Jharkhand Drug License
Jharkhand Drug License
Jharkhand drug license is a document of permission for carrying out businesses related to drugs, medicines and cosmetics. The government of Jharkhand issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Jharkhand drug license is issued under the Drug and Cosmetics Act, 1940 to a person dealing with drugs. As per this act, it is essential to get a Jharkhand drug license before the launching the drug business. In this article, we look at the procedure for obtaining Jharkhand drug license in detail.
Know more about How to start a pharmacy business
Drugs and Cosmetics Act
Jharkhand drug license is crucial according to the Drugs and Cosmetics Act; 1940. This act moderates the manufacture, distribution import and sale of drugs and cosmetics which includes allopathic drugs, homoeopathic medicines, and even the Ayurvedic, Siddha or Unani drugs.
Importance of Jharkhand Drug license
Some of the significance of Jharkhand drug license is explained in detail below:
- The Jharkhand drug license permits market, manufacture sale, resale, trade of drug and cosmetics.
- Without a Jharkhand drug license, no person can do pharmacy business or even start to associate with any dealings in Jharkhand.
- For protecting good health of our nation through adequately accessing the medicines and drugs, the Drugs and Cosmetics act made it mandatory for obtaining a drug license
- Jharkhand drug license also ensure that the drug and drugs are not misused or abused by any individuals in Jharkhand
- Dealing with drugs a without a drug license is a cognizable offence. Every trader in the pharmacy industry needs to have their drug incense to carry out their day-to-day business work.
- Jharkhand drug license contains the rules and regulation for the person who is dealing with drugs business
Note: It is the responsibility of all individuals dealing with medicine, drugs and cosmetics to maintain its quality. If any person consuming a drug or medicine suffers any harm from the negligence on the part of the seller or manufacturer of the medicine, the same is an offence, which is an offence of grievous hurt under IPC. Hence holding Jharkhand drug license is necessary.
Who needs Jharkhand Drug License?
Jharkhand drug license is mandatory for dealing with the following type of business. Any individual, partnership firm, limited liability company, corporation or business firm located In Jharkhand and is physically distributing the drugs in the state is required to hold a drug license.
- Business with any cosmetics intended to be sprinkled, rubbed, poured or introduced into the human body or for beautifying, cleansing, promoting attractiveness, or altering the appearance of a human, must obtain Jharkhand Drug license.
- It is vital to get a drug license to deal with medicine/drug which is used for internal or external in human beings
- Manufacturing and distribution drugs or cosmetics applied to the human body to repel insects like mosquitoes also need Jharkhand drug license.
- Business with medicines used for the destruction or insects which cause diseases in human beings must obtain a drug license.
- Jharkhand drug license also needed for dealing with empty gelatine capsule.
- To manufacture, store and distribute the drugs used for diagnosis, mitigation, treatment or prevention of disease or disorder in humans or animal, need Jharkhand drug license
Know more about the Medicine and drugs allowed for import without a licence
Basic Requirement for Obtaining Jharkhand Drug License
According to the provision of Drug and cosmetics act, 1940 to get a Jharkhand drug license the below-mentioned requirements to be met by the trader.
Area Recruitment
The minimum area required for setting up a medical shop or pharmacy is ten square meters. In case of the store business combination with the retail and wholesale than the minimum area of fifteen square meters is needed. License for the sale of drugs can be issued in the commercial premises or other premises independent of residence.
Storage Facility
It is crucial to have an air conditioner and refrigerator on the premises because some medicines such as insulin injections, vaccines are needed to be stored in the refrigerator.
Technical Staff
Sale of medicines should be carried in the presence of a registered Pharmacist approved by the Jharkhand Government who is needed throughout the working hours in the retail shop.
The wholesale of drugs can be made either by a registered pharmacist or any competent authority who graduate and having one year of experience in drugs or in the presence of an of person who has passed SSLC having experience of four years in drugs business, specially approved by medical, health and family welfare department.
