NEWS OF THE W EEK
FAULTS FOUND IN INDIA’S DRUG AGENCY PHARMACEUTICALS: Parliamentary committee identifies weaknesses and seeks change of focus, better support
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COMMITTEE OF INDIA’S Parliament has found
that the agency charged with regulating pharmaceuticals in India has approved new drugs without ensuring that all requirements for approval were followed. The committee has also found that the agency is critically understaffed and underequipped. In a 118-page report, the Parliamentary Committee On Health & Family Welfare stresses that many of the problems it identified at the agency, the Central Drugs Standard Control Organization, are caused by skewed priorities. Instead of supporting the development of the pharmaceutical industry, as it is currently mandated to do, CDSCO should focus on ensuring that drugs sold in India meet the needs of Indian patients, the committee concludes. And to serve the Indian public, the report SHUTTERSTOCK
India’s Parliament House in New Delhi behind closed gates.
MAINTAINING MERIT REVIEW POLICY: International science summit highlights importance of merit review
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N A GROUNDBREAKING MEETING last week,
science policy leaders from 44 countries gathered outside Washington, D.C., to endorse a set of fundamental principles underlying merit review. The two-day Global Summit on Merit Review, hosted by the National Science Foundation, affirmed the importance of merit review to science worldwide. Merit review—supporting research strictly based on its scientific merit—is a fundamental tenet of science funding in the U.S. and Europe but a work in progress in many developing countries. “This global summit is the first step toward a more unified approach to the scientific process,” NSF Director Subra Suresh said at a May 15 press conference announcing the principles. “Good SANDY SCHAEFFE R
Oliva (from left), Suresh, and Kleiner discuss merit review with the press on May 15.
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says, the agency needs more and better qualified employees. The committee recommends that the agency, currently headed by an interim manager, recruit a highcaliber person, comparable to Margaret A. Hamburg, the commissioner of the U.S. Food & Drug Administration. CDSCO’s focus on serving the drug industry has had undesirable consequences, the committee reports. From a random sample of 42 drugs approved between 2000 and 2011, the committee found that 11 had been cleared without going through required Indian clinical trials. Among the drugs the committee singled out is GlaxoSmithKline’s pulmonary arterial hypertension treatment Volibris, sold in the U.S. as Letairis. GSK responds that its 2010 approval was proper. Indian authorities had waived the need for local trials, the firm says, because the disease is debilitating and GSK had already conducted global trials on patients of various ethnicities. The committee similarly faulted the approval of Novartis’ Afinitor, used to prevent the rejection of transplanted organs and to treat kidney cancer. Novartis says the drug was properly approved without latestage Indian trials because it treats life-threatening and debilitating conditions. Separately, the parliamentary committee notes that CDSCO lacks the staff and technology needed to manage documents. The committee identified three drugs on sale in India that are missing a paper trail for their approval.—JEAN-FRANÇOIS TREMBLAY
science anywhere is good for science everywhere.” The summit endorsed six principles: expert assessment, transparency, impartiality, appropriateness, confidentiality, and integrity and ethics. The statement of principles is the culmination of a year of work, including five regional meetings of global science policymakers. Many developing countries need guidelines like these as they create their own science-funding policies, Glaucius Oliva, president of Brazil’s National Council for Scientific & Technological Development, explained at the press conference. For example, Brazil’s government is enacting new openness measures that Oliva fears might lead to court battles to reveal merit review deliberations. “An international statement that [confidentiality] is a fundamental principle of science is an important one,” he said. The summit was the founding meeting of the Global Research Council, which will gather annually to discuss important challenges facing science worldwide and develop guiding principles for science policymakers. The next meeting, hosted by Brazil and Germany, will tackle research integrity and open access to research. Matthias Kleiner, president of the German Research Foundation, said creating a council makes sense because science is international by nature. “But it is not easy because science is a question of cooperation and it is also a question of competition,” he said. To balance that, “I think we need many more standards and principles on which we agree.”—ANDREA WIDENER
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