根据天水汉博药业有限公司报告，自公告之日起至2026年5月15日暂停药品经营，停业期间不得开展药品经营活动，请社会各界予以监督。特此公告。企业名称天水汉博药业有限公司 注册地址 天水市麦积区花牛镇曹家埂村建工机械市场内东南侧 许可证编  号 甘AA938000179 有效期 2029-11-03 仓库地址 委托[天水新光药业有限公司]储存配送药品([天水市天水经济技术开发区社棠工业园区孵化园4号楼]) 经营范围 中成药、化学药、生物制品、上述经营范围不含冷藏冷冻药品                              甘肃省药品监督管理局2025年11月25日

根据《甘肃省监督实施示范建设实施方案》和《甘肃省中药材生产质量管理规范基地符合性检查管理规程（试行）》，经企业创建申报，由辖区中药材GAP示范创建领导小组办公室初审后，省药监局会同省农业农村厅、省林业和草原局、省中医药管理局，于2025年10月13日至11月6日期间，对企业建设申报的中药材GAP基地进行符合性检查（延伸检查）。经现场检查及整改复核后，综合评定，甘肃佛慈红日药业有限公司、甘肃河西制药有限责任公司、甘肃东方韵药业科技有限公司等16家企业符合要求，现予以公示，公示期5个工作日，自2025年11月26日始至2025年12月2日止。附件：甘肃省中药材GAP符合性检查结果 甘肃省药品监督管理局         甘肃省农业农村厅 甘肃省林业和草原局          甘肃省中医药管理局2025年11月26日

各药品生产企业：按照国家医保局价采中心推送医药价格风险线索及药品挂网价格治理有关要求，现开展部分药品价格风险治理工作，具体事项通知如下：一、调整范围挂网价格10元以上，日均治疗费用价差较大的疑似高价中成药（见附件）。二、调整要求相关企业须以已挂网同种药品最低日治疗费用药品价格为锚点，主动规范价格行为，调整挂网价至合理价格水平，同通用名其他规格和包装的药品按照药品差比价规则同步调整。在调整时间结束后仍未调价的药品，活跃区药品未按要求进行挂网价格调整或调整不到位的，将参照相关规定对折算后挂网价格高于“省内最低日均治疗费用”3倍（含）至5倍的药品进行黄标管理；5倍（含）至10倍（含）进行红标管理；高于10倍的药品予以暂停挂网。红黄标管理药品，后期可根据价格调整情况申请调整或取消标识；暂停挂网的药品，可申请价格调整后恢复挂网，并视价格调整情况进行风险标识。不活跃区药品未按要求进行挂网价格调整或调整不到位的予以暂停挂网；暂停挂网后企业可申请价格调整后恢复挂网。三、调整时间及方式1.调整时间：即日起至11月28日12:002.调整方式：登录黑龙江省医疗保障信息平台，进入“动态调整管理”→“挂网动态调整申请”→“发起调整”→“挂网价格”模块自主调价。附件：风险价格线索黑龙江省公共资源交易中心（黑龙江省政府采购中心）2025年11月26日

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销吉安泽照康科技有限公司、江西鸿创药业有限公司的《药品经营许可证》（详见附件）。特此公告。附件：注销药品经营许可证企业名单                               江西省药品监督管理局                                2025年11月26日附件注销药品经营许可证企业名单序号企业名称法定代表人许可证编号注册地址注销原因1吉安泽照康科技有限公司廖利根赣T796030江西省吉安市吉州区原有线电厂棚户区改造北区2#地块2幢附2-01号主动申请注销2江西鸿创药业有限公司池文根赣AA7960571江西省吉安市新干县河西机电产业园8幢1单元主动申请注销

各市州医疗保障局，各相关医疗机构，各相关企业：    现将《湖南省医药集中采购平台药品挂网和采购规范》印发你们，请遵照执行。湖南省医疗保障局湖南省公共资源交易中心2025年10月11日湖南省医药集中采购平台药品挂网和采购规范    为进一步规范我省药品挂网采购工作，更好满足人民群众用药需求，根据《中共中央国务院关于深化医疗保障制度改革的意见》（中发〔2020〕5号）、《国务院办公厅关于推动药品集中带量采购工作常态化制度化开展的意见》（国办发〔2021〕2号）等文件精神，结合我省实际，制定本规范。 第一章 基本要求    第一条 挂网申报主体    药品挂网申报主体为药品上市许可持有人，其中外资企业可由上市许可持有人正式授权的境内总代理代为办理（以书面授权证明为准）。药品上市许可持有人（以下统称“企业”）应对药品挂网价格、质量、供应保障负主体责任。    第二条 挂网申报内容    企业供应各级各类公立医疗机构的所有药品应在省医药集中采购平台（简称“平台”，下同）公开挂网挂价。企业申报内容须包括在平台展示的药品产品信息和挂网价格，“挂网不挂价”属于无效挂网，逐步清理完善。    产品信息和挂网价格完整，但企业“线上价格不供、线下涨价供应”的，属于失信行为，按规定严肃处置。药品短缺等特殊情况下，确有必要通过医院议价或备案采购“先挂网后挂价”的，应作为临时性措施，从严把握品种规模、过渡时间和议价医院的代表性。    企业申报药品挂网需按照要求提供相关资料，并如实披露必要的价格信息。按照医药价格和招采信用评价制度要求，提交书面守信承诺。对申报药品价格涉嫌商业贿赂、垄断涨价、涉税违法等重大失信情节时授权查询相关药品增值税发票信息等作出承诺。    第三条 落实企业自主定价和协议价格    药品价格主要由企业综合临床价值、市场供求、竞争格局等因素自主合理确定，符合挂网规则的，按照“高效办成一件事”相关要求及时办理。    新上市药品首发挂网逐步试行以药学和临床价值为基础的药品自评制度，企业实事求是做好自评和自主定价，公开接受社会监督和同行评议。    短缺易短缺药品清单的药品，按照《短缺药品价格的风险管理操作指引》要求，排除价格风险后直接挂网。    政府定价范围的麻醉和第一类精神药品，按当前国家和我省相关政策管理，后期如申报挂网，挂网价格不高于政府指导价或备案价。其他麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等特殊管理药品，防治传染病和寄生虫病的免费用药，国家免费艾滋病抗病毒治疗药品，计划生育药品，国家免疫规划疫苗等按照国家相关规定执行。    中药饮片、中药配方颗粒按照国家和我省相关要求阳光挂网采购。    价格风险处置、医药价格和招采信用评价、医院备案采购等其他情形药品，挂网价格不高于企业承诺价格并符合相应规定。    第四条 药品挂网形式和计价单位    口服制剂（含片剂、胶囊剂、散剂、颗粒剂、溶液剂、混悬剂等）以最小零售包装单位（如盒、瓶、袋）挂网并展示挂网价格。最小制剂单位价格按照《药品差比价规则》换算。    注射剂（含水针、粉针、输液等各类注射剂）以及其他剂型统一以最小制剂单位（具体如支、瓶、袋，组合包装按套）挂网并展示挂网价格。注射剂需重新切换挂网方式的，对于挂网价格换算、保留小数、前后价格协同、价格风险防范等问题，按照国家医保局办公室《关于规范注射剂挂网工作的通知》（医保办函〔2024〕61号）处理。    膏剂（软膏、乳膏、贴膏）最小制剂单位价格按照《药品差比价规则》的装量差比价换算，不同浓度产品确有必要单列代表品的，低浓度价格不高于高浓度价格。采用特殊给药装置一体化包装，《药品差比价规则》未明确换算关系的，最小制剂单位价格中扣减特殊给药装置费用的部分，按含量、装量差比价换算。    外用液体剂最小制剂单位价格原则上按照《药品差比价规则》的含量差比价换算，不同浓度产品确有必要单列代表品的，低浓度价格不高于高浓度价格、低含量价格不高于高含量价格。    第五条 实行药品按组管理和比价    化学药质量层次包括：参比制剂；通过仿制药质量和疗效一致性评价的仿制药品（含视同过评）；其他药品。    中成药不区分质量层次。    生物类似药质量层次包括：参照药；其他药品。    同通用名、同剂型（未集采药品按医保药品目录合并归类的剂型、已集采药品按招标剂型归并，下同）、同质量层次、同价格形成方式药品在挂网申报时，按单位可比价（中成药按日均费用计，下同）实行同组比价。同通用名、同质量层次、同价格形成方式、不同剂型药品申报挂网时，价差应控制在合理范围之内。    第六条 实行药品分区管理    挂网药品按“活跃区”和“不活跃区”管理。两年内无平台交易记录或未按要求在规定期限内建立配送关系等情况药品，纳入不活跃区管理，其他纳入活跃区管理。不活跃区药品价格不作为比价锚点，仍纳入价格风险管理。 第二章 药品常规挂网    第七条 同种药品同厂牌差价比价关系    地区间的差价比价关系：同厂牌同种药品在平台新申报挂网价格的，除另有规则的集采中选和续约药品外，不超过已挂网省份挂网价格或已挂网省份其他剂型、规格、包装挂网价格按《药品差比价规则》换算的结果，同时存在多种比较锚点的，按照“先包装后规格再剂型”的顺序就“近”比较，排除倒挂。省际间价格联动时，口服制剂最小零售包装单位价格差异在5%且5元以内的，注射剂以及其他剂型最小制剂单位价格整数位及小数点后第1位均相同的，视为价格一致，不强制要求向下联动。    剂型、规格和包装间的差价比价关系：除符合地区间的差价比价关系外，对于成分相同、厂家相同的药品，企业申报不同剂型、规格和包装的挂网价格，原则上应符合《药品差比价规则》。片剂、胶囊剂从多剂量包装变更为单剂量包装的，单剂量包装满足常见疗程周期最大用量的包装规格作为比较锚点，按照不高于多剂量包装（主流包装数量）挂网价格中位数确定挂网价格，或按照日均治疗费用保持相当原则确定挂网价格。单剂量包装的其他规格以锚点价格为基准，按照《药品差比价规则》形成挂网价格。中成药申报挂网，重点关注相同剂型的日均治疗费用差比价、包装数量和装量差比价。    不同渠道间的差价比价关系：企业申报药品挂网价格原则上应与供应当地定点民营医院价格保持相当，应与当地社会药店零售价格和互联网售药平台“即时达”价格保持相当，申报挂网价格高于当地社会药店零售价格和互联网售药平台“即时达”价格集中区间1.3倍的，平台及时督促企业调整挂网价格至合理水平。    第八条 化学药口服固体制剂同种药品不同厂牌差价比价关系    参比制剂：以同通用名药品（参比制剂除外）最高挂网价格的1.8倍为黄标价格；同通用名药品最高挂网价超过同通用名药品黄标价格的，以同通用名药品黄标价格为计算锚点。暂不设置红标价格。同通用名药品（规格相同情况下，下同）有多个参比制剂时，相互之间暂不设比价锚点。    过评同通用名药品：在平台挂网的首个过评同通用名药品（指平台挂网价格最高的过评同通用名药品），挂网价格不高于参比制剂（有多个参比制剂挂网时，以单位可比价最低的参比制剂为比价锚点；无参比制剂挂网时，以全国挂网药品一览表中单位可比价最低的参比制剂为比价锚点，下同）挂网价70%。后续过评同通用名药品挂网价格不高于已挂网过评药品平均挂网价格，且不高于过评前挂网价格的2倍；无过评前挂网价格，挂网价格不高于平台未过评药品最高挂网价格的2倍，其中过评前最小制剂单位价格不高于豁免标准的，过评后按不高于最小制剂单位豁免标准把握。同通用名不同厂牌间药品挂网价格保持合理价差。未开展集采的，以过评同通用名药品最低挂网价的1.8倍为黄标价格，最低挂网价的3倍为红标价格。已开展集采的，以集采最高中选价的1.8倍为黄标价格，最高中选价的3倍为红标价格。    未过评同通用名药品：在平台挂网的首个未过评同通用名药品（指平台挂网价格最高的未过评同通用名药品），挂网价格不高于参比制剂挂网价60%。后续未过评同通用名药品挂网价格不高于已挂网未过评药品平均挂网价格。    同通用名不同厂牌间药品挂网价格保持合理价差。无过评同通用名药时，以未过评同通用名药最低挂网价的1.8倍为黄标价格，最低挂网价的3倍为红标价格。有过评同通用名药，且过评同通用名药挂网企业少于3家时，未过评药品挂网价格高于过评药品最低挂网价格的按黄标管理，高于过评药品最低挂网价格1.8倍的按红标管理；过评同通用名药挂网企业达到三家及以上时，未过评药品挂网价格不高于过评药品最低挂网价格。已经开展国家或省级、省际联盟集中带量采购（简称“集采”，下同）的，未过评同通用名药品挂网价格不高于集采最高中选价。    豁免条件：以我省挂网药品最大规格为锚点，最小制剂单位价格不高于0.2元的，不适用上述采购风险标识的差价比价规则，其他规格的豁免标准按含量差比价计算。    第九条 化学药注射剂同种药品不同厂牌差价比价关系    参比制剂：以同通用名药品（参比制剂除外）最高挂网价格的1.8倍为黄标价格；同通用名药品最高挂网价超过同通用名药品黄标价格的，以同通用名药品黄标价格为计算锚点。暂不设置红标价格。    过评同通用名药：在平台挂网的首个过评同通用名药品（指平台挂网价格最高的过评同通用名药品），挂网价格不高于参比制剂挂网价70%。后续过评同通用名药挂网价格不高于已挂网过评药品平均挂网价格，且不高于过评前挂网价格的2倍；无过评前挂网价格，挂网价格不高于平台未过评药品最高挂网价格的2倍，其中过评前最小制剂单位价格不高于豁免标准的，过评后按不高于最小制剂单位豁免标准把握。同通用名不同厂牌间药品挂网价格保持合理价差。未开展集采的，以过评同通用名药品最低挂网价的1.8倍为黄标价格，最低挂网价的3倍为红标价格。已开展集采的，以集采最高中选价的1.8倍为黄标价格，最高中选价的3倍为红标价格。    未过评同通用名药品：在平台申报挂网的未过评同通用名药品（指平台挂网价格最高的未过评同通用名药品），挂网价格不高于参比制剂挂网价60%，后续申报价格不高于已挂网未过评药品平均挂网价格。    通用名不同厂牌间药品挂网价格保持合理价差。无过评同通用名药品时，以未过评同通用名药品最低挂网价的1.8倍为黄标价格，最低挂网价的3倍为红标价格。有过评同通用名药品，且过评同通用名药品挂网企业少于3家时，未过评药品挂网价格高于过评药品最低挂网价格的按黄标管理，高于过评药品最低挂网价格1.8倍的按红标管理；过评同通用名药品挂网企业达到3家及以上时，未过评药品挂网价格不高于过评药品最低挂网价格。已开展集采的，未过评同通用名药品挂网价格不高于集采最高中选价。    豁免条件：小水针最小制剂单位挂网价格不高于1元、大输液最小制剂单位挂网价格不高于2元的，不适用上述采购风险标识的差价比价规则。    第十条 中成药同种药品不同厂牌差价比价关系    同组药品的挂网价格（按日均费用计，下同）不高于在平台挂网的首个中成药价格（指平台挂网日均费用最高的同组药品）的80%。    