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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 Drug 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 drug 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 drug licence online apply!
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What is Drug Licence?
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 drug licence registration that depend specifically on the business activities. After obtaining the certificate, you have to apply every 5 years for drug licence renewal.
Contact Legal Infinix now for the process of Drug licence renewal online!
Types Of Drug Licences
There are a total of 6 types of drug licences. You have to choose the license that is correct for your Business:- 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.
- 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.
- Drug Manufacturing Licence - Companies that produce products like allopathic, ayurvedic, homoeopathic medicines, and any other pharmaceutical products require this license to operate.
- Drug sale licence - People or companies involved in the sale of drugs must registered licence. The sale licence is categorised into:
- Wholesale Drug License: Businesses that supply medicines in bulk to hospitals, pharmaceutical companies, and any other retailers are required to have this license.
- Retail Drug License: All the stores that sell medicines directly to consumers, like Ayurvedic shops, Pharmacies, and medical stores, must hold this license.
- Drug Export License - This is for the business that exports pharmaceutical products. It clarifies that the products meet the regulatory requirements of both India and the destination Country.
- Multi-Drug Licence - This licence allows a single business to manufacture or sell multiple types of drugs, like Ayurvedic, allopathic, and homoeopathic, under one common registration, simplifying compliance for diversified operations.
- 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.
Call our consultant now for your Pharmacy registration application or pharmacy registration renewal!
Call Legal Infinix for your medical store drug licence certificate registration!
Why Drug Licence 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.
- To Stop Fake and Substandard Drugs - The licensing system makes it harder for counterfeit, contaminated, or low-quality medicines to enter the market and reach people.
- 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 Drug Licence 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.
- Customers will trust you more - When the customer sees your pharmacy's drug license, they are assured that they are getting genuine and effective medicines. This trust will help you boost your sales.
- Good quality medicines - Getting a licence means you have to follow rules for proper storage and record-keeping. This helps you keep your medicines safe and effective, which protects both your customers and your business.
- Financially Strong Business - With the license, you can sell a wide range of medicines with better profit margins. This helps ensure your business makes enough money to be stable and successful in the long run.
Eligibility Criteria For Drug Licence Registration
There are some specific conditions set by the drug control authorities that your medical business must meet.To apply for a drug 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 drug licence now through Legal Infinix.
Documents Required For A Drug Licence Registration in India
Here’s a list of essential documents needed to apply for a drug 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
How to Apply for Drug Licence 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 Drug Licence
To begin with, you need to identify the type of drug licence that suits your business activity, for example:
- Retail Drug Licence
- Wholesale Drug Licence
- Manufacturing Drug Licence
- Restricted Drug 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 drug 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
The required documents that need to be uploaded are:
- Identity and address proof of the applicant
- Premises ownership or rent agreement
- Site plan and layout of the premises
- Qualification certificates of the competent person
- Affidavit and undertaking as required
Step 5: Pay the Government Fees Online
Pay the applicable drug licence registration fees through the online payment gateway provided on the portal. Fee structure varies based on licence type and state.
Step 6: Inspection by Drug Inspector
Once submitted, the application is evaluated, and a physical inspection of the premises may be carried out by a Drug Inspector to check if the requirements for storage, manpower, and other regulations are met.
Step 7: Verification and Approval
If the inspection report and documents are satisfactory, the Licensing Authority will approve the application and issue the Drug Licence Certificate online.
Step 8: Download the Drug 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 Pharmacy registration renewal online. Call us now!
Penalty and Fees Structure For Drug 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) | |
| 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) | |
| 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) | |
| 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 Drug licence registration can be very hectic and annoying for you. By hiring us for your Drug licence application, 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.Other Services from Legal Infinix
We manage complete business setup and compliance across India.
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