The document discusses the application process and requirements for obtaining licenses and permits related to importing, exporting, manufacturing and distributing narcotic drugs, psychotropic substances, precursor chemicals and poppy seeds in India from the Central Bureau of Narcotics. It outlines the application forms and documents needed for manufacturing licenses, export authorizations, import certificates, no objection certificates for export/import of precursor chemicals and registration for poppy seed import. Key requirements include license and permit copies, import/export orders, technical details and fees. Compliance with estimate quotas and reporting obligations is also emphasized.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
The document discusses the globalization of drug discovery and development. It examines factors that influence where research and production occurs such as workforce costs, market size, intellectual property laws, and government policies. Countries like the US and Europe have traditionally led in innovation due to strong markets and patent protection, but Asia is increasing its role with lower costs and a growing skilled workforce. Where drugs are invented is shifting over time, with the US share declining and Asia rising in recent decades.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
The document summarizes the key aspects of the Drug Price Control Order (DPCO) Acts of 1995 and 2013 in India. It provides definitions of important terms, explains how prices of bulk drugs and formulations are determined, and outlines the powers of the government to fix prices. Some of the key points covered are:
- The DPCO Acts aim to ensure adequate drug production and equitable distribution at fair prices.
- The Acts define terms like bulk drugs, formulations, and ceiling prices and explain how manufacturing costs are considered in price determinations.
- The government has powers to direct manufacturers on bulk drug sales and fix retail prices of scheduled drugs and formulations.
Summary of instructions for implementation of pharmacovigilance (PV) system in the UK according to the MHRA guidelines and instructions. For more information visit www.tepsivo.com
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
The document discusses the globalization of drug discovery and development. It examines factors that influence where research and production occurs such as workforce costs, market size, intellectual property laws, and government policies. Countries like the US and Europe have traditionally led in innovation due to strong markets and patent protection, but Asia is increasing its role with lower costs and a growing skilled workforce. Where drugs are invented is shifting over time, with the US share declining and Asia rising in recent decades.
Acceptance of foreign clinical trials.pptxdipakkendre2
FDA guidence for industry acceptance of foreign clinical trials. -
Clinical trials conducted under IND
Clinical trials not conducted under IND
Good clinical practices
Acceptance of foreign clinical studies
Waivers
The document summarizes the key aspects of the Drug Price Control Order (DPCO) Acts of 1995 and 2013 in India. It provides definitions of important terms, explains how prices of bulk drugs and formulations are determined, and outlines the powers of the government to fix prices. Some of the key points covered are:
- The DPCO Acts aim to ensure adequate drug production and equitable distribution at fair prices.
- The Acts define terms like bulk drugs, formulations, and ceiling prices and explain how manufacturing costs are considered in price determinations.
- The government has powers to direct manufacturers on bulk drug sales and fix retail prices of scheduled drugs and formulations.
Summary of instructions for implementation of pharmacovigilance (PV) system in the UK according to the MHRA guidelines and instructions. For more information visit www.tepsivo.com
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
Japan drug and cosmetics regulation.pdfBhavikaAPatel
The Pharmaceuticals and Medical Devices Agency (PMDA) is the main regulatory body for pharmaceuticals and medical devices in Japan. It was established in 2004 to review drugs and medical devices, monitor post-marketing safety, and provide regulatory services. PMDA conducts reviews of clinical trial applications, new drug applications, and medical device applications to evaluate safety, efficacy, and quality. It aims to protect public health while facilitating efficient development of drugs and devices. PMDA's reviews and consultations are a major part of bringing new pharmaceuticals and medical technologies to the Japanese population.
The European Medicines Agency (EMA) was founded in 1995 and is responsible for coordinating the evaluation and supervision of medicinal products in the European Union. Some key milestones include recommending authorization of 975 human medicines in its first 20 years and marking its 20th anniversary in 2015. The EMA operates through various committees that assess different drug types and ensures clinical trials and medicines meet EU standards of quality, safety and efficacy. There are centralized, mutual recognition and national procedures for marketing authorization, and the EMA plays an important role in reviewing applications and facilitating approval across EU states.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
Drug Registration in GCC (Gulf Cooperation Council) - by Akshay AnandAkshay Anand
A presentation on Drug Registration in GCC Region. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015.
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Tabular summary of New Drugs & Clinical Trials Rules, 2019 [INDIA]Vikas Dhiman
The new Drugs and Clinical Trials Rules 2019 introduced by the Ministry of Health and Family Welfare in India came into effect on March 25, 2019. Key changes include new definitions, shorter timelines for approval of clinical trials and bioequivalence studies, compensation processes in case of injury or death during trials, and increased oversight of ethics committees. The new rules aim to strengthen and streamline the clinical research approval process in India.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
The European Medicines Agency (EMA) regulates medicines for human and veterinary use in Europe. Based in London, the EMA ensures medicines are safe and effective, working with authorities in EU member states. Over its 25 year history, the EMA has authorized over 1000 human and 200 veterinary medicines. While facilitating timely access to medicines, the EMA monitors safety and provides information to healthcare professionals and patients, but does not regulate pricing, advertising, patents, or certain other products. The EMA comprises several scientific committees and is supported by the European Directorate for Quality of Medicines.
