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CDSCO South Zone - Chennai
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Services offered by CDSCO-SOUTH ZONE
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Issuance / revalidation of Certificate of Pharmaceutical Products (COPPs). |
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Grant/renewal of Blood Bank license. |
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Grant/renewal of license for Vaccine / Sera manufacturing units for both human as well as veterinary. |
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Grant/renewal of license for LVP manufacturing units. |
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Grant of license for Class C and Class D notified Medical Devices & In-vitro diagnostics. |
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Grant of approval for test / analysis of Drugs & Cosmetics. |
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Grant of permission in Form CT11/CT-14/CT-15 to manufacture drugs for the purpose of examination, test or analysis. |
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Permit for import of small quantities of drugs for personal use under Form 12B of the Drugs and Cosmetics Rules. |
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No objection certificates for grant of permissions for import of dual use items, not for medicinal use. |
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About CDSCO-South Zone
CDSCO South Zone covers the regions of Kerala, Pondicherry, Lakshadweep and Tamil Nadu. It helps in monitoring the quality of drugs through joint inspections and other licenses like blood bank license, vaccines and sera, large volume parenteral, r-DNA products, medical devices etc.
CDSCO South zone also assists in inspection of clinical trial facilities, and public drug testing laboratory along with drawing of regular drugs samples and carrying out surprise checks/raid jointly/independently.
Following sub-zonal and port offices come under South Zone:
Sub-Zonal Office: Bengaluru
Port Offices:
- Chennai (Airport)
- Chennai (Seaport)
- Hyderabad
- Cochin (Seaport)
- Vishakhapatnam (Seaport)
- Krishnapatnam (Seaport)
- Bangalore (Airport)
Functions of CDSCO-South Zone
Drug Approval
CDSCO South Zone is responsible for reviewing and granting approvals for the import, manufacture, and sale of drugs in its jurisdiction. It assesses applications for new drug approvals. It grants approvals for new drugs, including prescription drugs, over-the-counter medications, and biologics, based on their safety, efficacy, and quality.
Clinical Trial Approvals
CDSCO reviews and approves clinical trial applications for investigational drugs and medical devices, ensuring ethical considerations, patient safety, and compliance with regulatory guidelines.
Manufacturing Licensing
CDSCO South Zone grants manufacturing licenses to pharmaceutical companies within its jurisdiction. It ensures compliance with Good Manufacturing Practices (GMP) and other quality standards before issuing manufacturing licenses.
Inspections and Audits
CDSCO South Zone conducts inspections and audits of manufacturing facilities, clinical trial sites, and distribution channels to ensure compliance with regulatory standards. It verifies adherence to quality control measures, storage and transportation practices, and other regulatory requirements.
Pharmacovigilance
CDSCO South Zone is involved in monitoring and reporting adverse drug reactions (ADRs) as part of the national pharmacovigilance program. It collects and analyzes ADR data to ensure the safety of marketed drugs.
Import and Export Regulation
CDSCO South Zone regulates the import and export of drugs and medical devices in its jurisdiction. It verifies compliance with import and export regulations, quality standards, and licensing requirements.
Quality Control and Testing
CDSCO South Zone is involved in quality control activities, including testing and analysis of drugs and medical devices. It ensures compliance with quality standards and specifications through laboratory testing and analysis.
Regulatory Compliance
CDSCO South Zone ensures that pharmaceutical companies and stakeholders comply with regulatory requirements. It provides guidance, support, and enforcement actions to ensure adherence to applicable laws and regulations.
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Form Names: N/A
Issuance / revalidation of Certificate of Pharmaceutical Products (COPPs)
The Certificate of Pharmaceutical Product (COPP) is an official document issued by CDSCO. Its purpose is to verify the status of a pharmaceutical product and the applicant in the exporting country.
Regulatory Body Requirement
Following are the documents required for the grant or revalidation of COPPs:
- Application from Manufacturer
- Site Master file
- Copy of Manufacturing License
- List of Approved Products
- List of products applied for issuance of COPPs
- List of SOPs and STPs
- Stability Data (3 batches) Accelerated / Real Time
- List of equipment and Instruments
- List of Technical staff, their qualification, experience and approval status
- Manufacturing Layout Plan
- Process validation for 3 batches of each product
- Schematic diagram of Water system specifying circulation loop and MOC (Material of Construction)
- Schematic diagram of HVAC system specifying terminal filter configuration
- Export data of last 2 years in case of revalidation
- Product Summery sheet
Other details
When a pharmaceutical product is intended for registration, licensing, authorization, or renewal in an importing country, the Certificate of Pharmaceutical Product is required. This document is necessary for the commercialization or distribution of the product within the importing country.
Form Names: 27 C
Grant/renewal of Blood Bank license
The grant of a blood bank license is the process by which a blood bank facility receives approval from the relevant regulatory authority to operate legally and provide blood and blood products to the public. Authorities Involved for obtaining Blood bank license is CDSCO/ Zonal Office/ State FDA.