不同厂牌间药品挂网价格按日均治疗费用折算后保持合理价差。未开展集采的，以最低价折算日均治疗费用的3倍为黄标价格，以最低价折算日均治疗费用的5倍为红标价格。已开展集采的，按集采最高中选价折算日均治疗费用的3倍为黄标价格，最高中选价折算日均治疗费用的5倍为红标价格。    豁免条件：日均治疗费用不高于5元的药品，不适用上述采购风险标识的差价比价规则。    第十一条 生物类似药同种药品不同厂牌差价比价关系    在平台申请挂网的首个生物类似药品，挂网价格不高于参照药（参照药未在平台挂网时，以全国挂网药品一览表中参照药为锚点）挂网价格的80%。后续同种药品挂网价格不高于已挂网药品（不含参照药）平均挂网价格。    生物类似药同通用名不同厂牌间挂网价格按日均治疗费用折算后保持合理价差。未开展集采的，以日均治疗费用最低价为参考，黄标价格为最低价的3倍，红标价格为最低挂网价的5倍。已开展集采的，以集采最高中选价折算日均治疗费用的3倍为黄标价格，最高中选价折算日均治疗费用的5倍为红标价格。    豁免条件：挂网企业不高于2家的药品，不适用上述采购风险标识的差价比价规则。    第十二条 已挂网企业增补同通用名同剂型药品    已挂网企业增补同通用名同剂型药品须符合差比价规则，其中集采中选企业增补中选产品的其他规格或包装挂网（儿童专用规格除外），按集采牵头单位有关要求处置。    第三章 谈判、集采等药品挂网    第十三条 医保目录谈判和竞价药品挂网    协议期内的谈判药品和竞价药品挂网价格不得高于国家医保药品目录确定的支付标准。协议期内，若谈判药品或竞价药品新增医保目录未载明的规格，须以不高于国家医保局明确的医保支付标准申报挂网。协议期内，若有与谈判药品同通用名的药品上市，其挂网价格适用于本规范第七条、第八条、第九条、第十条、第十一条相关规定。通过竞价纳入国家医保目录的药品，参与现场竞价的企业在支付标准有效期内，申报挂网价格不得高于现场报价。转入医保目录常规乙类后，原则上不得上调挂网价格，并纳入价格联动比对管理。    第十四条 国家组织集采中选、续约药品挂网    供应我省的中选药品（含备供药品）按中选价直接挂网，非供应我省的中选产品，按不高于中选价格的1.5倍或同品种最高中选价挂网。    第十五条 国家联盟集采中选、续约药品挂网    供应我省的中选药品（含备供药品）按中选价直接挂网，非供应我省的中选产品，按不高于中选价格的1.5倍或同品种最高中选价挂网。若我省未参与的联盟集采，其集采中选产品按我省挂网规则相关要求办理。    第十六条  集采品种非中选药品挂网    国家或联盟集采，实行主备供模式时，非中选企业同质量层次产品挂网价格，不高于本规范第十四、十五条规定的最高挂网价和我省已挂网非中选产品最低价的低值。    国家或联盟集采，实行非主备供模式时，非中选企业同质量层次产品挂网价格，不高于中选产品的最高价和我省已挂网非中选产品的最低价的低值。    第十七条 价格风险处置药品挂网    纳入价格风险处置的药品，按不高于企业承诺价挂网。同通用名同厂牌其他剂型包装规格，以承诺价为基准，按照《药品差比价规则》确定挂网价格。    同通用名其他厂牌，按不高于价格风险防范的黄标价格重新确定挂网价格；已转入不活跃区的，原挂网价格不高于黄标价格可激活交易恢复采购；不活跃区挂网价格高于黄标价格的，按程序新申报挂网且申报价格不高于黄标价格。    价格风险处置药品自生效之日起3年内，企业申报上调挂网价格的，平台不予受理，不得采用医院备案采购等变通措施，防止变换包装、规格等变相涨价。    实行价格比对，对已挂网药品，在其他省份出现新的低价，企业需在30日内申请联动调整挂网价格。对未按要求联动最新全国省级平台挂网低价的产品，一经核实暂停挂网。新申报挂网药品，经核实未如实申报同价格形成方式的全国最低价，3个月内不接受再次申报。 第四章 挂网药品管理    第十八条 规范管理药品暂停挂网和撤销挂网    暂停挂网：符合以下条件之一的暂停挂网。暂停3个月以上，达到挂网条件的，依申请恢复挂网。申请恢复挂网的药品，挂网价格不得高于暂停挂网时的价格及暂停挂网时要求调整的价格。    （1）挂网药品无法正常生产供应，企业应主动申请暂停挂网。    （2）未落实挂网管理相关要求。    （3）省医疗保障局认定应予暂停挂网的其他情形。    撤销挂网：符合以下条件之一的撤销挂网。撤销挂网2年内不受理挂网申请。    （1）暂停挂网且1年以上没有恢复挂网。    （2）挂网满2年且无平台交易，企业主动提出撤网。    （3）法律或职能部门不允许上市销售的相关情形。    （4）被查实存在以欺诈、串通、倾销等不正当方式参与挂网、交易，包括但不限于提供虚假证明材料、围标串标等。    （5）省医疗保障局认定应予撤销挂网的其他情形。    撤销挂网药品原挂网记录（产品信息和挂网价格）按照“留低不留高”的原则处理。平台建立撤网药品信息库（关联医保编码、生产企业、上市许可持有人、药品注册证号等信息），做好申请新增挂网药品与撤网药品信息比对，防止企业通过改换包装数量、变更医保编码等方式变相提高挂网价格。    第十九条 完善药品价格风险管理    健全医药价格风险处置机制，将销售价格、销售费用率明显偏高等价格异常，且年销售额较高或连续涨价的药品纳入价格风险品种范围，约谈督促申报企业规范价格行为，降低价格水平。对约谈后企业承诺整改价格高于黄标价格的药品，进行黄标提示，平台将其名称字体或背景显示为黄色，且弹窗提示“同通用名药品有其他较低价产品”。对约谈后企业承诺整改价格高于红标价格的药品，进行红标提示，平台将其名称字体或背景显示为红色，且弹窗提示“该企业本药品存在价格风险，同通用名药品有其他企业低价产品，请慎重采购”。    结合市场竞争、供应情况等因素，可对同质量层次中超过最低挂网价10倍等情形的药品进行暂停挂网、撤销挂网处理；同一企业同一时期红标价格警示药品数累计达到一定数量的，重点关注其销售合规性情况。    第二十条 探索挂网药品动态调整    已挂网药品以集采等有效竞争形成的价格为锚点做好动态调整。探索末位淘汰的竞争性挂网机制。已挂网药品价格符合本规范差比价规则的，维持原价格水平；因生产成本、供求关系和市场格局等发生重大变化，企业申报上调挂网价格的，在符合前述规则的条件下，探索比照《短缺药品价格的风险管理操作指引》的主要思路和具体做法，坚持实事求是、透明均衡、风险可控、责任可追的原则，分类办理挂网药品动态调整。    第二十一条 落实挂网药品追溯管理    挂网药品必须按规定全面应用药品追溯码，相关企业应主动提供药品追溯码信息，配合做好药品追溯码扫描工作，严格落实“带码挂网、带码采购”。 第五章  医院采购管理    第二十二条 集中采购机构范围    各级各类公立医疗机构须通过省平台统一采购所需药品，并按“零加成”进行销售，严禁线下采购。鼓励和引导其他医保定点医药机构参加省平台采购（医保定点村卫生室药品应由所属一体化管理的基层医疗机构进行网上代采），确需自主采购的药品按照不超过平台挂网价销售。对按规定应通过平台采购药品的医药机构，逐步实行医保定点医药机构“非网采不结算”。    第二十三条 直接采购    集中带量采购中选（含续约）药品，医疗机构按挂网价格直接采购，不得再进行议价或变相议价，不得在进院、库存、使用等任何环节向中选企业和配送企业收取任何附加费用。    第二十四条 议价采购    平台挂网的其他药品，医疗机构按不高于挂网价格与生产企业进行议价采购，议价应在平台药品自主议价系统上进行，双方一经确认即为有效采购价格，严禁价格低进高出和结算时的明折暗扣等任何方式的变相返点、返利、回扣等违规行为。鼓励医疗机构组团进行议价采购，充分发挥规模采购优势，有效降低药品价格。    平台自主议价系统议定的实际采购价格，仅供医保部门掌握价格动态使用，数据归集方面将在挂网价格之外单独建表建库管理，不在平台对外展示，不直接替代挂网价格。    第二十五条 备案采购    平台无同通用名同剂型挂网的药品，因临床或科研必需，医疗机构应按照“比价合理”原则，完成医院内部审批流程后，可与药品生产企业自主议价并在平台进行备案采购。允许医疗机构先采购使用、后补办挂网手续的临时性措施。具体由医疗机构与供货企业自主议定采购价格，并于7个工作日内在平台备案采购数量和采购价格。    从严控制备案采购药品范围，医疗机构备案采购的药品金额不超过本年度药品采购总金额的1%，且品种数量应不超过其常备药品数量的5%（通常为50个，协议期内的医保目录谈判药品不受此要求限制）。二级及以下公立医疗机构、议价药品与专科医疗机构专业范围不对口、或者实际采购规模和采购连续性差的公立医疗机构，所议价格不作为确定挂网价格的依据。    第六章 监管监测    第二十六条 加强药品挂网的前置监测    省医疗保障局指导医药集中采购机构切实加强药品挂网的前置监测，将各类差价比价关系和挂网规则内置到平台受理企业申报挂网的流程中，符合内置规则的挂网申报自动放行，15个工作日内办结。不符合内置规则的挂网申报，需申请特例单议，由省医药集中采购机构组织研究初核，经省医疗保障局复核后挂网，并给予价格风险标识。企业公开价格信息，且各方无异议的，可不给予价格风险标识。    第二十七条 加强药品挂网采购情况监测分析    平台管理和执行机构依托系统，在保障和持续提升数据质量的基础上，按照《湖南省医疗保障局关于建立湖南省医药价格信息监测与处置机制的通知》（湘医保发〔2025〕10号）要求，开展监测分析工作，发挥大数据和信息化的作用。省医药集中采购机构定期对药品挂网、医疗机构议价结果、医疗机构线上采购统计分析，重点关注价格异常波动、采购量异常变化、配送情况不良、采购行为不规范等情况的药品。    第二十八条 实施信用评价管理    执行国家招采信用评价目录清单和裁量基准，实施申报企业主动信用承诺，将医药企业的挂网采购行为全程纳入信用评价管理范围，向社会公布医药企业挂网采购信用情况。    对药品生产经营活动中有严重违规记录、未如实及时申请挂网价格调整、未能及时供货和配送、提供虚假证明文件等违规失信行为的，按照国家和我省招采信用评价制度等规定予以处置。    第二十九条 加强医药集中采购机构内控管理    省医药集中采购机构加强药品价格挂网业务的内控管理。受理挂网申报时，要对老药新做、变换包装的价格变化重点关注，涉及新申报挂网价格水平畸高、变化幅度巨大的，用好信息披露、公开问询等政策工具，排除价格风险。要建立交叉互验、责任到人的信息核对制度，高度重视业务质量、数据质量，确保每个药品在同一平台同一阶段只存在唯一有效的挂网记录，认真核对企业提交的挂网资料，重点关注包装数量（转换比）等易错的涉价信息。要重点关注集中带量采购、医保目录谈判、价格风险处置等方式形成的价格动态，主动及时更新挂网价格，杜绝新旧挂网价格并存的漏洞，避免用药单位采旧不采新、采高不采低的风险隐患。要加强对信息系统建设单位、运维单位、驻场服务人员的信息安全教育、培训，合理配置操作权限，及时排查信息安全风险。                 第七章 附则    第三十条 附则    本规范自2026年1月1日起实施，有效期五年。此前发布文件规定与本规范不一致的，以本规范为准。

行政相对人名称 江苏亚光医疗器械有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 913210007241895232 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 沈军 法定代表人证件类型 身份证 法定代表人证件号码 3****************4 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕39号 违法行为类型 生产不符合经注册的产品技术要求电子输注泵的行为；违反了《医疗器械监督管理条例》第三十五条第一款的规定 违法事实 江苏亚光医疗器械有限公司，生产不符合经注册的产品技术要求电子输注泵的行为；违反了《医疗器械监督管理条例》第三十五条第一款的规定，根据《医疗器械监督管理条例》第八十六条第一项规定，应予处罚。 处罚依据 根据《医疗器械监督管理条例》第八十六条第一项规定 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 罚款贰万肆仟伍佰元整；没收涉案物品 罚款金额（万元） 2.45 没收违法所得没收非法财物的金额（万元） 0.2 暂扣或吊销证照名称及编号 处罚决定日期 2025/11/25 处罚有效期 2026/05/25 公示截止期 2028/11/25 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