The document discusses regulatory bodies and processes related to drugs in the United States and Canada. It provides information on the organization and functions of the US Food and Drug Administration (FDA), including the Federal Register, Code of Federal Regulations, and history of the Federal Food, Drug, and Cosmetic Act. It also discusses the Hatch-Waxman Act, Orange Book, Purple Book, and Drug Master File system in the US.
This document summarizes the major changes brought about by the new European Union pharmacovigilance legislation. It overviews the goals of improving safety monitoring and decision making. Key changes include new guidelines on pharmacovigilance systems and risk management, the establishment of the Pharmacovigilance Risk Assessment Committee, more stringent reporting rules, and increased transparency including public access to safety information. The legislation aims to modernize the EU pharmacovigilance system and better protect public health.
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYSai Datri Arige
This document discusses procedures for exporting and importing pharmaceuticals in India. It provides an overview of India's pharmaceutical industry and regulations regarding export/import licenses, quality control inspections, labeling/packaging, and medical device imports. The general export process involves obtaining necessary licenses, procuring goods, packing/labeling, shipping, and completing documentation. Import regulations specify registration requirements and conditions for licenses, standards, and record keeping for imported pharmaceuticals. Certain medical devices are also regulated as drugs under Indian law.
The document summarizes the African Medicines Regulatory Harmonisation (AMRH) Initiative. It discusses the background and vision of AMRH, which aims to improve access to essential medicines through regulatory harmonization across Africa. It outlines achievements including establishing an advisory committee and technical working groups, developing a model law, and launching regulatory harmonization projects in several regions. The document also notes industry support for AMRH and how regulatory harmonization can boost healthcare, access to new drugs, and the pharmaceutical industry in Africa over the short and long term. It concludes by highlighting next steps such as expanding the scope of harmonization and establishing sustainable training programs.
Europe CE Marking for medical devices under new MDREMERGO
Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.
The document discusses the process of new drug discovery and development. It begins with an overview of how drug discovery aims to identify compounds that can treat diseases through testing and assays. It then discusses the history of drug discovery from early use of plants/animals to current scientific processes. The stages of drug development are outlined as preclinical testing on animals, followed by four phases of clinical trials on humans to test safety, efficacy, and get regulatory approval. Finally, it notes the long timelines, high costs, and regulatory hurdles of getting a new drug approved and on the market.
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
Formal Meetings between the FDA and Sponsors or ApplicantsAakashdeep Raval
This document discusses guidelines for formal meetings between drug and biologics sponsors/applicants and the FDA. There are three types of meetings - Type A for stalled development programs, Type B for key milestones, and Type C for other issues. Type A meetings should occur within 30 days, Type B within 60 days, and Type C within 75 days of an FDA request. Meeting requests must include an agenda, questions, and lists of attendees to allow the FDA to assess utility and identify necessary staff. The guidelines aim to promote efficient management of meetings between regulators and industry.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
Controlled substances are drugs with high potential for abuse that are regulated by the Controlled Substances Act. This law established a closed system for proper handling of these drugs through licensing and established the DEA to enforce the law. Controlled substances are categorized into 5 schedules based on their abuse potential and legal restrictions. Strict record keeping and security measures are required for ordering, receiving, inventorying, and distributing controlled substances to ensure proper use and prevent diversion.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
Japan drug and cosmetics regulation.pdfBhavikaAPatel
The Pharmaceuticals and Medical Devices Agency (PMDA) is the main regulatory body for pharmaceuticals and medical devices in Japan. It was established in 2004 to review drugs and medical devices, monitor post-marketing safety, and provide regulatory services. PMDA conducts reviews of clinical trial applications, new drug applications, and medical device applications to evaluate safety, efficacy, and quality. It aims to protect public health while facilitating efficient development of drugs and devices. PMDA's reviews and consultations are a major part of bringing new pharmaceuticals and medical technologies to the Japanese population.
The European Medicines Agency (EMA) was founded in 1995 and is responsible for coordinating the evaluation and supervision of medicinal products in the European Union. Some key milestones include recommending authorization of 975 human medicines in its first 20 years and marking its 20th anniversary in 2015. The EMA operates through various committees that assess different drug types and ensures clinical trials and medicines meet EU standards of quality, safety and efficacy. There are centralized, mutual recognition and national procedures for marketing authorization, and the EMA plays an important role in reviewing applications and facilitating approval across EU states.
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
Drug Registration in GCC (Gulf Cooperation Council) - by Akshay AnandAkshay Anand
A presentation on Drug Registration in GCC Region. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015.
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Tabular summary of New Drugs & Clinical Trials Rules, 2019 [INDIA]Vikas Dhiman
The new Drugs and Clinical Trials Rules 2019 introduced by the Ministry of Health and Family Welfare in India came into effect on March 25, 2019. Key changes include new definitions, shorter timelines for approval of clinical trials and bioequivalence studies, compensation processes in case of injury or death during trials, and increased oversight of ethics committees. The new rules aim to strengthen and streamline the clinical research approval process in India.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
The European Medicines Agency (EMA) regulates medicines for human and veterinary use in Europe. Based in London, the EMA ensures medicines are safe and effective, working with authorities in EU member states. Over its 25 year history, the EMA has authorized over 1000 human and 200 veterinary medicines. While facilitating timely access to medicines, the EMA monitors safety and provides information to healthcare professionals and patients, but does not regulate pricing, advertising, patents, or certain other products. The EMA comprises several scientific committees and is supported by the European Directorate for Quality of Medicines.
