Campillo-Meseguer, María-José and Galiano-Martínez, Antonio and Gómez-Hernández, José-Antonio and Hidalgo-Pérez, Antonio and López Aniorte, María-del-Carmen and Martínez-Navarro, Emilio and Molina-Molina, José and Mayor-Balsas, José-Manuel and Ros-Media, José Luis and Oliva-Palazón, Elena and Reverte-Martínez, Francisco-Manuel and Baeza-Hernández, María-José . Educar para la transparencia y una ciudadanía informada: diseño, aplicación y evaluación del programa IRIS para alumnado de Bachillerato de la Región de Murcia (España)., 2020 In: Competencias en Información y Políticas para Educación Superior: Estudios Hispano-Brasileños, volumen 1. Universidad Complutense de Madrid, pp. 123-138. [Book chapter]
Nenko, Yuliia and Кybalna, Nelia and Snisarenko, Yana The COVID-19 Distance Learning: Insight from Ukrainian students. Revista Brasileira de Educação do Campo, 2020, vol. 5, pp. 1-19. [Journal article (Paginated)]
Verdugo-Sánchez, José-Alfredo La medición de la satisfacción de usuarios como indicador de calidad en los sistemas bibliotecarios: el caso de las universidades públicas de noroeste de México., 2015 PhD Thesis thesis, Universidad Complutense de Madrid. [Thesis]
Gómez-Hernández, José-Antonio . Leer, escribir y aprender con Internet. La función educativa de las bibliotecas y las tecnologías participativas de la web social., 2008 In: Infodiversidad. La biblioteca como centro multicultural. Universidad de Guadalajara, pp. 55-74. [Book chapter]
Sequeiros, Paula . Cosas de mujeres: lectura y penitenciaría., 2019 In: Las prácticas de lectura en los recintos penitenciarios de la región de Valparaíso. Universidad de Playa Ancha, pp. 91-101. [Book chapter]
Nazarovets, Serhii Controversial practice of rewarding for publications in national journals., 2020 [Preprint]
Anton, Laura and Guallar, Javier Análisis de los servicios 'a la carta' de las televisiones autonómicas españolas., 2020 . In IV Congreso ISKO España y Portugal, Barcelona, 11-12 July 2019. [Conference paper]
Sequeiros, Paula and Silveira, Fabrício José Nascimento da and Rivera Donoso, Miguel and Armingol Jaime, Karla and Díaz Rubio, Sara and Sáez Alarcón, Daniela and Muñoz Muño, Alexia and Saurin Parra, Julia and Cosgrove, Kimberly and Parra, Pablo and Barbosa, Andreza Gonçalves and Piñeiros, Gabriela . El libro y la lectura en los recintos penitenciarios de la región de Valparaíso., 2019 Universidad de Playa Ancha. [Book]
Saurin-Parra, Julia . El aspecto social de la biblioteca pública y la inclusión social de las minorías., 2019 In: El libro y la lectura en recintos penitenciarios. Gráfica Nacional, pp. 73-81. [Book chapter]
Baños-Moreno, María-José and Valentín-Ruiz, Francisco-José and Blázquez-Martín-de-las-Mulas, Antonio e-EMGDE, RIC, NEDA y las normas de codificación: más allá de un perfil de aplicación en archivos., 2019 . In IV Congreso ISKO España-Portugal, Barcelona, 11-12 de julio de 2019. [Conference paper]
Guallar, Javier and Cornet, Anna Centros de documentación de diarios en el siglo XXI. Panorama después del tsunami. BiD, 2020, n. 44. [Journal article (Unpaginated)]
Cuevas-Cerveró, Aurora and Razquín-Zazpe, Pedro and Parra-Valero, Pablo and Barrios-Martínez, Cristina and Gómez-Hernández, José-Antonio . Accesibilidad informacional y diversidad funcional en el contexto universitario: el caso de la Universidad Complutense de Madrid., 2020 In: Competencia en Información y Políticas para Educación Superior: Estudos Hispano-Brasileiros. Universidad Complutense de Madrid, pp. 132-146. [Book chapter]
Six years ago, the then editor of the Hindustan Times invited me to write a fortnightly column. I agreed, on condition that there would be no censorship. While occasionally some changes to my text were made without my consent, there was no attempt to get me to rewrite my column or change its arguments. Until [...]
Years ago, working in the archives in New Delhi, I came across a brief, handwritten, letter from Jawaharlal Nehru to C. Rajagopalachari. It was dated 30th July 1947, and it read: ‘My dear Rajaji, This is to remind you that you have to approach Shanmukham Chetty—this must be done soon. I have seen Ambedkar and [...]
The 19th century Italian writer Emilio Salgari once remarked that ‘reading is travelling without the bother of baggage’. That is great advice, particularly in the time of COVID-19. Now that one is forcibly home-bound, works of literature and of scholarship can help transport one to different countries, different times. They can stimulate the mind, and [...]
On 30th January I was in Ahmedabad, a city that was central to Mahatma Gandhi’s life and work. It was here that he established the most celebrated of his ashrams, on the banks of the Sabarmati River; here that he revised and refined his moral and political philosophy; here that he conceived and planned the [...]
