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Food and Drugs

Madhya Pradesh Drug License 

Fee Rs: 3500/-

In India, carrying out any business activity requires an appropriate license. Drug license issued by the Government is a legal permit to conduct businesses that deal with drugs and cosmetics. Drug license is region specific and location specific, i.e. if the business operation occurs in two or more states, then each state requires a different license, and if sold at more than one place, a separate license must be acquired. The drug license comprises drug manufacturing license and drug sale license. In this article, we look at the procedure of obtaining Madhya Pradesh Drug License in detail.

Drugs and Cosmetics Act, 1940

Drug license is a permit granted by the competent authority to carry out a business concerning drugs/medicines or cosmetics under the Drugs and Cosmetic Act, 1940.  As per the act, the license covers all kinds of drug or cosmetic businesses including ayurvedic, homoeopathic, allopathic or Unani drugs. The manufacturer or seller of the drugs or cosmetics is responsible if any person using the product is affected due to the negligence of the same and is considered an offence under the act.

Conditions of License

  • The licensee should have at least four years of practical experience in the distribution of drugs.
  • Any drug made by the licensee must be under the direct and personal supervision of a registered pharmacist.
  • The retail supply of any drug on the prescription of the registered medical practitioner should be under the supervision of a registered pharmacist.
  • The retail supply of the drug should be recorded in a register at the time of supply. The following particulars should be made in the register.
  1. The serial number of the entry
  2. Date of supply
  3. Name and address of the prescriber
  4. Name and address of the patient; if the drug supplied is for veterinary use, name and address of the animal’s owner
  5. Name of the drug and the quantity
  6. In case of a drug specified in Schedule C or Schedule H, the name of the drug manufacturer, batch number and the date of expiry
  7. Signature of the registered pharmacist under whose supervision the medicine was supplied
  • The licensee should maintain the purchase record of the drugs intended for sale or sold by retail. The record should include the following particulars.
  1. Date of purchases
  2. Name and address of the person from whom the drug was purchased and the license number held by him
  3. Name of the drug, quantity and the batch number
  4. Name of the manufacture of the drugs
  • The drugs specified in Schedule H or Schedule X should be supplied to registered Medical Practitioners, hospitals, dispensaries and nursing homes only on the signed order in writing, which is valid for a period of two years.
  • The licensee should not sell or stock any drug after the expiry date.
  • The licensee should not store or stock any drugs on his premises that are intended for distribution as a free sample to the medical profession.
  • The medicine in a retail shop for the treatment of animals should be labeled as “Not for human use _ for treatment of animals only.”

Note: The expired drugs stored to claim a rebate from the income tax will not be considered an offence under the act unless not intended for sale.

Madhya Pradesh Drug Sale License

The drug sale license is issued for both retail as well as wholesale purpose for the distribution of drug in India. The issuance of license for drug sale subjects to conditions attached with the competent person who deals with drugs and the premises (area of pharmacy shop and storage facility).

Documents Required

For New Drug Sale License

The documents required for obtaining a new drugs sale license are mentioned below. The applicant should duly attest the documents.

a) Documents needed for Applicant

  • Proof of Identity as specified in the online application
  • Applicant’s qualification document – Mark Sheet (SSC, HSC & Graduation) as applicable.
  • Residential Proof.
  • Map of Shop/Firm Premises.
  • Shop/Firm related documents (in the case of a firm, partnership deed, in case of a private limited, firm MOA and COI, limited list of directors etc.)
  • Proof of ownership/rent agreement with the actual landowner.
  • Affidavit of the applicant.
  • Purchase bill of the refrigerator.
  • Electricity bill of shop/firm premises.
  • Two passport size photographs.

b) Documents for pharmacist or qualified person

  • Two passport size Photographs.
  • Identity proofs as specified in the online application
  • Applicant’s qualification document – Mark Sheet (SSC, HSC & Diploma or Graduation) as applicable.
  • Proof of residence
  • Appointment Letter of Pharmacist /Competent Person.
  • Registration Certificate of Pharmacist in case of retail sale license application
  • Pharmacist Registration Certificate and Experience Certificate in case of the wholesale license application
  • Copy of drugs sale license along with the Affidavit of the person who issued the Experience Certificate.
  • Affidavit of Pharmacist / Competent Person (If Applicant / Pharmacist / Competent person are same, a combined affidavit must be submitted)
  • Consent Letter of Pharmacist / Competent Person.

c) Documents for Shop or premises

If the premise is owned:

  • Registered sale deed / conveyance deed / registered GPA in the name of the owner should be submitted
  • In the case of unregistered sale deed / unregistered GPA, it must be supported with water bill / electricity bill / property tax receipt.
  • In the case of a village, Khasra Khatauni documents are accepted.