The document discusses regulatory bodies and processes related to drugs in the United States and Canada. It provides information on the organization and functions of the US Food and Drug Administration (FDA), including the Federal Register, Code of Federal Regulations, and history of the Federal Food, Drug, and Cosmetic Act. It also discusses the Hatch-Waxman Act, Orange Book, Purple Book, and Drug Master File system in the US.
This document summarizes the major changes brought about by the new European Union pharmacovigilance legislation. It overviews the goals of improving safety monitoring and decision making. Key changes include new guidelines on pharmacovigilance systems and risk management, the establishment of the Pharmacovigilance Risk Assessment Committee, more stringent reporting rules, and increased transparency including public access to safety information. The legislation aims to modernize the EU pharmacovigilance system and better protect public health.
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYSai Datri Arige
This document discusses procedures for exporting and importing pharmaceuticals in India. It provides an overview of India's pharmaceutical industry and regulations regarding export/import licenses, quality control inspections, labeling/packaging, and medical device imports. The general export process involves obtaining necessary licenses, procuring goods, packing/labeling, shipping, and completing documentation. Import regulations specify registration requirements and conditions for licenses, standards, and record keeping for imported pharmaceuticals. Certain medical devices are also regulated as drugs under Indian law.
The document summarizes the African Medicines Regulatory Harmonisation (AMRH) Initiative. It discusses the background and vision of AMRH, which aims to improve access to essential medicines through regulatory harmonization across Africa. It outlines achievements including establishing an advisory committee and technical working groups, developing a model law, and launching regulatory harmonization projects in several regions. The document also notes industry support for AMRH and how regulatory harmonization can boost healthcare, access to new drugs, and the pharmaceutical industry in Africa over the short and long term. It concludes by highlighting next steps such as expanding the scope of harmonization and establishing sustainable training programs.
Europe CE Marking for medical devices under new MDREMERGO
Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.
The document discusses the process of new drug discovery and development. It begins with an overview of how drug discovery aims to identify compounds that can treat diseases through testing and assays. It then discusses the history of drug discovery from early use of plants/animals to current scientific processes. The stages of drug development are outlined as preclinical testing on animals, followed by four phases of clinical trials on humans to test safety, efficacy, and get regulatory approval. Finally, it notes the long timelines, high costs, and regulatory hurdles of getting a new drug approved and on the market.
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
Formal Meetings between the FDA and Sponsors or ApplicantsAakashdeep Raval
This document discusses guidelines for formal meetings between drug and biologics sponsors/applicants and the FDA. There are three types of meetings - Type A for stalled development programs, Type B for key milestones, and Type C for other issues. Type A meetings should occur within 30 days, Type B within 60 days, and Type C within 75 days of an FDA request. Meeting requests must include an agenda, questions, and lists of attendees to allow the FDA to assess utility and identify necessary staff. The guidelines aim to promote efficient management of meetings between regulators and industry.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
Controlled substances are drugs with high potential for abuse that are regulated by the Controlled Substances Act. This law established a closed system for proper handling of these drugs through licensing and established the DEA to enforce the law. Controlled substances are categorized into 5 schedules based on their abuse potential and legal restrictions. Strict record keeping and security measures are required for ordering, receiving, inventorying, and distributing controlled substances to ensure proper use and prevent diversion.
This document outlines procedures for controlling regulated substances like narcotics in a hospital setting. It discusses identifying and resolving discrepancies in controlled substance counts, defines who can prescribe and handle these drugs, and lists some commonly used narcotics. It provides details on ordering, prescribing, dispensing, and tracking controlled substances within the hospital. The document also describes protocols for reporting diversion or abuse of drugs, including which outside agencies to notify. It discusses types of diversion cases and notes that physician and pharmacy diversion is most common. It outlines investigating incidents internally and procedures for reporting to outside agencies, as well as potential penalties for employees.
1) The document outlines the revised pay structure for fresh recruits and existing employees under the 6th Central Pay Commission. It fixes entry pay levels depending on grade pay and pay bands.
2) It details rules for annual increments of 3% of total pay, and a variable 4% increment for higher achievers.
3) Examples are provided for pay fixation in cases of promotion, direct recruitment, upgraded posts, and on receiving increments. Stepping up of pay is allowed if a senior draws less than a directly recruited junior.
This document discusses different types of drugs including narcotics and non-narcotics. It provides details on opium, morphine, heroin, codeine, barbiturates, cocaine, amphetamines, methamphetamine, marijuana, LSD and other drugs. It explains that narcotics are derived from the Greek word meaning lethargy and includes opium-based drugs and barbiturates. Non-narcotics include LSD, amphetamines and are divided into depressants, stimulants and hallucinogens. The document also outlines the Narcotic Drugs and Psychotropic Substances Act of 1985 in India and the role of forensic laboratories in drug identification and analysis
This document outlines policies and procedures for the administration and storage of narcotics. It defines narcotics and describes the assessment that should be done prior to administration including pain scale, vital signs, sedation level and mental status. It provides a sedation scale and states when levels require reporting. It describes safety procedures for administration and reporting conditions. It discusses narcotic storage, counting, documentation and key control. Expired narcotics should be replaced one month prior to expiration. Staff must ensure secure storage and clean areas.