Delivery Method:Via EmailProduct:DrugsRecipient:Mahesh ChadaCEOMahita LLC dba PushMyCart202 Terrace Creek CourtRichmond,TX77406United Statessales@pushmycart.comsupport@pushmycart.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 17, 2025RE: 716286Mahesh Chada:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://pushmycart.com/ in September 2025. The FDA has observed that your website offers, “Morbillinum 10M CH,” “Morbillinum 200 CH,” “Cornus Circinata 12 CH,” “Ocimum Canum 200 CH,” “Tarentula Hispana 30 CH,” “Nux Mosch 10M,” “Kerala Ayurveda Parkinsons Choornam,” “Maharishi Ayurveda Erand Pak,” “REPL Dr. Advice No.45 Glaucoma Drop,” “Dibonil Drop,” and “Wheezal WL16 Drop” (hereinafter Mahita products) for sale in the United States. We have also reviewed your Facebook account at https://www.facebook.com/pushmycartglobal where you direct consumers to your https://pushmycart.com/ website to purchase your products. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Your Mahita products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Morbillinum 10M CH,” “Morbillinum 200 CH,” “Cornus Circinata 12 CH,” “Ocimum Canum 200 CH,” “Tarentula Hispana 30 CH,” “Nux Mosch 10M,” “Kerala Ayurveda Parkinsons Choornam,” “Maharishi Ayurveda Erand Pak,” “Dibonil Drop,” and “Wheezal WL16 Drop” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, cancer, diabetes, Parkinson’s and hepatitis, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process. In addition, your unapproved “REPL Dr. Advice No.45 Glaucoma Drop,” drug product is concerning because ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.Based on a review of your website, your Mahita products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website and Facebook account, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Morbillinum 10M CHOn the webpage https://pushmycart.com/products/dr-willmar-schwabe-india-morbillinum-dilution-10m-ch?_pos=1&_sid=ba209cbc7&_ss=r:“[P]rimarily used to treat skin infections.”“Benefits And Uses . . .o Known for its use in preventing and curing measleso Its [sic] also used to cure skin infections disorderso This dilution is also used in the treatment of ear and eye infections, cough”Morbillinum 200 CHOn the webpage https://pushmycart.com/products/sbl-morbillinum-dilution-200-ch?_pos=1&_sid=84daa9380&_ss=r:“SBL Morbillinum Dilution is a measles nosode also known under the name of rubeola or red measles. It us used to give relief from skin itching, skin irritation and eruptions with cough.”“Key Benefits:o Catarrh, cough, coryza are all treated by taking the right dosage of morbillinumo Chiefly used as a prophylactic against infection, and to clear up after-effects of an attacko Cures the poison of measles that has a great affinity for the mucous passages, the eyes, the ears and the respiratory mucous membranes”On a September 8, 2022 video post on your Facebook account at https://www.facebook.com/pushmycartglobal:“Suffering from Measles? don't worry pushmycart offers you most effective homeopathic remedies to get rid of MeaslesOrder Measles homeopathic medicines from pushmycart(link to order) . . .SBL Morbillinum Dilution 200 CHhttps://pushmycart.com/.../sbl-morbillinum-dilution-200-ch . . .#measles #measlesoutbreak #measlesawareness #measlesattack #measlesbegone”Cornus Circinata 12 CHOn the webpage https://pushmycart.com/products/sbl-cornus-circinata-dilution-12-ch?_pos=1&_sid=c1bb0df51&_ss=r:“SBL Cornus Circinata Dilution is helpful in treatment of diseases like malaria, jaundice and hepatitis. It helps in relieving pain in the abdomen and pit of the stomach. Chronic liver related ailments and pain in genitals and buttocks can also be cured by its use. It also helps in reducing soreness at base of mouth and gum.” • “Key Benefits:o Used for the treatment of malaria, jaundice, hepatitis and other serious renal ailmentso Reduces morning weaknesso Relieves stomach and abdomen paino Relieves genital and buttock eruptionso Relieves mouth and gum sorenesso Relieves mouth, gum and tongue ulcerso Reduces burning sensation in stomach, throat, and moutho Useful for treating bilious diarrhea, dark stools, and anus burningo Helps in curing vesicular eczema on a newborn's face”On a November 3, 2022 post on your Facebook account at https://www.facebook.com/pushmycartglobal:“Suffering from Hepatitis C? don't worry pushmycart offers you most effective homeopathic remedies to get rid of Hepatitis C problemOrder Hepatitis C homeopathic medicines from pushmycart(link to order) . . .SBL Cornus Circinata Dilution 12 CHhttps://pushmycart.com/.../sbl-cornus-circinata-dilution . . .#hepatitisc #hepatitisccure #hepatitiscure #hepatitiscdrugs #hepatitisccommunity #hepatitiscawarness #hepatitiscmedicine #hepatitis #hepatitisawareness”Ocimum Canum 200 CHOn the webpage https://pushmycart.com/products/dr-willmar-schwabe-india-ocimum-canum-dilution-200-ch?_pos=1&_sid=35bcf0fdd&_ss=r:“Dr Willmar Schwabe India Ocimum Canum Dilution 200 CH is useful remedy for the treatment of ailments like asthma, ophthalmia neonatorum, worm related complaints, cold, typhoid, and tonsillitis. It is helpful for treating a remittent fever”“Benefits And Uses Of Dr Willmar Schwabe India Ocimum Canum Dilution 200 CHo Helps in reducing intermittent fevero Reduces fever with bone paino Cough, flu, tonsillitis and influenza”Tarentula Hispana 30 CHOn the webpage https://pushmycart.com/products/dr-willmar-schwabe-india-tarentula-hispana-dilution-30-ch?_pos=1&_sid=baf91c4f4&_ss=r:“Dr Willmar Schwabe India Tarentula Hispana Dilution 30 CH is a homeopathic solution that can be used for a variety of ailments including headache, restlessness, ADHD, autism and behavioral problems in children. It helps in preventing against many types of mood variations”“Benefits And Uses Of Dr Willmar Schwabe India Tarentula Hispana Dilution 30 CHo It helps in treating hyperactivity and restless leg syndromeo Migraineso Helps in ADD and ADHD”Nux Mosch Dilution 10MOn the webpage https://pushmycart.com/products/dr-reckeweg-germany-nux-mosch-dilution-10m-ch?_pos=1&_sid=5a9dc526b&_ss=r:“Dr. Reckeweg Germany Nux Mosch Dilution 10M CH is primarily used for the treatment of allergy, symptoms related to Alzheimer's Disease, colic, confusion, weak memory, sore throat, constipation and vertigo.”“Benefits And Uses Of Dr. Reckeweg Germany Nux Mosch Dilution 10M CHo It is also used for the treatment of symptoms related to Alzheimers [sic] Diseaseo Improves memory and concentrationo It is helpful in the treatment of dry mouth and sore throat”Kerala Ayurveda Parkinsons ChoornamOn the webpage https://pushmycart.com/products/kerala-ayurveda-parkinsons-choornam?_pos=1&_sid=e571a60f2&_ss=r:“Kerala Ayurveda Parkinsons Choornam 50 g is an herbal powder formulation used in Ayurveda, the traditional medicine system of India, to manage Parkinson's disease. Parkinson's Choornam contains several herbs believed to benefit the nervous system and brain.”