If Rented:

  • Registered rent agreement with rent receipt must be furnished. In case of unregistered rent agreement or owner document, No Objection Certificate from the owner of the premises should be produced.
  • Site plan and key plan of the premises duly attested by an approved architect or mapmaker of the municipality.

Fees Structure

For New Drugs Sale License

S.No. License Type Fee Portal Fee
1 Retail sales drug License  
  a)  Form 20 Rs. 1500 Rs. 150
  b)  Form 21 Rs. 1500
  c)  Form 20-F Rs. 500
2 Whole sales drug License  
  a)  Form 20-B Rs. 1500 Rs. 150
  b)  Form 21-B Rs. 1500
  c)  Form 20-G Rs. 500
3 Retail and Whole sales drug License  
  a)  Form 20 Rs. 1500 Rs. 150
  b)  Form 21 Rs. 1500
  c)  Form 20-B Rs. 1500
  d) Form 21-B Rs. 1500
  e) Form 20-F Rs. 500
  d) Form 20-G Rs. 500
4 Restricted and whole sales drug License  
  a)  Form 20-B Rs. 1500 Rs. 150
  b)  Form 21-B Rs. 1500
  c) Form 20-A Rs. 500
  d) Form 21-A Rs. 500
  e) Form 20-G Rs. 500
5 Restricted License  
  a) Form 20-A Rs. 500 Rs. 150
  b) Form 21-A Rs. 500

 

For Drugs Sale License Renewal

S.No. License Type Fee Portal Fee
1 Retail sales drug License  
  a)  Form 20 Rs. 1500 Rs. 100
  b)  Form 21 Rs. 1500
  c)  Form 20-F Rs. 500
2 Whole sales drug License  
  a)  Form 20-B Rs. 1500 Rs. 100
  b)  Form 21-B Rs. 1500
  c)  Form 20-G Rs. 500
3 Retail and Whole sales drug License  
  a)  Form 20 Rs. 1500 Rs. 100
  b)  Form 21 Rs. 1500
  c)  Form 20-B Rs. 1500
  d) Form 21-B Rs. 1500
  e) Form 20-F Rs. 500
  d) Form 20-G Rs. 500
4 Restricted and whole sales drug License  
  a)  Form 20-B Rs. 1500 Rs. 100
  b)  Form 21-B Rs. 1500
  c) Form 20-A Rs. 500
  d) Form 21-A Rs. 500
  e) Form 20-G Rs. 500
5 Restricted License  
  a) Form 20-A Rs. 500 Rs. 100
  b) Form 21-A Rs. 500

Late fee charge for Drugs Sale License Renewal

S.No. License Type Fee
1 Retail sales drug License  
  (a) Form 20 2% of Fee per month
  (b) Form 21 2% of Fee per month
2 Whole sales drug License  
  (a) Form 20B 2% of Fee per month
  (b) Form 21B 2% of Fee per month
3 Retail and Whole sales drug License  
  (a) Form 20 + Form 20B 2% of Fee per month
  (b) Form 21 + Form 21B 2% of Fee per month
4 Restricted and whole sales drug License  
  (a) Form 20A + Form 21A 2% of Fee per month
  (b) Form 20B + Form 21B 2% of Fee per month
5 Restricted License  
  (a) Form 20A 2% of Fee per month
  (b) Form 20B 2% of Fee per month

 

Note: The late fee is calculated for every six months.

Online Application Process for Drug Sale License

The applicant can apply online for Madhya Pradesh Drug Sale License through the official website of the Food and Drugs Administration.

Madhya Pradesh FSSAI

The Food and Drugs Administration under the Public Health and Family Welfare Department, Government of Madhya Pradesh is an independent department that offers licensing and registration of Food Businesses in Madhya Pradesh. In this article, we look at the procedure for obtaining Madhya Pradesh FSSAI (Licensing and Registration) in detail.

FSSAI Registration Vs FSSAI License:

Every Food Business Operators should have either an FSSAI License or registration to operate. FSSAI registration is essential for all petty food business operators that have an annual turnover below 12 lakhs or if the production capacity falls below 100 kg/ litre per day. However, FSSAI License is required for businesses that are not classified as petty business or whose annual turnover does not exceed Rs.12 Lakhs. Know more.

All Food Business Operators in the country should be registered or licensed according to the following procedures.