Narcotics are drugs that are derived from opium or produce opium-like effects. Examples include morphine, codeine, heroin, oxycodone, and methadone. Opium was first used and abused in China hundreds of years ago. Narcotics are highly addictive and prolonged use can lead to both physical and mental health effects as well as social consequences. They are associated with crime and societal issues.
Radiopharmaceuticals are radioactive substances used for diagnostic or therapeutic purposes. They consist of a radioactive isotope attached to a carrier molecule that delivers the isotope to the area being examined or treated. Radiopharmaceuticals are commonly used in nuclear medicine to diagnose and treat diseases like cancer. Their production, handling, and dispensing requires strict adherence to good radiation practices and good manufacturing practices to ensure safety.
Narcotic and Psychotropic Substance act 1985Prakash Mali
The statutory control over narcotic drugs was being exercised under The Opium Act, 1857, The Opium Act, 1878 and The Dangerous Drugs Act, 1930.
India had no legislation regarding narcotics until 1985. Cannabis smoking in India has been known since at least 2000 BC and is first mentioned in the Atharvaveda, which dates back a few hundred years BC.
NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT (NDPS), 1985 WITH RULE Sagar Savale
The Narcotic Drugs and Psychotropic Substances Act of 1985 consolidated and amended previous laws to more strictly control narcotic drugs and psychotropic substances in India. It established the Narcotic Control Bureau to enforce the new law. The Act defines narcotic and psychotropic substances and prohibits various activities related to them without a license. It gives authorities the power to permit and regulate certain activities and establishes penalties for violations. The overall aim is to prevent drug abuse and trafficking while allowing legitimate medical and scientific use.
CDSCO & Central Bureau of Narcotics are the two organizations which regulate Narcotic Drugs.
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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.
These presentation contains rules and regulation regarding import of drugs. These presentation is the part of series Drug & Cosmetics Act and will be followed by other parts.
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.
To prepare an application for manufacturing license for allopathic drugs in I...Aakashdeep Raval
The document outlines the process for obtaining a manufacturing license for allopathic drugs in India, including submitting layout plans for approval, applying using the appropriate forms along with documents such as technical staff details and product information, and an inspection of the premises. It also discusses the application process for obtaining licenses to sell drugs wholesale and the forms and documents required.
Import of drugs - Drugs and cosmetic Act 1940 and rules 1945Swarna kumari S
Drugs and cosmetic Act 1940 and rules 1945. How drugs can be imported. Licensing procedure in India. Prohibited drugs for Import. classes of drugs allowed to import.
The document discusses letters of credit (LC), which are financial instruments used in international trade to mitigate risks for buyers and sellers located in different countries. An LC involves a bank that guarantees the seller will be paid once they deliver goods meeting specifications. This builds trust between parties who may not know each other. The document outlines the importance of LCs in reducing financial risks and ensuring fair transactions. It also describes the types of LCs and licensing forms and applications used when opening LCs in Bangladesh.
This document discusses the process for importing and registering drugs and cosmetics in India according to the Drugs and Cosmetics Act of 1945 and Rules of 1945. It outlines the following key points:
1. There are two phases - registration and import license. In Phase 1, an application is made using Form 40 to obtain a Registration Certificate for manufacturing premises and drugs. In Phase 2, Form 8/8A is used to apply for an Import License.
2. Schedules D(I) and D(II) require information about the manufacturer, manufacturing premises, and drugs. A fee of $1500 per manufacturing site and $1000 per drug is paid.
3. If registration is approved,
Legislation in respect of Homeopathic PharmacyRamJyothis
The document summarizes key legislation related to homeopathic pharmacy in India. It discusses the origin of pharmaceutical legislation beginning in 1927 and the recommendations of committees that helped form acts like the Drugs and Cosmetics Act of 1940. The act established standards for importing, manufacturing, and selling drugs and set up licensing for pharmacists. It also covers laws specific to homeopathic medicines regarding licensing of sellers and manufacturers, conditions of licenses, labeling, and restrictions on packaging and alcohol content. The document traces the evolution of drug policy and regulation in India.
Đơn xin công nhận các nhà sản xuất nước ngoài lưu hành thuốc tại Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Phân loại việc công nhận các nhà sản xuất nước ngoài lưu hành thuốc tại Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
The document discusses India's drug regulatory system. The Drug Controller General of India regulates drugs and medical devices in the country to ensure quality, safety and efficacy. New drugs require approval through a New Drug Application process which involves submitting documentation on manufacturing, non-clinical studies, and clinical trials for review. It takes about a year to review an NDA and various forms and fees are involved in the approval and import license application processes.
This document discusses import regulations for drugs and cosmetics under the Drugs and Cosmetics Act in India. It outlines classes of drugs and cosmetics that are prohibited from import, including expired, substandard, misbranded, or adulterated products. It also discusses requirements for importing drugs, including obtaining an import license or permit. Licenses are required for drugs listed in Schedules C, C1, and X, as well as for importing new drugs. Small quantities can be imported for examination or personal use with the proper documentation. The places drugs can be imported through and record-keeping requirements are also summarized.
