| Title | Type | Source | Release Date | Scraped | Download | Status |
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Gujarat FDCA & US FDA Commissioner discuss on information sharing & capacity bui...
▶ Summary
This document is a news article about a meeting between the Gujarat Food and Drug Control Administration (FDCA) and the US FDA Commissioner Robert M Califf. The discussion focused on plans to enhance the regulatory enforcement capabilities related to Good Manufacturing Practices (GMP) for Indian drug regulators. The article is sourced from Pharmabiz and was published on September 28, 2023.
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news article |
Gujarat FDA - News Feed
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Sep 28, 2023
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Dec 12, 2025
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Gujarat FDA - News Feed
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Dec 16, 2025
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Gujarat FDA - News Feed
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Dec 16, 2025
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Gujarat FDA - News Feed
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Dec 16, 2025
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WHO Model List of Essential Medicines, 20th List
▶ Summary
The document is the 20th edition of the WHO Model List of Essential Medicines, which outlines the minimum medicine needs for a basic health-care system. It lists the most efficacious, safe, and cost-effective medicines for priority conditions, as well as medicines for diseases requiring specialized care. It includes guidance on medicine selection within pharmacological classes and considerations for children's medicines.
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document |
Gujarat FDA - News Feed
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Dec 15, 2025
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Gujarat FDA - News Feed
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Dec 15, 2025
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Gujarat FDA - News Feed
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Dec 12, 2025
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| Unclassified |
Gujarat FDA - News Feed
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Dec 12, 2025
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neml-nep-2011-govtwebsite-ok.pdf
▶ Summary
This document is the National List of Essential Medicines as of 2011, detailing both the main and complementary lists of medicines considered essential. It includes a variety of medical categories such as anaesthetics, analgesics, antiepileptics, anti-infective medicines, and others, specifying the dosage forms available for each drug. The document is likely intended for healthcare professionals and policy makers to ensure the availability of these essential medicines.
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Gujarat FDA - News Feed
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Dec 12, 2025
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Gujarat FDA - News Feed
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Dec 12, 2025
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National List of Essential Medicines 2022
▶ Summary
The document is the 'National List of Essential Medicines 2022', which includes a comprehensive index of medicines categorized by therapeutic use. It outlines various classes of medicines, their healthcare levels, and dosage forms. This list is likely intended for healthcare policy makers and medical professionals in India as a reference guide.
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Gujarat FDA - News Feed
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Dec 12, 2025
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National List of Essential Medicines 2003
▶ Summary
This document is a listing from the Directorate General of Health Services under the Ministry of Health & Family Welfare of India, detailing various categories of essential medicines along with their therapeutic uses. It includes a comprehensive index of medicines classified by their medical application. The main emphasis is on categorizing medicines for health services management, rather than a new advisory, announcement, or public notice.
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Gujarat FDA - News Feed
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Dec 12, 2025
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National List of Essential Medicines 2011
▶ Summary
This document is the National List of Essential Medicines for the year 2011, listing various medications alongside their dosage forms and categories such as anaesthetics, analgesics, and anti-infective medicines. It details medicines considered essential for healthcare systems, categorizing them into main and complementary lists. The document aims to guide drug procurement and supply in healthcare settings.
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Gujarat FDA - News Feed
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Dec 12, 2025
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Gujarat FDA - News Feed
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Dec 12, 2025
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Drugs (Prices Control) Order 1995
▶ Summary
This document is the Drugs (Price Control) Order, 1995 issued by the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals, detailing the control measures for pricing and distribution of bulk drugs in India. It outlines the definitions, responsibilities, and powers of the government to set prices and regulate the drug market under the Essential Commodities Act, 1955. The order also specifies procedures for manufacturers and the powers of the government to ensure compliance and fair pricing.
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order |
Gujarat FDA - News Feed
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Dec 12, 2025
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Schedule_Y.pdf
▶ Summary
This document is a notification issued by the Ministry of Health and Family Welfare regarding the Drugs and Cosmetics (Second Amendment) Rules, 2005. It outlines detailed amendments to the original 1945 rules, including new definitions and requirements for clinical trials and the import/manufacture of new drugs. The document specifies procedural guidelines, data requirements for drug approval, and regulatory conditions applicable to new pharmaceuticals in India.
