Research For selling SCORON in Bangladesh

[Info] Research for Selling SCORON in Bangladesh SL. | Content (Japanese) | Content 1 | スコーロンは日本では「防除用医薬部外品」にあたらないが、バングラデシュにおける医薬品（Drugs）の定義に当てはまるのか。 例えば、「人体の構造または機能に影響を及ぼすことを目的としている、またはヒトまたは動物の病気を引き起こす害虫または昆虫の駆除に使用されることを目的とした物質（食品以外）。」に該当するのか | SCORON is not classified as 'quasi-drug for pest control' in Japan, but does it fall under the definition of a drug in Bangladesh? For example, does it correspond to 'a substance (other than food) intended to affect the structure or function of the human body, or intended to be used for the extermination of pests or insects that cause diseases in humans or animals.'? 2 | 日本の景品表示法の部分で、バングラデシュでも表現の規制があるのかどうか。 | Are there regulations on expressions in Bangladesh similar to Japan's Act against Unjustifiable Premiums and Misleading Representations? Authority | The Directorate General of Drug Administration (DGDA)/保健家族福祉省 医薬品管理総局 Reference 1 | Fiscal Year 2018: Research Report (Summary) on Regulatory Information and Analysis of Pharmaceuticals and Medical Devices in Asian Countries 平成30年度 アジア諸国医薬品・医療機器規制情報・分析事業 調査報告書（概要） https://www.pmda.go.jp/files/000229073.pdf Word 1 | Pharmaceuticals (医薬品) and "Quasi-drugs" (医薬部外品) Word 2 | The Act against Unjustifiable Premiums and Misleading Representations (景品表示法, Definision | "Drug" [Word 1] In Japan, there are clear distinctions between "Pharmaceuticals" (医薬品) and "Quasi-drugs" (医薬部外品). Here's an explanation in English: Pharmaceuticals (医薬品) Pharmaceuticals are substances that are used with the primary purpose of diagnosing, treating, alleviating, or preventing diseases in humans or animals. These substances have a direct effect on the body, either by influencing bodily functions or targeting pathogens (such as bacteria or viruses). They require rigorous safety and efficacy assessments by health authorities and are tightly regulated under the Pharmaceutical and Medical Device Act. Examples of pharmaceuticals include prescription medications, over-the-counter (OTC) drugs, vaccines, and certain treatments for serious conditions. Quasi-drugs (医薬部外品) Quasi-drugs, on the other hand, are products that have a milder effect compared to pharmaceuticals. While they still have some medicinal or preventative properties, they are generally intended for daily use and have a much lower risk profile. Quasi-drugs do not require the same level of rigorous testing as pharmaceuticals, though they still need approval from regulatory bodies for their safety and efficacy. They typically include products such as medicated cosmetics, toothpastes with fluoride, hair growth tonics, or insect repellents. In summary, the key differences lie in their intended use and regulatory requirements: Pharmaceuticals: Stronger therapeutic effects, stricter regulatory controls, and used for more serious medical purposes. Quasi-drugs: Milder effects, less stringent regulations, and used more for daily health maintenance or hygiene purposes. [Word 2] The Act against Unjustifiable Premiums and Misleading Representations (景品表示法, Keihin Hyōji-hō) is a Japanese law designed to protect consumers from misleading advertisements and unfair business practices related to the promotion and sale of goods and services. It aims to maintain fair competition among businesses and ensure that consumers make informed purchasing decisions based on accurate and truthful information. Key Aspects of the Act: 1. Misleading Representations: The law prohibits businesses from making false or exaggerated claims about the quality, performance, price, or other attributes of their products or services. For example, a product must not be advertised as superior or more effective than it actually is. 2. Unjustifiable Premiums: The act also restricts the use of excessive premiums (such as gifts, discounts, or rewards) to entice consumers into purchasing products. The goal is to prevent unfair competition and ensure that promotions do not mislead consumers about the true value of a product. 