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 licenses to regulate the manufacture, storage, distribution and sale of drugs. Rajasthan Drug License is issued under the Drug and Cosmetics Act of 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.
Meaning of Drugs
Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.
Importance of Rajasthan Drug License
- 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.
- To ensure the good health of our nation through adequate access the drugs and medicines, the Drugs & Cosmetics Act made it mandatory to obtain a drug license
- Rajasthan drug license also ensures that the drugs 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 regulations for the person who is dealing with drugs and details of the business premises.
Purpose of Drug Licence
The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs, cosmetics, ayurvedic, Siddha and Unani drugs have to mandatorily obtain drug license under the Drugs and Cosmetics Act, 1940.
The purpose of the drug license is to grant permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics. No enterprise or individual can operate a business dealing in drugs, medicines or cosmetics without obtaining a drug license in India. In addition to a drug license, they must also obtain a trade license and a shop and establishment registration.
The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. The government exercises control over drugs from the raw material stage during manufacture, sale, distribution and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary.
The government also exercises control in the aspects related to import and export of medicines, sale of the drug to a minor, consumption of schedule H & X drugs, etc., that requires thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.
Who needs a Drug License?
- Businesses 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 a Rajasthan Drug license.
- It is essential to obtain a 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.
- Businesses with substances used for the destruction of insects which cause disease in human beings should obtain a drug license.
- A 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 animals, need a Rajasthan drug license
Types of Drug License
- Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
- Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License
- Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.
- Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this license.
- Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee to manufacture drugs.
- Import License – License issued to any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India.
- Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.
Drug Controlling Authority or Regulatory Authority
- State Drugs Standard Control Organisation (SDSCO) – Issues licenses for the sales, distribution, and manufacture of drugs regulated by the state authorities.
- Central Drugs Standard Control Organisation (CDSCO) – Responsible for approving and issuing licenses for the newly made drugs and clinical trials of drugs. It also controls the quality of the imported drugs and coordinates with the SDSCO.
- State Drug Controlling Authority with approval by the Central License Approving Authority – Issues licenses for establishing blood banks and their components and products like Vaccines, Sera, etc.
- Department of Ayush – Issues licenses for ayurvedic, Unani, Siddha, homoeopathic and herbal products for cosmetic and medical use.
Documents Required
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, AHUs, water systems, analytical instruments, and apparatus for physicochemical, microbiological, and biological along with their attested photocopies of purchase invoices
- Medical examination Certificates of technical staff & employees include the absence of contagious disease
- Registration from the 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 the plant and pieces of machinery (dimensions in Metric system), & site plan
- A 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
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.
Step 3: If the applicant is new to the Rajasthan SSO portal, you have to click on the new user register button for registration.
There are three options for
SSOID as tabulated
| 1 | For Citizen | 1. Bhamashah ID (only for citizens) 2. Aadhaar ID (UID) (Only for Citizens) 3. Facebook (Citizens- Limited App Access) 4. Google (Citizens- Limited App Access) |
| 2 | For Udhyog | 1. Udhyog Aadhaar (UAN) (Only for Udhyog) 2. Business Registration No. (BRN) (Only for Udhyog) |
| 3 | Govt. Employee | 3. Govt. of Rajasthan Employee (SIPF Users) |
Step 4: After registration, to log into the portal, select the option as existing user- sign in and enter SSOID, username, Password and Captcha. By clicking the Login option, you will be redirected to a new page.
Step 5: After logging into SWCS, the applicant has to proceed as per the following steps. Select Submit a new application.
Step 6: You need to select the Medical & Health Drug Control Organization to apply for a 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 in all the required fields:
- Categories of drugs to be sold
- Establishment & Applicant(s) Details
- Seller Details
- Shop/ Premises Details
- Refrigerator Details (if any)
Step 8: After providing details, the applicant needs to upload all required documents as mentioned above.
Step 9: Ensure and tick all the facilities and arrangements that are to be provided in the shop and click on the submit button.
Step 10: The amount payable for the application will appear automatically. Pay the requisite fee online. After successful payment, the online application will be submitted to the Department.
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 the 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.
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.
FAQs
What is the validity of a drug license?
A drug licence is valid for five years unless cancelled and suspended by the drug department. It can be renewed before its expiration period by logging into the respective drug controlling website, entering the drug licence number, filling up the renewal application and submitting the document along with the fee for the issue of renewal of the drug license. The drugs controller will issue a renewed drug license.
What are the drugs included under the Drugs and Cosmetics Act, 1940?
The drugs included under the Drugs and Cosmetics Act are as follows:
- All medicines for external or internal use of animals or human beings and all substances intended to be used for or in the treatment, diagnosis, prevention, or of any disease or disorder in animals or human beings, including preparations applied on the human body for repelling insects like mosquitoes.
- Substances (other than food) intended to affect the function or structure of the human body or intended to be used to destroy insects that cause disease in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette.
- All substances intended for use as components of a drug, including empty gelatin capsules.
- Such devices intended for external or internal use in the treatment, diagnosis, prevention, or mitigation of disorder or disease in animals or human beings, as may be specified by the Central Government by notification in the Official Gazette.