India amends law to make generic drugs safer - C&EN Global

Bioequivalence studies are conducted to establish that two medicines, normally the original patented drug and a generic version, work in the same way,...
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PESTICIDES

▸ Industry disputes chemicals’ risks to endangered species

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Manufacturers of three organophosphate insecticides are urging EPA to abandon its process for assessing the risks of pesticides on endangered species. The companies— Dow AgroSciences, Makhteshim Agan of North America (Adama), and FMC Corp.— claim that EPA’s approach is fundamentally flawed. At issue are biological evaluations of three pestiS cides—chlorpyriN O P O fos, diazinon, and malathion—reO leased by EPA in Cl the final days of the Chlorpyrifos Obama Administration. The evaluations conclude that the three chemicals are likely to adversely affect more than 1,000 endangered species. The three companies claim that EPA failed to adequately describe its risk assessment approach, making it difficult to evaluate and reproduce the results. The companies are also questioning EPA’s use of studies that were not evaluated for data quality and relevance and why the agency failed to consider several studies submitted by the pesticide industry. In addition, the companies say that EPA’s estimates for exposure to the pesticides are “unrealistically high and sometimes physically impossible.” The Center for Biological Diversity, an environmental group, says that Dow is profiting by pressuring the Trump Administration to scrap efforts to regulate pesticides.—BRITT ERICKSON

PHARMACEUTICALS

CREDIT: SHUTTERSTOCK

▸ India amends law to make generic drugs safer India has made bioequivalence studies mandatory for certain classes of generic drugs before they are launched. The move is to ensure that generic medicines have the same quality and efficacy as their branded counterparts. Bioequivalence studies are conducted to establish that two medicines, normally the original patented drug and a generic version, work in the same way, to the same extent, and for the same purpose. India’s Drugs & Cosmetics Rules, 2017, have been formally amended to require bioequiv-

CHEMICAL REGULATION

New York to require disclosure of chemicals in cleaning products New York is poised to become the first U.S. state to require manufacturers to disclose ingredients in household cleaning products. Under a regulation proposed on April 25 by Gov. Andrew M. Cuomo (D), manufacturers would be required to reveal all of the chemicals, including impurities, in cleaning products sold in New York. In addition, manufacturers would have to provide a range of how much of each chemical by weight is in their cleaning products. Companies would need to display the information on their websites, which will eventually be linked to a database called the Interstate Chemicals Clearinghouse. “These new regulations will help protect New Yorkers and give them the peace of mind of knowing what’s in their Makers of household homes and in their communities,” Cuomo says. cleaning products will The American Cleaning Institute, a trade group for soon have to disclose the U.S. soaps and detergents industry, claims that ingredients if they are manufacturers already provide “detailed informasold in New York. tion online about the ingredients in the products they use safely and effectively every day.” New York’s Department of Environmental Conservation is accepting comments until June 14 on the draft disclosure certification form that cleaning product manufacturers would need to file to sell their products in New York.—BRITT ERICKSON

alence studies on generic drugs with low solubility. The move follows the government’s recent effort to ensure that doctors prescribe generic medicines that are priced far lower than branded ones. Currently, generic drugs that have been in India for less than four years are required to undergo bioequivalence studies if they are in use in developed markets such as the U.S. and Europe. Generics that entered the market four or more years ago require permission only from state licensing authorities, who are not required to demand bioequivalence studies.—K. V.

VENKATASUBRAMANIAN, special to C&EN

NUCLEAR POWER

▸ U.S. lawmakers consider bill to restart waste repository Lawmakers in a U.S. House of Representatives subcommittee last week considered draft legislation that would revive stalled

plans for managing the nation’s nuclear waste stockpile at Nevada’s Yucca Mountain. Rep. John Shimkus (R-Ill.), chairman of the House Energy & Commerce Subcommittee on Environment, offered the draft to guide discussions aimed at finalizing long-awaited comprehensive nuclear waste legislation. The draft bill would grant the federal Department of Energy jurisdiction over the land in Nevada on which Yucca Mountain sits and prevent the state from refusing to issue needed air and water pollution permits for the proposed geologic repository. Nevada lawmakers criticize the draft, saying that it preempts states’ rights and ignores national security risks related to transporting nuclear waste to the site. Shimkus says the draft bill is the outcome of six years of hearings about Yucca Mountain. Interim storage and permanent disposal of nuclear waste stalled under the Obama Administration, which halted licensing for the repository in 2010. President Donald J. Trump’s proposed fiscal 2018 budget would restart funding for a nuclear waste repository at Yucca Mountain and calls for $120 million to restart licensing of the facility.—JESSICA MORRISON MAY 1, 2017 | CEN.ACS.ORG | C&EN

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