The Drugs and Cosmetics Act, enacted to safeguard public health, necessitates that manufacturers, distributors, and sellers of drugs and cosmetics adhere to a stringent licensing process. This process involves thorough scrutiny of the manufacturing facilities, product formulations, and adherence to Good Manufacturing Practices (GMP). The Act aims to regulate the production, distribution, and sale of drugs and cosmetics, thereby mitigating potential risks associated with substandard or adulterated products

The Food Safety and Drug Control Commissionerate (Drug Control Wing) is a Regulatory Agency under the Medical & Health Department of Rajasthan. It regulates the manufacture of drugs, Meedical Devices & cosmetics and sales of drugs in the state of Rajasthan. The Commissionerate is the head of the Commissionerate and for the enforcement of various Drug Laws, officers including Drug Controller, Assistant Drugs Controllers and Drugs Control Officers are posted at Head Quarters as well as in the field in all the districts

• Drugs & Cosmetics Act 1940 & Rules 1945
• Drugs Magic Remedies (Objec. Advert.) Act 1954
• Drugs (Price Control) Order 2013
• Medical Device Rules 2017
• Cosmetic Rules 2020

Procedure For Obtaining Sales LicenseSales License – License for sale by Retail, Wholesale or Retail +
Wholesale are issued online at the state portal sso.rajasthan.gov.inas per the
provisions of Drugs & Cosmetics Act and Rules. The Licensing Authority for such
licenses is the Assistant Drugs Controllers of the concerned area.
The area requirements of Sales premises are as follows:
Minimum carpet area:-
For Retail sale : 10 square meter.
For Wholesale : 10 square meter.
For Retail +Wholesale : 15 square meter.
Procedure for getting sale license
Step 1 Application for grant of Licence for sale of drugs.
The applicant has to make application online in the requisite Form No. 19, and pay necessary
fees as given in fee chart under ‘Forms & Fees’.
Fee can be paid through the application portal itself or through Government Treasury challan,
under Head of Account0210- 04-800-02-00 Other receipts
Documents to be uploaded along with the application form:
(Aadhar card number with valid mobile number is mandatory)
1. Application Form 19.
2. Receipt of fees challan, if not paid through online portal.
3. Declaration of Proprietor / partners / director, etc. in prescribed proforma.
4. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and
article of association, etc.
5. Particulars of the registered pharmacist /competent person along with their educational
qualification, experience and registration certificates.
6. Declaration of Registered Pharmacist / Competent person.
7. Registration certificate of Registered Pharmacist.
8. Document related to lawful possession of the premises like document of ownership- purchase
documents (registered) / rent agreement, rent receipt.
9. Map/ Layout plan of shop.
10. Refrigerator purchase invoice.
Step 2 Scrutiny of application. In case any shortcoming / discrepancy is noted, ‘objection’
shall be raised. Further action shall be taken upon receipt of clarification from the applicant. In
case the application is found in order, it will be processed for inspection of shop.
Step 3 Inspection of shop premises.
Step4 Grant of Licence
If all the prescribed conditions are complied with, licence is granted. 

Procedure to obtain Drug Manufacturing License
License for manufacturing of drugs are issued online at the state portal
sso.rajasthan.gov.in as per the provisions of Drugs & Cosmetics Act and Rules. The
Licensing Authority for such licenses is the Drugs Controller of the state.
Step 1
Application for grant of Manufacturing Licence (The unit should be in industrial area).
The applicant has to make application online in the requisite Form No. 24, or 27, or as applicable
(Form 24C for Homoeopathic medicines) and pay necessary fees as given under ‘Forms & Fees’.
Fee can be paid through the application portal itself or through Government Treasurychallan,
under Head of Account0210- 04-800-02-00 Other receipts
Department Name: Commissionerate, Food Safety and Drug Control Jaipur
Office Name: Commissioner Food Safety & Drug Control
On-line application portal: Drug Control Organization (DCO) at sso.rajasthan.gov.in
Documents to be uploaded along with the application form:
(Aadhar card number with valid mobile number is mandatory)
1. Application Form.
2. Receipt of fees challan, if not paid through online portal
3. Affidavit/ Declaration of Proprietor/ Partners/ Director(s)/ Managing Director
4. List of all the Partners/ Directors with age & complete postal & residential address.
5. Specific Power of attorney in favour of Authorised Signatory for submitting Application
on behalf of the Company on Rs 10/- Non-judicial Stamp paper duly attested by Notary
Public.
6. Affidavit / Declaration of Manufacturing Chemist.
7. Affidavit / Declaration of Analytical Chemist.
8. Documents of educational qualification, experience and approval certificates of proposed
Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id Proof;
Registration certificate issued by Pharmacy Council (if applicable).
9. Site Master File duly signed.
10. Product sheets in specified proforma for approval of products.
11. Section wise list of Plant and machineries, analytical instruments, apparatus for physico
chemical, microbiological , biological testing along with attested photocopies of their
purchase invoices. List of safety equipments.
12. Details of AHUs (Air Handling Units) including Qualification details and Schematic
Diagram. Details of Water System including Qualification details and Schematic
diagram; Water testing reports.
13. Medical examination Certificate of technical staff & employees includes absence of
contagious disease.
14. Registration from District Industries Center.
15. Consent to establish & consent to operate from Rajasthan State Pollution Control Board.
16. List of Reference books and literature provided.
17. Document pertaining to ownership for the proposed site of the unit & documents in its
support.
18. Partnership deed / Memorandum & Article of Association.
19. Specific resolution for commencing Drugs Manufacturing activities (if not already
included in Memorandum of Association)
20. Section wise lay-out /blue print of location of plant and machineries (dimensions in
metric system), & site plan.
21. NOC from Fire Safety Office, and/ or NOC from Controller of Explosives (as applicable)
if dealing with explosive / inflammable material.
22. List of Products alongwith their manufacturing process, analysis procedure, stability data
and standard operating procedures.
23. Consent letter from government approved laboratory for sophisticated tests. (If
applicable).
Following additional documents are required if applied for loan license on Form 24-A or 27-A or
any other form as applicable:
1. Consent letter from principal manufacturing unit in case of loan license.
2. Wholesale licenses of the applicant loan licensee.
3. Statement of production capacity, and capacity utilization of the principal manufacturer.
4. Valid manufacturing licenses and copies of product permission of the product in question
(if applicable) of the principal manufacturer.
5. Id Proof of Directors, PAN Card copies, TIN no / GST reg. certificate of applicant firm.
* For proforma of affidavits, see under ‘Downloads’.
Step 2
Scrutiny of application. In case any shortcoming / discrepancy is noted, query shall be raised.
Further action shall be taken upon receipt of clarification from the applicant. In case the
application is found in order, it will be processed for inspection of factory premises. CDSCO will
be informed about the application and it will be requested to depute an inspector for joint
inspection of the premises.
Step 3
Inspection of proposed premises.
Step 4
If shortcomings / discrepancies are observed during inspection, the applicant shall be intimated
to rectify the same and submit compliance report.
Step 5
Upon receipt of the compliance report from the applicant, it will be sent to the concerned officer
for verification. If found satisfactory, it will be forwarded for the next step.
Step 6
Products Scrutiny. The details of the products applied for shall be scrutinized and if they are
found to comply with the norms, the application will be considered for grant of license.
Step 7
Grant of Licence
If all the prescribed conditions are complied with, licence is granted.

Procedure to obtain Manufacturing License for Medical Devices
License for manufacturing of Medical Devices including in-vitro
diagnostic devices are issued online at the CDSCO portal
cdscomdonline.gov.in as per the provisions of Drugs & Cosmetics Act and
Medical Device Rules 2017. The Licensing Authority for such licenses for Class A
and B products is the Drugs Controllerof the state.
[License for Class C and D products is granted by the Central Licensing Authority,
New Delhi]
Step 1
Application for grant of Manufacturing Licence
The applicant has to make application online at the CDSCO portal cdscomdonline.gov.in
inrequisite form such as MD-3 (or MD-4 for loan license) for license to be issued on form MD-5,
or as applicable as per the Medical Device Rules, along with necessary fees challan as given in
fee chart under ‘Forms & Fees’.
Fee can be paid through Government Treasury challan, under Head of Account0210- 04-800-02-00 Other receipts
Department Name: Commissionerate, Food Safety and Drug Control Jaipur
Office Name: Commissioner Food Safety & Drug Control
Documents to be uploaded along with the application form:
1. Covering Letter
2. Application Form.
3. Receipt of fees challan
4. Constitution of firm including
a. Partnership deed / Memorandum & Article of Association
b. Declaration of Proprietor/ Partners/ Director(s)/ Managing Director
c. List of all the Partners/ Directors with age & complete postal & residential
address.
5. Documents of Site ownership / Tenancy agreement
6. Plant Master File (as per appendix I of Part III of fourth schedule)
Apart from the mandatory information as per appendix I of Part III of fourth schedule,
following documents should also be submitted:
a. Declaration of Manufacturing Chemist.
b. Declaration of Analytical Chemist.
c. Documents of educational qualification, experience and approval certificates of
proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id
proof.
d. Registration from District Industries Centre.
e. Consent to establish & consent to operate from Rajasthan State Pollution Control
Board.
7. Device Master File for each product (as per appendix II / appendix III of fourth schedule)
8. Performance Evaluation Report (if applicable)
9. Copy of Test License (if applicable).
10. Undertaking that the manufacturing site is in compliance with the provisions of Fifth Schedule.
Following additional documents are required if applied for loan license on Form MD-4:
1. Consent letter from principal manufacturing unit in case of loan license.
2. Wholesale licenses of the applicant loan licensee.
3. Valid manufacturing licenses and copies of product permission of the product in question
of the principal manufacturer.
Step 2
Scrutiny of application. In case any shortcoming / discrepancy is noted, query shall be raised.
Further action shall be taken upon receipt of reply of query from the applicant. In case the
application is found in order, it will be processed for audit of factory premises by a notified body
as per Medical Device Rules.
Step 3
Audit of applicant premises by notified body. The non-compliances, if any, shall be rectified by
the applicant. The audit report and the NC closure will be uploaded by the notified body.
Step 4
Upon receipt of the audit report, it will be examined and if found satisfactory, it will be
forwarded for the next step.
Step 5
Products Scrutiny. The details of the products applied for shall be scrutinized and if they are
found to comply with the norms, the application will be considered for grant of license.
Step 6
Grant of Licence
If all the prescribed conditions are complied with, licence is granted.