Classification of Jharkhand Drug License
Based on the requirement of the pharmaceutical or drug business, Jharkhand Drug License can be classified in the following categories:
- Sale License
- Manufacturing License – Blood Bank
Sale License
Sale license is issued to persons or agencies engaged in the sales of drugs or medicines in Jharkhand. The sale drug license can be further classified into the following two types.
- Retail License: It is provided to run and sell drugs or drug products in Jharkhand.
- Wholesales License: It is issued to a person or agency engaged in wholesale of medicine or drugs
Manufacturing License
Manufacturing license is issued to a person or agencies involved in the manufacturing of drugs or medicines and cosmetics. Government also issued Manufacturing loan license.
Loan License
It is a license issued to a person who does not have his arrangement for manufacture but who intends to avail the manufacturing facilities owned by another licensee. This loan license will be issued to licensee using the premises, equipment and staff of another drug licensee having a manufacturing drug license.
Licensing Authority
The Department of Health, Medical Education and Family Welfare, Government of Jharkhand issues manufacturing drug license as per the provisions of drug and cosmetics act. State Drugs Control Directorate issues the license for sale of drugs and cosmetics. The prescribed authority for issuing Jharkhand drug license is tabulated here:
- License for Sale of Drugs – Joint Director (Drugs) or Director (Drugs), State Drugs Control Directorate
- License for Manufacture of Drugs – Dy. Secretary or Joint Secretary, Health Medical Education & Family Welfare Department
Application Processing Time
Timeline for grant and renewal of Jharkhand drug retail sales, wholesale and drug manufacturing license is tabulated here:
| S.No. |
Service Name |
Timeline |
| 1 | License for retail sale of Drugs | 30 Days |
| 2 | Wholesale License for sale of Drugs | 30 Days |
| 3 | Licenses for manufacturing of Allopathic Drugs | 90 Days |
| 4 | License for Manufacturing of Ayurvedic Drugs | 90 Days |
| 5 | License to Manufacture Ayurvedic, Siddha/ Unani Drugs | 90 Days |
| 6 | License for Manufacturing of Cosmetics | 90 Days |
| 7 | License for Manufacturing of Homeopathic Drugs | 90 Days |
| 8 | Manufacturing of homoeopathic drugs license renewal | 120 Days |
| 9 | Manufacturing of ayurvedic drugs license renewal | 120 Days |
| 10 | Renewal of license for testing of drugs and Cosmetics | 120 Days |
| 11 | Renewal of wholesale drug license | 30 Days |
| 12 | Renewal of retail sale drug license | 30 Days |
Validity Details
The Jharkhand drug license granted to carry out business related to the drug is valid for five years from the date of issue. After expiry, the license can be renewed.
Applicable Fee
The fee structure for Jharkhand drug license will be varied according to the type of drug license.
|
S.No |
Type of drug license |
Fee Structure |
| 1 | New Retail Drug License | Rs.3000 |
| 2 | New Wholesale Drug License | Rs.3000 |
| 3 |
New Manufacturing Drug License
|
Rs. 7500 per application and fees for the additional fee of Rs.300 per item |
Note: Fee to be paid through online payment gateway or JeGRAS
Documents Required
Following documents need to be provided for Obtaining Jharkhand Drug license
Documents for New Manufacturing Drug License
- Copy of layout plan of the manufacturing area
- All the drawings (It must be signed by the applicant as well as chartered Engineer or Architect Requisite)
- Rent receipt, Lease/Rent agreement, If own premises then purchase documents showing lawful possession of the premises/places
- Documents referring to the constitution of the firm such as partnership-deed, memorandum and article of association, the power of attorney
- Applicants ID proof, Residential proof,
- Qualification certificate and photograph
- List of machinery and equipment for manufacturing with make, model and capacity along with their numbers
- List of machinery and equipment for testing along with their make and model
- Full particular of the competent technical staff employed for manufacturing and testing of drugs along with copies of their educational qualification, experience certificates, approval letter, appointment letter, acceptance letter, joining letter as competent staff.
