FDI is permitted in Different Sectors like Agriculture, Mining and Petroleum & Natural Gas Manufacturing, Services Sector Financial Services, and other sectors such as Pharmaceuticals, etc.,
This document outlines the rules and regulations for medical devices in Pakistan, including classification, licensing, registration, labeling, and other requirements. Key points include:
- The Medical Device Board is responsible for regulating medical devices and conformity assessment bodies.
- Medical devices must be classified based on risk and undergo conformity assessment prior to registration and import/sale.
- Manufacturers and importers must obtain establishment licenses, which require meeting quality and premises standards and are valid for 5 years.
- Detailed procedures are defined for licensing, registration, labeling, post-market surveillance, exemptions, and other aspects of the medical device approval process.
Overview of the pharmaceuticals and life sciences sector in india mp dec 2 2020Akil Hirani
With compatible laws, low-cost manufacturing alternatives, and a strong supply chain structure, India continues to hold its position as a global market leader in the pharmaceutical and life sciences industries.
This document discusses provisions around pharmaceutical products and medical devices between parties. It recognizes differences in healthcare systems but a shared commitment to developing high-quality products to improve public health. It affirms the importance of adequate access, incentives for innovation, ethical practices, and cooperation between parties. The document outlines that parties will ensure fair and transparent procedures for listing products for reimbursement. It also requires transparency around pricing and reimbursement regulations and procedures.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
Guidelines of the scheme promotion of bulk drug parks 1Atique Mohammed
This document outlines guidelines for India's "Promotion of Bulk Drug Parks" scheme. The key points are:
1) The scheme aims to promote setting up bulk drug parks with common infrastructure to reduce manufacturing costs and make India self-reliant in bulk drug production.
2) Up to Rs. 1000 crore will be provided as a one-time grant for common infrastructure in selected parks proposed by state governments.
3) A Project Management Agency will oversee implementation and states must set up agencies to develop detailed plans and manage the parks on a day-to-day basis.
The document provides an overview of regulations for medicinal products in Germany. Medicinal products are regulated by laws addressing manufacturing, marketing, distribution, and pharmacovigilance. Medicinal products for human use require a marketing authorization from either the Federal Institute for Drugs and Medical Devices or the Federal Agency for Sera and Vaccines. The document then discusses specific regulations regarding pricing and state funding, manufacturing, clinical trials, marketing, advertising, packaging and labeling, traditional herbal medicines, patents, trademarks, and regulatory authorities.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
This document outlines the rules and regulations for medical devices in Pakistan, including classification, licensing, registration, labeling, and other requirements. Key points include:
- The Medical Device Board is responsible for regulating medical devices and conformity assessment bodies.
- Medical devices must be classified based on risk and undergo conformity assessment prior to registration and import/sale.
- Manufacturers and importers must obtain establishment licenses, which require meeting quality and premises standards and are valid for 5 years.
- Detailed procedures are defined for licensing, registration, labeling, post-market surveillance, exemptions, and other aspects of the medical device approval process.
Overview of the pharmaceuticals and life sciences sector in india mp dec 2 2020Akil Hirani
With compatible laws, low-cost manufacturing alternatives, and a strong supply chain structure, India continues to hold its position as a global market leader in the pharmaceutical and life sciences industries.
This document discusses provisions around pharmaceutical products and medical devices between parties. It recognizes differences in healthcare systems but a shared commitment to developing high-quality products to improve public health. It affirms the importance of adequate access, incentives for innovation, ethical practices, and cooperation between parties. The document outlines that parties will ensure fair and transparent procedures for listing products for reimbursement. It also requires transparency around pricing and reimbursement regulations and procedures.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
Guidelines of the scheme promotion of bulk drug parks 1Atique Mohammed
This document outlines guidelines for India's "Promotion of Bulk Drug Parks" scheme. The key points are:
1) The scheme aims to promote setting up bulk drug parks with common infrastructure to reduce manufacturing costs and make India self-reliant in bulk drug production.
