For our friends in India, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in India, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         

What are the areas of potential risks when undertaking global clinical trials in emerging markets?

GCPs in Emerging Countries

What are the GCP quality trends in US and emerging countries?
Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
Partnering and #outsourcing in India: Strategies for integrating diverse skills around operational deliverables.
A Regulatory Perspective of Biosimilars in Emerging Markets
What are similarities/differences in biosimilar regulatory requirements in APAC and Latin America?


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Indian pharma expects US FDA’s SUPAC Mfg Eqpt Addendum to boost global regulatory compliance

Policy & Regulations

Nandita Vijay, Bengaluru Friday, April 12, 2013, 08:00 Hrs [IST]

The Indian pharma industry expects the US FDA's recently released SUPAC (scale-up and post-approval changes): Manufacturing Equipment Addendum will further give fillip to faster clearances in plant audit and product approval. After releasing the Addendum, the US regulatory authority is seeking comments from the pharma industry before June 30, 2013. India already has over 170 US FDA approved units and has bagged 178 Abbreviated New Drug Applications (ANDAs) in 2012 which is over 34 more than the 2011. These include companies from Aurobindo to Biocon, Dr Reddy’s Labs, Lupin, Sun, Indoco Remedies, Ranbaxy and Strides Arcolab. Now with a strong focus for generic drug prescriptions from the governments of US, European Union and Japan, there are many Indian companies exporting to these markets. Therefore the new draft guidelines on scale-up and post-approval changes: Manufacturing Equipment Addendum will only strengthen compliance to the global regulator’s requirements, said representatives from pharma industry. The draft guidance combines the scale-up and post-approval changes for industry for the immediate release and modified release solid oral dosage forms and non-sterile semisolid dosage forms. It removes the lists of manufacturing equipment that were in both guidance and clarifies the types of processes being referenced.

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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? 

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).

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

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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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Book Now to Enjoy Insightful Sessions in May Dear Colleagues, Due to unavoidable circumstances we will be postponing the 6th Regulatory Conference in India. The conference will now be held on Thursday 23rd and Friday 24th May at the Courtyard Marriott in Ahmedabad, Gujarat. It is DIA’s constant endeavor to bring to you world class programs with renowned speakers. We hope you can join us at the conference in May. Seats are still available for the event. Please take a look at the conference program to find the sessions that interest you and register today. Best regards, DIA India Read More Download Program Register

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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.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

Subscribe to the DIA Daily.
View archives.
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.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191

Book Now to Enjoy Insightful Sessions in May Dear Colleagues, Due to unavoidable circumstances we will be postponing the 6th Regulatory Conference in India. The conference will now be held on Thursday 23rd and Friday 24th May at the Courtyard Marriott in Ahmedabad, Gujarat. It is DIA’s constant endeavor to bring to you world class programs with renowned speakers. We hope you can join us at the conference in May. Seats are still available for the event. Please take a look at the conference program to find the sessions that interest you and register today. Best regards, DIA India Read More Download Program Register

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Stay competitive in the world market despite ever-evolving pharma regulation - Date changed to May 23-24th in Ahmedabad

Date changed to May 23-24 - Same venue Courtyard Marriott, Ahmedabad

Plan Your Attendance to Gain Valuable Insight Staying competitive in the world market despite ever-evolving regulation is the hot topic at India’s largest conference on regulatory affairs – the 6th Regulatory Conference. The two-day event, to be held in Ahmedabad, Gujarat on May 23-24, will bring together prominent industry experts, senior management professionals, academicians, and regulators to share the knowledge they’ve gained from decades of experience and note-worthy contributions to the development of the Indian pharmaceutical industry. Attendees will discuss what the current challenges are in the field and decide proactive measures that could be taken by the industry. Read More Download Program Register Other events of Interest Download the India Calendar of Events Check Out These Session Highlights and Get Ready for the 6th Regulatory Conference in India. Quality by Design (QbD) Approaches in Drug Development Regulatory in Aseptic Technologies Anticipating Regulatory Deficiencies – Post Filing Regulatory Pathway in Biosimilars Role of Biological Assessment in Drug Discovery ICH Q11 – Challenges in Implementation Challenges in Harmonization in Quality/Regulatory System in Indian Perspective Laboratories Expectations in Regulatory Market Environment Meeting Regulatory Expectations in Drug Devices Despite Formal Laid Down Regulatory Guidelines Who Should Attend Professionals with experience in clinical safety and who are involved in: Regulatory Affairs from Government and Industry Clinical Research and Development Safety and Pharmacovigilance Clinical Trial and Project Management Chemistry, Manufacturing and Controls/Quality Quality Assurance and Quality Control Product Development Read More Download Program Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partners

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