FSSAI Registration

Every petty Food Business Operator should register them by submitting an application for registration in Form A with the Registering Authority along with the required fees. On receipt of the application for registration, the Registering Authority issues a notice for inspection within 7 days and may either grant or reject the application with reasons recorded in writing. The petty food manufacturer should follow the basic hygiene and safety requirements provided in the regulations in order to register. If satisfied with the safety, hygienic and sanitary conditions of the premises during the inspection, the Registering Authority will register within a period of 30 days. The issued registration certificate should be displayed within the premises or any other place where sale/manufacture of food is carried out in case of Petty Food Business. The food safety inspection of the registered establishments will be carried out at least once a year. If registration is denied or if the decision is not communicated within 30 days, the petty food manufacturer can begin the business by later complying with any improvement recommended by the Registering Authority.

Documents Required for Madhya Pradesh FSSAI Registration

The following are the requisites to obtain FSSAI registration certificate.

  • Proof of identity – Ration Card, Voter ID Card, PAN Card, Driving License, Passport, Aadhar Card, Senior Citizen Card, Department Issued ID
  • Passport size photograph of the Food Business Operator
  • Supporting Documents (if applicable):- NOC by Municipality/Panchayat, Health NOC

Fees for Madhya Pradesh FSSAI Registration Certificate

For new registration certificate: Rs.100

For renewal of registration certificate: Rs.100

For duplicate copy of registration certificate: 10 per cent of the applicable fee

FSSAI Licensing

Any food business should not be commenced unless a valid license is possessed. An application for the provision of a license should be made in Form B along with the necessary documents and required fees. The license will be provided within a period of 60 days from the date of issue of an application ID number.

Documents Required for Madhya Pradesh FSSAI License

The following documents must be attached along with the application form to obtain an FSSAI license.

  • Name list of Directors / Proprietor / Partner / Executive Members of Society or Trust with full address and contact details (Mandatory for Companies only).
  • Food category list desired to be manufactured (For manufacturer only).
  • Blueprint/layout of the processing unit displaying the dimensions and allocation of the operation-wise area necessary for manufacturing and processing units.
  • Name and list of machinery and equipment along with the number, installed capacity and horsepower used (Mandatory for manufacturing and processing units only).
  • Authority letter with the name and address of the person responsible along with alternative responsible person nominated by the manufacturer, a collection of samples, packing and dispatch. (For manufacturers and processors).
  • Analysis report of water to be used as an ingredient in food from a recognised / public health laboratory to confirm the portability. (Mandatory for manufacturing and processing units).
  • Partnership Deed or MOA & AOA along with  Incorporation Certificate and list of Directors with the address. Note: In the case of a company, three pages must be uploaded:
    • First Page – Certificate of Incorporation
    • Second Page – Food business activity authorisation
    • Third Page – List of Directors with respective addresses
  • No Objection Certificate & Copy of License from the manufacturer (Mandatory for repackers)
  • Pesticide residues report of water if packaged mineral water, units manufacturing packaged drinking water or carbonated water from a recognised health laboratory.
  • Certificate provided by the Ministry of Tourism (HRACC). (Mandatory for Hotels).
  • Documentary proof of turnover or self-declaration of number of vehicles (Mandatory for Transporters)
  • FSSAI Declaration Form
  • Copy of certificate obtained under the Coop Act – 1861 / Multi-State Coop Act – 2002 in case of Cooperatives. (If applicable)
  • Food Safety Management System Certificate or Plan (if any).
  • Raw material source for meat and meat processing plants.
  • In case of milk or milk products processing units, milk source or procurement plan for milk that includes the location of milk collection centres. (if applicable).
  • Photo id proof and address proof of Proprietor / Partner / Authorized Signatory issued by the Government (Optional).
  • Proof of possession of premises (Sale deed / Rental Agreement / Electricity Bill) (Optional)
  • Recall plan wherever applicable, with details of to whom the product is distributed (optional).
  • NOC from Municipality or Local Body (optional).

Fees for Madhya Pradesh FSSAI License

License FeeFees Per Year
For Fresh License
For Hotels up to 4 StarRs. 5000
Above 1 million ton production per dayRs. 5000
From 10,001 to 50,000 Litres Per Day of milk or 501 Million Ton to 2500 MT of solid milk production p.a.
Below 1 milllion ton production per dayRs. 3000
From 501 Million Ton to 10,000 Litres Per Day of milk or 2.5 Million Ton to 500 Million Ton of solid milk production per annum
All Food Service Providers that include Restaurants/ Canteens (in Schools, Colleges, Office, Institutions)/ Caterers/ Boarding Houses/ Clubs/ Banquet Halls with food catering arrangements/ Food Vendors/ Dabbawallas and other food business operators.Rs. 2000
For License RenewalDepends on the number of years selected.
For Amendment of LicenseFees for modification of license for 1 year will be charged the same during modification.
For Duplicate License10% of license fees is applicable
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