Rajasthan Drug License

Rajasthan drug license is a document of permission for carrying out businesses related to pharmaceutical industries that deal with drugs, medicines and cosmetics. The government of Rajasthan issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Rajasthan Drug License issues under the Drug and Cosmetics Act, 1940 to the person dealing with drugs. As per this act, it is mandatory to obtain a drug license before the commencement of the drug business. In this article, look at the procedure for obtaining Rajasthan drug license in detail.

Know more about How to Start a Pharmacy Business

Drugs & Cosmetics Act

Rajasthan drug license is mandatory under the provisions of Drugs & Cosmetics Act; 1940. This act moderates the import, manufacture, distribution and sale of drugs and cosmetics which includes allopathic drugs, homoeopathic drugs and even the Ayurvedic, Siddha or Unani drugs.

Importance of Rajasthan Drug license

Some of the significance of Rajasthan drug license is explained in detail below:

• The Rajasthan drug license gives the permit to sale, resale, market, manufacture, trade, etc. of drug and cosmetics.
• Without a drug license, no person can do pharmacy business or even start to associate with any dealings in Rajasthan.
• For ensuring good health of our nation through adequately accessing the drugs and medicines, the Drugs & Cosmetics Act made it mandatory for obtaining a drug license
• Rajasthan drug license also ensure that the drug and goods are not misused or abused by any individuals
• Dealing with drugs and cosmetics without a drug license is a cognizable offence. Every business person in the pharmacy industry needs to have their drug incense to carry out their day-to-day business work.
• Rajasthan drug license contains the rules and regulation for the person who is dealing with drugs and details of the business premise.

Note: It the responsibility of all persons dealing with medicine/drugs and cosmetics to maintain its quality. If any person consuming a drug/medicine suffers any harm from the negligence on the part of the manufacturer or seller of the drug, the same is an offence, which is an offence of grievous hurt under IPC. Hence holding drug license is essential.

Know more about the Medicine and Drugs Allowed for Import Without a Licence

Who needs Drug License?

Rajasthan drug license is essential for dealing with the following type of business. Any individual, partnership, limited liability company, corporation or business firm located In Rajasthan and is physically distributing the drugs and cosmetics in the state is required to hold a valid drug license.

• Business with any cosmetics intended to be poured, sprinkled, rubbed or introduced into the human body or for cleansing, beautifying, promoting attractiveness, or altering the appearance of a Human, must obtain Rajasthan Drug license.
• It is essential to obtain Drug license to deal with medicines which are used for external or internal use of human beings or animals
• Manufacturing and distribution drugs/cosmetics applied to the human body to repel insects like mosquitoes also need Rajasthan drug license.
• Business with substances used for the destruction or insects which cause disease in human beings should obtain a drug license.
• Rajasthan drug license is essential for dealing with empty gelatine capsule
• To manufacture, store and distribute the medicines used for diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animal, need Rajasthan drug license

Basic Requirement for Obtaining Rajasthan Drug License

As per the provision of drug and Cosmetics Act to get a Rajasthan Drug license the following requirements to be met by the businessman.

Area Recruitment

The minimum area of ten square meters is required to set up a medical shop or pharmacy, In case store business combination with the retail and wholesale than the minimum area of 15 square meters is needed.

Storage Facility

It is mandatory to have an air conditioner and refrigerator on the premises because some drugs such as vaccines, insulin injections are needed to be stored in the fridge.

Technical Staff

Sale of drugs should be carried in the presence of a registered Pharmacist approved by the Government who is required throughout the working hours in the retail shop.

The wholesale of medicines and drugs can be made either by a registered pharmacist or another competent authority who must be a graduate with one year experience in drugs or in the presence of anyone who has passed SSLC having experience of four years in drugs, specially approved by medical, health and family welfare department.

Classification of Rajasthan Drug License

Based on the requirement of the pharmaceutical/drug business, Rajasthan Drug License can be classified in the following categories:

• Sale License
• Manufacturing License – Blood Bank License

Sale License

Sale license is issued to the persons or agencies engaged in the sales of drugs/medicines in Rajasthan. The sale license can be further classified into two types.

• Retail License: It is granted to run and sell drugs or drug products in Rajasthan.
• Wholesales License: It is issued to persons or agencies engaged in wholesale of drugs and medicine.

Manufacturing License

Manufacturing License is released to the persons or agencies involved in the manufacturing of drugs/medicines and cosmetics. Government also issued Manufacturing loan license.

A manufacturing loan license will be issued to licensee or person using the premises, equipment and staff of another drug licensee having a manufacturing license.

Blood Bank License

It is a license to moderate a Blood Bank for collection, storage and processing of whole human blood and/ preparation of blood components for sale or distribution.

Application Processing Time

Timeline for grant and renewal of retail sales, wholesale and Drug Manufacturing license will be 20 working days from the date of application.

Prescribed Authority

Assistant Drug Controller (ADC) of the Department of Medical, Health, & Family Welfare, Government of Rajasthan issues drug license as per the provisions of drug and cosmetics act.

Applicable Fee

The fee structure for Rajasthan drug license will be varied according to the type of drug license. The applicant can go through the document attached here for verifying the fee structure.

Documents Required

Following documents need to be submitted for Obtaining Rajasthan Drug license.

