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corpseedgroup · 1 year
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It's important to note that the specific eligibility criteria for CDSCO registration may vary depending on the type of product and the regulatory requirements at the time of application. It's recommended to consult with a qualified regulatory professional or CDSCO representative to ensure that you meet the latest eligibility criteria for CDSCO registration in India.
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corpseedites · 5 years
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State Pollution Control Board Consent/NOC
CTO refers to Consent to Operate, before carrying out any action at the industrial plant / activity / project, the entrepreneur is required to obtain consent to operate (CTO) from the State Pollution Control Board to operate an outlet u/s 25 of the Water (Prevention & Control of Pollution) Act, 1974 and to operate an industrial plant u/s 21 of the Air (Prevention & Control of Pollution) Act, 1981.  For all categories of Industries and Projects, The Punjab Pollution Control Board has prescribed a composite preformed for obtaining consent to operate, The Delhi pollution board has also prescribe the same consent to operate.
Sitting Criteria
·         The Punjab Pollution Control Board will grant consent to operate to all the industries/projects/ establishments in the areas / zones, where such industry/project/establishment is allowed to establish.
·         For the facilitation of industries, the Punjab Pollution Control Board will accept analysis results of National Accreditation Board for testing and calibration laboratories (NABL) accredited private laboratories for the purposes of grant of consent/ authorization.
Fee Structure
Fee for NOC as prescribed by the Rajasthan State Pollution Control Board may vary from project to project depending on the formula – Fixed Cost + Current Cost – Current Liabilities.  The fee also depends on the category of the business applying for renewal of Consent.
Procedure for State Pollution Registration
Our Expert team will draft & file the application with the State Pollution Registration Department & will follows-up with State Pollution Registration Department. For more information contact our customer care on 8448 444 985 or [email protected]
Documentation required for CTO/CTE from Punjab State Pollution Control Board
Application for Consent to operate under Water Act, 1974/ Air Act, 1981 for Red/Orange Category - Fresh Case
·         Consent Conditions or Compliance report of NOC in illustrative form
·         Completion certificate of Effluent Treatment Plant or Add-on pollution control
·         devices along with Dimensional Drawing
·         Plan showing the location of Effluent Treatment Plant or Add-on pollution control
·         devices and all outlets and various channels/pipes/sewers with requisite colours as mentioned below:
·         Fresh Water -  Blue Colour
·         Effluent Channel - Red Colour.
·         Recirculation Water Channel - Green Colour.
·         Storm Water - Orange Colour.
·         Domestic Sewer - Dotted Black ink.
·         CA's certificate regarding un-depreciated value of the fixed assets of the industry at the end of last financial year.
 Application for the industry which is already established / operational, following additional documents are also required to be uploaded.
·         Location Plan or Site Plan of the industry
·         Proof of date commissioning of the Industry ( Registration of the industry/ Electricity bill /Sales Tax no )
·         Manufacturing process details along with the process flow chart
·         Latest granted NOC/CTE/CTO, if obtained offline, then copy of NOC/CTE/CTO granted to be uploaded
·         Analysis report of treated emission from State Pollution Board CTE/CTO/ waste effluent / Approved Lab
·         Documents regarding designation of area/compliance of specific guidelines:
(Any one of the following)
A.      Allotment letter of the Allotting Authority, if the site of the project is located in the designated Industrial Area/ Industrial Estate/ Focal Point.
B.      Certificate from the Designated Authority to the effect that the site of the project / industry is located in the designated Industrial zone/ area of the notified/ draft Master Plan in which the establishment of such industry/ project is permissible. The undertaking shall clearly indicate the revenue entries I.e. Headfast Number, khewat/khatauni number and Khasra numbers.
C.      Certificate of the Revenue Authorities (SDM/DC/ADC) indicating the distance of site of industry from the Municipal Corporation Limits Lallakir /Phirni of the nearest village, in case, the industry is to be established at a plot other than the plot in the industrial estate /industrial zone/ industrial area of the draft master plan / industrial zone of the notified master plan.         
D.      For industry specific guidelines, certificates/ documents as mentioned in the said guidelines (In case of Rice Sheller/Saila Plant/Stone Crusher/Brick Kiln/Hot Mix plant/Cement Grinding units etc.)
 Application for Consent to operate under Water Act, 1974/ Air Act, 1981 for Green Category - Fresh Case
·         Compliance report of NOC / Consent Conditions in annotated form
·         CA's certificate regarding un-depreciated value of the fixed assets of the industry at the end of last financial year
 Application where the industry is already established / operational, following additional documents are also required to be uploaded
·         Location Plan or Site Plan of the industry
·         Proof of date commissioning of the Industry (Registration of the industry/ Electricity bill /Sales Tax no. )
·         Manufacturing process details along with the process flow chart.