The document discusses the pharmaceutical industry development process in India. It outlines the legal requirements and licenses needed to manufacture or import APIs and drugs. Companies must seek approval from the DCGI and adhere to CDSCO guidelines. The application process requires submitting chemical, pharmaceutical, pre-clinical and clinical data. Various forms are used for obtaining manufacturing, import, and sales licenses from the CDSCO. The CDSCO-SUGAM project aims to streamline approval processes.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
The document provides information on import procedures and regulations in India. It discusses that imports are governed by the Foreign Trade (Development & Regulation) Act of 1992 and outlines the key steps, which include selecting an import product, obtaining an Importer-Exporter Code, applying for an import license if required, and finalizing import contracts considering pricing terms and INCO terms. Key import schemes like Export Promotion Capital Goods and Duty Exemption are also summarized.
Guideline for application and grant of manufacturing and selling of pharmaceutical drugs , cosmetics, biologics and medical devices to be followed by pharmaceutical industry.
The document summarizes the regulation of drug imports under the Drugs and Cosmetics Act of 1940 in India. It outlines that certain drugs cannot be imported if they are not of standard quality, misbranded, spurious, adulterated, or do not have an import license. Drugs specified in Schedules C and C1 can be imported under license, excluding those in Schedule X. An import license application requires a fee and must be accompanied by information about the drug. Licenses are valid until the end of the year issued and can be suspended or cancelled for non-compliance. Personal imports of drugs are allowed if for exclusive personal use and declared to customs.
The document outlines the procedure for foreign manufacturers to obtain and operate under a Bureau of Indian Standards (BIS) license. Key points:
1) Foreign manufacturers can apply for a BIS license to mark their products with the Standard Mark if they meet manufacturing and testing standards.
2) Applicants must set up a liaison office or appoint an agent in India to be responsible for meeting BIS requirements.
3) The application process involves a preliminary inspection, independent testing of samples, agreeing to inspection and testing schedules, and paying fees.
4) If approved, the BIS license is valid for one year and involves annual renewal, surveillance inspections, responding to complaints, and bearing costs of
This document provides information about drug regulatory affairs in India. It discusses that drug manufacturing licenses are issued by state authorities, new drug approvals are issued by the Drug Controller General of India, and clinical trial permissions are also provided by the Drug Controller General of India. It also outlines the required legal, regulatory, and technical documents for obtaining drug registrations and import licenses in India, including plant master files, device master files, labels and inserts. It describes the processing procedures and typical timelines for document submission, evaluation, and obtaining registration certificates and import licenses from the Central Drugs Standard Control Organization in India.
The document summarizes India's drug regulation system. The Drug Controller General of India oversees the Central Drug Standard Control Organisation and regulates medical devices and drugs. New drugs must go through an approval process involving clinical trials and submissions to various departments before gaining an import license and being allowed for manufacture and sale in India. The process can take around one year and involves filing various regulatory, technical and legal documents with fees.
The document outlines the drug registration process in India. It describes the regulatory bodies like the Drug Controller General of India and its subordinate offices. It provides details on the fees, various required documents like legal forms, manufacturing licenses, quality certificates, and technical documents like plant master files, device master files, labels, and inserts. It explains the submission and processing procedure that takes around 2-3 months to scrutinize the documents and issue a registration certificate. It also describes the subsequent import license application process.
The document discusses various Indian food laws and regulations, including the Food Safety and Standards Authority of India (FSSAI), which regulates food manufacturing, storage, distribution, and imports. It also mentions other regulatory bodies like the Bureau of Indian Standards and AGMARK that set quality standards. Several orders are summarized, such as the Fruit Products Order, Meat Food Products Order, and Milk and Milk Products Order, which require licensing and set hygiene standards for specific food types. The Prevention of Food Adulteration Act is also briefly outlined.
The document outlines the process for drug and device registration in India. It explains that the Drug Controller General of India regulates drugs and devices through the Central Drug Standard Control Organization. Fees of 1500 USD are required for site registration and 1000 USD per product. The process involves submitting legal, regulatory, and technical documents to the CDSCO who reviews the application over 2-3 months before providing a registration certificate. An import license can then be obtained by the Indian agent to import products from the manufacturer.
The document discusses regulations for importing in vitro diagnostic products (IVDs) into India. It explains that IVDs are substances used to diagnose diseases in humans or animals. The Drugs Controller General of India regulates IVD imports to ensure quality, safety and efficacy. IVDs are classified as notified, non-notified, non-critical or semi-critical. Import requirements include forms, fees, certificates and other documentation depending on the IVD classification. The licensing authority aims to issue import licenses within three months if all application requirements are met.
The document discusses medical device regulations in India. The Drugs Controller General of India oversees the Central Drugs Standard Control Organisation, which regulates medical devices. Only notified devices are regulated, which include items like syringes, stents, and implants. Device registration requires submitting legal, regulatory, technical, and quality documents and can take 4-5 months. Import licenses for registered devices may take an additional month. The contact details of Accredited Consultants Pvt. Ltd. are provided.