“Benefits and Uses of Kerala Ayurveda Parkinsons Choornam[ ]o Improving motor symptomso Boosting cognitive functiono Reducing inflammationo Improving sleep”Maharishi Ayurveda Erand PakOn the webpage https://pushmycart.com/products/maharishi-ayurveda-erand-pak-for-management-of-rheumatoid-arthritis-100g?_pos=1&_sid=84d1c5f54&_ss=r:“For Management Of Rheumatoid Arthritis . . . medicine used for abdominal colic pain, bloating, rheumatoid arthritis etc.”“Benefits And Uses Of Erand Pak - For Management Of Rheumatoid Arthritis (100gms)o Abdominal paino Edemao Inflammationo Asciteso Urinary tract disorders”REPL Dr. Advice No.45 Glaucoma DropOn the webpage https://pushmycart.com/products/repl-dr-advice-no-45-glaucoma-drop?_pos=1&_sid=acd3a4612&_ss=r:From the product packaging:o In the name of the product – “Glaucoma”“REPL Dr. Advice No.45 Glaucoma Drop is an herbal formulation designed to help manage glaucoma and support eye health. . . . This product is typically used as an adjunctive therapy to manage eye pressure and promote overall eye wellness.”“Benefits and useso Helps Manage Intraocular Pressure (IOP)o Supports Overall Eye Healtho Natural Antioxidant Supporto May Reduce Eye Irritationo Enhances Blood Circulation in the Eyeso Helps Slow the Progression of Glaucoma”Dibonil DropOn the webpage https://pushmycart.com/products/sbl-dibonil-drop?_pos=1&_sid=89b4359f3&_ss=r:“[D]eveloped to manage increased blood sugar. It takes care of associated symptoms and delays complications of high blood sugar, thus improving the lives of people with diabetes and enabling them to get back into their everyday lives. SBL Dibonil Drop checks the commonly associated problems of diabetes and has no side effects.”“Benefits and Uses of SBL Dibonil Dropso Effective in frequent urination.o It helps to decrease excessive thirst.o Relieves and checks cramps and muscular pain.o It builds up tissues and overcomes mental and physical fatigue.”On an August 30, 2022 post on your Facebook account at https://www.facebook.com/pushmycartglobal:“Suffering from Diabetes? don't worry pushmycart offers you most effective homeopathic remedies to get rid of DiabetesOrder Diabetes homeopathic medicines from pushmycart(link to order) . . .SBL Dibonil Drophttps://pushmycart.com/products/sbl-dibonil-drop#diabetes #diabete #bloodsugarlevels #bloodsugarlevel #bloodsugarlevelcontrol #bloodsugarlevelsbalanced #bloodsugarcontrol”Wheezal WL 16 DropsOn the webpage https://pushmycart.com/products/wheezal-wl16-hypertension-drop?_pos=2&_sid=44e55e62d&_ss=r:From the product packaging:o “Hypertension Dropso Helps Regulate Blood Pressure”“Wheezal WL16 Hypertension Drop . . . active constituent reserpine, which is well-known for its antipsychotic and antihypertensive action. It is used for calming the central nervous system and helps reduce anxiety.”“Benefits and Uses of Wheezal WL16 Hypertension Dropo Useful to manage high blood pressureo Reduces symptoms such as irregular beats, increased emotional excitability, irritative condition of CNS, mild depression, irritability, and restlessnesso It is also used in cases of hypertension without marked atheromatous changes in the vesselso It decreases the frequency of loose stools, checks bleeding and alleviates pain”Your Mahita products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “Morbillinum 10M CH,” “Morbillinum 200 CH,” “Cornus Circinata 12 CH,” “Ocimum Canum 200 CH,” “Tarentula Hispana 30 CH,” “Nux Mosch 10M,” “REPL Dr. Advice No.45 Glaucoma Drop,” “Dibonil Drop,” and “Wheezal WL16 Drop” drug products are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “716286” in the subject line of the email.Sincerely,/S/Brad Pace, J.D.Associate DirectorOffice of Unapproved and Labeling ComplianceSigned on behalf of:Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via EmailProduct:DrugsRecipient:Hiren GaglaniDirectorHandelnine Global, LLC dba Navafresh4300 S. Clinton Ave.South Plainfield,NJ07080United Statesinfo@navafresh.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 17, 2025RE: 716013Hiren Gaglani:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://navafresh.com/ in September 2025. The FDA has observed that your website offers “Dr. Patels Measles Tablets,” “Mans-Pachak Vati,” “Adel-54 Heart Care Drops,” “Ayuvardhak Sutta Yog,” “Parkikyor Tablets,” “Tri-Origin Ayurveda Diabetic Tablets,” “Ayuvision Herbal Eye Drop,” “Adel-17 Eye Care Drops,” “Haslab Mamira Eye Drops,” and “Rheumacare Capsules” (hereinafter Navafresh products) for sale in the United States. In addition, FDA has obtained a sample of your “Rheumacare Capsules” product. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, your “Rheumacare Capsules” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).The results of the FDA laboratory testing of two lots of “Rheumacare Capsules” demonstrate that this drug product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), because the presence of lead in the amounts identified by FDA raises significant safety concerns and demonstrates that the product has not been manufactured and processed in a manner that conforms to CGMP requirements.Your Navafresh products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Dr. Patels Measles Tablets,” “Mans-Pachak Vati,” “Adel-54 Heart Care Drops,” “Ayuvardhak Sutta Yog,” “Parkikyor Tablets,” and “Tri-Origin Ayurveda Diabetic Tablets” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as cancer, diabetes, and measles, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process. In addition, your unapproved “Ayuvision Herbal Eye Drop,” “Adel-17 Eye Care Drops,” and “Haslab Mamira Eye Drops” products are concerning because ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.Unapproved New Drug and Misbranding ViolationsBased on a review of your website, your Navafresh products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Dr. Patels Measles TabletsOn the webpage https://navafresh.com/products/dr-patels-homeopathic-measles-tablets-natural-relief-for-sneezing-thin-nasal-discharge-watery-eyes-cough-and-febrile-condition-effective-support-for-all-stages-of-the-disease-25-gm:From the product packaging:o In the name of the product – “14 MEASLES”o “Indications: Sneezing and thin discharge from nose, eyes are watery, cough & febrile condition. It is of good help in all stages of the disease.”