What is the Cost of Getting a Drug License in India

India’s pharmaceutical sector is showing rapid growth and is turning out to be the biggest producer and exporter of pharmaceutical products worldwide. Starting a pharmaceutical business in India is not that complex if you have the proper knowledge. The most essential requirement is obtaining a drug license. Following this blog we are going to discuss how we can get a drug license and What is the Cost of Getting a Drug License in India. 

India’s pharmaceutical sector is experiencing exponential growth and is turning out to be one of the biggest markets in the pharmaceutical sector. India’s pharmaceutical market value is expected to reach US$ 130 billion by the year 2030. India is one of the chief producers and exporters of pharma or related products and is ranked 3rd worldwide according to economic survey in 2022-2023. 

The Need for a Drug License

The drug license of India comes under the Drugs and Cosmetics Act, of 1940 and the Drug and Cosmetics Rules, of 1945. This license is issued by the State Drugs Standard Control Organization(SDSCO) and the Central Drug Standard Control Organization (CDSCO). The main role of this license is to grant permission to the enterprises for easy running of pharmaceutical business involving Drugs and Cosmetics. This license authority controls who can manufacture and distribute drugs and cosmetics.

Various types of Drug License

There are many different types of Drug License depending upon the level of business.

• Manufacturing Drug License – This license is granted to the manufacture of pharma drugs and related products. 
• Wholesale Drug – This category of license is issued to the person who deals with the wholesale distribution business of Allopathic and ayurvedic drugs. These persons deliver medicinal products and services to various healthcare facilities and healthcare professionals. 
• Retail Drug License – This license is used by the chemist shop owners. These deal with selling medicinal products to hospitals, dispensaries, and medical or research institutes. They provide their services to the end users.
• Loan Drug License – A loan License is issued to the person who is interested in starting a pharma business but does not own a premise or manufacturing such as machinery, equipment, or staff. So, they use the manufacturing unit of another registered licensee. 
• Import Drug License – The import License enables the applicant to sell their products and services all over India. This License is issued by the CDSCO ( Central Drugs Standards Control Organization).
• Multi Drug License – Multi Drug License permits the owner to operate their pharma business in more than one state. 

List of the required documents for obtaining the Drug License

To get the Drug License the applicant should make sure that they contain the mentioned documents.

• ID proof of the Owner/Proprietor/Partner.
• Firm constitutions like MOA/AOA or Partnership deeds.
• Owners Address Proof
• Property paper/Rent agreement copy
•  Blueprint or Site plan of the premises
• Details of bills of the purchased appliances like refrigerators and air conditioners for business use.
• Covering letter with the purpose of the application.
• Applicable application form 19.
• Affidavit regarding compliance 
• Pharmacy council Registration
• Qualification proof
• List of hired  technical staff with general biodata, ID Proof, qualification along with experience Machinery list and laboratory equipment
• NOC of pollution control and fire safety department 
• Lastly, Nominate an authorized Indian Representative

General Process for Obtaining a Drug License

To get the Drug License you must follow the mentioned steps.

1. Documentation – The first step is to collect the needed documents. The types of documents depend upon the type of the location and the state from where you are applying for the Drug License. Without the documents, you can not continue the step further. 
2. Registration – After making sure that you have all the required documents you then need to register yourself on the Drug Licensing Portal of your state. Every state has its own Drug Licensing Portal for issuing Drug licenses. 
3. Application – After logging into the portal now you need to fill in the appropriate information. Make sure to double-check the information that you have filled and make the changes if required and then submit your application. 
4. Inspection – After applying, the Drug Licensing Authority(DLA) conducts a thorough inspection. A Drug Inspector appointed by the DLA visits the premises on the scheduled date. The inspection covers the premises and the original documents of the applicant.
5. Grant of the Drug License – After the inspection, the Drug Licensing Authority goes through the report submitted by the appointed Drug License. If the DLA is satisfied by the report and the application then grant the Drug License. 

What is the Cost of Getting a Drug Licence in India? 

If you are interested in getting a Drug License in India the cost depends on many factors like the state rules, type of license, and the form number. You can submit this cost either offline by visiting the government office or online.

• For retail sale Drug License and wholesale Drug License – Rs 1500 + Rs 150(portal fees).
• For restricted and wholesale License – Rs 1500 + Rs 150(portal fees)
• For restricted License – Rs 500 + Rs 150 (portal fees) 

FEES in HIMACHAL PRADESH

• For Wholesale Drug License – Rs 1500+1500
• For Retail Drug License – Rs 1500+1500
• For restricted drug License – Rs 500+500

FEES in PUNJAB

• For Manufacturer License – Rs 5000
• For Repairer License – Rs 2000
• For Dealer License – Rs 1000

Fee in Jammu & Kashmir 

The eligibility criteria for getting a Drug License in India

Who is eligible to apply for a Drug license and who is not depends on the educational qualification the person holds. To obtain a Drug License you must possess a Degree in pharmacy and should have relevant experience in distribution of the drugs. Moreover, the person applying for a drug license should be a registered pharmacist and should possess valid proof of that. 

Conclusion

To conclude, the cost of getting a Drug license is not fixed. Every state has its own cost depending upon the type of License and form number. For obtaining a Drug License you must possess all the required documents and then go through the application process.  

FAQS on the cost of drug license in India

Question 1. What are the different types of manufacturing licenses?

Answer 1. A manufacturing license is issued to someone who deals with the production and manufacturing of medicinal drugs and related products. Manufacturing licenses further have different types.

1. Manufacturing Test License
2. Notified Medical devices license
3. Post-successful Clinical trial license

Question 2. Till how much time is a Drug License valid for?

Answer 2. Once you obtain your drug license it is valid for 5 years unless or until it gets canceled by the granting authority under any relevant circumstances. You can renew the license before the expiry date by providing the required documents. 

Question 3. What is meant by  Restricted License?

Answer 3.  This license refers to a license on which the issuing board places some restrictions as to the Place of practice, scope of practice, the validity of the license, and the applicant of the license.

Question 4. What are the basic minimum requirements for having a Drug license?

Answer 4. For obtaining a Drug License you must ensure to have the following requirements first.

• Minimum area of operation. For retail, you should have 10 square meters of land and for wholesale the space must be 15 square meters.
• Detailed layout plan
• Proper knowledge 
• Properly working refrigerators and air conditioners. 
• Enough storage facilities 
• A technical staff along with a registered pharmacist