The document summarizes the drug registration and regulation process in India. It explains that the Drug Controller General of India heads the Central Drug Standard Control Organization and regulates drugs. It outlines the fees required for site registration and product registration. It also provides details on the regulatory authorities and documents required at various stages of the process, including legal documents, regulatory documents, technical documents, labels, and inserts. It describes the processing procedure and timeline for registration and import license.
The document discusses regulations for importing in vitro diagnostic products (IVDs) into India. It explains that IVDs are substances used to diagnose diseases in humans or animals. The Drugs Controller General of India regulates IVD imports to ensure quality, safety and efficacy. IVDs are classified as notified, non-notified, non-critical or semi-critical. Import requirements include application forms, fees, certificates and other documentation depending on the IVD classification. If the application is complete, an import license will be issued within three months. The document provides contact information for Accredited Consultants Private Limited, the organization assisting with IVD imports to India.
The document discusses medical device regulations in India. The Drugs Controller General of India oversees the Central Drugs Standard Control Organisation, which regulates medical devices. Only notified devices are regulated, which include items like syringes, stents, and implants. Device registration requires submitting legal, regulatory, technical, and quality documents and can take 4-5 months. Import licenses for registered devices may take an additional month. The contact details of Accredited Consultants Pvt. Ltd. are provided.
The document discusses regulations for cosmetics in India. The Drug Controller General of India regulates cosmetics through the Central Drug Standard Control Organisation. Cosmetics must be registered prior to importation to India by providing documents like forms, licenses, certificates, and lab reports. The registration process takes about 2-3 months as the documents are scrutinized. Manufacturing of cosmetics in India also requires state licenses that are issued based on facility and personnel details.
This document provides information about drug regulatory affairs in India. It discusses that drug manufacturing licenses are issued by state authorities, new drug approvals are issued by the Drug Controller General of India, and clinical trial permissions are also provided by the Drug Controller General of India. It also outlines the required legal, regulatory, and technical documents for obtaining drug registrations and import licenses in India, including plant master files, device master files, labels and inserts. It describes the processing procedures and timelines for document submission, evaluation, and obtaining registration certificates and import licenses from the Central Drugs Standard Control Organization in India.
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
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Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
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Debunking Nutrition Myths: Separating Fact from Fiction"AlexandraDiaz101
In a world overflowing with diet trends and conflicting nutrition advice, it’s easy to get lost in misinformation. This article cuts through the noise to debunk common nutrition myths that may be sabotaging your health goals. From the truth about carbohydrates and fats to the real effects of sugar and artificial sweeteners, we break down what science actually says. Equip yourself with knowledge to make informed decisions about your diet, and learn how to navigate the complexities of modern nutrition with confidence. Say goodbye to food confusion and hello to a healthier you!
PGx Analysis in VarSeq: A User’s PerspectiveGolden Helix
Since our release of the PGx capabilities in VarSeq, we’ve had a few months to gather some insights from various use cases. Some users approach PGx workflows by means of array genotyping or what seems to be a growing trend of adding the star allele calling to the existing NGS pipeline for whole genome data. Luckily, both approaches are supported with the VarSeq software platform. The genotyping method being used will also dictate what the scope of the tertiary analysis will be. For example, are your PGx reports a standalone pipeline or would your lab’s goal be to handle a dual-purpose workflow and report on PGx + Diagnostic findings.
The purpose of this webcast is to:
Discuss and demonstrate the approaches with array and NGS genotyping methods for star allele calling to prep for downstream analysis.
Following genotyping, explore alternative tertiary workflow concepts in VarSeq to handle PGx reporting.
Moreover, we will include insights users will need to consider when validating their PGx workflow for all possible star alleles and options you have for automating your PGx analysis for large number of samples. Please join us for a session dedicated to the application of star allele genotyping and subsequent PGx workflows in our VarSeq software.
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How to Control Your Asthma Tips by gokuldas hospital.Gokuldas Hospital
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2. Narcotic, Psychotropic & processors are
Imported, Exported or Manufactured only
with the permission from Central Bureau of
Narcotic, Gwalior.
Schedule-I, II & III of NDPS Rules are the list
of these controlled substances
Accredited Consultants Pvt. Ltd.
3. Any company/applicant desirous to manufacture any synthetic narcotic drugs
shall applied to the Narcotics Commissioner in a prescribed manner and shall
submit the documents detailed at Annexure -I
The manufacture of Narcotic drugs is governed by estimate system. While allowing
the manufacturing licence, it is ensured that the total quantity of drug allowed to be
manufactured during any year does not exceed the annual estimated requirements of
India as furnished and subsequently published by to the International Narcotics
Control Board, Vienna, Austria.
As regards renewal of manufacturing licence, the manufacturers are required to
apply to the Narcotics Commissioner at least 30 days before the expiry of his
license along with documents detailed at Annexure-II
On the basis of the demand made by the manufacturers and keeping in view their
performance i.e. internal consumption and export of the drug, the manufacturing
licenses are renewed for suitable quantities within the estimates of that drug for the
year.
Accredited Consultants Pvt. Ltd.