“Descriptiono “SNEEZING RELIEF: Dr Patels Homeopathic Measles Tablets offer natural relief for sneezing, a common symptom of measles.”o “THIN NASAL DISCHARGE MANAGEMENT: These tablets help manage thin nasal discharge, reducing congestion and promoting clearer nasal passages. This relieves discomfort and allows for easier breathing during the course of measles.”o “WATERY EYES SOOTHING: The homeopathic formulation in these tablets helps soothe watery eyes, relieving eye discomfort”Mans-Pachak VatiOn the webpage https://navafresh.com/products/manspachak-vati-250-gm-anyedyshka-jwargalgandarbudgranthiudarvruddhiadhimaansfeverlymphadenitistumor:“Description . . .o Galgand (goitre)o Arbud (cancer)o Udarvruddhi (abdominal swelling)”“Anyedyshka Jwar (Fever of Unknown Origin): This Ayurvedic formulation may be beneficial in managing fevers of unknown origin (Anyedyshka Jwar) and assisting in the alleviation of fever-related symptoms. Galgand (Goiter): Mans-Pachak Vati is believed to be useful in addressing goiter (Galgand), a condition characterized by the enlargement of the thyroid gland in the neck. Arbud (Cancerous Growth): It may have properties that can help manage certain cancerous growths (Arbud), potentially aiding in reducing the size of tumors.”Adel-54 Heart Care DropsOn the webpage https://navafresh.com/products/adel-54-heart-care-dropspack-of-3:From the product packaging:o “Useful adjuvant for prevention of coronary disease and for follow up support after a heart attack.”“Description . . . This carefully selected blend of natural ingredients aims to promote cardiovascular well-being, address factors related to heart function, and contribute to the maintenance of a healthy circulatory system.”Ayuvardhak Sutta YogOn the webpage https://navafresh.com/products/ayuvardhak-sutta-yog-upper-respiratory-track-infections-immunity-booster-and-builder-copd-breathlessness-harshness-of-voice-and-throat-cough-cold-sinusitis-rhinitis-tonsillitis-ayurvedic-medicine-product-chew-able-30-tablets:From the product packaging:o “Indications: Quit Smoking, Upper Respiratory Tracft [sic] Infections, COPD, Breathlessness, Harshness of Voice and Throat, Cough Cold, Sinusitis, Rhinitis,”“Descriptiono COUGH COLD SINUSITIS RHINITISo ASTHMAo SEASONAL THROAT INFECTION ALLERGYo HARSHNESS OF VOICEo SMOKERS [sic] COUGH”Parkikyor TabletsOn the webpage https://navafresh.com/products/xovak-pharma-ayurvedic-parkikyor-helps-naturally-60-tablets-pack-of-2:From the product packaging:o In the product name – “Parkikyor Parkinson’s”o “Parkikyor helps Rejuvenate brain tissues, Enhance the functions of brain, boost cognitive ability, promote mental clarity and elevate mood, Lessen tremors, relax muscles, ease stiffness and aches. Recover digestive fire and flush out toxins from the body [.] Improves muscle strength and physical endurance.”“Descriptiono Helps to the [sic] boost cognitive abilityo Improve muscle strength and physical endurance.o Combat stress and have quality sleep”Tri-Origin Ayurveda Diabetic TabletsOn the webpage https://navafresh.com/products/tri-origin-ayurveda-diabetic-tablets-supports-sugar-control-for-diabetes-60-tabs:From the product packaging:o In the product name – “DIABETIC TABLETS”o “DIABETIC TABLETS helps [sic] control blood sugar … For Daibetes [sic] Care”“Description . . . Formulated with Gudmar, Mamejavo, Indrajav, Karela, Jamun, Methi, Kalijiri, Kadu Kariyatu, Amla, Harde, Neem leaves, and Giloy for effective sugar control.”“A safe and natural ayurvedic medicine for managing diabetic sugar levels”“Experience the holistic power of Tri-Origin Ayurveda Diabetic Tablets, designed to support sugar control for individuals managing diabetes care.”“[M]aintain your diabetic sugar/blood sugar levels with these better diabetic care tablets”Ayuvision Herbal Eye DropOn the webpage https://navafresh.com/products/ayuvision-herbal-eye-drop-for-relieves-dryness-irritationredness-itching-daily-use-eye-drop-10ml-pack-of-6:From the product packaging:o “Uses: Useful in blurred vision and improves eye sight.”“Description . . . Relieves Eye Dryness, Strain & Fatigue, Reduces Irritation & Itching and the Eye Drop Also Provides Eye Care from Harmful Environmental Pollutants.”Adel-17 Eye Care DropsOn the webpage https://navafresh.com/products/adel-17-eye-care-dropspack-of-3:From the product packaging:o “Supports the treatment for blurry, cloudy vision caused due to cataract or glaucoma as part of a complex treatment.”“Description . . . The drops may be designed to alleviate common eye discomforts such as dryness, irritation, and redness.”Haslab Mamira Eye DropsOn the webpage https://navafresh.com/products/haslab-mamira-eye-drop-pack-of-3-acute-or-chronic-conjunctivitisphotophobiablurring-visionred-eyeseye-soreeye-infectionlifestyle-problems:“Descriptiono Acute or chronic conjunctivitiso Muco-purulent, stringy.[ ] Photophobia.o Eye strain and fatigue Dull pain with burningo Dry and irritated eyes Blurring vision releived [sic] by winkingo Redness and inflammation”Rheumacare CapsulesFrom the product label:“Rheumacare is the Combination of non-steroidal anti-inflammatory, analgesic and disease modifying drugs. Rheumacare is very effective to treat all type [sic] of arthritic conditions.”“Rheumacare reduces all type [sic] of joint pain, swelling, stiffness and improve [sic] the efficiency of the joint.”