How to Start a Pharmaceutical Manufacturing Business?

India is a developing country and we are heading towards listing our country as a developed nation. Entrepreneurs are now getting support and motivation from the Government in all possible ways. The deserving people are actually reaping the benefits of several government schemes and provisions.


So if you are a budding entrepreneur, and you have a  handsome amount to invest, and the power of capital creation, and most importantly, if you have an in-depth knowledge of pharmaceutical manufacturing, then this article can surely help you. 

Here are the steps that you need to follow to set up a successful pharmaceutical manufacturing unit: 

  1. Select a name – The name should be unique and attractive. It should be very catchy. Make sure that you do not land yourself in any copyright issues. Make proper research before finalizing any name.


2. Choose amidst the broad category- There’s a huge list when it comes to the different categories of pharmaceutical manufacturing. You need to choose which one will you prefer for your business. These are:

  • OTC (over the counter) drugs
  • Branded pharmaceuticals
  • Generic pharmaceuticals
  • Powders and drops
  • Parental drugs
  • Hospital related supplies 
  • Surgical instruments
  • Export-oriented pharmaceuticals

3. Getting your firm registered- Registration is the utmost step in setting up a pharmaceutical manufacturing business. Without registration, your company does not exist. Make sure to get your company registered under the Companies Act 1965 or Companies Act 2013. If you are planning to go for a partnership, then Partnership Act 1932 will be applicable. This is also known as Limited Liability Partnerships or LLP.

4. MSME registration – This is something that you should not ignore at all. MSME registration provides lots of facilities which any business-minded person will definitely like to reap the benefits from. Once you have the access to MSME certificate, MSME loans are easily granted, the interest payable is much lesser; there are possibilities of tax exemption too under tax laws.

List of required documents- 

  • Fee receipt or bank challan copy
  • Details of staff
  • Consent on full-time employment
  • Layout plan and site plan of the pharmaceutical manufacturing unit
  • Purchase deed or rent agreement
  • Partnership deeds, MOA, AOA
  • Authorized signatory of the authorized persons or partners or directors
  • Materials and equipment purchase bills
  • Clearance from DCGI
  • NOC from State Pollution Control Board
  • NOC from Municipal Corporation or Panchayat

5. Acquiring the manufacturing license- 

  • You need to fulfill all the requirements according to the Drugs and Cosmetics Act 1940.
  • The blueprints of the layout plan have to be submitted to the concerned licensing authority.
  • The layout plan will be scrutinized and an inspection will be carried out for final approval.
  • You will be filling a number of related forms
  • And of course, payment of fees via a suitable payment mode should be done.

Although these steps and formalities seem to be too cumbersome, it’s necessary to fulfill all the requirements to ensure the smooth and efficient working of the business. Also, the layman receives pure, safe, quality medications. The requirements and formalities may vary from state to state.


With the recent boost in the economy, India has been rapidly climbing the ladder of success and achievements. We can surely say that because of some of the genius and hard-working entrepreneurs of our nation, there is surely no looking back from here onwards. 

The pharmaceutical manufacturing business is for sure one of the most engaging industries that is contributing a respectable amount to our growing economy. So, go ahead, take a leap of faith and venture out for a new beginning. Gaining the best Pharmaceutical manufacturing business is a hassle-free task if you follow the above-mentioned steps. 

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