How to Set Up a Pharma Manufacturing Unit?
Pharmaceuticals is among the top booming industries in India. However, starting a pharma manufacturing unit in India is a bit complicated. The major factor is about following the rules and regulations. One needs a proper research and homework before starting pharma production unit.
The process requires investment in plant and machinery. It also requires require professional skills and manpower as well. Here is a brief overview of how to start your own pharma producing unit in India.
Step-by-Step Guide to Set Up Pharma Manufacturing Unit
Here is a sequential process of starting a company for manufacturing pharma products. While there will be additional requirements which might be product-specific.
#1 Select Business Name and Type
Select a unique name for your pharma business. Determine the name and also select the type of product you will produce. Determine the type of the pharma business unit you will be.
- OTC drug company
- Generic or branded pharma company
- 100% EOU
- Export or import pharma company
- Registration of the Firm
Once you select the name and type of the business, get it registered. If you are forming a company, get it registered under Companies Act 1965. As for partnership, you can register under Partnership Act 1932 or LLP Act 2008.
Also, get registered under MSMED Act if applies.
#2 Licence Requirements
Depending upon the type of your business, you may require the following license. Apply for the licence with the respective authority and obtain it.
- Drug Manufacturing Licence from FDA
- Drug Distribution Licence from FDA
- Licence for Testing Laboratory
- GST Registration
- If you are an export-import firm, get IEC code number
- NOC from the local pollution control board or other relevant authority
At a later stage, you might require obtaining quality standard certificates like WHO, GMP and ISO.
Also get trademark registration if you need. Consult a professional trademark consultant. Once you complete all the registration and licencing formalities, open your corporate bank account.
#3 Plant & Machinery
The final step in the setting up pharma manufacturing business is obtaining plant and machinery. Buy a required plant, machinery, and testing equipment.
Documents Required for Pharma Manufacturing Unit
During the process of registration and licence formalities, many documents will be needed. You need to submit following set of documents to the authorities.
- Bank Challanor fee receipt of the registration fees
- Layout plan of your factory
- Rent agreement if the premises are on rent
- List of machinery and equipment and purchase bills
- Partnership deed
- Memorandum of Association and Articles of Association in the case of a company
- List of Directors of the name of the partners
- Papers related to loan licence if any
- Copy of FDA Drug Licence
You can hire a professional business consultant to submit the documents on your behalf. Or your chartered accountant can also execute the formalities for business formation. If you are a new start-up, you can avail governmental benefits floated for new start-ups.