“The main active princple [sic] Mahayogaraj Guggulu, with Trayodasang Guggulu, Maharasnadi kwath extract, Shallaki, Methi and Nirgundi having [sic] very good analgesic and Anti-inflammatory action. Their rapid action on joints reduces the pain, swelling and increases the joint mobility.”So, Rheumacare is the drug of choice for Osteoarthritis and Rheumatoid arthritis to reduce pain and swelling. Rheumacare is [sic] disease modifying agent, mainly for Rheumatoid arthritis. It is [sic] tonic for [sic] musculoskeletal system, improves [sic] joint movement and stability. Long term use of Rheumacare is safe and can prevent the bony deformities.”Indication: Osteoarthritis, Rheumatoid arthritis, Sciatica, Synovitis, Frozen shoulder, Ankylosing Spondylitis, Gout, Painfull [sic] nervine [sic] disorder etc.”Your Navafresh products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “Dr. Patels Measles Tablets,” “Adel-54 Heart Care Drops,” “Adel-17 Eye Care Drops,” and “Haslab Mamira Eye Drops” are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.Furthermore, your “Rheumacare Capsules” product is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used in the dosage or manner recommended in the labeling. As described below, FDA testing found that the “Rheumacare Capsules” contain approximately 7,000 times the amount of lead otherwise indicative of harmful exposure. Lead is toxic to humans, and there is no known safe level of exposure to lead. Even low levels of lead exposure can cause serious health problems, as described below, particularly in children and fetuses.1“Rheumacare Capsules” is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “Rheumacare Capsules” product does not declare that the product contains lead, which is a material fact with respect to consequences that may result from the use of this product. As discussed below, lead may pose health risks to consumers which are only compounded by the fact that the ingredient is not declared on the label. The failure to disclose this ingredient in the product labeling renders your “Rheumacare Capsules” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). The introduction or delivery for introduction into interstate commerce of this misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Adulteration ViolationsFDA laboratory testing of “Rheumacare Capsules” lot CAM040 and lot CAL079-N found unsafe levels of lead contamination. The individual sample results varied between 9,588ppm and 11,124ppm. Based on a Permitted Daily Exposure (PDE) of 5 μg/day, “Rheumacare Capsules” contain approximately 7,000 times the amount otherwise indicative of harmful exposure.2Furthermore, preliminary results indicate concerning levels of other poisonous materials (e.g., mercury, strychnine, brucine, and arsenic). As a result of excessive lead content, your “Rheumacare Capsules” are adulterated under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) because the presence of such substances in the amounts identified by FDA demonstrates that the product has not been manufactured and processed in a manner that conforms to CGMP requirements.Because certain elemental impurities pose toxicological concerns and do not provide any therapeutic benefit to the patient, their levels in drug products should be controlled within acceptable limits. In general, FDA recommends that the manufacturer of any U.S. marketed drug product follow FDA’s Guidance for Industry Q3D(R2) Elemental Impurities3recommendations to establish appropriate procedures for identifying and controlling elemental impurities in the drug product based on risk assessment and product-specific considerations.Lead has no known biological function in humans, and exposure to lead may cause neurological, reproductive, developmental, immune, cardiovascular, and renal health effects. In general, sensitivity to lead toxicity is greater when there is exposure in utero and in children compared to adults.ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “716013” in the subject line of the email.Sincerely,/S/Brad Pace, J.D.Associate DirectorOffice of Unapproved and Labeling ComplianceSigned on behalf of:Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration___________________1FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. See https://www.fda.gov/safety/medical-product-safety-information/fda-updates-warning-about-imported-cookware-may-leach-lead-august-2025.2FDA’s Guidance for Industry Q3D(R2) Elemental Impurities (September 2022). See https://www.fda.gov/media/148474/download.3FDA’s Guidance for Industry Q3D(R2) Elemental Impurities (September 2022). See https://www.fda.gov/media/148474/download and its companion document Guidance for Industry Elemental Impurities in Drug Products (August 2018).

Delivery Method:Via EmailProduct:DrugsRecipient:Neena Chowdary KogantiSwift Digital Group LLC dba Swadesii10101 Division DrRaleigh,NC27603United Statessupport@swadesii.comlegal@swadesii.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 17, 2025RE: 716644Neena Chowdary Koganti:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://swadesii.com/ in September 2025. The FDA has observed that your website offers “Deekshant Thyroid Tablet,” “Hepatina Syrup,” “Dr. Vasishth's Guduchi Tinospora cordifolia ghan Tablets,” “Bico 14 Haslab,” “Singhnad Guggul (A.S.S.),” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “Elaneer Kuzhambu,” “WG-5 Gold Drops,” and “WG-6 Gold Drops” (hereinafter Swadesii products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Your Swadesii products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Deekshant Thyroid Tablet,” “Hepatina Syrup,” “Dr. Vasishth's Guduchi Tinospora cordifolia ghan Tablets,” “Bico 14 Haslab,” “Singhnad Guggul (A.S.S.),” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “WG-5 Gold Drops,” and “WG-6 Gold Drops” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, cancer, diabetes, stroke, Alzheimer's, and hepatitis, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process. In addition, your unapproved “Elaneer Kuzhambu,” drug product is concerning because ophthalmic drug products, which are intended for administration into the eyes, generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.Based on a review of your website, your Swadesii products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Deekshant Thyroid TabletOn the webpage https://swadesii.com/products/ambic-deekshant-thyroid-60-tabs:From the product packaging:o In the name of the product – “Thyroid Tablet”o “Hypothyroidismo Helps in activating thyroid glands”“Description:o [N]atural ingredients that are [ ] highly effective in improving the health of the thyroid and avoiding thyroid