Start Pharmaceutical Manufacturing Unit – The government of India is keen to promote the Make In India movement by giving maximum facilities and support to the startup industries.
The efforts are being made to make the processes and procedures as lightweight as possible. Online processing of applications increase transparency and minimizes the corruption and malpractices.
If you are a budding entrepreneur who wants to reap the benefits of the boost in the economy by launching a pharmaceutical manufacturing unit, then the article is useful. It is a right decision taken at the right time.
Steps to Set Up a Pharmaceutical Manufacturing Plant in India
Here is a brief introduction to the steps to be followed.
Choose an appropriate name for the company first
You need to pick the name of the company if you do not have already. You should pick a catchy and appropriate name. Also, it has to be a unique name so that there are no copyright issues.
After that you should decide the type of manufacturing company you are looking for; Ayurvedic medicines, modern medicines, Unani, Homeopathy or Siddha?
After choosing the broad category, see in which category does it fall?
- Branded pharma company
- Over-the-counter drug company
- Generic pharma company
- Export-oriented pharma manufacturing company
- Pharma hospital supply and distribution company
You can also start a manufacturing unit for
- Medical or surgical devices
- Ophthalmic drops
- Parenteral drugs
There are many other categories that you can find by reading appropriate sources.
How do you register?
After deciding the type of unit, you have to register the company under Companies Act 1965 or Companies Act 2013.
For partnership firms, you need to register under the Limited Liability Partnerships (LLP) under Partnership Act, 1932.
To get several benefits and opportunities like loans under priority, you should do MSME registration. It can be a provisional registration or permanent.
List of Documents
- Bank challan copy or fee receipt
- Details of the staff and consent of full-time employment
- Layout plan
- Purchase document or rent agreement to prove the ownership of the premises
- Equipment and machinery purchase bills
- Partnership deed, MOA, and AOA
- Details of authorized partners
- Permission and NOC from State Pollution Control Board
- Site plan
- Letter of Loan License
- NOC of Municipal Corporation/Panchayat
- Clearance from Drug Controller General of India if applicable
The steps are required to get the Manufacturing License
- You need to fulfill the requirements mentioned in Drugs and Cosmetics Act 1940
- Blueprint of the layout plan (it will be verified and cleared by authorities)
- Drug and Cosmetic manufacturing license
- Payment of fees through the approved mode of payment
- You need to fill a variety of forms based on the type of drug
Though the steps are made pretty simple by the government, still you can seek help from an expert if needed.
Hire a consultant if you find the whole thing complex. There, you get support handholding at every stage.
Spend some time in research before you sign contract with the consultant.
Read More Articles: