How to start a Pharma Manufacturing unit in India?
How to start a Pharma Manufacturing unit in India – Are you looking for the right guidance to start a Pharma Manufacturing Unit in India but still confuse between several websites. Don’t worry ! you are in the right place. The Pharma industry is growing very strenuously from the last few years without any declining stage. This industry has golden business opportunities at low investment. Follow the whole procedure of How to start a Pharma Manufacturing unit in India carefully.
Steps to Start your Pharma Manufacturing Unit in India
There are multiple steps included at the start of the pharma manufacturing unit in India. The whole procedure involves a blueprint of the plan, nature of the manufacturing unit, registration process, acquiring of the license, documents.
Prepare a Blueprint / Strategy – For the set up of a Pharma manufacturing unit, prepare a plan and list how you are going to manage the things. Do proper research regarding the unit, equipment, team of professionals and manpower. Have basic knowledge regarding each and everything related to the manufacturing unit. Perform things as per the plan to make the whole procedure easy and less time- consuming.
Select a business name and type of product manufacturing – A creative and unique business name plays an important role in building the image of the company among the audience. So choose an eye catchy, alluring and retentive name of the manufacturing unit. After selecting an irresistible name, select the type of manufacturing unit you want to start –
- Generic pharmaceuticals
- OTC (Over the Counter) drugs
- Branded pharmaceuticals
- Hospital supply and distribution
- Export-oriented pharmaceutical unit
- Medical or surgical devices
- Parenteral drugs
- Powders and drops
Above are the few examples of the type of manufacturing units. The chosen type of manufacturing unit includes the type of pharma products your unit will manufacture. Understand the demand and requirements of customers from the pharma market, this will help in knowing the target audience of your company.
Registration Process -Under Companies Act, 1956 or Companies Act, 2013, it is mandatory for all the companies to register under this act. If you are doing business on a partnership basis you need to register under the Limited Liability Partnerships (LLP) under Partnership Act, 1932. It will help to provide legal authorization to your company from the government. The registration includes Digital Signature Certificate(DSC), Director Identity Number(DIN) and filing for an e-form.
Four major steps to register a company/ startup in India:
Step 1: Acquire Digital Signature Certificate (DSC)
The Information Technology Act, 2000 has provisions for use of digital signatures on the documents submitted in electronic form in order to ensure the security and authenticity of the documents filed electronically.
Step 2: Acquire Director Identification Number (DIN)
The concept of a Director Identification Number (DIN) has been introduced for the first time with the insertion of sections 266A to 266G of Companies (Amendment) Act, 2006.
Step 3: Create an account on MCA portal- New user registration @ mca.gov.in
Step 4: Incorporate or Apply for the company to be registered
Acquiring License for Manufacturing Unit
Under the Drugs and Cosmetics Rule, the license of the manufacturing unit is granted. Dealing in selling and purchasing of drugs requires legal permission. (In India, Drug manufacturing License is issued by state drug controller generally located at the capital region of concern state of Indian Territory. State Drug Controller is appointed by the state government and work under guidelines of Drug Controller General of India (DCGI)
List of general documents we are listed below (Documents requirements may be changed according to concern country laws and regulations and/or any amendments):
- Introductory Covering Letter mentioning Name and address of plant and administration office
- Application at prescribed Form and format
- Prescribed Fee Receipt
- Details of the constitution of the firm, partnership or Company
- Documents related to Ownership of premises or Rent or Lease documents
- Identification Proof of all Authorized persons, proprietor, partners and/or directors
- Details of Technical Staff e.g. Manufacturing Chemist and Analytical Chemist with education documents and approval certificates which is applicable
- List of machinery and laboratory equipment
- Site Mater File
- Blueprint of Plant and layout of premises specifying installation of machinery and equipment
- Design and Layout of the HVAC system
- List of medicines to be manufactured in the manufacturing unit
- Water analysis report
- NOC if required from other departments like a health department, pollution department or MC, etc.
- Factory Act Registration if applicable
The pharma industry is full of thriving opportunities for a business venture. Own your business like a boss and expand your huge network of business with associates.