As I have written before, if India had been a start-up in August 1947 not even the most venturesome of venture capitalists would have invested in it. No new nation was born in more inhospitable circumstances. The Partition of the country had been awful enough, in the scale of its violence and the mass displacement [...]
In December 2018, I was having lunch with an entrepreneur-friend who works closely with the Central Government. The BJP had just lost state elections in Madhya Pradesh, Rajasthan and Chattisgarh, putting three Chief Ministers out of office and out of work. I suggested to the entrepreneur that when the Prime Minister won re-election the following [...]
There have been many protests against the Citizenship Amendment Bill (now Act), and there will be many more. This piece of legislation strikes at the heart of the Constitution, seeking to make India another country altogether. It is thus that so many people from so many different walks of life have raised their voices against [...]
On 26th January 2006, the New York Times ran a story headlined ‘India Everywhere in the Alps’. The story began: ‘Delhi swept into Davos on Wednesday, with an extravagant public relations campaign by India intended to promote the country as the world's next economic superstar, and as a democratic alternative to China for the affections [...]
In December 1947, the annual Indian History Congress was held in Bombay. The President-elect that year was Professor Mohammad Habib of the Aligarh Muslim University, a historian of early medieval India, known especially for his studies of the Delhi Sultanate. From the late 1930s, many students and faculty at AMU had been active supporters of [...]
Mahatma Gandhi famously claimed that ‘India lives in her villages’. The focus of his political and social work, and his philosophical writings, was that India was essentially an agrarian civilization, and that it must remain that way. In fact, India had always lived in her towns too. Our epics spoke of the fabled cities of [...]
Posted by Roger BateThe World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began [...]
Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...]
Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations. Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price. But researchers (in [...]
Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...]
Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...]
Posted by Roger Bate (on behalf of the authors of the paper) India’s pharmaceutical industry wants its government to sue us because of our “smear campaign” against it (Click here) and if today’s media in India are correct, India’s government is considering it (Click here). This so-called campaign is actually an academic study which identifies uncomfortable data that some Indian companies, or their distributors, seem to be sending inferior medicines to Africa (s [...]
Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]
Posted by Roger Bate A Star Newspaper investigation of drug quality in Canada (see here) demonstrates the risks patients in rich nations like Canada run from receiving poor quality medicines, especially imported from India. What is most worrying is the lack of transparency at some western health agencies. What the investigation shows is that Health Canada has hidden information about problems with medications. While it is true that educated people occasionally make bad medicine choices (think [...]
Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) On September 8, we posted a blogspot about our recent article published in Health Law in Canada, in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally. We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating. We offered example [...]
Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa) In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada. Worse, 32 of the drugs were found to be counterfeit. All of these pacakges were ente [...]
Congress is starting to consider ways to address the budget cap problem that hangs over the entire FY 21 appropriations process for non-defense discretionary (NDD) programs. Last year, Congress broke a long-running stalemate by agreeing to budget caps for FY 20 and FY 21. They decided to front-load the increases, making spending decisions (relatively) easier […]
Top-line: Congress is inching forward on the FY 21 appropriations process. However, neither the House nor the Senate has adopted rules permitting virtual committee mark-ups. Also hanging over the process is the tight budget ceiling for non-defense discretionary (NDD) programs. Various ways it might be solved and implications for FDA are discussed in this week’s Analysis […]
FDA — along with NIH, CDC, and other front-line public health agencies — is caught up in the urgent COVID-19 efforts. Appropriately, enormous resources are being devoted to fighting the pandemic and more funding will come, if needed. At the same time, we are getting positive reports on the FDA’s efforts to carry out the […]
Top-Line: This week we look at House and Senate schedules for returning to DC and starting on the FY 21 appropriations process. This week’s Analysis and Commentary explores the reasons why advances in science and technology foretell that FDA will need significant additional funding in FY 21. This column focuses on vaccine development. Senate Returns […]
Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […]
Top-Line: There is no new information about the appropriations schedule for Congress. The House will require a rules change for appropriators to work remotely. The death of former FDA Commissioner Donald Kennedy is noted. More on FDA’s extraordinary efforts to address food safety and supply issues. Eventually, Congress will need to address FY 21 funding and […]
The Alliance met (virtually) on April 15 with Dr. Caitlin Boon, FDA Associate Commissioner for Food Policy and Response and several of her colleagues. She described CFSAN’s and CVM’s role in responding to the current pandemic, as well as how the agency is assuring a continued safe food supply. About 50% of food spending in the […]
Top-line: The Congressional schedule and work practices are uncertain over the next few months, leaving many questions about whether and how appropriations bills will move forward. There is a possibility that increased funding at public health agencies, including FDA, may be exempt from FY 21 budget caps. The Alliance’s meeting with Dr. Boon, FDA Associate Commissioner […]
US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.
On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].
Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].
Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.
In response to the COVID-19 pandemic, authorities in Australia and the European Union have allowed drug producers to collaborate to ensure medicine production and supply.
An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.
Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.
The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.
There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.
US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.