How to Start the Pharmaceutical Manufacturing Unit

Pharmaceutical manufacturing means a set of operations that includes buying of raw material, processing, production, packaging, liberating, storage and shipment of drug treatments and pharmaceutical products in accordance with a good manufacturing practice.  

Here’s a sequential process of beginning a Pharma Franchise company for production pharma products. Even as there will be additional requirements which are probably product-specific.

#1 Selects Business Name And Kind:

Select a completely unique name for your pharma enterprise. Determine the name and also select the type of product you'll produce. Determine the form of the pharma business unit you will be.

• OTC Drug Company
• A universal or branded pharma company
• One hundred% EOU
• Export or import Pharma Company
• Registration of the company

Once you select the name and form of the enterprise, get it registered. In case you are forming a company, get it registered below companies Act 1965. As for partnership, you can register under the Partnership Act 1932 or LLP Act 2008.

#2 Requirements:

• Premises, building, and plant as per GMP standards
• Constitution of the firm and/or company
• Section wise partition in plant
• Technical people (manufacturing chemist and Analytical Chemist)
• Machinery and Laboratory equipment
• HVAC Unit
• Employees and Supervisors
• Listing of drug treatments to be manufactured
• NOC from required departments whichever applicable like pollution board, MC, etc.
• Manufacturing License and Distribution License
• Registration of the factory below the factory Act
• Raw material suppliers
• Packaging material suppliers
• Vendors and/or marketing companies for output consumption

#3 Licenses:

A manufacturing unit may also require different types of licenses and registrations depend on location and country. Most important license for setting up a pharmaceutical manufacturing unit is manufacturing License. List of generally required licenses are:

• Company Registration (If required)
• Drug manufacturing License
• Drug Distribution License (For distributing completed goods)
• Testing Laboratory License
• Good and provider Tax (GST) or any Tax registration required in concern country
• NOC from other departments if required

#4 PLANTS & Machinery:

The final step inside the setting up pharma manufacturing business is acquiring plant and machinery. Buy a required plant, machinery, and testing device.

Documents REQUIRED FOR PHARMA Manufacturing UNIT

During the process of registration and license formalities, many documents may be needed. You need to post the following set of documents to the government.

• Bank Challan fee receipt of the registration fees
• Format plan for your factory
• Rent agreement if the premises are on lease
• Listing of machinery and equipment and purchase payments
• Partnership deed
• Memorandum of association and Articles of association inside the case of a company
• Listing of administrators of the name of the partners
• Papers related to loan license if any
• Copy of FDA Drug License