4. Any company/applicant desirous of obtaining Export Authorisation shall apply to the Narcotics
Commissioner in a prescribed manner and shall submit the documents detailed at Annexure-III
Apart from the above documents, additional information in respect of companies approaching this
office for the first time for grant of such Export Authorisations shall also be submitted along with
the application which are detailed at Annexure-VII
The export of narcotic drugs and Psychotropic substances are governed by estimate system. While
allowing Export Authorisation, it is ensured that the annual estimated requirement in respect of a
particular narcotic drugs and psychotropic substances ( as published by INCB, Vienna, Austria)
does not exceed the estimated requirement in respect of the importing country. Such export
authorisation are allowed by Central Bureau of Narcotics subject to following conditions :-
a. Any kind of amendment as well as extension in validity of Export Authorisation would not be
allowed.
b. The shipment should be made in one consignment within the validity of the Export Authorisation.
c. The exporters are required to submit export details immediately after effecting export.
Accredited Consultants Pvt. Ltd.
Export Authorisations for Export of Narcotic
Drugs and Psychotropic Substances
5. Any company/applicant desirous of obtaining import certificate shall apply in a
prescribed manner submitting the documents detailed at Annexure IV
Apart from the above documents, additional information in respect of companies
approaching this office for the first time for grant of import Certificates shall also
submit the documents detailed at Annexure- VII
The import of narcotic drugs and Psychotropic substances are governed by estimate
system. While allowing Import Certificate, it is ensured that the estimated
requirement of a particular narcotic drug and psychotropic substance
(reported to the INCB and subsequently published by INCB) does not exceed the
requirement in respect of India. Such import Certificates are granted subject to
condition that the importer will submit the import details immediately after
effecting import and any kind of amendment as well as extension in validity of
Export Authorisation would not be allowed.
Accredited Consultants Pvt. Ltd.
6. Any company/applicant desirous of obtaining NOC for export of select precursor
Chemicals are required to apply to the Narcotics Commissioner in a prescribed manner
submitting the documents detailed at Annexure-V
Apart from the above documents, additional information in respect of companies
approaching this office for the first time for grant of such NOC shall also submit the
documents detailed at Annexure -VII
The export of Precursor Chemicals are governed by System of Pre- Export
Notification (PEN). This office uses a system of PEN to verify the genuineness of the
transaction and to notify the Competent Authority of the importing and transhipping
country of the impending export. Such NOCs are allowed by Central Bureau of
Narcotics subject to following conditions :
a. Any kind of amendment as well as extension in validity of Export Authorisation
would not be allowed.
b. The shipment should be made in one consignment within the validity of the NOC.
c. The exporter are required to submit export details immediately after effecting
export. Accredited Consultants Pvt. Ltd.
No Objection Certificate (NOC) for export of Precursor
Chemicals
7. Accredited Consultants Pvt. Ltd.
Any company/applicant desirous of obtaining NOC for import of a select
number of precursor chemical, are required to apply to the Narcotics
Commissioner in a prescribed manner along with the documents detailed
at Annexure-VI
Apart from the above documents, additional information in respect of
companies approaching this office for the first time for grant of such
NOC shall also be submitted which are detailed at Annexure-VII
Such import NOC's are granted subject to condition that the importer
will submit the import details immediately after effecting import and any
kind of amendment as well as extension in validity of Export
Authorisation would not be allowed.
8. Accredited Consultants Pvt. Ltd.
Registration for import of Poppy Seeds
Any company/applicant desirous of importing poppy seeds shall apply to
the Narcotics Commissioner in a prescribed manner along with the
documents detailed at Annexure-IX
Apart from the above documents, additional information / documents in
respect of applicants approaching this office for the first time for
registration are also required to submit documents detailed at
Annexure -IX
While registering contracts for import of poppy seed, it is ensured that the
conditions of the Ministry of Commerce and Industry, Department of
Commerce, Notification No.27(RE-2000)/1997-2002 dated 1.8.2000 and
subsequent import policy & import policy conditions framed under EXIM-
Policy (Please refer import licensing note (3) issued under Chapter-12 of the
EXIM-Policy, 2004-09) are complied with.
9. Accredited Consultants Pvt. Ltd.
1.Application Form in the prescribed Format.
2. Copy of licence granted under the rules framed under section 10 of the State
Narcotic Drugs and Psychotropic Substances Act by the State Govt. of the State in
which the company have place of business, for the possession, sale, and distribution
of the drugs.
3.Copy of valid Drug Manufacturing License issued by the State Drug Controller/
Food and Drug Administration (FDA) under the Drugs and Cosmetics Act/ Rules.
4. List of approved technical person in the production and quality control.
5. List of Directors.
6. List of Laboratory equipments and raw materials.
7. Copy of site plants.
8. Original National Saving Certificate of Rs. 5000/- as Security Deposit.
9. A fee of Rs.5000/- in form of a Demand Draft drawn in favour of Drawing and
Disbursing Office, Central Bureau of Narcotics, Gwalior.
10. Balance Sheet of Company for the last 3 years.
11. Flow Chart of manufacturing process and per annum capacity
10. Accredited Consultants Pvt. Ltd.
1. Application form for renewal of manufacturing licence in prescribed
format.
2. Renewal fee of Rs. 5000/ - in favour of Drawing and Disbursing
Officer, Central Bureau of Narcotics, Gwalior.
