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.”

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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.

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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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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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Industry Groups Urge Lawmakers To Address Trade Policies With India's Regulators.

Reuters (3/14, Palmer) reports executives from agricultural, pharmaceutical and technology industries on Wednesday, called for the US government to step up pressure on India to revise its trade and intellectual property policies, which the industry reps claim are stifling US exports and violating its patent rights. In testimony before the House Ways and Means trade subcommittee, Pfizer's Chief Intellectual Property Counsel Roy Waldron said the protectionist policy India has developed to enable its generic drug makers to thrive is hurting US employment growth. He cited several examples, such as India's revocation of the patent Pfizer held on the cancer treatment Sutent (sunitinib malate), emphasizing the country's tendency to dissolve drug patents by issuing compulsory licenses, which are supposed to be awarded only in certain situations. Waldron concluded his testimony by urging Federal lawmakers to address those issues actively, though direct talks with Indian regulators and to use available policy standards to compel India to honor intellectual property rights.

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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