- List of drugs proposed to be manufactured with composition and pack sizes to be uploaded If the medicine is new homoeopathic medicine
- If the products are covered under ‘patent and proprietary’ definition, the methods of analysis of the product to be uploaded
- The draft label of drugs proposed to be manufactured
- Flowchart of the manufacturing process
- Standard Site master file
- Operating Procedure
- Power connectivity
- NOC from Pollution Control Board certificate from State Electricity Board
- NOC from Chief Fire Safety Officer
Documents for Manufacturing Drug License – Renewal
- Copy of layout plan of the manufacturing area
- All the drawings (It must be signed by the applicant as well as chartered Engineer or Architect Requisite)
- Rent receipt, Lease/Rent agreement, If own premises then purchase documents showing lawful possession of the premises/places
- Documents refer to the constitution of the firm such as partnership-deed, memorandum and article of association, the power of attorney
- Drug License with a list of products approved in the last licensing period
- List of Additional drugs (if any) proposed to be manufactured with composition and pack size will be submitted along with requisite fee
- Production details for the last licensing period
- Declaration regarding no change in plan layout, Constitution, Directors/Partner, Technical Staff of the firm/Company
- Original Labels of the drugs being manufactured
- Draft labels of additional drugs proposed to be manufactured. If any change in authorised signatory, update with relevant documents.
- Applicants Aadhaar Card, PAN Card, Residential proof, qualification certificates and a photograph of each applicant
- List of machinery and equipment for manufacturing with make, model and capacity along with their number
- List of machinery and equipment for testing along with their make and model along with their number
- Particulars of the competent technical staff for manufacturing and testing of drugs with Aadhaar Card, PAN Card, Residential proof, Educational qualification, Experience Certificates, Approval letter, Appointment letter, Joining letter.
- For addition of Competent Technical staff with documents mentioned above.
- Standard Testing Procedure and method validation
- Flowchart of the manufacturing process
- Site Master File
- Standard Operating Procedure
- Copy of the Electricity bill last paid
Jharkhand Drug License Application Procedure – Retail and Wholesale
The procedure to obtain sale drug license in Jharkhand is explained in step by step procedure here:
Access XLN INDIA
Step 1: Applicant needs to visit the XLN INDIA web-portal. From the home page select Jharkhand from the drop-down menu and click on sales login button.
Registration
Step 2: The link will be redirected to the new page. In this page apply for User ID and Password. You will get the user ID and Password on the Registered Mobile number.
Step 3: After obtaining user login credential, login to the portal by entering the username and password. Click on the submit button.
Login to Portal
Step 4: Once you login to this XLN portal, you can change the password for privacy and security. The option for changing the password is available on right top corner.
Step 5: After providing a password, click on update my details and correct it, if required. Once the application is corrected, click on update option to proceed further.
Provide Details
Step 6: Go to the menu and click on Prepare or edit online application option.
Step 7: After that click on the new inward option, click on Ok button.
Step 8: Select the Storage type from the drop-down menu. You have to select at least one from the list.
Step 9: You need to select the document type from the drop-down menu and select the Aadhaar Card and provide Aadhaar Number in the space provided.
Step 10: You have to select the inward type option from the drop box and select Fre-add/Fresh license option. Click on the RP in Retail & CP in Wholesale button.
Note: It is not required for Form 20C & 20A/21A
Step 11: By clicking on the ADD button, you can provide all details for Jharkhand drug license.
Upload Documents
Step 12: Upload all supporting documents. The certificate should consist of registration certificate of a pharmacist from state pharmacy tribunal and current renewal. After uploading the required documents click on the save button.
Step 13: You can provide all other details by clicking on the CON button and then on the ADD option.
Step 14: Take the print out of self-declaration of RP or CP and proprietor. Get it signed by a registered pharmacist and proprietor or authorised signatory.
Step 15: By following the same method, you can upload all other documents when required.
Step 16: After uploading documents, click on the Back button. In the new page, click on by firm and print application form.
