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Are you one of the people who want to start their own manufacturing and selling of drugs? Or are you planning to open your own Pharmacy shop? In both cases, you are going to need a Medical shop Licence registration or a Pharmacy registration to open and run your business. A medical licence registration is mandatory in India to run any business related to drugs and medicines.
The Government of India has tightened the rules of owning a medical shop Licence to ensure equal and fair access to genuine and real medicines and drugs for everyone. Through 1940, the Drugs and Cosmetics Act governed the end-to-end process from manufacture to the sale of drugs in India. Get help from Legal Infinix for Medical shop Licence online apply!
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What is a Medical Shop License?
To control the quality and distribution of pharmaceuticals and ensure that all medicines available to the public are safe and effective to use, a legal permit is issued by the government authorities to a person or company. This certificate gives legal permission to the holder to manufacture, sell, distribute, or import medicine, drugs, and cosmetics. There are also types of Medical shop Licence registration that depend specifically on the business activities. After obtaining the certificate, you have to apply every 5 years for the Medical shop Licence renewal.Contact Legal Infinix now for the process of Medical Licence renewal online!
Types Of Medical Shop Licences
There are a total of 6 types of Medical Store Licences. You have to choose the license that is correct for your Business:
1. Loan License
Businesses that market their drug brands and manufacture products using another company’s approved facility, without owning a manufacturing unit for themselves, are required to have this license.2. Drug Import License
This license is important for companies that import pharmaceutical products or raw materials for manufacturing. This ensures compliance with national safety and quality regulations.3. Drug Manufacturing Licence
Manufacturers of products such as allopathic medicine, ayurvedic medicine, homoeopathic medicines, and other pharmaceutical products need to obtain this license.4. Drug sale licence
The individuals or organisations dealing with the selling of drugs have to be licensed. The licenses can be classified as follows:
- Wholesale Drug License: This license is mandatory for organisations that supply drugs in bulk to hospitals, pharmaceutical firms, and other such organisations.
- Retail Drug License: This is mandatory for all retail drug stores selling drugs directly to customers, such as Ayurvedic stores, pharmacies, and other medical stores.
5. Licence for Exportation of Drugs
This document pertains to the company that exports drugs. The document confirms that all drugs satisfy the requirements of both India and the importing country.6. Licence for Multi-Medical Shops
This license enables one entity to produce or distribute different kinds of drugs, such as Ayurvedic, allopathic, and homoeopathic drugs.7. MD-42 or Medical device registration
A manufacturing license is issued to businesses that manufacture, sell, stock, exhibit, or distribute medical devices, including In-Vitro Diagnostic Devices.
Holding all these licences is not compulsory for doctors, but they must purchase drugs from a registered vendor.
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Call Legal Infinix for your medical store Medical shop Licence certificate registration!
Why Medical Shop License Registration Is Required?
A Drug license is not just a legal permit that allows you to deal with drugs and cosmetics; it serves a more important role than that. For example:Protects the Health
The license reduces the risk of harm to consumers by ensuring that medicines are sold from a clean, safe environment and that to by a qualified person.For Stopping the Sale of Counterfeit/Contaminated or Low-Quality Medicines
This would prevent fake or substandard medicines from entering the market and becoming accessible to patients.To Create Accountability
The license specifies an individual and a business as being responsible for the medications being sold. If Something goes wrong, the authorities know who to hold accountable.To Standardize Pharmacy operations
It ensures that all legal pharmacies in the country have the same basic standards for storage, record-keeping, and personnel, so a standard of care is provided.Importance Of Getting A Medical Store Registration
Drug certificate registration is a necessity in today's time for any entity that wants to deal with Drugs and cosmetics; without it, you can’t operate any medical business. Some of the reason that makes it important are:Legal Right To Run Your Shop
Obtaining the license gives you the legal permit to run a medical store. This license saves your store from getting shut down, fined, or facing other legal troubles.Medicines From Real Companies
A licence allows you to buy a stock directly from the official drug manufacturers and distributors. This ensures that the medicines you sell are genuine and legally sourced.You will be trusted by many more customers
The moment a customer sees your licence for drugs, they will feel confident that they are receiving real medicine from you. This level of trust will help increase your sales.High-quality medicines
A licence will ensure that there are regulations regarding how the medicine will be stored and how records will be kept.Financially Strong Business
This means that through the license, you will be able to sell various types of medications, which will provide good profits. Thus, this will help to assure that your company is profitable in the future.How to apply for a pharmacy licence registration? If you have this query or any other related question, you can ask Legal Infinix's expert consultants.
Eligibility Criteria For Medical Shop Licence Registration
There are some specific conditions set by the drug control authorities that your medical business must meet.
To apply for a Medical shop Licence in India, the following conditions must be met:
- The applicant must have a suitable premise (minimum 10 sq. meters for retail/wholesale and 15 sq. meters for both).
- The premise must have proper storage facilities like refrigeration and ventilation.
- A registered pharmacist (for retail) or a competent person with relevant experience (for wholesale) must be appointed.
- The applicant must comply with the zoning regulations of the local municipal authority.
- The business entity must be registered (as a proprietorship, partnership, LLP or private limited company).
If you fall under these categories, then hurry up and register your medical Licence application now through Legal Infinix.
Documents Required For A Medical shop License Registration in India
Here’s a list of essential documents needed to apply for a Medical shop Licence with Legal Infinix’s assistance:
- System-generated application form for relevant drug sale (19/19A/19B/19C as applicable)
- Site plan and key plan of the premises
- Constitution of the firm
- In case of the company: MOA, AOA, and a copy of the resolution passed;
- In case of a partnership firm: partnership deed, duly attested by a Notary Public;
- In case of trust/society: Trust deed;
- Photo ID proof of the director/partner/proprietor of the firm.