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order |
Gujarat FDA - News Feed
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Dec 12, 2025
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GSR%20512%20%28E%29%20dtd%209.7.08.pdf
▶ Summary
This is a public notice issued by the Ministry of Health and Family Welfare published in The Gazette of India. The notice announces amendments to the Drugs and Cosmetics Rules, 1945, specifically concerning the record-keeping requirements for licensed manufacturers of Ayurveda, Siddha, and Unani drugs. It details the requirements for submitting records of raw materials to the State Drug Licensing Authority and the National Medicinal Plants Board.
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public notice |
Gujarat FDA - News Feed
Unknown
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Dec 12, 2025
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pdf ↓ | ✓ Relevant |
| Unclassified |
Gujarat FDA - News Feed
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Dec 12, 2025
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Gujarat FDA - News Feed
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Dec 12, 2025
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ScheduleO.pdf
▶ Summary
This document is a notification from the Ministry of Health and Family Welfare regarding the 8th Amendment to the Drugs and Cosmetics Rules, 1945. It outlines amendments related to the standards for disinfectants and specifies that they should conform to Indian Standards laid down by the Bureau of Indian Standards. The amendments come into effect on their publication date in the Official Gazette, dated 21st December 2005.
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order |
Gujarat FDA - News Feed
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Dec 12, 2025
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schedule_MIII.pdf
▶ Summary
This document is the Drugs Rules, 1945, issued under the Drugs and Cosmetics Act, 1940 by the Central Government of India. It outlines the regulatory framework governing drugs and in-vitro diagnostics, specifying requirements for quality management, records, and manufacturing standards. The document provides comprehensive definitions and guidelines for medical devices and related administrative processes within India.
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Gujarat FDA - News Feed
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Dec 12, 2025
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schedule_MI.pdf
▶ Summary
This document contains the rules and regulations established under the Drugs and Cosmetics Act, 1940, as amended. It details the specific guidelines for drug manufacturing, including good manufacturing practices, facility requirements, and safety measures for homoeopathic medicines. The rules are issued by the Central Drugs Standard Control Organization, Government of India, to ensure compliance and public safety in pharmaceutical manufacturing.
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Gujarat FDA - News Feed
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Dec 12, 2025
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251166.pdf
▶ Summary
This document is an official order published by the Ministry of Health and Family Welfare of India. It details amendments to existing regulations regarding good manufacturing practices for pharmaceuticals and radiopharmaceutical products. The order aims to update standards to ensure quality, safety, and efficacy of these products.
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order |
Gujarat FDA - News Feed
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Dec 12, 2025
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ScheduleM.pdf
▶ Summary
This document outlines Good Manufacturing Practices and requirements for premises, plants, and equipment involved in the production of pharmaceutical products. It specifies guidelines for factory locations, building design, water systems, waste disposal, warehousing, and other operational areas to comply with health and safety standards. The document appears to be a reference guide for pharmaceutical manufacturers to maintain regulatory compliance.
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document |
Gujarat FDA - News Feed
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Dec 12, 2025
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ScheduleL-I.pdf
▶ Summary
This document is an extraordinary edition of the Gazette of India, published by authority, detailing official amendments and legal notices. The primary focus is on statutory changes and provisions related to regulations set around 2008 and earlier, suggesting governmental decisions on legal or regulatory frameworks. It includes mentions of dates and statutory instruments, indicating its relevance as a public notice.
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public notice |
Gujarat FDA - News Feed
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Dec 12, 2025
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schedule_k.pdf
▶ Summary
The document is a detailed presentation of "The Drugs Rules, 1945" issued by India's Central Drugs Standard Control Organization. It covers numerous regulations and definitions related to the Drugs and Cosmetics Act, 1940, including classifications, exemptions, and conditions for drug distribution and usage. This is part of a comprehensive legal framework for drug control in India.
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Gujarat FDA - News Feed
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Dec 12, 2025
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schedule_h1.pdf
▶ Summary
This document is the Drugs Rules, 1945, issued by the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, Government of India. It outlines the rules and definitions under the Drugs and Cosmetics Act, 1940, including classifications and regulations for various pharmaceuticals. The document serves as a legal framework for the manufacture and sale of drugs in India.
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document |
Gujarat FDA - News Feed
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Dec 12, 2025
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schedule_h.pdf
▶ Summary
This is the Drugs Rules, 1945, issued by the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, Government of India. The document outlines various rules related to the Drugs and Cosmetics Act, including definitions and classifications of pharmaceutical substances. Despite its relevance to drug regulations, it lacks recent context or direct connection to Gujarat FDA news.