Regulatory Body Requirement
Following are the documents required for the grant of blood bank license:
- Plan of the premises
- List of machinery and equipment for collection, processing, storage and testing of whole blood and its components
- Memorandum of association/ constitution of the firm
- Copies of certificate relating to educational qualifications
- Experience of the competent technical staff
- Documents relating to ownership or tenancy of the premises
Other details
Grant/renewal for operation of blood bank license is in Form 27 C.
Fees involved for obtaining the license is
- Fee for grant of license is INR 7500.
- Fee for renewal of license is INR 7500.
Form Names: 27 D
Grant/renewal of license for Vaccine / Sera manufacturing units
The process of obtaining or renewing a license for vaccine and sera manufacturing units is stringent to ensure the safety, efficacy, and quality of these critical medical products. Regulatory oversight plays a crucial role in safeguarding public health and ensuring that vaccines and sera produced meet the highest standards of quality and safety.
Regulatory Body Requirement
Following are the documents required for the grant of license for Vaccine/Sera manufacturing units:
- Application from Manufacturer
- Site Master file
- (a) Copy of Manufacturing License (b) Form 27-D /li>
- Plan of premises
- Constitution of the firm
- List of equipment and Instrument
- List of technical staff, their qualification, experience and approval status
- Quality of water & its generation at the site
- List of SOPs and STPs
- Details of HVAC system including schematic diagram used for Classified Area
- Washing arrangements for the components
- Procurement of Master Cell Bank
- Preparation of Cell Bank
- Manufacturing process flow chart
- Certificate of Analysis
- Package Insert & Label
Other details
Application for grant of a license to manufacture sera/vaccines is made in Form 27 D.
Fees involved for obtaining the license is
- Fee for grant of license is INR 6000.
- Fee for renewal of license is INR 6000.
Form Names: 27 D
Grant/renewal of license for LVP manufacturing units
LVPs are sterile liquid drug products typically administered intravenously, and they are used for various medical purposes, including hydration, nutrition, and drug administration. The grant or renewal of a license for Large Volume Parenterals (LVP) manufacturing units involves a systematic process to ensure compliance with regulatory requirements and adherence to quality standards.
Regulatory Body Requirement
Following are the documents required for the grant of license for LVP manufacturing units:
- Application from Manufacturer
- Form 27-D
- Copy of Manufacturing License in case of renewal of license
- Site Master file
- Plan of the premises along with details of the areas of each section
- Name, address, qualification and experience of the technical staff responsible for manufacture and testing
- Name and address of the Directors, Partners or Proprietor
- Proof of Payment of fee (Challan)
- List of drugs intended to be manufactured (along with formula, pack size and details of primary packing material)
- Ownership, rent or lease details of the premises
- Stability Studies for all products (3 batches, 6 Months) in case of renewal of license
- List of machinery installed/ laboratory equipment
- Validation and calibration of essential and critical equipment and instruments
- Validation of HVAC system
- Copies of procurement documents of machinery
- Description of the manufacturing process in case of grant of license
Other details
Application for grant of a license to manufacture for sale or for distribution for large volume parenteral/sera and vaccines is made in Form 27 D.
Fees involved for obtaining the license is
- Fee for grant of license is INR 6000.
- Fee for renewal of license is INR 6000.
Form Names: MD-7, MD-9
Grant of license for Class C and Class D notified Medical Devices & Invitro diagnostics
A manufacturer license allows the sale or distribution of Class C and Class D medical devices & IVDs in Form MD-9 which is obtained by applying via Form MD-7. For obtaining the grant of manufacturing license for Class C and Class D medical devices, an inspection must take place within 60 days from the date of application by the Medical Devices Officers (MDO) of the Central Licensing Authority (CLA), as per the Medical Devices Rules (MDR) 2017.
Regulatory Body Requirement
Following are the documents required for the grant of license for Class C and Class D notified medical devices and in-vitro diagnostics:
- Device Master File
- Site Master File
- QMS Documents
Other details
The fees involved for Class C or Class D for one site of manufacturing medical devices & IVDs is 50000 INR whereas each distinct device cost is 1000 INR.
Form Names: 37
Grant of approval for test / analysis of Drugs & Cosmetics
The testing and analysis of drugs and cosmetics play a vital role in ensuring their safety, quality, and efficacy before they are made available to the public. It involves a comprehensive evaluation of the products' ingredients, formulation, and performance to comply with regulatory requirements and protect consumer health.
Regulatory Body Requirement
Following are the documents required for the grant of license for test/analysis of drugs and cosmetics:
- Testing Protocol
- Specification sheet of the product
- A copy of the manufacturing license or a copy of the Department of Scientific and Industrial Research (DSIR) certificate
Other details
Form 36 is the application form for the grant or renewal of approval for carrying out tests drugs/cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs/ cosmetics. The permission for the same is procured by CDSCO in Form 37.
