Service Details:
Location | Mumbai |
Product Certification (ISI Mark)
The Product Certification Schemes of BIS aims at providing Third Party assurance of quality, safety and reliability of products to the customer. Presence of BIS certification mark, known as Standard Mark, on a product is an assurance of conformity to the specifications. The manufacturer is permitted to self-certify the licenced products after ascertaining its conformity to the Standard. Through its surveillance operations, the Bureau maintains a close vigil on the quality of certified goods. The conformity is ensured by regular surveillance of the licensee’s performance by surprise inspections and testing of samples, drawn both from the market/factory.
Shamkris team (use as method Known as IRALG)
I - Indentification of Product Standard applicable
R- Readiness of documents required by standard & Dept.
A- Application to respective Department
L- Liaosn with Department for Inspection
G -Grant of license
Procedure for Certification (ISI Mark License)
1. Documentation – Preparation of documentation as per prerequisite document checklist and applicable Indian Standard.
2. Application – After verification of prepared documents, we will make an application to BIS. And BIS will check and revert if any additional documents required.
3. Inspection – BIS will plan Preliminary Inspection at manufacturer premises. Inspecting Officer will verify plant and machinery, Testing equipements, Quality control personal testing knowledge and other requirements. Also selected random sample for verification and testing in BIS approved lab during Visit.
4. Testing – After inspection sample will submitted to BIS Lab for Testing.
5. Grant of License – If product sample passed in BIS approved lab, license will granted to manufacturer.
Timeline of Process
For Indian Manufacturer - After Application it will take 1-2 months.
For Foreign Manufacturer – After Application it will take 4 – 5 months.
Service Details:
Type Of Service Provider | Pvt ltd. |
Type Of Industry | Service |
DL – Drug License (20B, 21B – Wholesale Distribution License)
A License to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedules C, C (1) and X and by retail on restricted license or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 –B, as the case may be
A license to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted license or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be.
Procedure for DL( Drug License )
Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form.
1. User id Creation – Crate user id on FDA Portal for State with required documents.
2. Application to FDA – After verification of prepared documents, we will make an application to State FDA
3. Inspection Plan - After application FDA officer will plan the inspection and will visit the location to verify the place, Competent Person and Legality of Company.
4. License Grant : After successful completion of Inspection License Grant for 5 Years
Consultancy Charges – DL ( Drug License)
1. Professional Fees – 20000.00
2. Out Of pocket Expenses – 10000- 35000 ( Depend upon location) will be as per actuals.
Govt Fees:
3. Govt Application Fees – 20B and 21 B – ( 1500 + 1500)= Total INR 3000.00
Timeline of Process
After application to DL ( Drug License) – 30-45 Days.
Service Details:
Type Of Industry | Service |
DL – Drug License (20B, 21B – Wholesale Distribution License)
A License to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedules C, C (1) and X and by retail on restricted license or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 –B, as the case may be
A license to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted license or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be.
Procedure for DL( Drug License )
Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form.
1. User id Creation – Crate user id on FDA Portal for State with required documents.
2. Application to FDA – After verification of prepared documents, we will make an application to State FDA
3. Inspection Plan - After application FDA officer will plan the inspection and will visit the location to verify the place, Competent Person and Legality of Company.
4. License Grant : After successful completion of Inspection License Grant for 5 Years
Consultancy Charges – DL ( Drug License)
1. Professional Fees – 20000.00
2. Out Of pocket Expenses – 10000- 35000 ( Depend upon location) will be as per actuals.
Govt Fees:
3. Govt Application Fees – 20B and 21 B – ( 1500 + 1500)= Total INR 3000.00
Timeline of Process
After application to DL ( Drug License) – 30-45 Days.
WHAT ARE THE BENEFITS OF ISO 55001?