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document |
Gujarat FDA - News Feed
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Dec 12, 2025
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Schedule_d2.pdf
▶ Summary
The document outlines the required information and documentation for the registration of bulk drugs or formulations for import into India. It includes details on regulatory status, chemical and pharmaceutical information, biological and pharmacological data, and clinical documentation. Issued likely by a regulatory body, it serves as a guideline for manufacturers to comply with Indian drug importation standards.
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Gujarat FDA - News Feed
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Dec 12, 2025
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Schedule_d1.pdf
▶ Summary
This document is a regulatory order providing a detailed checklist for manufacturers or their authorized agents applying for a drug registration certificate in India. It outlines the information required, conditions to adhere to under the Drugs and Cosmetics Rules, 1945, and an undertaking of compliance related to changes in manufacturing processes and adverse drug reactions. The document appears to be aimed at ensuring the registration and quality control of imported drugs intended for the Indian market.
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order |
Gujarat FDA - News Feed
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Dec 12, 2025
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schedule_d.pdf
▶ Summary
This document contains parts of the Drugs and Cosmetics Rules, 1945 from the Central Drugs Standard Control Organization, detailing various classifications and exemptions related to drug importation and usage regulations. It covers definitions and requirements for substances not intended for medicinal use and conditions for import/export of drugs and cosmetics. It's a legal regulatory document intended for professionals in healthcare and pharmaceuticals.
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document |
Gujarat FDA - News Feed
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Dec 12, 2025
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labelling.pdf
▶ Summary
This document is an extensive set of rules titled 'The Drugs Rules, 1945,' issued by the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, India. It includes detailed information on drug classification, the application of drugs under various schedules, and labeling requirements, among other regulatory guidelines. The document functions as a comprehensive guide regarding the regulations governing drugs and cosmetics in India, referencing sections of the Drugs and Cosmetics Act, 1940.
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document |
Gujarat FDA - News Feed
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Dec 12, 2025
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cond_testlabs.pdf
▶ Summary
This document consists of the Drugs Rules, 1945 as amended, issued by the Ministry of Health and Family Welfare under the Central Drugs Standard Control Organization of India. It outlines regulatory frameworks, including definitions, approvals, and conditions related to the manufacture and testing of drugs, with particular instructions for laboratory conditions and the use of animals in testing. The document is a regulatory guideline for drugs manufactured and tested in India.
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document |
Gujarat FDA - News Feed
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Dec 12, 2025
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licence_sales_allopathic.pdf
▶ Summary
This document, issued by the Central Drugs Standard Control Organization, outlines the Drugs Rules established under the Drugs and Cosmetics Act of 1940. It includes detailed regulations on licensing conditions, definitions, and procedural requirements for drug distribution and production in India. The document serves as a comprehensive guide for adherence to pharmaceutical regulations set by the Indian government.
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Gujarat FDA - News Feed
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Dec 12, 2025
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licence-sales-homeopathic.pdf
▶ Summary
This is a document issued by the Central Drugs Standard Control Organization, outlining the rules and regulations under The Drugs and Cosmetics Act, 1940. It details licensing procedures, classifications, and conditions for the sale of homeopathic medicines in India. The document is comprehensive, aimed at regulatory compliance and drug standardization.
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Gujarat FDA - News Feed
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Dec 12, 2025
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cond_mfg_bloodbanks.pdf
▶ Summary
This document is a comprehensive legal text detailing the Drugs Rules of 1945 enacted under the Drugs and Cosmetics Act, 1940 by the Central Government of India. It outlines various definitions, procedures, and requirements for drug approval, manufacturing, and distribution, including specifics on blood and blood component handling. It is largely a technical and legal framework with detailed terminology and regulations primarily relevant to those involved in pharmaceuticals and regulatory compliance.
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Gujarat FDA - News Feed
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Dec 12, 2025
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cond_mfg_cosmetics.pdf
▶ Summary
This document is the Drugs Rules of 1945 issued by the Central Drugs Standard Control Organization under India's Ministry of Health and Family Welfare. It outlines various rules and regulations regarding the manufacture, import, and sale of drugs and cosmetics in India. The document includes specific conditions and requirements for licensing and testing within the pharmaceutical and cosmetic industries.
