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PKS CORPORATE SERVICES PVT LTD

FINANCIAL & TAX ADVISORY SERVICES CORPORTE COMPLIANCES

Drug License Registration in India

Compulsory Drug License for Pharmaceutical Business in India

  • Retail Drug License
  • Wholesale Drug License
  • Pharmaceutical Manufacturing Drug License
  • Cosmetic Manufacturing Drug License

Our Price Starts @ Rs 12,890/-

Drug License in India at a glance

For any Individual/Corporate/Partnership Firms etc , it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this has been made in Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.

basic pre-requisites for a Drug License

  • Minimum area of the Office/Shop.
  • Granted in the commercial premises or other premises independent of residence.
  • Refrigerator or Air Conditioner on the premises.
  • Needs to comply with the conditions of licence of the issuing Authority.
  • Displayed at premises of business.
  • A technical staff :- A registered pharmacist or competent person with same line experienced as approved by the Department if Drug Control.

Based on business type, an entity may require different types of drug license. For exact requirement and applicability, consult with our Consultant.

Conditions for obtaining Drug License in India

Minimum Area & Height of Premises

The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required.
The clear height of the premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.

Storage Facility

Must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.

Phamacist / Competent / Technical Staffs

Manufacturing :- for an Drug manufacturing unit there must be Technical Staff at manufacturing and Technical Staff for testing as well. Wholesale :– The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4 years experience in dealing in drugs, specially approved by the department of drug control for the purpose. Retail :– The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.

Commercial Premises

Licences for the sale of drugs can be granted only at premises that is commercial premises or premises independent of residence. For this purpose state drug office issues guidance which may be referred to.

Location Based License

If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location

License for Each State

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

Importer of Drugs or Cosmetics

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License

Documents Requirement for

Our Service Coverage

After Company incorporation, you will receive below documents 

  • Company Certificate of Incorporation
  • Memorandum of Association & Article of Association (MOA & AOA)
  • PAN Card and TAN Allotment
  • EPF & ESI Registration
  • Digital Signatures (Class 2)
  • Directors Identification Number (DIN)
  • Assist in Bank A/c Opening
  • Professional Tax Registration (if required)
  • GST Registration (Optional)

Our Services Charges

For Medicine Retailers

Retail Drug License ( for one premises)

Rs. 12980

Add To Cart

For Medicine Wholesalers and Stockist

Wholesale Drug License ( for one premises)

Rs. 17700

Add To Cart

For Medicine Manufacturers

Pharmaceutical Manufacturing Drug License

Rs. 17700

Add To Cart

For Cosmetic Manufacturers

Cosmetic Manufacturing Drug License

Rs. 17700

Add To Cart

Apply Additional Drug license

Application of additional Retail/Wholesale license

Rs. 12980

Add To Cart

Drug License Amendment

Changes of Pharmacist/Competent Person in Existing License

Rs. 9440

Add To Cart

Drug License Amendment

Addition or Reduction of premises

Rs. 12980

Add To Cart

Our Service Package Inclusion in Drug License Registration

Consultation

First, Get Consultation from our Drug License Consultant to know the Drug License Rule, Documents Requirements, License Expenses, Renewal , Types of License applicability as per your business nature, etc.

Documentations

Drug License registration need various documents in support of application filing. Documents varies Region wise as well as business to business and type of Drug License. We prepare all required documents first.

Preparing Application

Once your documents is prepared, we starts preparing your application along.

Application Submission

Once your application is completed in all respect, we proceed to file with state Drug Control Authority.

Inspection assistance

We Assist client at the time of Inspection of premises by the Drug Inspector appointed by the Authority to check the Documents in Original and inspection of premises to ensure the particulars as mentioned in the applications is correct and premises fit for the drug business as per guidelines.

Update and Followup

We follow up with the Authority for an updated status of the application and we update client time to time.

Registration Copy

The whole process of approval shall take upto 45 to 60 days by the Authority.

Drug License Registration process in India ( General Instruction)

  • Login ID and Password Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.
  • Online Application Please be sure that, all the information is filled precisely for respective application mentioned below and only then e-send the application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited.
  • Upload Documents

    All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose. The licensing authority may ask for any other specific documents if required.

  • Physical Inspection Show all the original documents to the inspector at the time of inspection. Inspector may ask you any further documents relevant to your application.
  • Approval/Rejection After grant or rejection of your application, you will receive an SMS about the same. Take a print out of the approval/rejection from ‘Print License’ option for fresh license and renewal and click ‘MISC approvals’ for other approvals within 3 days. You will receive licenses/approvals with the valid e-signature and official seal.
  • Change in constitution If the proprietor/ partner are changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.
  • Separate Password for Pharmacists Registered Pharmacists are also required to update their details by obtaining separate password.

How We Proceed

get information first

Discuss with Our Consultant on Call/Chat

OR

Check service details on website

Pay Fee

  • Either pay Online OR Through NEFT/RTGS/Cheque
  • EMI facility available on online payment above Rs. 5000/-
  • Get Payment Confirmation on SMS and acknowladge on Email.

Get Call & Email

Our consultant shall call you on success payment to start the process.
You shall receive mail for documents requirement

Document upload

Upload Document online with Client login

OR

Email us at admin@pks.co.in

*Login id & password deliver on registered email id and sms you

Reporting

Login to check your assignment status

FAQs

It is important your Application is filed correctly and properly as per legal requirement. Our Experts are well experienced in this line to get your work done smoothly.

Yes.

When barcodes are used in the business process, procedures are automated to increase productivity and reduce human error. Whenever there is a need to accurately identify or track something, bar-coding should be used. For example, in a data entry work environment, workers may be required to enter an enormous amount of data into a customer database system. Instead of manually typing a customer identification number into a database, if the information is contained in a barcode, a data entry operator may scan it in. This would increase automation and reduce human error.

The 12 digit UPC bar code system was designed in the early 1970’s by George J. Laurer in the USA (when he was working as an engineer for IBM). A few years later he developed a 13 digit version of this code – the EAN-13 code – for use internationally (outside of the USA).

Talk to our Consultant on call or Email at info@fintaxx.in to know the process, Pricing etc.

Yes. Your codes are guaranteed to be unique for your products. All barcodes have originated from GS1 and come delivered with an included certificate to guarantee their authenticity.

Determining the best type of barcode to use depends on the environment, requirements, application, and printer.

Online Pay Options

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