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How to start medicine business?

Medicines are regulated under drug and cosmetic act 1940 & rules 1945. Manufacturing, import, export, sale, purchase, supply, distribution and dispensing of medicines etc are regulated through this act and a licence is required to conduct any type of business related to medicines. Different types of medicine business will require different types of licences.

Types of Businesses in medicine industry:
  • Import of Medicines (Raw material and Finished products)
  • Manufacturing of Active Pharmaceutical Ingredients (API)/Bulk Drugs
  • Manufacturing of medicines (Finished products)
  • Wholesale and Distribution of medicines and API/Bulk Drugs
  • Retailing and dispensing of medicines
  • Export of medicines
  • Medicine marketing company

Import of Medicines:
For importing medicines in India, import licence is required. Along with import licence, Registration certificate of every medicine is required that is to be imported into India along with registration of premises where manufacturing of medicines is conducted. For registration and import licence, licnecee has to fulfill all requirements and formalities that you can read at below linked articles.
Check out complete details about import of medicines in our articles about import:


Manufacturing of Active Pharmaceutical Ingredients (API) / Bulk Drugs:
For manufacturing of bulk drugs and raw material for pharmaceutical industry, manufacturing license is required. Bulk drug manufacturing plant is complex in nature and requires special requirements. Premise for manufacturing of bulk drugs has to fulfill requirements as specified in Schedule M and Schedule M Part1 of drug and cosmetic act & rules. We have written dedicated articles related to manufacturing of bulk drugs where you can find out complete information about plant, specifications, technical persons requirements, machinery and licneces etc.



Manufacturing of Medicines:
For manufacturing of medicines, Drug manufacturing licence is required. Finished medicine products are less complex as compare to bulk drug manufacturing. Manufacturing licence is issued by the licensing authority appointment by state drug authority for this purpose. A medicine manufacturing unit should compile with the requirements specified in Schedule M or as per WHO: GMP (Good manufacturing practice) regulations.
You can read complete detail about starting drug manufacturing unit in our article:
Steps for Starting pharmaceutical manufacturing unit

Wholesale and Distribution Business of Medicines:
For medicine distribution business, wholesale drug licence is required. Requirements for wholesale business of medicines are less as compare to manufacturing business. Area and technical person’s qualifications are also relaxed. For staring wholesale medicine business, licencee required only minimum of ten square meter premises area.
Other details, business plan, qualification of technical person etc, you can read at our article dedicated to distribution business of medicines: How to become a pharmaceutical distributor/wholesaler?




Medicine Retail Business:
Medicine retail business includes chemists shop, pharmacy stores, online pharmacy, drug stores, medical store etc. For medicine retail business, licencee is required to take Retail drug license. Complete information about starting medicine retail business in our article: How to start Pharmacy retail store in India?






Export of Medicines:
Along with medicine manufacturing licence, manufacturing premises from which you want to export medicines should be WHO:GMP approved or from concerned authority (e.g. USFDA, EUFDA etc) in which you are going to export is approved. COPP is required to obtain before exporting medicines from India along with importer-exporter code number. Check out complete for exporting medicines in our articles: 
Medicine Marketing Company:
Interested in starting medicine company but don't have fund to set-up medicine manufacturing unit then medicine marketing company is one of the best possible business opportunity. Medicine marketing company requires less investment and easy to start.For medicine marketing company, company registration/Firm constitution, wholesale drug license and GST number is required. After fulfillment of licences and requirements, products with own marketed by company name can be manufactured through third party manufacturing, contract manufacturing or loan license basis. 
Check out complete detail of setting up medicine marketing business in our articles:



Hope above information is helpful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

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