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Gujarat FDA - News Feed
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Dec 12, 2025
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cond_mfg_allopathic.pdf
▶ Summary
This document is a section of the Drugs Rules, 1945, issued by the Central Drugs Standard Control Organization of the Government of India. It details procedures related to the manufacturing and licensing of drugs in India, including applications for licenses and conditions under which licenses may be cancelled. The text includes definitions and procedural guidelines relevant to drug regulation.
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Gujarat FDA - News Feed
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Dec 12, 2025
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cond_mfg_homeo.pdf
▶ Summary
This document outlines the Drugs Rules, 1945, issued by the Central Drugs Standard Control Organization of India, detailing the regulations governing the manufacture and licensing of homoeopathic medicines. It describes the procedures for obtaining licenses, the fees involved for both initial application and renewals, and the conditions to be met for manufacturing homeopathic medicines. The document is a legal framework related to drug control and regulation in India.
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Dec 12, 2025
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cond_mfg_ayur.pdf
▶ Summary
This document is a detailed description of The Drugs Rules, 1945, issued by the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, Government of India. It outlines the rules and definitions related to the manufacturing of drugs, including licensure and regulatory guidelines for Ayurvedic, Siddha, and Unani drugs. The document serves as a foundational regulatory framework for drug control in India.
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Dec 12, 2025
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Form44.pdf
▶ Summary
This document is a FORM 44 application used for obtaining permission to import or manufacture a new drug or to conduct clinical trials. It includes details on the drug's composition, manufacturing process, pharmacological classification, and the necessary data submitted for approval. The document outlines various categories such as market permission, subsequent drug approval, and fixed dose combination approval.
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Dec 12, 2025
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Form36.pdf
▶ Summary
This is a form used to apply for the grant or renewal of approval to carry out tests on drugs, cosmetics, or raw materials for licensees. The form outlines the categories of items involved, qualifications of staff, and necessary equipment. The document also includes details about required inspection fees and space for applicants to complete relevant information.
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Dec 12, 2025
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Form30.pdf
▶ Summary
This is an application form for obtaining a license to manufacture drugs for examination, test, or analysis. The form includes fields for the applicant's information, occupation, the names of the drugs to be manufactured, and an undertaking to comply with applicable license conditions. The document lacks specific context or additional details.
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Dec 12, 2025
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Form27E.pdf
▶ Summary
This document is an application form (Form 27-E) for the grant or renewal of a license to manufacture blood products for sale or distribution, as stipulated by Rule 122-F. It outlines the required information such as names of responsible technical staff, list of items to be manufactured, and fees involved. Additionally, it mentions necessary attachments including a plan of premises and qualifications of staff.
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Dec 12, 2025
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Form27D.pdf
▶ Summary
This document is a form (Form 27-D) related to the application for a license to manufacture and distribute certain drugs like large volume parenterals, sera, and vaccines. It outlines the requirements for applicants, such as details about the premises, technical staff qualifications, and necessary enclosures. There is no clear release date mentioned in the content provided.
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Gujarat FDA - News Feed
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Dec 12, 2025
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Form27C.pdf
▶ Summary
This document is an application form (Form 27-C) for the grant or renewal of a license to operate a blood bank for processing whole blood or preparing blood components. It outlines details required from the applicant, such as the names of medical staff and premises details. The application must be accompanied by various supporting documents and a copy sent to specific regulatory authorities.
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Dec 12, 2025
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Form27B.pdf
▶ Summary
This is a general document, Form 27-B, for the application to distribute drugs specified in Schedules C, C(1), and X under the Drugs and Cosmetics Rules, 1945. It details the necessary licensing requirements, including details about the expert staff and premises where drugs will be manufactured and tested. A fee structure and the submission of a premises plan are also mentioned as part of the application process.
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Form27A.pdf
▶ Summary
This document is Form 27-A related to the application for a loan license to manufacture drugs specified in Schedules C and C(1) of the Drugs and Cosmetics Rules, 1945. It covers requirements such as details of expert staff, agreements with the manufacturing concern, and other procedural formalities for the application. The document includes a date of GSR amendment as 27.10.2017.
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Gujarat FDA - News Feed
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Dec 12, 2025
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Form27.pdf
▶ Summary
This document appears to be a form (Form 27) related to the application process for obtaining a license to manufacture certain drugs under the Drugs and Cosmetics Rules, 1945. It includes details such as the location of the manufacturing premises and the qualifications of the staff responsible for manufacturing and testing the drugs. The document also mentions fees related to the licensing process.
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