3. Monitoring and Enforcement: The Consumer Affairs Agency in Japan is responsible for enforcing the law. If a violation is found, the agency can issue administrative guidance, warnings, or fines to businesses. In severe cases, companies may be publicly named for their violations. Example: If a company claims that their product will lead to significant health benefits without sufficient scientific evidence, such representation would be considered misleading under this law. In summary, the Act against Unjustifiable Premiums and Misleading Representations ensures that businesses provide accurate information about their goods and services and that promotions are fair, which in turn protects consumers from being misled. [Definision] The Drugs Act of 1940 and the Drugs (Control) Ordinance of 1982 define drugs as follows: ・All medicines intended for internal or external use in humans or animals, as well as all substances intended for the treatment, alleviation, or prevention of diseases in humans or animals, including substances used in accordance with the Ayurvedic, Unani, Homeopathic, or Biochemic system of medicine. ・Substances for diagnosis, abortion, and contraception, as well as surgical ligatures, sutures, bandages, cotton, bacteriophages, adhesive plasters, gelatin capsules, and disinfectant solutions. ・Substances (other than food) intended to affect the structure or function of the human body, or intended to be used for the extermination of pests or insects that cause diseases in humans or animals. ・Substances listed as monographs in the British Pharmacopoeia, British Pharmaceutical Codex, United States Pharmacopoeia, United States National Formulary, or International Pharmacopoeia, either alone or in combination with other substances used in the Ayurvedic, Unani, Homeopathic, or Biochemic system of medicine, intended for any of the purposes listed in sections 1, 2, or 3. ・Any other substance that the government, through a notification in the official gazette, designates as a "drug." [Legal Dept.] Research for Selling SCORON in Bangladesh Sl. | Authority /Law | Way of communication | Findings | Contact Person | Remakrs 1 | Office of Chief Controller of Imports and Exports | Phone call | This authory could not answer directly, the said to take permission from relevent authority before import. But they could not ensure the specific authority. As per Import policy 2021-2024 the are some list of goods which can not be import in Bangladesh. Since this product is not in the import restricted goods, it can be imported. | Nurul Islam, Executive Officer 2 | Department of Textile | Visit | As per Textile Act 2018 there are no policy for this kind of product in Bangladesh.. | 1. Jahidul Islam (Shahin), PA to DG; 2. Help Desk 3 | Bangladesh Garment Manufacturers and Exporters Association | Phone call | Not relevent authority. They are involved only with manufacturing. | Help Desk 4 | Bangladesh Knitwear Manufacturers and Exporters Association. | Phone call | Not relevent authority. They are involved only with manufacturing. | Md. Ferdous Ibne Razzaque (Bappa), Deputy Secretary 5 | Import policy 2021-2024 | Checked the Act | There are no restrictions on importing the product as per import policy order 2021-2024 but it is not mentioned specifically. 6 | Directorate General of Health Services (DGHS) | Visit | They said they are not responsible authority. They do not work with textile. | Md Farhad Hussain, Director (Disease Control) 7 | Ministry of Agriculture (Department of Agricultural Extension) | Visit | We have visited with the product and shown it to top person of the authority. As per the Nation Agricultural Extension Rules 2023 and Pesticide Act 2018, they are not responsible for this product. | 1. Md. Maksudul Islam, PA; 2. Sekh Murshidul Islam, Deputy Secretary; 3. Shamim, Head of Assistant (PPC Wing) 8 | Bangladesh Chemical Industries Corporation | Visit | Not relevent authority. This Authority is dealing with fertilizer. | Shahinur Islam, PA (Chairman) 9 | Ministry of Industry | Visit | Not relevent authority. | Help Desk 10 | Directorate of National Consumers' Right Protection | Visit | Not relevent authority. They are only he Consumers’ Right Protection Act, 2009 they are only dealing with the complain of consumers. | Muhammad Hasanuzzaman, Assistant Director 11 | Department of Environment | Visit | As per Environment Conservation Rules 2023 and Hazardous Waste and Shipwreck Waste Management Rules, 2011 there is noting written about this kind of product. So they are unable to issue any approval for this product. | 1. Md. Abul Kalam Azad, Deputy Director; 2. Farid Ahmed, Director; 3. Razinara Begum, Director 12 | National Board of Revenue | Visit | If there are no HS Code found for this Product, NBR (Additional Rules Dept.) will register this product after import for customs clearance. | Help Desk 13 | Costoms Bond Commssionarate | Visit | They are not responsible for this as per Bonded Warehouse Licensing Rules 2023. | 1. Shamima Akter, Deputy Commissioner; 