infections.o [E]nhance the immune system and fights seasonal pathogens.o It is among the most effective antibacterial . . . help in the efficient functioning of thyroid hormone.o With the power of Ambic Deekshant thyroid tablets, you can get your way to a healthier thyroid.o This is an effective ayurvedic tablet for thyroid that will help you achieve healthier thyroid hormone levels.”Hepatina SyrupOn the webpage https://swadesii.com/products/bhargava-hepatina-syrupFrom the product packaging:o “Liver Tonic”“Description:o Bhargava Hepatina Syrup is helpful in the treatment of liver problems such as jaundice and fatty liver.o It aids in the improvement of digestive functions and the treatment of hepatocellular jaundice and liver damage as a supportive therapy.o It contains Chelidonium majus, a herb that aids in the clearance of toxins from the body and is especially beneficial in the treatment of liver issues.”Dr. Vasishth's GuduchiOn the webpage https://swadesii.com/products/dr-vasishths-guduchi-30-tabs“Modulates the immunity – Guduchi has been reported to modulate the abnormal immunity as happens in auto-immunity (where the immune cells attack own cells).It is thus useful in auto-immune disorders, including – Rheumatoid arthritis, psoriasis, SLE, lichen planus, IBD, multiple sclerosis, alopecia areata and type-I diabetes. . . .It is used for the management of liver disorders – Hepatitis, jaundice, abnormal liver enzymes, fatty liver, and early cirrhosis.Useful in acid peptic diseases – Guduchi has been reported to inhibit the excessive production of gastric acid. . . .It is useful in the management of various kidney disorders – Early / reversible kidney failure, nephritis and nephrotic syndrome.”Bico 14 HaslabOn the webpage https://swadesii.com/products/haslab-homeopathy-bico-14-biochemic-compound-tablets:“Description: . . .o It helps in all stages of disease and fevers of unknown origin; dry, hard, painful, itchy cough with sore chest.o [M]anage measles problems.”“Key Benefits:o It may help to reduce sneezing and watery discharge from the nose and eyes with fevero [H]elp to boost your immune systemo [P]revent catarrhal affectionso It can help to condition dry, hard, painful, itchy cough with sore chest”Singhnad Guggul (A.S.S.)On the webpage https://swadesii.com/products/patanjali-divya-singhnda-guggul-20-gms“Description:o Beneficial in chronic rheumatism (arthritis rimutaid), paralysis stroke, arthritis, etc. . . .o This is used for all types of vata diseases. This enhances and stimulates the uterus, regulates menstrual disorders, growth of white blood cells in blood, diuretics, mucilage secretory, worm destroyer etc.”“Benefits:o Useful in rheumatoid . . . arthritis”Repl Dr. Advice No. 69 Measales (Measles)On the webpage https://swadesii.com/products/dr-advice-no-69-measaless-lp8kj:From the product packaging:o In the name of the product – “measles”“Description:o Helps with symptoms associated with inflammation of the mucous membranes.o Helps with symptoms like measles, red rash in measles, and measles outbreaks.o Helps with burns, Heat, burning, red and shiny swelling of the diseased organs.o Helps to get rid of problems like swelling, heat, and redness of the whole body.”Baryta Carbonicum 200 CHOn the webpage https://swadesii.com/products/sbl-homeopathy-baryta-carbonicum-dilution:“[R]ecommended for old people when they suffer from paralysis and is used in multiple sclerosis of the brain and spinal cord.The elderly people have senile dementia, a disorder showing deterioration of mental abilities usually associated with getting old.Stroke and Alzheimer's disease are the two most common causes of this deterioration.”Elaneer KuzhambuOn the webpage https://swadesii.com/products/vaidyaratnam-elaneer-kuzhambu-z4vxs:“[U]sed to help in the treatment of eye ailments and balance the Pitta and Vata doshas to promote eye health.This Ayurvedic medicine for eye health helps calm eye irritation and can supplement the treatment of vision problems that are caused by sun, heat and smoke.The Ayurvedic eye drops helps safeguard you from eye infections and is used to help treat problems such as corneal ulcer, glaucoma, pterygium and the early stage of cataract.It is a natural Ayurvedic formulation that can help in the treatment of conjunctivitis and other eye infections and inflammations.”WG-5 Gold DropsOn the webpage https://swadesii.com/products/wheezal-homeopathy-wg-5-gold-drops:From the product packaging:o “Anti Strokeo Helps to Restore Blood Flow”“Description:o Wheezal WG5 Anti Stroke Gold Drop can improve blood circulation and manage circulatory debility.o It may also be useful against increased intracranial tension and brain oedema in . . . patients suffering from brain stroke and other brain-related diseases.o The drop’s homoeopathic ingredients might also help dissolve blood clots induced by stroke or other related diseases.”WG-6 Gold DropsOn the webpage https://swadesii.com/products/wheezal-homeopathy-wg-6-gold-drops:From the product packaging:o “Pancreas Healtho Supports normal functioning of Pancreas”“Description:o [H]elp relieve pancreatic disorders and balance the normal functioning of the pancreas.o [E]ase associated symptoms like abdominal pain, diarrhoea, and other commonpancreatic disorders.o It may be helpful against a range of pancreatic disorders, including pancreas malfunction, pancreatitis, cystic fibrosis, and pancreatic cancer.”“Key Benefits:o Helps balance and restore normal functioning of pancreaso [U]seful against cystic fibrosis, pancreatic cancer, and other associated pancreatic diseaseso [E]ase related symptoms like malnutrition, abdominal pain, oily stools, and other problems”Your Swadesii products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “Hepatina Syrup,” “Bico 14 Haslab,” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “WG-5 Gold Drops,” and “WG-6 Gold Drops” are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “716644” in the subject line of the email.Sincerely,/s/Brad Pace, J.D.Associate DirectorOffice of Unapproved and Labeling ComplianceSigned on behalf of:Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:VIA Electronic MailProduct:DrugsRecipient:VarunKart Group LLC dba Organic Wellnesses8206 Louisiana Blvd NE, STE A #4959Albuquerque,NM87113United Statessupport@organicwellnesses.