2) Up to Rs. 1000 crore will be provided as a one-time grant for common infrastructure in selected parks proposed by state governments.
3) A Project Management Agency will oversee implementation and states must set up agencies to develop detailed plans and manage the parks on a day-to-day basis.
The document provides an overview of regulations for medicinal products in Germany. Medicinal products are regulated by laws addressing manufacturing, marketing, distribution, and pharmacovigilance. Medicinal products for human use require a marketing authorization from either the Federal Institute for Drugs and Medical Devices or the Federal Agency for Sera and Vaccines. The document then discusses specific regulations regarding pricing and state funding, manufacturing, clinical trials, marketing, advertising, packaging and labeling, traditional herbal medicines, patents, trademarks, and regulatory authorities.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
The document outlines the procedures for registering medical devices in Pakistan according to the Medical Devices Rules of 2015. It discusses what constitutes a medical device and the application process for initial registration and renewal of registration. It lists the conditions of registration including maintaining records of clinical investigations and reporting adverse events. It also describes the procedures for cancelling or suspending a registration if the conditions are not met.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
The document discusses regulations around importing medical devices into India. It notes that the global medical devices market was over $200 billion in 2006 while India's market was $2.6 billion. Medical devices must be registered with the Central Drug Standard Control Organization and various state-level agencies. If a device is approved by the US FDA or bears a CE mark, registration is simpler. Registration costs $1500 for a site and $1000 per device, and is valid for 3 years. Certain devices are classified as drugs and have different regulatory processes. Clinical trials are generally not required for devices already approved in the US or EU. Import licenses are needed to import devices for clinical trials. While drug prices are regulated, medical device prices currently are
Medical devices are regulated under the Medical Device Rules published in 2017 and effective in 2018 in India. They include any instrument or material intended for human or animal use for diagnosis, treatment or prevention of disease. The Central Drugs Standard Control Organization regulates medical devices and some are notified under the Drugs and Cosmetics Act. There have been efforts to improve regulation of medical devices in India to focus on safety and appropriate use.
This document outlines the content requirements for an Investigational New Drug (IND) application submitted to the FDA. It describes the general content that must be included in an IND according to FDA regulations, including an introductory statement, investigator's brochure, clinical study protocols, and detailed information on the drug's chemistry, manufacturing, and controls. The level of detail required varies depending on the study phase and type of investigation. The primary purpose of an IND is to provide investigators and regulators with sufficient information on a drug's safety and study plans to ensure the protection of human subjects.
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
The document discusses the import requirements for various medical devices including contact lenses, sunglasses/eyeglasses, and medical equipment. It defines what constitutes a medical device and provides the registration numbers, forms, and other documentation required for import depending on the device and its intended use such as for medical procedures, research, repair, or personal use. Key requirements discussed are medical device listing numbers, manufacturer registration numbers, device premarket approval numbers, and valid prescriptions for items like contact lenses.
CDSCO & Central Bureau of Narcotics are the two organizations which regulate Narcotic Drugs.
ACCREDITED CONSULTANTS PVT LTD
info@acplgroupindia.co.in
+919310040434
This document discusses import and export regulations for drugs in India. It provides details on key facts about the Indian pharmaceutical industry, including that India is the largest provider of generic drugs globally. It also outlines the agencies that regulate drug import and export, such as the Central Drugs Standard Control Organisation. The document discusses export and import licensing procedures, quality control and inspection requirements, labeling and packaging standards, and conditions for granting import licenses.
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Export and import policies as per india , u.s., eu, japanPriyanka Gangarapu
This document summarizes export and import policies and procedures for pharmaceuticals in India, the US, and the EU. It outlines the general steps for export and import, including obtaining licenses and permits, packaging and labeling, shipping procedures, and customs requirements. It provides details on import regulations and documentation required in India and the US, including forms, fees, and conditions for licenses.