·         Latest granted NOC/CTE/CTO, if obtained offline, then copy of NOC/CTE/CTO granted to be uploaded.
·         Documents regarding designation of area/compliance of specific guidelines (Any one of the following):
 A.      Allotment letter of the Allotting Authority, if the site of the project is located in the designated Industrial Area/ Industrial Estate/ Focal Point.
B.      Certificate from the Designated Authority to the effect that the site of the project / industry is located in the designated Industrial zone/ area of the notified/ draft Master Plan in which the establishment of such industry/ project is permissible. The undertaking shall clearly indicate the revenue entries I.e. Hadbast Number, khewat /khatauni number, khatta number and Khasra numbers.
C.      Certificate of Revenue Authorities (DC/ADC/SDM) indicating the distance of site of industry from the Municipal Corporation Iimits / Lallakir/Phirni of the nearest village, in case, the industry is to be established at a plot other than the plot in the industrial area / industrial zone/ industrial estate of the draft master plan / industrial zone of the notified master plan.  
Important Note:
·         In case the NOC was not granted online, you requested to submit a copy NOC granted, copy of Project Report and Feasibility Report submitted at the time of obtaining NOC
·         Application shall be accompanied by CTO fee  as per the un-depreciated fixed assets of industry
 1 Crore MSME Loan,Health Certificate,FSSAI Registration & FSSAI License,Environment Protection Act
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corpseedgroup · 1 year
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Voluntary registration of medical devices refers to the process by which manufacturers or importers of medical devices registration can choose to register their products with a regulatory agency, such as the FDA in the United States or the EMA in the European Union, even if it is not required by law.
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corpseedgroup · 1 year
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The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for approving new drugs for the Indian market. The approval process involves several steps, which are as follows:
Submission of application: The drug manufacturer or sponsor submits an application to CDSCO along with the necessary data and documents.
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corpseedgroup · 1 year
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The Central Drugs Standard Control Organization (CDSCO) is the regulatory body that oversees the import of cosmetics into India. To import cosmetics into India, a company must obtain a registration certificate from CDSCO. Submit an application for CDSCO registration to the Drugs Controller General of India (DCGI), which is a part of CDSCO. Provide the required documents, such as product information, manufacturing details, and safety data.
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corpseedgroup · 1 year
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CDSCO (Central Drugs Standard Control Organization) is the national regulatory body in India responsible for regulating the import, manufacture, distribution, and sale of drugs, cosmetics, medical devices CDSCO, and diagnostics. It is the apex regulatory body under the Ministry of Health and Family Welfare, Government of India. The primary role of CDSCO is to ensure that all drugs, cosmetics, medical devices, and diagnostics available in India are safe, effective, and of high quality. Some of the key functions of CDSCO include:
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corpseedgroup · 1 year
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CDSCO, or the Central Drugs Standard Control Organization, is the national regulatory body for pharmaceuticals and medical devices in India. It is responsible for the regulation of drugs and medical devices in India, including the registration and licensing of these products. The registration process for drugs and medical devices in India is governed by the Drugs and Cosmetics Act of 1940, as well as the rules and regulations made under this Act. The CDSCO Online is responsible for enforcing these regulations and ensuring that drugs and medical devices are safe, effective, and of high quality.
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corpseedgroup · 1 year
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The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for medical devices in India. To register an ENT (ear, nose, and throat) medical device in India, the manufacturer or importer. It is recommended to engage with a local regulatory consultant or legal expert who has experience in navigating the Indian regulatory landscape to ensure a smooth and successful application process.
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corpseedgroup · 1 year
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CDSCO checklist for self assessment
The Central Drugs Standard Control Organization (CDSCO registration) is the national regulatory body responsible for approving and monitoring pharmaceutical and medical devices in India. Self-assessment is an important part of the regulatory process and helps companies ensure that they are in compliance with all relevant regulations.
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Here is a general checklist for self-assessment based on CDSCO regulations:
Good Manufacturing Practices (GMP) compliance: Ensure that your manufacturing facilities are compliant with the GMP regulations set forth by the CDSCO certificate.
Quality Management System (QMS) compliance: Verify that your QMS meets the requirements set forth by the CDSCO, including documentation, risk management, and product quality control.
Licensing and Registration: Ensure that all necessary licenses and registrations are up-to-date and in compliance with the CDSCO regulations.
Clinical Trials: If you are conducting clinical trials, ensure that they are in compliance with the CDSCO regulations, including ethical standards and reporting requirements.
Adverse Event Reporting: Ensure that you have established a system for reporting adverse events, and that you are reporting them in accordance with CDSCO regulations.
Product Labeling and Packaging: Verify that your product labeling and packaging comply with the regulations set forth by the CDSCO, including language, labeling requirements, and warnings.
Import/Export Regulations: Ensure that your import and export processes are in compliance with the regulations set forth by the CDSCO online.
Compliance with Scheduled Drugs: If your product is a scheduled drug, ensure that you are in compliance with the regulations set forth by the CDSCO, including licensing, manufacturing, and distribution requirements.
Note: This list is not exhaustive and is intended only as a general guide. Companies should refer to the specific regulations set forth by the CDSCO for more detailed information.
CDSCO Registration Document Checklist for Pre-screening
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body responsible for approving and monitoring pharmaceutical and medical device import license in India. Pre-screening is the process of evaluating a company's application for registration before it is submitted to the CDSCO for review.
Here is a general checklist for pre-screening of registration documents for CDSCO:
Company Information: Ensure that all necessary company information, such as name, address, and contact information, is included and up-to-date.
Licenses and Registrations: Verify that all necessary licenses and registrations, including GMP, QMS, and clinical trial approvals, are included and up-to-date.
Product Information: Ensure that all product information, including name, composition, dosage form, and strength, is accurate and complete.
Manufacturing Information: Verify that all manufacturing information, including location, facilities, and equipment, is accurate and up-to-date.
Quality Control Information: Ensure that all quality control information, including procedures, testing methods, and specifications, is accurate and complete.
Stability data: Provide complete stability data as per the ICH guidelines for each batch of the product.
Clinical Trial Information: If the product has undergone clinical trials, ensure that the results and data are accurately and completely reported.
Product Labeling and Packaging Information: Ensure that all labeling and packaging information, including language, labeling requirements, and warnings, is accurate and compliant with CDSCO regulations.
Adverse Event Reporting: Verify that a system for reporting adverse events is in place and that the company is reporting them in accordance with CDSCO regulations.
Import/Export Regulations: Ensure that all import and export information, including customs clearance, is accurate and compliant with CDSCO regulations.
Note: This list is not exhaustive and is intended only as a general guide. Companies should refer to the specific regulations set forth by the CDSCO new drug approval for more detailed information.
CDSCO Guidance Document
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body responsible for approving and monitoring pharmaceutical and CDSCO medical device registration in India. The CDSCO provides guidance documents to help companies understand and comply with its regulations.
Here are some of the key guidance documents issued by the CDSCO:
Good Manufacturing Practices (GMP)
Read more This Blog :- CDSCO Import License for Medical Devices In India
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corpseedgroup · 1 year
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The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for the control and regulation of the import, manufacture, distribution, and sale of pharmaceutical and medical devices in India. The CDSCO Online ensures that these products are acceptable, safe, and effective for their intended use. The organization also provides guidelines, norms, and standards for the pharmaceutical and medical device industries to follow. It is headquartered in New Delhi and operates under the Ministry of Health and Family Welfare, Government of India.
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corpseedgroup · 1 year
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DCGI and CDSCO refer to the same body, the Central Drugs Standard Control Organization, which is the central drug regulatory authority in India responsible for approving drugs for marketing in the country. DCGI stands for the Drugs Controller General of India, the regulatory authority for pharmaceuticals and medical devices in India. CDSCO Online stands for Central Drugs Standard Control Organization, which is the central drug regulatory authority in India responsible for approving drugs for marketing in the country.
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corpseedgroup · 1 year
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The Central Drugs Standard Control Organization (CDSCO Online) is the national regulatory body for pharmaceuticals and medical devices in India. Its primary role is to ensure that all drugs and medical devices available in the country are safe, effective, and of good quality.
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corpseedgroup · 1 year
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We are the best CDSCO License/certificate and registration service, provider. If you want to apply to CDSCO manufacturing license Authorized Signatory / Responsible person of the organization should fill out the form. Submit ID proof, Undertaking, and Address Proof Documents in hard copy. Under the Drugs and Cosmetics Act, CDSCO is responsible for approving Drugs, and Conduct of Clinical Trials. CDSCO test license is the regulatory authority regulating the manufacture and import of drugs and cosmetics.
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corpseedgroup · 1 year
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The Central Drugs Standard Control Organization (CDSCO registration) is the regulatory authority in India for pharmaceuticals and medical devices. Any person or entity involved in the manufacture, distribution, import, or sale of drugs or import license for medical devices in India must obtain a license from CDSCO.
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corpseedgroup · 1 year
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It's important to note that the specific eligibility criteria for CDSCO registration may vary depending on the type of product and the regulatory requirements at the time of application. It's recommended to consult with a qualified regulatory professional or CDSCO representative to ensure that you meet the latest eligibility criteria for CDSCO registration in India.
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corpseedgroup · 1 year
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Importing medical devices CDSCO into a country requires complying with various regulations and obtaining necessary licenses. The steps to apply for a medical device import license may vary depending on the country and its regulations. However, here is a general step-by-step guide that you can follow:
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