Form Names: CT-11, CT-14, CT-15
Grant of permission in Form CT11/CT-14/CT-15 to manufacture drugs for the purpose of examination, test or analysis
For any new drug which is yet to be introduced in the country, the manufacturer or importer shall conduct the clinical trials, collect the sample data and get the approval as per the process given in New Drugs and Clinical Trials Rule, 2019.
The Central Drugs Standard Control Organization (CDSCO) grants permission for application in Form CT-11, CT-14, CT-15 for manufacturing or import of new drugs for test and analysis under the New Drugs and Clinical Trials Rules, 2019.
Regulatory Body Requirement
Following are the documents required for the grant of permission to manufacture drugs:
- Form 30
- Testing Protocol
- Specification of the product & analytical procedures
- SOPS, details of equipments & technical staff
- A copy of the manufacturing license or a copy of the Department of Scientific and Industrial Research (DSIR) certificate
Other details
- Form CT-10 : Application for permission to manufacture of new drug or investigational new drug for clinical trial or bioavailability and bioequivalence study or for examination, test and analysis.
- Form CT-11 : Permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study, or for examination, test and analysis.
- Form CT-12 : Application for permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability and bioequivalence study.
- Form CT-13 : Application for permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study.
- Form CT-14 : Grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability and bioequivalence study.
- Form CT-15 : Grant of permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study.
Form Names: 12 A, 12 B
Permit for import of small quantities of drugs for personal use under Form 12B of the Drugs and Cosmetics Rules
In the medical practice, sometimes drugs which are not permitted to be imported or marketed in the country are required exclusively for the treatment of patients to save their lives. To facilitate import of such drugs in small quantities for personal use, it is provided under the Drugs and Cosmetics Rules, 1945, that a permit for import of small quantities of drugs for personal use in Form 12B could be obtained from the office of the Drugs Controller General (India) or designated Port Offices of CDSCO.
The quantities of any single drug so important shall not exceed 100 average doses and shall be declared to the customs authorities, if so directed.
Regulatory Body Requirement
Following is the procedure for obtaining the permission:
- Download the application in FORM 12 A.
- Prescription from Registered Medical Practitioner (RMP) in respect of the drug requirements for the purpose of patient use required to be attached. Prescription shall bear Medical Council of India (MCI) Registration No. of the Physician.
- Fill and sign the application in Form 12 A along with the Prescription and submit to ADC(I)/TO/DI of the respective port offices of Central Drugs Standard Control Organization (CDSCO).
- The name of the drug, quantity of the drug and duration of medication shall be clearly mentioned in the Prescription.
- Permission in FORM 12 B shall be issued to applicant on priority basis preferably in a day or two.
Other details
No fee is required under the rule for said purpose.
Form Names: N/A
No objection certificates for grant of permissions for import of dual use items, not for medicinal use
Import of Drugs having “Dual use” and drugs, which are used as Raw Material for the manufacturing of other drugs requires permission from Zonal Offices of CDSCO.
Based on the intended use of the product, the drugs that are falling under Schedule-D of Drugs and Cosmetic Rules have been categorized into:
- Drugs meant for Non- medicinal use.
- Drugs meant for Animal feed supplement, Feed premix.
- Drugs meant for further processing / conversion to other drug.
Regulatory Body Requirement
Following are the documents required for the grant of permission:
- Covering letter
- A copy of Valid Drug Manufacturing License for the Drug to be manufactured
- A copy of Master Formula Record of the product to be manufactured (signed and stamped by the authorized signatory of the firm)
- A copy of Certificate of Analysis of the drug to be imported, issued by the manufacturer
- Detailed Justification of the quantity of Drug to be imported
- Brief Manufacturing Process including Flowchart wherein the imported product will be used
- Detailed Technical Literature of the drug to be imported
- For Subsequent permission, Reconciliation data of previously permitted quantity in addition to above details
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Frequently Asked Questions
What are the functions of zonal offices of CDSCO?
The CDSCO's Zonal office was established to co-coordinate with State Drugs Controllers, ensuring uniform implementation and smooth enforcement of provisions from Chapter IV of the D&C Act and Rules.
What are the services offered by CDSCO-South zone?
- Issuance / revalidation of Certificate of Pharmaceutical Products (COPPs).
- Grant/renewal of Blood Bank license.
- Grant/renewal of license for Vaccine / Sera manufacturing units for both human as well as veterinary.
- Grant/renewal of license for LVP manufacturing units.
- Grant of license for Class C and Class D notified Medical Devices & In-vitro diagnostics.
- Grant of approval for test / analysis of Drugs & Cosmetics.
- Grant of permission in Form CT11/CT-14/CT-15 to manufacture drugs for the purpose of examination, test or analysis.
- Permit for import of small quantities of drugs for personal use under Form 12B of the Drugs and Cosmetics Rules.
- No objection certificates for grant of permissions for import of dual use items, not for medicinal use.
How many sub zonal offices are there?
CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
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