Drug License
The Indian pharmaceuticals market is the 3rd largest in terms of volume and 13th largest in terms of value, and it accounts for around 20 percent in the volume terms and 1.5 percent in value terms of the Global Pharmaceutical Industry.
The Indian pharmaceuticals market is the 3rd largest in terms of volume and 13th largest in terms of value, and it accounts for around 20 percent in the volume terms and 1.5 percent in value terms of the Global Pharmaceutical Industry.
The Indian pharma industry is projected to grow over 16 percent per annum during the period 2015 till 2020 as compared to global pharma industry’s 5 percent.
There is a huge potential in Indian pharmaceuticals industry which opens door to entrepreneurs and start-ups involved in pharma business.
As per Drugs & Cosmetics Act, 1940, Drug License is mandatory throughout India for carrying out the business related to pharmaceutical industries that deal with drugs, medications and cosmetics.
To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally.
There are more than 10 different types of drug licenses. However, a business unit may require a particular license based on their business requirement. Drug license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.
Types of Drug Licenses
• Retail License: – Issued to run a General chemist shop
• Wholesales License: – Issued to persons or agencies engaged in wholesale of drugs and medicines
• Manufacturing License: – Issued to persons or agencies engaged in manufacturing of drugs and medicine.
• Loan License: – Issued to those authorities/agencies who are using premises, equipment and staff of another drug licensee having a manufacturing license.
Essential Requirements for Obtaining Drug License in India?
• Applicant has to provide Plan of Premises for which license is being applied, with the Blueprint showing actual dimensions in meters.
• Applying for Retail or wholesale license: – A minimum area of 10 square meters is required. Height of the premises should be in accordance with the National Building Code of India, 2005.
• Applying for both Retail and wholesale license: – A minimum area of 15 square meters is mandatory. Height of the premises should be in accordance with the National Building Code of India, 2005.
• Drug license is not granted to a premise located on a DDA allotted residential plot/land or flat unless it fulfills the requirements of MPD-2021.
• The qualified and experienced applicant is necessary to operate a retail pharmacy in India.
Documents Required for Obtaining the Drugs License in India?
• Constitution of the firm (MOA/AOA)
• Photo ID proof of proprietor/partner/director.
• Copy of Property paper (If owned property)
• Copy of Rent agreement (If rented property)
• Site Plan and key plan of the premises.
• Refrigerator invoice and details.
Kaushikii Process for Drug License
• Connect with Kaushikii team
• Submit all the documents required for Drug License
• We will draft & file the application with Drug Control Department.
• We will Follows-ups with Drug Control department
• We will send certificate copy to you via email and courier