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERNovember 17, 2025RE: 716154VarunKart Group LLC:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://organicwellnesses.com/ in September 2025. The FDA has observed that your website offers “Lord's L 143 Measles Drop,” “Dabur Swarna Bhasma,” “Dr. Willmar Schwabe India Aviaire Dilution,” “Himalaya Pure Herbs Arjuna Cardiac Wellness,” “Muniyal Muniojus Tablets,” “Mohammedia Kalonji Oil,” “Patanjali Divya Godhan Ark (Gaumutra),” “Himalaya Ophthacare Eye Drops” and “Patanjali Drishti Eye Drop” (hereinafter Organic Wellnesses products) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Your Organic Wellnesses products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Lord's L 143 Measles Drop,” “Dabur Swarna Bhasma,” “Dr. Willmar Schwabe India Aviaire Dilution,” “Himalaya Pure Herbs Arjuna Cardiac Wellness,” “Muniyal Muniojus Tablets,” “Mohammedia Kalonji Oil,” and “Patanjali Divya Godhan Ark (Gaumutra)” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, syphilis, tuberculosis, cancer, diabetes, and hepatitis, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process. In addition, your unapproved “Himalaya Ophthacare Eye Drops” and “Patanjali Drishti Eye Drop” drug products are concerning because ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.Based on a review of your website, your Organic Wellnesses products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Lord's L 143 Measles DropOn the webpage https://organicwellnesses.com/products/lords-l-143-measles-drop-30-ml:From the product packaging:o “Measles Drops”“It is beneficial for measles and feverIt helps to reduce mild to high temperaturesIt is beneficial for cough, blisters, watery nose, and eyes”Dabur Swarna BhasmaOn the webpage https://organicwellnesses.com/products/dabur-swarna-bhasma-500-mgs:“This ayurvedic medicine improves muscle strength and helps in all diseases like muscular dystrophy.”“Specially prescribed in hemiplegia and complete paralysis.”“Effectively treat Malabsorption syndrome, dyspepsia, hiccup, anaemia, dyspnoea, asthma, fever, tissue wasting, tuberculosis, impaired intelligence, epilepsy, rupture / weakness of ligaments, heart disease, disease due to Vata dosha, syphilis, poison, loss of memory, mania, psychosis, hoarseness of voice, diseases of skin, senility/progeriasis”“Exceptional efficacy in skin ailments and syphilis.”Dr. Willmar Schwabe India Aviaire DilutionOn the webpage https://organicwellnesses.com/products/dr-willmar-schwabe-india-aviaire-dilution:“Dr. Willmar Schwabe India Aviaire Dilution is a powerful homeopathy medicine, recommended for treating tuberculosis.”“It is helpful in curing respiratory disorders after measles.”“Provides support in treatment of tuberculosis”“Relieves difficulties in breathing”Himalaya Pure Herbs Arjuna Cardiac WellnessOn the webpage https://organicwellnesses.com/products/himalaya-pure-herbs-arjuna-cardiac-wellness:From the product packaging:o “Regulates circulation”o “Arjuna is well known for its beneficial effect on blood circulation.”“Arjuna helps in improving coronary artery blood flow, reducing the chances of clot formation and protects the heart muscles.”Muniyal Muniojus TabletsOn the webpage https://organicwellnesses.com/products/muniyal-muniojus-tablets-100-tabs:From the product packaging:o “Supportive Therapy for Immune Deficiency Syndrome”“Studies have proved that Muniojus reduces viral load.”“The ingredients improve host resistance by reducing disease progression and increasing CD cell counts.”“Improves non-specific & acquired immunity-deficiency, which is seen in HIV infections”“Helps in preventing opportunistic infections”“Acts as an antioxidant”Mohammedia Kalonji OilOn the webpage https://organicwellnesses.com/products/mohammedia-kalonji-oil:“Mohammedia Oil is useful in allergies, joint pains, arthritis stomach problems, kidney pain and infection, headache, falling of hair, piles, earache, dental disease, anaemia, cough, skin diseases, lack of sleep, acidity, constipation etc”“Mohammedia Kalonji oil prevents hair loss”“Kalonji oil for Asthma treatment”“Kalonji oil to cure joint pain”Patanjali Divya Godhan Ark (Gaumutra)On the webpage https://organicwellnesses.com/products/patanjali-divya-godhan-ark-gaumutra-450-ml:“Divya Godhan Ark is an ancient Ayurvedic medicine made by extracting the goodness from gomutra or cow urine. It has multiple benefits and cures a variety of serious ailments.”“It gives you relief from problems of liver and stomach. It cures eczema, controls diabetes and cancer.”“Get holistic cure and experience Ayurvedic healing at its best.”“Diseases curable by cow urine[:] cancer . . . tumor . . . diabetes . . . dysentery . . . measles . . . high blood pressure . . . syphilis . . . leprosy”Himalaya Ophthacare Eye DropsOn the webpage https://organicwellnesses.com/products/himalaya-ophthacare-eye-drops-1:From the product packaging:o “Relieves eye strain, redness and dryness.”“Himalaya Ophthacare Eye Drops helps to keep eyes safe.”“Honey helps to soothing effect on the eyes.”“Damask rose has cooling properties.”“Helps to keep the eyes safe”“Provides relief to those wearing lenses”Patanjali Drishti Eye DropOn the webpage https://organicwellnesses.com/products/patanjali-drishti-eye-drop:From the product packaging:o “Indication: . . . Eye disorder and Beneficial for eyes”“Patanjali Drishti Eye Drop is a very effective eye drop for any kind of eye problem. It is very safe to use ayurvedic medicine which also helps in increasing eyesight.”Your Organic Wellnesses products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “Lord's L 143 Measles Drop,” and “Dr. Willmar Schwabe India Aviaire Dilution” drug products are labeled as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “716154” in the subject line of the email.Sincerely,/S/Brad Pace, J.D.Associate DirectorOffice of Unapproved and Labeling ComplianceSigned on behalf of:Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration