How to obtain Drug License in Rajasthan?

In a large state like Rajasthan, stepping into the Pharmaceutical industry seems quite challenging that already has multiple numbers of drug stores. In fact, if we talk about Rajasthan, the market of Retail Pharmacy has grown tremendously over the last few years. The increasing deterioration in the health of the people has led the need for opening multiple Drug and Pharmacists store in every nook and corner of the state. So, in case you are planning to manufacture, distribute, store, sale of drugs, or wish to open a drug store, then you need to take appropriate legal permission from the Government of Rajasthan in the form of a Drug License.

For your Knowledge:

Drug includes all medicines and devices which are made for internal or external use for diagnosis, treatment, mitigation, destruction, or prevention of any

The below article will provide you detailed information related to Drug License Certificate in Rajasthan.

Importance of Drug License in Rajasthan

Anyone who is interested in carrying out the activities relating to the sale, trade, manufacture, import, or resale of Drugs in the Pharmaceutical market has to mandatorily obtain a Drug License. As per the Drugs and Cosmetics Act, 1949, it is compulsory to obtain a Drug License Certificate. The said Act ensures good health and safety of India with the following features:

• Without a drug license, no individual is allowed to do pharmacy business or any dealings relating to it, in the state of Rajasthan.
• A Drug license in Rajasthan ensures that the drugs have not been abused or misused by any individual
• Drug License safeguards the health of public at large, and any negligence on the part of the manufacturer or retailer will be considered as an offence
• Drug License in Rajasthan is indispensable to have for businesses of cosmetics, homeopathic, ayurvedic, allopathic and unani drugs.

Who can apply for Drug License in Rajasthan?

The following entities which are engaged in manufacturing or selling of drugs and cosmetics in the state of Rajasthan are required to have a valid Drug License:

• Any Individual
• Partnership Firm
• Limited Liability Partnership
• Corporate or Business Firm

Prescribed Authority issuing Drug License in Rajasthan

In Rajasthan, a valid Drug License is issued by the Assistant Drug Controller (ADC) of the Department of Medical, Health, & Family Welfare, Government of Rajasthan, complying with the provisions of Drugs and Cosmetics Act.

Conditions for obtaining a Drug License in Rajasthan

To obtain a Drug License in Rajasthan, there are certain conditions that an applicant needs to keep in mind and fulfill:

• A Qualified Pharmacist and Technical Staff
  This is one of the important condition which requires a competent and specialist pharmacist, having valid certification, who can manage and have knowledge about the medicines in retail drug business.
  For wholesale drug business, a registered pharmacist or a graduate within minimum one year of experience in dealing with drugs or a person who has passed S.S.L.C. with four years experience in dealing with drugs and specially approved by the Rajasthan Drug Control Department, is required.
• Area of Pharmacy Shop
  To open a pharmacy or medical shop, the area of floor covering the store must be at least 10 square meters. On the other hand, for retail and whole sale drug store, the minimum area of 15 square meters is required which must be enough ventilated.
• Drugs Storage Facility
  It is necessary that Medicines must be kept at low-temperature freezing zone. Further, medicines must be stored at a proper ventilated, clean and cool storage facility. Hence, it is compulsory to have refrigerator and air conditioner at the premises before you apply for drug license in Rajasthan.
• Critical Inspection by the Inspector of Drug
  Before receiving a Drug License in Rajasthan, the inspector having the jurisdiction of the area will visit the premises and will have a thorough inspection of the premises by measurement of the premises where drug license is required.

Types of Drug Licenses in Rajasthan

The Drug Licenses in Rajasthan can be classified as follows:

• Manufacturing Drug License: This License is required by the manufactures of Homeopathic/Allopathic Medicines, ayurvedic products or cosmetics as specified under the Drugs and Cosmetics Act, 1940. Also, this license is required to repack the drugs.
• Sale Drug License: Sale Drug License is procured by those which are engaged in business activity of selling the drugs. The business activity may be retail based or wholesale based. Hence sale drug license is classified into types:
  • Retail License
  • Wholesale License

Documents Requirement for Drug License in Rajasthan

As we discussed above that there are two types of different Drug Licenses, hence the documents requirement of both the licenses are different. Hence, we have discussed the documents required for both the licenses below:

• While Obtaining Manufacturing Drug License
  • Application on prescribed form
  • Affidavit of Proprietor/ Partners/ Director(s)/ Managing Director on Rs 10/= Non Judicial Stamp Paper duly attested by Notary Public
  • List of all the Partners/ Directors with age & complete postal & residential address.
  • Specific Power of attorney in favor of Authorised Signatory for submitting 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.& Analytical Chemist
  • Original & Attested copies of Registration issued by Pharmacy Council in the name of Manufacturing Chemist &/or Analytical Chemists. ( If any)
  • Site Master File duly signed.
  • Performa for approval of products
  • Section wise list of Plant and machineries ,AHU’s, water system, analytical instruments, apparatus for physico chemical, microbiological , biological along with their attested photocopies of purchase invoices provided.
  • Medical examination Certificate of technical staff & employees includes absence of contagious disease,
  • Registration from District Industries Center.
  • Consent to establish & consent to operate from Rajasthan State Pollution Control Board. Document pertaining to ownership for the proposed site of the unit & documents in its support.
  • 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 blue print of location of plant and machineries (dimensions in Metric system) , & site plan .
  • Consent letter from government approved laboratory for sophisticated tests.
  • Consent letter from principal manufacturing unit in case of loan license.
• While Obtaining Sale Drug License
  • Memorandum of Association and Article of Association of the entity
  • Photograph and signature of owners, if individual
  • Latest photograph and signature of pharmacists
  • Registration Certificate of Pharmacists
  • Declaration of Pharmacists
  • Shop/Premises map
  • Proof of ownership of premises
  • Rent Agreement of premises, if rented
  • Declaration or Voucher of Purchase of Refrigerator

Online process for Drug License Registration in Rajasthan

To obtain a Drug License Certificate in Rajasthan, follow the below step by step process:

• Visit the official website of Rajasthan Govt: sso.rajasthan.gov.in.
• log in to the portal with your login details.
• If you haven’t registered on the website then you have to register on SSO Rajasthan which will take you to the portal of Medical Department
• Click on New Application and select the type of license you wish to obtain
• After selecting, “new application”, enter your GST Number and select type of establishment
• Enter details like PAN Number, Aadhar Number, email and attach photograph
• Enter the details of seller and premises
• Now, you need to enter Refrigerator details, post which click on “Save” and make payment
• After making the payment, your application will be verified by the ADC who will review the application and upload the documents.
• In case of any objection by ADC, the applicant will be duly intimated and then the applicant has to re-submit the application
• The ADC will also inspect the premises and will report its findings and based on its findings, will upload the scanned copy of the inspection report & verified map. ADC might Approve or Reject the application or Raise clarification.
• Once approved by ADC, a sale/manufacturing license will be alloted.

The process of Drug License Certificate Registration might seem easy, but the preparation of documents and Form selection is a tedious task. Thus, take the assistance of Legal Window which has years of experience in applying for Drug License in Rajasthan.

Wrapping Up

Being a businessman who is dealing in the business of drugs and cosmetics, complying with all the rules and regulations of Drug license at all the time during the course of their business is compulsory. It is obligatory to maintain all the records/registers/forms in the specified manner and authorities shall be informed of all the changes made in the business activity.