- Affidavit regarding non-conviction of Property/Partner/Director as well as the firm under the Drugs & Cosmetics Act, 1940.
- Affidavit regarding compliance of MPD 2021, if the premises are located on a DDA residential flat / plot /building.
- Online fee deposit receipts.
- System-generated affidavit from the registered pharmacist/competent person.
- For Wholesale License Competent person:
- Proof of qualification, i.e., final degree certificate / provisional certificate with mark sheets
- Experience Certificate
- Appointment Letter and Bio-data.
- If Owned: Registered Sale Deed / Regd. GPA / Conveyance Deed in the name of the owner or Unregistered Sale Deed / unregistered GPA supported with Electricity Bill / Water Bill/property tax receipt.
- If Rented: Rent receipt, registered rent agreement, unregistered rent agreement, along with ownership documents of the property owner.
- In the case of a village, the Khatauni documents will be considered
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How To Apply for Medical Shop Registration Online?
There are several steps for applying drug license in India. Most states now provide licence registration online. Follow these steps :
Step 1: Identify The Type of Medical Shop License
To begin with, you need to identify the type of Medical shop Licence that suits your business activity, for example:
- Retail Medical shop License
- Wholesale Medical shop Licence
- Manufacturing Medical shop Licence
- Restricted Medical shop Licence
Step 2: Registration on the State Drug Control Portal
One needs to visit the official State Drug Control Department or CDSCO online portal (as applicable) and register by providing basic business and applicant details.Step 3: Fill the Online Application Form
You need to log in to the online portal and fill out the online application form for a Medical shop Licence with the following details:
- Applicant details
- Business constitution
- Premises address
- Drug categories to be dealt with
Make sure that all the details provided in the form are consistent with the supporting documents.
Step 4: Upload Required Documents
Required documents to upload are:
- Proof of identity and residence for the applicant
- Proof of ownership/rental agreement for premises
- Plan and site layout of the premises
- Certificate(s) of competence for the competent person
- Affidavit and undertaking as applicable
Step 5: Payment of Government Fees Online
The applicant needs to pay the relevant Medical shop Licence registration fees through the online payment gateway available at the portal. The fee depends upon the type of licence as well as the State.Step 6: Inspection by a Drug Inspector
Once the application form and other documents have been submitted, an inspection might be performed by a Drug Inspector to ensure whether or not the necessary requirements regarding storage, manpower, etc., are fulfilled.Step 7: Approval and Issuance of the Licence
Once the inspection process is successfully completed and if everything goes well, the application is then approved and the Medical Shop License Certificate is issued online.Step 8: Download the Medical shop Licence
Once approved, the licence can be downloaded directly from the portal and must be displayed at the business premises.Apart from the new licence, Legal Infinix can help you with medical licence renewal online. Call us now!
Penalty and Fees Structure For Medical shop Licence Registration
| Category | Type Sale | Fees for Grant/ Retention | Penalty after expiry but within six months (GSR 1337 (E) dated 27.10.2017) | Fees for a duplicate copy of the Org. Lie. |
|---|---|---|---|---|
| Drugs other than those specified in Schedule C&C (1)&X | Whole Sale | Rs.1500 | Rs 1500+ 2 % of Licence Fee p.m. or part thereof | Rs.150 |
| Retail Sale | Rs.1500 | Rs. 1500+2 % of Licence Fee p.m. or part thereof | Rs.150 | |
| Restricted (Gen. Store) | Rs 500 R-59 (2) | Rs. 500+2 % of Licence Fee p.m. or part thereof | Rs 150 R- 59 (3) |
| Category | Type Sale | Fees for Grant/ Retention | Penalty after expiry but within six months (GSR 1337 (E) dated 27.10.2017) | Fees for a duplicate copy of the Org. Lie. |
|---|---|---|---|---|
| Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’ | Whole Sale | Rs.1500 | Rs 1500+ 2 % of Licence Fee p.m. or part thereof | Rs.150 |
| Retail Sale | Rs.1500 | Rs. 1500+2 % of Licence Fee p.m. or part thereof | Rs.150 | |
| Restricted (Gen. Store) | Rs 500 R-59 (2) | Rs. 500+2 % of Licence Fee p.m. or part thereof | Rs 150 R- 59 (3) |
| Category | Type Sale | Fees for Grant/ Retention | Penalty after expiry but within six months (GSR 1337 (E) dated 27.10.2017) | Fees for a duplicate copy of the Org. Lie. |
|---|---|---|---|---|
| Drugs specified in Schedule ‘X’ | Whole Sale | Rs.500 | Rs 500+2 % of Licence Fee p.m. or part thereof | Rs.150 |
| Retail Sale | Rs.500 R-59(2) | Rs 500+ 2 % of Licence Fee p.m. or part thereof | Rs 150 R- 59 (3) |
| Category | Type Sale | Fees for Grant/ Retention | Penalty after expiry but within six months (GSR 1337 (E) dated 27.10.2017) | Fees for a duplicate copy of the Org. Lie. |
|---|---|---|---|---|
| Homoeopathic Medicines | Whole Sale | Rs.250 | Rs 250+Rs. 50 p.m. or part thereof | Rs. 50 |
| Retail Sale | Rs. 250 R-67- A(2) | Rs.250+Rs.50p.m. or part thereof R-67-A(2) | Rs. 50 R-67-A(2) |
How can Legal Infinix help you?
You can hire us for the entire process of submitting documents, verifying, and renewing the medical store license registration can be very hectic and annoying for you. By hiring us for your medical license in India, you will secure your precious time and mental health, stress-free. Legal Infinix will do all the necessary activities by your side, from running to different departments for the approval of your licence.
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