Note: Keep the printed application safe for uploading with other documents after making payment.
Payment of fee through E-payment Gateway
Step 17: Make the payment through the e-payment gateway option available in the portal. Once the payment is successful e-challan will be displayed. Take the print out of the e-challan for uploading.
Upload Challan
Step 18: After receiving the challan receipt, login to the portal for uploading e-Challan. After login to portal Click on By Firm option. Select payment entries and click on New.
Step 19: Select payment type as FRAS Payment and fill all required details. Upload the scanned copy of deposited challan by using ‘Choose file’ option and click on Save.
Step 20: Click on upload option for uploading all other required documents then click on the Close button.
Additional information/Undertaking
Step 21: Click on Additional information/Undertaking option. Fill all details and click on s-sign button. Select the additional form information button and then on the Back button.
Forward Application to licensing authority
Step 22: Certify and e-Send Application to Department, i.e. the licensing authority. Licensing authority will forward the application to Drug Inspector within five working Days for verification.
Site Verification by Drug Inspector
Step 23: The drug inspector will verify the document and premises, and Drug Inspector will submit his report to the Licensing Authority within 15 working.
Step 24: After viewing the report the licensing authority will grant or reject the License within ten working days.
Status of Application
Applicant should log in frequently to check the status of Application in the dashboard. Application Status will also be available in the INBOX to see if any query raised by the Department and should reply accordingly.
Print License
By login, to the portal, you can print the Jharkhand drug license. It needs to be printed within three days from the date of issue.
Jharkhand Drug License Application Procedure – Manufacturing
The procedure to obtain manufacturing drug license in Jharkhand is explained in step by step procedure here:
Step 1: Visit the home page of Single Window Clearance System From the main page, click on the sign-up/Login option, the link will redirect to the new page.
User Registration
Step 2: In this page, you can see the option new registration, Click on the link to open the Registration form.
Step 3: Provide details in the form such as Name, Email ID and Mobile number and click on the submit button.
OTP Request
Step 4: By clicking on submit, an OTP will be sent to the registered mobile number. The system will prompt a window to enter the OTP sent to the mobile number. Provided the same for verification
Email Confirmation
Step 5: An email is sent to the registered mail ID. Click on the link for activating the account.
Step 6: Once the email and mobile number are verified, and then you can log in to the portal using the login id and password.
Login to Portal
Step 7: After login to the portal, the services of a single window portal will be displayed. You can apply for Jharkhand drug license by clicking on the respective links as shown below:
Provide Details and Upload Documents
Step 8: The application form for manufacturing drug license will be displayed, provide all mandatory details and click on save button.
Step 9: The respective supporting documents need to be uploaded directly and then click on the button ‘Submit for Approval’.
Note: Keep the printed application safe for future reference
Payment of Fee
Step 10: Make the payment through the e-payment gateway option available in the portal. Once the payment is successful e-challan will be displayed. Take the print out of the e-challan.
Note: You can also pay the fee through treasury. In this case, treasury challan needs to be paid.
Verification by Drugs Controller
Step 11: Application should be submitted at Drugs Controller Office with all Documents Mentioned above and challan. Drugs Controller will scrutinise the application and the treasury challan.
Step 12: Drugs Controller will forward the application to Committee within 15 days of submission.
Committee Verification
Step 13: Committee will verify the premises and documents submitted by the applicant. After verification, the Committee will submit the report to Drugs Controller within 45 days.
Status of Application
The status of application and intimation of license approval will be given through Email/SMS.
Get License
After receiving a Satisfactory report from Committee, Drugs Controller will grant the License. A hard copy of the License can be collected from the respective Drugs Controller office.
Jharkhand Drug License Renewal Procedure
Jharkhand Drug License needs to be renewed not less than one month before the earliest day on which liquor license expires. The applicant has to apply for drug license renewal in the prescribed format to concerned authority as mentioned above.
The fee and procedure of renewal of Jharkhand Drug License are same as explained above.