2. Miraj, Revenue Officer 14 | Bangladesh Standards and Testing Institution (BSIT) | Visit | For importing the product Colour Fastness Rating Test must be done as per Bangladesh Standard (BDS) 1758:2022. But there is no checking process for product safty is BSTI. As per the regulation of BSTI, for importing any kind of readymade Garments Product, Clearance certificate need to obtain for customs clearance of the product. BSTI also allows advanced testing before import of textile products. As per Bangladesh Standards and Testing Institution Act, 2018 they is no option for checking product safty issue. | 1. Engr. Khalid Reza Chuwdhury, Assistant Director; 2. Farabi, Deputy Director 15 | Dhaka Custom House | Visit | The Director of Dhaka Customs House Mr. Mustafiz said there is no restriction of importing the product as per the Import policy 2021-2024. There are some restricted chemical list those are not allowed (need special approval from relevant authorities) to import. Namely: Yhalothrin, Cypermethrin, Cyfluthrin, Fenvelarate, Alpha Cypermethrin, Es-Fenvalerate, Deltamethrin Danitol 1 EC (Fenpropathrin) But, Teijin cloth does not contain the above chemicals. It contains only Cyano-3-phenoxybenzyl(+)-trans-chrysanthemate. However, he suggested to talk to Bangladesh Council of Scientific and Industrial Research (BCSIR). We have already checked in online, and we found that BCSIR has a service of Product Analysis. We will visit Bangladesh Council of Scientific and Industrial Research (BCSIR) on the next day morning. | Md. Mustafizur Rahman, Deputy Commissioner 16 | Bangladesh Council of Scientific and Industrial Research (BCSIR) | Visit | Product Analysis needed from Analytical Sevice Cell, Dhaka Lab for Import. | 1. Md. Khabir Uddin Sarker, Senior Scientific Officer; 2. S. M. Mahmudul Hasan, Principal Scientific Officer (PSO) 3. Dr. Md Monarul Islam, Chemistry 4. Shabiba Parvin, Scientist [Additinal Queries] Japanese | English 1 | Permethrinについて、 ①「Permethrin」は製品名なのか、剤（殺虫剤/防虫剤）そのものなのか？ ②スコーロンと同様に「アパレル衣料品」への加工剤として使用されているのか？ ③その加工が施された衣料品としてバングラデシュ農業省で「承認」を取得しているのか？ ④あるいはPermethrinという剤（殺虫剤/防虫剤）そのものが「承認」されているのか？ ⑤農業省からの承認は、製品に対してなのか、剤（殺虫剤/防虫剤）そのものに対してなのか？ ⇒SCORONの場合、SCORONという製品に対して承認が必要なのか、そこの使われている剤（殺虫剤/防虫剤）そのものに対して承認が必要なのか？ | Regarding Permethrin, ① Is "Permethrin" the product name, or the agent (insecticide/repellent) itself? ② Is it used as a processing agent for "apparel clothing" like SCORON? ③ Has it been "approved" by the Bangladesh Ministry of Agriculture as a processed garment? ④ Or has the agent (insecticide/repellent) called Permethrin itself been "approved"? ⑤ Is the approval from the Ministry of Agriculture for the product, or for the agent (insecticide/repellent) itself? ⇒In the case of SCORON, is approval required for the product SCORON, or for the agent (insecticide/repellent) itself that is used there? 2 | 農業省からの承認を取得するのに、どんな必要書類や提出物が要求されるのか？改めて確認する。 ⇒（以前の調査時）製品の詳細情報及び成分、日本での製品の取り扱い（証明書等の法的文書）について確認したいと回答を受けた。 ①詳細情報とは、生地規格や製品スペックのこと？ ②サンプルは持ち込める。仕様書やサンプルで事足りるなら、OK. ③日本での製品の取り扱いについて、日本での薬機法や景品表示法に抵触しない範囲で販促物作成や製品製造を行っており、日本の法的機関や行政から証明書なり法的文章の取得はない。 | What documents and submissions are required to obtain approval from the Ministry of Agriculture? We will check again. ⇒ (During a previous survey) we got answer that they wanted to confirm detailed product information and ingredients, and how the product will be handled in Japan (certificates and other legal documents). ① By detailed information, do you mean fabric standards and product specifications? ② Samples can be brought in. If specifications and samples are sufficient, then OK. ③ Regarding the handling of products in Japan, promotional materials are created and products are manufactured within the scope that does not violate the Pharmaceutical and Medical Device Act or the Act against Unjustifiable Premiums and Misleading Representations, and no certificates or legal documents have been obtained from Japanese legal institutions or government agencies. 3 | IEDCR やBCSIR での許可について、 ①何に対して許可が必要になるのか？ 製品？剤？ ②Permethrinも同機関で許可取得しているのか？ | "About permissions from IEDCR and BCSIR, 1) What do we need permission for? Product? A drug? ②Has Permethrin also been approved by the same agency? “ 4 | まとめ ①承認、許可が必要な機関はどこか？ ②何に対して承認/許可が必要なのか？ ③承認/許可プロセスにおいて、必要書類/提出物やプロセスそのものについての情報。 | Summary ① Which agencies require approval or permission? ② What do you need approval/permission for? ③ Information about the necessary documents/submissions and the process itself for the approval/permission process