Steps To Set Up A Pharmaceutical Manufacturing Plant In India
Setting up a pharmaceutical unit is not difficult, but it involves some additional formalities.
This blog explains the basic requirements and formalities.
Before that, let’s understand what is manufacturing in the pharma sector?
It means a set of operations such as procurement of raw material, processing unit, production, and packaging, releasing, storage and shipment of products, etc.
Get a basic understanding of the pharma sector before you do anything else. Without that, it is impossible to compete or survive in the industry.
Search an appropriate premise. The building and location must comply with the GMP Standards. You need to get information about it from the right resources.
You need two types of investments; fixed assets and liquid assets.
Fixed assets are building, infrastructure, land, furnishing, and so on. Liquid assets are human resources, raw material, marketing and promotions, and so on.
Steps at a glance
Here is the list of essential steps required for setting up a pharmaceutical manufacturing unit.
- Make a business plan
- Choose a company name
- Select location
- Form a company-private, partnership, proprietorship, etc.
- Registration of the company
- Arrangement of documents, resources and authorization
- Procurement of machines and tools
- NOC of respective departments
- Wholesale and drug distribution license
- GST registration
It is a broad guideline. You need to refer appropriate resources online where detailed information is available.
License procurement
Licensing is an important part of establishing a pharmaceutical unit. Types of license and registration depend on local regulations. A few required license types are:
- Company registration
- Drug manufacturing license
- Drug distribution license
- Laboratory testing license
- Goods and Service Tax requirement
- NOC from other departments
Machines and equipment
Different processing steps need different types of tools and machinery.
A few essential machines are high-speed mixers, liquid filling and capping machines, filtration units, air compressors, capsule filling and loading machines, powder filling, and sealing machines, and so on.
Technical staff
Again, eligibility and qualification of technical people depend on what type of medicines you will be manufacturing?
Appointment of technical staff also has to be in line with the GMP norms. There should be separate resources for managing analytical and manufacturing processes. Similarly, there should be a separate process for quality control and quality assurance.
Pharmaceutical business in India offers a bright future. It has performed brilliantly in the past, and the trend will continue in future as well. One can reach incredible heights if the planning and implementation are appropriate.
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