Importance of Annual Information Statement while filing Income Tax Return.pptxtaxguruedu
The Central Board of Direct Taxes (CBDT) has introduced a new functionality in the Annual Information Statement (AIS) for taxpayers, enhancing transparency and accuracy in tax reporting. This new feature allows taxpayers to view the status of their feedback in real-time, ensuring that their financial transactions are correctly reported. In this article, fictional characters Arjuna and Krishna discuss the implications and impact of AIS on filing Income Tax Returns, highlighting the benefits of the new functionality.
Income Tax Regime Dilemma – New VS. Old pdftaxguruedu
The evolution of tax regulations witnessed a significant milestone with the amendments to Section 115BAC of the Income Tax Act, 1961, brought forth by the Finance Act of 2023.
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Similar to Sector Specific Conditions on FDI For Pharmaceuticals.pptx
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
The document outlines the procedures for registering medical devices in Pakistan according to the Medical Devices Rules of 2015. It discusses what constitutes a medical device and the application process for initial registration and renewal of registration. It lists the conditions of registration including maintaining records of clinical investigations and reporting adverse events. It also describes the procedures for cancelling or suspending a registration if the conditions are not met.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
The document discusses regulations around importing medical devices into India. It notes that the global medical devices market was over $200 billion in 2006 while India's market was $2.6 billion. Medical devices must be registered with the Central Drug Standard Control Organization and various state-level agencies. If a device is approved by the US FDA or bears a CE mark, registration is simpler. Registration costs $1500 for a site and $1000 per device, and is valid for 3 years. Certain devices are classified as drugs and have different regulatory processes. Clinical trials are generally not required for devices already approved in the US or EU. Import licenses are needed to import devices for clinical trials. While drug prices are regulated, medical device prices currently are
Medical devices are regulated under the Medical Device Rules published in 2017 and effective in 2018 in India. They include any instrument or material intended for human or animal use for diagnosis, treatment or prevention of disease. The Central Drugs Standard Control Organization regulates medical devices and some are notified under the Drugs and Cosmetics Act. There have been efforts to improve regulation of medical devices in India to focus on safety and appropriate use.
This document outlines the content requirements for an Investigational New Drug (IND) application submitted to the FDA. It describes the general content that must be included in an IND according to FDA regulations, including an introductory statement, investigator's brochure, clinical study protocols, and detailed information on the drug's chemistry, manufacturing, and controls. The level of detail required varies depending on the study phase and type of investigation. The primary purpose of an IND is to provide investigators and regulators with sufficient information on a drug's safety and study plans to ensure the protection of human subjects.
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
The document discusses the import requirements for various medical devices including contact lenses, sunglasses/eyeglasses, and medical equipment. It defines what constitutes a medical device and provides the registration numbers, forms, and other documentation required for import depending on the device and its intended use such as for medical procedures, research, repair, or personal use. Key requirements discussed are medical device listing numbers, manufacturer registration numbers, device premarket approval numbers, and valid prescriptions for items like contact lenses.
CDSCO & Central Bureau of Narcotics are the two organizations which regulate Narcotic Drugs.
ACCREDITED CONSULTANTS PVT LTD
info@acplgroupindia.co.in
+919310040434
This document discusses import and export regulations for drugs in India. It provides details on key facts about the Indian pharmaceutical industry, including that India is the largest provider of generic drugs globally. It also outlines the agencies that regulate drug import and export, such as the Central Drugs Standard Control Organisation. The document discusses export and import licensing procedures, quality control and inspection requirements, labeling and packaging standards, and conditions for granting import licenses.
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
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Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
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This document summarizes export and import policies and procedures for pharmaceuticals in India, the US, and the EU. It outlines the general steps for export and import, including obtaining licenses and permits, packaging and labeling, shipping procedures, and customs requirements. It provides details on import regulations and documentation required in India and the US, including forms, fees, and conditions for licenses.
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Find Latest India News and Breaking News these days from India on Politics, Business, Entertainment, Technology, Sports, Lifestyle and Coronavirus News in India and the world over that you can't miss. For real time update Visit our social media handle. Read First India NewsPaper in your morning replace. Visit First India.
