the view voiced by the government and most recently upheld by a federal appeals court. At least three other federal appeals courts have previously said those payments are legal, however, when made under the settlement of a patent infringement lawsuit. Those courts sided with drug company arguments that the payments are what Congress intended in setting up guidelines to encourage the production of generic drugs. The question before the justices pits a company's constitutional right to protect its intellectual property - through reliance on a patent that excludes competitors - against antitrust law, which holds that a company cannot unfairly exclude others from legitimately entering a business with a rival product."

The AP (3/25, Holland, Johnson) reports, "The Obama administration, backed by consumer groups and the American Medical Association, says these so-called 'pay for delay' deals profit the drug companies but harm consumers by adding 3.5 billion annually to their drug bills. But the pharmaceutical companies counter that they need to preserve longer the billions of dollars in revenue from their patented products in order to recover the billions they spend developing new drugs. And both the large companies and the generic makers say the marketing of generics often is hastened by these deals."

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iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

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Monday, March 18, 2013

Generic drugmakers concerned over FDA turmoil

Director of OGD resigns after 8 months as his office loses staff

Read more: Generic drugmakers concerned over FDA turmoil - FiercePharma http://www.fiercepharma.com/story/gerneric-drugmakers-concerned-over-fda-turmoil/2013-03-15#ixzz2NtWD0aBy
Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma

Generic drugmakers are feeling a little taken advantage of. They produce 80% of the drugs used in the U.S. Their products are saving federal health programs billions of dollars, and they are now helping cover some of the FDA budget through user fees. But it took the FDA two years to fill the top position at the Office of Generic Drugs (OGD), and then after 8 months the new director, Dr. Gregory Geba, is calling it quits. His resignation today comes as about half the OGD staff is being reassigned to a new office overseeing quality.

Ralph Neas--Courtesy of GPhA

"Now, with Dr. Geba's departure, we are significantly concerned about further disruption at the FDA," Ralph Neas, CEO of the Generic Pharmaceutical Association (GPhA), said in a statement Thursday. "These vacancies and changes hold the potential to distract from the critical mission of the OGD, and slow the flow of information, guidance, and approvals needed to achieve an optimal generic drugs market for patients, payers and the health care system ... We trust that FDA is doing everything possible to ensure that the Office of Generic Drugs is fully staffed so that it can continue its regulatory mandate and GDUFA implementation."

Read more: Generic drugmakers concerned over FDA turmoil - FiercePharma http://www.fiercepharma.com/story/gerneric-drugmakers-concerned-over-fda-turmoil/2013-03-15#ixzz2NtW8WKaa
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Thursday, February 28, 2013

Groups to Ala. Supreme Court: Reconsider generic-drugs decision

Groups to Ala. Supreme Court: Reconsider generic-drugs decision
Business groups led by the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America are pressing the Alabama Supreme Court to reconsider its ruling that makes brand-name drugmakers liable for injuries caused by generic versions of their treatments. "By essentially absolving [generic-drug-makers] of any responsibility, you're saying they don't have to perform that job very carefully," PhRMA General Counsel Mit Spears said. In a separate court brief, the Chamber of Commerce said the decision "threatens to unleash the plaintiffs' bar on all manufacturers doing business in Alabama" and "eviscerates basic tort limitations." The Wall Street Journal(2/24)

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Report: Fifth of global generic drugs produced in India

Report: Fifth of global generic drugs produced in India
India manufactures 20% of the world's generic injectables, capsules and tablets, according to data released by Union Health Minister Ghulam Nabi Azad. "The Industry is ranked third globally in volume and 14th in value, supplying around 10% of total global production," Azad said. "This also amounts to around 20% of total volume of global generics." PharmaBiz.com (India)(2/23)