3. Renewed licence granted to the manufacturer under the Drugs and
Cosmetics Act, 1940 (23 of 1940) for the manufacture of the drug.
4. Renewed licence granted to the manufacturer under the rules framed
under Section 10 of the Act by the State Govt. of the state in which
the manufacturer has place of business, for the possession, sale and
distribution of the drug.
5. Statement of annual production & consumption in prescribed format.
11. Accredited Consultants Pvt. Ltd.
1.Application form and the Background information in the prescribed format
for export of Narcotic Drugs or Psychotropic Substances and their salts.
2.Original Import Certificate issued by the Govt. of the importing country
certifying the official approval of the concerned Govt.
3.Licence Fee of Rs. 1000/- in form of Demand Draft drawn in favour of
Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.
4.Copy of valid drug manufacturing licence possessed by the exporter (in case
of manufacturer on loan licence) and copy of valid drug licence for sale,
distribution or exhibit (in case of merchant exporter).
5.Copy of the purchase order placed by the foreign buyer for the proposed
import.
6.Original Transport permit issued by the State Excise Authority (in case
of Narcotic Drugs)
12. Accredited Consultants Pvt. Ltd.
1.Application form and the Background information in the prescribed
format for import of Narcotic Drugs or Psychotropic Substances and
their salts.
2.Licence Fee of Rs. 1000/- in form of Demand Draft drawn in favour of
Drawing and 3.Disbursing Office, Central Bureau of Narcotics, Gwalior.
4.Copy of valid drug manufacturing licence possessed by the exporter (in
case of manufacturer on loan licence) and copy of valid drug licence for
sale, distribution or exhibit (in case of merchant exporter).
5.Original Test Licence/Import Licence from Drug Controller General
(India) for the proposed import.
6.Copy of import-export contract with the overseas supplier.
7.Original Transport permit issued by the State Excise Authority (in case
of Narcotic Drugs).
13. Accredited Consultants Pvt. Ltd.
1.Application form and the Background information in the prescribed format
for export of select precursor chemicals and their salts.
2.Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of
Drawing and Disbursing Office, Central Bureau of Narcotics, Gwalior.
3.Copy of valid drug manufacturing licence possessed by the exporter (in case
of manufacturer) and copy of valid drug licence for sale, distribution or exhibit
(in case of merchant exporter).
4.Copy of the purchase order placed by the foreign buyer for the proposed
import.
5.Original Import Certificate issued by the Govt. of the importing country
certifying the official approval of the concerned Govt.
14. Accredited Consultants Pvt. Ltd.
1. Application form and the Background information in
the prescribed format for import of select Precursor
Chemicals and their salts.
2.Licence Fee of Rs. 560/- in form of Demand Draft drawn
in favour of Drawing and Disbursing Office, Central
Bureau of Narcotics, Gwalior.
3.Copy of valid drug manufacturing licence possessed by
the exporter (in case of manufacturer) and copy of valid
drug licence for sale, distribution or exhibit (in case of
merchant exporter).
4.Original Test Licence/Import Licence from Drug
Controller General (India) for the proposed import.
5.Copy of import-export contract with the overseas
supplier.
15. Accredited Consultants Pvt. Ltd.
1. Complete postal address and telephone, fax no. of various factories of the company
manufacturing Narcotic Drugs and Psychotropic Substances including Jurisdictional Central
Excise division and Central Excise Commissionerate and Zonal office of Narcotics Control
Bureau in respect of factories.
2.List of Narcotic drugs and Psychotropic Substances being manufactured by the company
and details of manufacture of Narcotic drugs and Psychotropic Substances by the company in
the last three calendar years (1st January to 31st December).
3.Details of export/import of Narcotic drugs and Psychotropic Substances by the company
during the last three calendar years (1st January to 31st December).
4.Name, address, telephone Nos. and Fax No. of the Chairman, Managing Director and other
Directors, proprietor/ partners, in charge of production and finance.
5.Name of concerned Jurisdictional Commissionerate of Customs and Central Excise.
6.Balance Sheet of Company for last 3 years.
7.Amount of Excise Duties paid by company during last three years.
8.Profile of the company.
9.Sales Tax Registration No., Central Excise Registration No. and Company’s PAN No.
(Attested copies of these documents shall also be submitted.)
16. Accredited Consultants Pvt. Ltd.
1.Application form and the Background
information in the prescribed format.
2.Licence Fee of Rs. 560/- in form of Demand
Draft drawn in favour of Drawing and
Disbursing Office, Central Bureau of Narcotics,
Gwalior.
3.Original Sales Contract/ Export-Import
Contract
17. Accredited Consultants Pvt. Ltd.
1. Whether the firm have imported poppy seed earlier .
If, yes mention the year, quantity and name of
exporting country.
2.Annual turn-over of the firm.
3.The items, in which the firm deals with.
4.Name of the Jurisdictional Commissionerate of
Central Excise under which the firm lies. In case
registered with Central Excise, the copy of
registration may also be submitted.
5.Full address of the company, factory and warehouse.
6.Income Tax return for last three years with PAN
Number (certified copies shall be submitted)
18. Accredited Consultants Pvt Ltd
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