Unlocking Your Regulatory Success
CDSCO West Zone - Mumbai
Empowering Businesses with CDSCO-West Zone Expertise - Choose CliniExperts for Seamless End-to-End Regulatory Services
CliniExperts – Your Obvious Choice For A Regulatory Partner
Services offered by CDSCO-WEST ZONE
 |
Involved in Issuance / revalidation of Certificate of Pharmaceutical Products (COPPs) as per WHO certification scheme. |
 |
Involved in Grant/renewal of license for Vaccine / Sera manufacturing units for both human as well as veterinary. |
|
Involved in Grant/renewal of license for LVP manufacturing units. |
|
Involved in Grant of license for Class C and Class D notified Medical Devices & In-vitro diagnostics. |
 |
Involved in Grant of permission in Form CT11/CT-14/CT-15 to manufacture drugs for the purpose of examination, test or analysis. |
|
Involved in Grant of license for import of small quantity of old drugs in Form 11 for the purpose of examination, test or analysis. |
|
Grant of license for import of small quantity of new drugs in Form CT-17. |
 |
Grant of license to import unapproved New Drug for treatment of patients of life threatening disease in a government hospital or medical institute in Form CT-25. |
 |
No objection certificates for grant of permissions for import of dual use items, not for medicinal use. |
Streamline your applications from Start to Approval with CliniExperts successfully.
About CDSCO-WEST Zone
The Central Drugs Standard Control Organization (CDSCO), West Zone, Mumbai was started during the year 1967 headed by Deputy Drugs Controller (India). The Zonal office of the CDSCO, WZ Mumbai was initially created to co-coordinate with the various State Drugs Controllers (who are the Licensing Authority under the Act) for uniform implementation and smooth enforcement of the provisions of Chapter IV of the D&C Act and Rules.
CDSCO West Zone Office has the jurisdiction over the States of Maharashtra, Chhattisgarh, Goa, Daman & Diu, Silvassa and Madhya Pradesh.
Following sub-zonal and port offices come under West Zone:
Sub-Zonal Office: Goa, Indore
Port Offices:
- Mumbai (Airport)
- Mumbai (Seaport)
- Goa
- Indore
Functions of CDSCO-WEST Zone
The Central Drugs Standard Control Organization (CDSCO) West Zone offers a range of services related to the regulation and oversight of drugs and medical devices in the western region of India. Some of the functions of CDSCO West Zone include:
Approvals and Licensing:
Grants permission for Form CT-11/CT-14 and CT-15 to manufacture drugs for the purpose of examination, test or analysis and permission to import small quantity of drugs for personal use as well.
Quality Control and Inspections:
The West Zone CDSCO conducts inspections and audits of pharmaceutical manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards. It monitors the quality, safety, and efficacy of drugs and medical devices through quality control measures.
Clinical Trials Regulation:
To participate in the inspection of Clinical Trial facilities and BA/BE centres as directed by the Drugs Controller General (India) from time to time.
Enforcement Actions:
To discuss the matter with various State Controllers in the zone in connection with enforcement of the provisions of Drugs and Cosmetics Act & Rules there under from time to time.
Collaboration and Coordination:
To follow up action on NSQ drugs with State Licensing Authorities in the respective zone as well as with other zonal offices.
HAVE A QUERY?
REACH US!INDIA OFFICE
CliniExperts Services Pvt. Ltd.
CliniExperts May assist you for:
Form Names: N/A
Issuance / revalidation of Certificate of Pharmaceutical Products (COPPs) as per WHO Certification Scheme
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: 11
Grant of license for import of small quantity of old drugs in Form 11 for the purpose of examination, test or analysis
The grant of a license for the import of a small quantity of old drugs in Form 11 is a regulatory process that allows specific organizations, such as authorized laboratories or research institutions, to import a limited amount of previously manufactured drugs for examination, testing, or analysis. For obtaining Test License in Form 11, one has to fill the application in Form 12. All the applications should be made through CDSCO’s SUGAM portal.
Regulatory Body Requirement
Following are the documents required:
- Covering Letter
- Form 12
- TR 6 Challan Utilization/Justification
- Testing Protocol
- Product Labels and Brochures
- Free Sale Certificate in the country of origin
- Notarized Agreement
- Ethics Committee Approval
Other details
The validity period of test license is one year from the date of its issue.
Renewal facility is not available for test license. One has to reapply for new Form 11 license with relevant documents and challan.
Form Names: 27 D
Grant/renewal of license for Vaccine / Sera manufacturing units for both human as well as veterinary
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.
Authorities Involved: Zonal Office For joint inspection & recommendations & SFDA for approval process.
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 + INR 1500 inspection fee.
- 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.
Authorities Involved: Zonal Office & SFDA.
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 + INR 1500 inspection fee.
- 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: CT-17
Grant of license for import of small quantity of new drugs in Form CT-17
An importer or manufacturer who wants to import small quantities of samples for the purpose of testing and analysis must apply for a test license. The regulatory body involved in this process is the Zonal Food and Drug Administration (FDA).
- Form CT-17 is a license to import new drug or investigational new drug (ND or IND) for the purpose of bioavailability or bioequivalence, clinical trial or for examination, test and analysis.
- The applicant shall make an application on Form CT-16 and then he will be granted CT 17.
Regulatory Body Requirement
Following are the documents required:
- A copy of the manufacturing license or wholesale license
- Justification of quantity that needs to be imported
- An undertaking for product under NDPS Act,1985
- An undertaking for the samples not imported last three years
Other details
Fee: The applicant must pay INR 5000 per drug.
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: CT-25
Grant of license to import unapproved New Drug for treatment of patients of life threatening disease in a government hospital or medical institute in Form CT-25
The importation of unapproved new drugs for compassionate use is subject to rigorous evaluation and approval by the regulatory authority to ensure patient safety and the drug's potential efficacy.
Other details:
Form CT-25: License to import unapproved new drug for treatment of patients of life threatening disease in a government hospital or medical institution.
Form CT-24: Application for license to import of unapproved new drug for treatment of patients of life threatening disease in a government hospital or government medical institution.
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
Testimonials
The Brand That Promises To Turn, Your Business Around!
Atomy India Pvt ltd
We have been associated with CliniExperts for about a year now for our food products related services for FSSAI compliances and licenses from CliniExperts and are completely satisfied with their performance. Quick turnaround time in responding to queries, meticulous planning in completing the task, alongside the extensive knowledge of the regulations of the entire team is highly appreciable and marks the professionalism and quality driven ethics of the organization. We highly recommend their services as we believe it is best in the industry so far.
Rajeev Rattava
Finance Manager
Morepen Laboratories Ltd.
The team at CliniExperts is proficient in the subject matter and provide prompt services . We are satisfied with our engagement and would recommend their services.
Anubhav Suri
Business Head
Proficon Medisol Pvt. Ltd.
We have been professionally associated with Cliniexperts for more than 5 years now. They have smoothly sailed us all these years in different projects & this has been possible because of the knowledge & dedication cliniexpert team has in their portfolio. All the best Cliniexpert. Keep going.
Ajitesh Trehan
Director
Unity Enterprises
We appointed Cliniexperts for our Cosmetic registration project for one of our critical products for which we received the registration certificate much before the timelines committed by the company. The entire project was handled efficiently with sheer professionalism and in our comfort zone . We are very happy with the overall working experience with CliniExperts and will highly recommend their services to everyone.
Faiyaz
Founder, Unity Enterprises
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.
Contact us
Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.