How to start a Pharma Manufacturing unit in India?

February 22, 2020Saphnix Life Sciences Pharma Manufacturing

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, the nature of the manufacturing unit, the registration process, the acquiring of the license, and documents.

Prepare a Blueprint / Strategy – For the setup of a Pharma manufacturing unit, prepare a plan and list how you are going to manage 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 a vital role in establishing your company’s image among customers. After choosing a name, select the type of manufacturing unit you want to establish. Here are some options:

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 a 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 the Companies Act, 1956, or Companies Act, 2013, it is mandatory for all 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 the Partnership Act, 1932. It will help to provide legal authorization to your company from the government. The registration includes a 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 mandates the use of digital signatures for documents submitted in electronic form to ensure security and authenticity.

Step 2: Acquire Director Identification Number (DIN)
The DIN is a unique number issued to individuals who intend to become directors of a company. It helps to maintain transparency and accountability in the corporate structure.

Step 3: Create an Account on the MCA Portal
Register as a new user on the Ministry of Corporate Affairs (MCA) portal at mca.gov.in.

Step 4: Apply for Company Incorporation
After registration, file the necessary documents and forms to officially incorporate your company.

Acquiring a License for a Manufacturing Unit

Under the Drugs and Cosmetics Rule, the license of the manufacturing unit is granted. Dealing in selling and purchasing drugs requires legal permission. (In India, a Drug manufacturing License is issued by a state drug controller generally located in the capital region of the concerned state of Indian Territory. The State Drug Controller is appointed by the state government and works under the guidelines of the Drug Controller General of India (DCGI)

List of general documents we are listed below (Document requirements may be changed according to concerned 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, proprietors, 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.

How to start a Pharma Manufacturing unit in India?

Steps to Start Your Pharma Manufacturing Unit in India

Select a Business Name and Type of Product Manufacturing

Acquiring a License for a Manufacturing Unit

Most Searched at Saphnixlifesciences Regarding Pharma Manufacturers Company In India

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