CLICK:- https://firstindia.co.in/
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Slide deck with charts from our Digital News Report 2024, the most comprehensive exploration of news consumption habits around the world, based on survey data from more than 95,000 respondents across 47 countries.
Shark Tank Jargon | Operational ProfitabilityTheUnitedIndian
Don't let fancy business words confuse you! This blog is your cheat sheet to understanding the Shark Tank Jargon. We'll translate all the confusing terms like "valuation" (how much the company is worth) and "royalty" (a fee for using someone's idea). You'll be swimming with the Sharks like a pro in no time!
केरल उच्च न्यायालय ने 11 जून, 2024 को मंडला पूजा में भाग लेने की अनुमति मांगने वाली 10 वर्षीय लड़की की रिट याचिका को खारिज कर दिया, जिसमें सर्वोच्च न्यायालय की एक बड़ी पीठ के समक्ष इस मुद्दे की लंबित प्रकृति पर जोर दिया गया। यह आदेश न्यायमूर्ति अनिल के. नरेंद्रन और न्यायमूर्ति हरिशंकर वी. मेनन की खंडपीठ द्वारा पारित किया गया
15062024_First India Newspaper Jaipur.pdfFIRST INDIA
Find Latest India News and Breaking News these days from India on Politics, Business, Entertainment, Technology, Sports, Lifestyle and Coronavirus News in India and the world over that you can't miss. For real time update Visit our social media handle. Read First India NewsPaper in your morning replace. Visit First India.
CLICK:- https://firstindia.co.in/
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projet de traité négocié à Istanbul (anglais).pdfEdouardHusson
Ceci est le projet de traité qui avait été négocié entre Russes et Ukrainiens à Istanbul en mars 2022, avant que les Etats-Unis et la Grande-Bretagne ne détournent Kiev de signer.
विवादास्पद फिल्म के ट्रेलर से गाली-गलौज वाले दृश्य हटा दिए गए हैं, और जुर्माना लगाया गया है। सुप्रीम कोर्ट और बॉम्बे हाई कोर्ट दोनों ने फिल्म की रिलीज पर रोक लगा दी है और उसे निलंबित कर दिया है। पहले यह फिल्म 7 जून और फिर 14 जून को रिलीज होने वाली थी, लेकिन अब यह 21 जून को रिलीज हो रही है।
Christian persecution in Islamic countries has intensified, with alarming incidents of violence, discrimination, and intolerance. This article highlights recent attacks in Nigeria, Pakistan, Egypt, Iran, and Iraq, exposing the multifaceted challenges faced by Christian communities. Despite the severity of these atrocities, the Western world's response remains muted due to political, economic, and social considerations. The urgent need for international intervention is underscored, emphasizing that without substantial support, the future of Christianity in these regions is at grave risk.
https://ecspe.org/the-rise-of-christian-persecution-in-islamic-countries/
13062024_First India Newspaper Jaipur.pdfFIRST INDIA
Find Latest India News and Breaking News these days from India on Politics, Business, Entertainment, Technology, Sports, Lifestyle and Coronavirus News in India and the world over that you can't miss. For real time update Visit our social media handle. Read First India NewsPaper in your morning replace. Visit First India.
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ग्रेटर मुंबई के नगर आयुक्त को एक खुले पत्र में याचिका दायर कर 540 से अधिक मुंबईकरों ने सभी अवैध और अस्थिर होर्डिंग्स, साइनबोर्ड और इलेक्ट्रिक साइनेज को तत्काल हटाने और 13 मई, 2024 की शाम को घाटकोपर में अवैध होर्डिंग के गिरने की विनाशकारी घटना के बाद अपराधियों के खिलाफ सख्त कार्रवाई की मांग की है, जिसमें 17 लोगों की जान चली गई और कई निर्दोष लोग गंभीर रूप से घायल हो गए।
Federal Authorities Urge Vigilance Amid Bird Flu Outbreak | The Lifesciences ...The Lifesciences Magazine
Federal authorities have advised the public to remain vigilant but calm in response to the ongoing bird flu outbreak of highly pathogenic avian influenza, commonly known as bird flu.