Documents Required for Sale License

• Memorandum of Articles / Constitution
• Current photo of individual owners
• Signature of individual owners
• Declaration by owners
• Current photo of Pharmacists
• Signature of Pharmacists
• Pharmacist Registration Certificate (both sided) of Pharmacists
• Declaration of Pharmacists
• Map of shop premise
• Ownership Title Deed in case of shop ownership is own), Rent Agreement and Rent Receipts (in case of shop ownership is on Rent or Lease), Allotment Letter (in case of ownership is Allotted Premises)
• Refrigerator Purchase Voucher/ Declaration

Documents Required for Manufacturing License

• Application on prescribed format
• Affidavit of Proprietor/ Partners/ Director/Managing Director on Rs 10/= Non-Judicial Stamp Paper duly attested by Notary Public
• List of partners, directors names with age and residential address
• Specific Power of attorney in favour of Authorized signatory for submitting an application on behalf of the Company on Rs.10 Non-judicial Stamp paper duly attested by Notary Public
• Affidavit of Manufacturing Chemist & Analytical Chemist on Rs 10/= Non-judicial Stamp paper duly attested by Notary Public
• Attested Photostat Copies of qualification, experience and approval certificates of Manufacturing Chemist and Analytical Chemist
• Original & Attested copies of Registration issued by Pharmacy Council in the name of Manufacturing Chemist or Analytical Chemists
• Site Master File duly signed
• Performa for approval of products
• Section wise list of Plant and machinery, AHU’s, water system, analytical instruments, apparatus for physicochemical, microbiological, biological along with their attested photocopies of purchase invoices
• Medical examination Certificate of technical staff & employees include the absence of contagious disease
• Registration from District Industries Center
• Consent to establish & consent to operate from Rajasthan State Pollution Control Board
• List of Reference books and literature
• Document of ownership for the proposed site of the unit & reports Attested copies of partnership deed / Memorandum & article of Association
• Specific resolution for commencing Drug/Cosmetic- Manufacturing activities (if not already included in Memorandum of Association)
• Section wise blueprint of the location of plant and pieces of machinery (dimensions in Metric system), & site plan
• Consent letter from government approved laboratory for sophisticated tests
• Consent letter from the principal manufacturing unit in case of loan license

Documents Required for Blood Bank License

• Affidavits of Medical Officer, Blood Bank Technician, & Registered Nurse on Rs 10/= Non-judicial Stamp paper duly attested by Notary Public
• Attested Photostat Copies of qualification, experience and approval certificates
• No objection certificate from Rajasthan State Transfusion Council

Rajasthan Drug License Application Procedure

The procedure to obtain drug license in Rajasthan is explained in step by step procedure here:

Step 1: The applicant has to visit the Department of Medical, Health & Family Welfare; Government of Rajasthan.

Step 2: From the main page, select Drug Control and then click on license option. Click on Apply Online; the link will be redirected to Rajasthan’s Single Window Clearance System (SWCS) portal. The applicant can also directly visit the SWCS website.

Important Note:

The applicant has to make sure that Aadhaar number of owner and pharmacist are linked with a mobile number which is with the applicant at the time of application, as OTP will be sent on mobile number linked with Aadhaar number.

New User Registration

Step 3: If the applicant is new to Rajasthan SSO portal, you have to click on new user register button for registration.

There are three options for creating SSOID as tabulated

Generate Business Registration Number (BRN) through BRN website for applying for Rajasthan drug license.

Login to Portal

Step 4: After registration, for login to the portal, select option as existing user- sign in and enter SSOID, username, Password and Captcha. By clicking Login option, you will be redirected new page.

Step 5: After login into SWCS, the applicant has to proceed as per following steps. Select submit a new application.

Step 6: You need to select the Medical & Health, Drug Control Organization for applying for drug license. Select “anyone” service for which the applicant wishes to apply for a license.

Step 7: Upon selecting the required service, the online application form opens wherein the applicant is required to fill all the required fields:

• Categories of drugs to be sold
• Establishment & Applicant(s) Details
• Seller Details
• Shop/ Premises Details
• Refrigerator Details (if any)

Upload Documents

Step 8: After providing details, the applicant needs to upload all required documents as mentioned above.

Note: All documents should be in PDF format, and the maximum size of the file should be 5 MB.

The format of application and documents required for Sale License is attached here:

We have here with attached an application and documents required for Manufacturing License:

Declaration

Step 9: Ensure and tick all the facilities and arrangements that are to be provided in the shop and click on the submit button.

Make Payment

Step 10: Amount payable for application will appear automatically. Pay the requisite fee online. After successful payment, the online application will be submitted to the Department.

Wait for the processing of online application at respective ADC office.

Verification by ADC

Step 11: The online application will be received by the concerned Assistant Drug Controller (ADC), who will review the online application details and the uploaded documents.

Step 12: The concerned ADC will object if any, for which the applicant will receive a message on the registered mobile number as well as on the Dashboard of the applicant.

Step 13: The applicant has to fulfil the objections raised by concerned ADC and re-submit the application online.

Step 14: The applicant will be intimated about the inspection schedule of the premises by ADC for further processing of the application.

Site Inspection

Step 15: The Assistant Drug Controller (ADC) / Drug Control Officer (DCO) will inspect the premises and will report its findings.

Step 16: Based on the findings of the inspection report, the Assistant Drug Controller shall upload the scanned copy of the inspection report & verified map and Approve or Reject the application or Raise clarification.

Step 17: Once approved by Assistant Drug Controller, digitally signed. The system would generate a Sale/Manufacturing license.

Status of Application

The applicant will receive a message on the registered mobile number, and the status of the drug license application will be updated on the applicant’s dashboard (on Single Window Clearance System) at each stage of the application process.

Download Rajasthan Drug License

Once the applicant received intimation from the SWSC regarding the issue of license, and then he/she can download the digitally signed “Sale/Manufacturing License” from his/her dashboard.

After downloading the digitally signed “Sale License”, it is required to verify the digital signature on the same online. Before verification of digital signature, there will be (?) mark which will be converted as (√) after verification of digital signature.