लालू यादव की जीवनी LALU PRASAD YADAV BIOGRAPHYVoterMood
Discover the life and times of Lalu Prasad Yadav with a comprehensive biography in Hindi. Learn about his early days, rise in politics, controversies, and contribution.
2. FDI is permitted in Different Sectors like Agriculture, Mining and Petroleum & Natural Gas
Manufacturing, Services Sector Financial Services, and other sectors such as Pharmaceuticals,
etc., Here we will discuss sector-specific conditions specified for FDI in Pharmaceuticals.
SECTOR-SPECIFIC CONDITIONS ON FDI FOR PHARMACEUTICALS
SR NO. Sector/Activity % of Equity/ FDI Cap Entry Route
1 Greenfield 100% Automatic
2 2 Brownfield 100% Automatic upto 74% Government route beyond 74%
OTHER CONDITIONS (i) ‘Non-compete’ clause would not be allowed in automatic or government
approval route except in special circumstances with the approval of the Government. (ii) The
prospective investor and the prospective investee are required to provide a certificate along
with the application for foreign investment as per Annexure
3. (iii) Government may incorporate appropriate conditions for FDI in brownfield cases, at the time of granting
approval. (iv) FDI in brownfield pharmaceuticals, under both automatic and government approval routes,
is further subject to compliance of following conditions: (a) The production level of National List of
Essential Medicines (NLEM) drugs and/or consumables and their supply to the domestic market at the
time of induction of FDI, being maintained over the next five years at an absolute quantitative level. The
benchmark for this level would be decided with reference to the level of production of NLEM drugs and/or
consumables in the three financial years, immediately preceding the year of induction of FDI. Of these, the
highest level of production in any of these three years would be taken as the level. (b) R&D expenses being
maintained in value terms for 5 years at an absolute quantitative level at the time of induction of FDI. The
benchmark for this level would be decided with reference to the highest level of R&D expenses which has
been incurred in any of the three financial years immediately preceding the year of induction of FDI. (c)
The administrative Ministry will be provided complete information pertaining to the transfer of
technology, if any, along with induction of foreign investment into the investee company. (d) The
administrative Ministry (s) i.e. Ministry of Health and Family Welfare, Department of Pharmaceuticals or
any other regulatory Agency/Development as notified by Central Government from time to time, will
monitor the compliance of conditionalities.
4. NOTE: 1. FDI up to 100%, under the automatic route is permitted for manufacturing of medical devices.
The above mentioned conditions will, therefore, not be applicable to greenfield as well as
brownfield projects of this industry. 2. Medical device means –
(a) any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination,
including the software, intended by its manufacturer to be used specially for human beings or animals for one or
more of the specific purposes of – diagnosis, prevention, monitoring, treatment or alleviation of any disease or
disorder; diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; investigation,
replacement or modification or support of the anatomy or of a physiological process; supporting or sustaining life;
disinfection of medical devices control of conception, and which does not achieve primary intended action in or
on the human body or animals by any pharmacological or immunological or metabolic means, but which may be
assisted in its intended function by such means;
5. b) an accessory to such an instrument, apparatus, appliance, material or other article; (c) in-vitro diagnostic device which is a
reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone
or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes
by means of examination of specimens derived from the human bodies or animals. Annexure– 9 Certificate to be furnished
by the Prospective Investor as well as the Prospective Recipient Entity It is certified that the following is the complete list of
all inter-se agreements, including the shareholders agreement, entered into between foreign investor(s) and investee
brownfield pharmaceutical entity
1. ………………………………..
2. …………………………………
3. …………………………………
(Copies of all agreements to be enclosed) It is also certified that none of the inter-se agreements, including the shareholders
agreement, entered into between foreign investor(s) and investee brownfield pharmaceutical entity contain any non-
compete clause in any form whatsoever.