How To Start Pharmaceutical Manufacturing Company in India?

Pharmaceutical Business is one of the fastest growing business in India. It is growing at the rate of more than 20% percent per year. If you are thinking to start own pharmaceutical manufacturing company, we are providing here brief idea and requirements to establish manufacturing plant.

First part is set-up of company and basic requirement for company. Procedure and sequence of starting pharma manufacturing company we will discuss. After that we will discuss about documentation and licenses.

A Pharma manufacturing unit should compile with two regulations:

  1. Factory Act regulations
  2. cGMP regulations under Drug and Cosmetic act & Rules

Procedure and Sequence:

  • Choose Company Name
  • Finalize location for premises and start-up of company (must compile with norms)
  • Incorporation of Company
  • Company Registration
  • Collection and fulfillment of Documents
  •  Furnishing and finishing of premises as per Drug and Cosmetic Act
  • Purchase of required machinery for smooth running of plant (Read detail of machinery by clicking at desired section below)
  • Prepare a file with all necessary documents (list of documents are given below)
  • Submit file for manufacturing license at State Drug Control Office at concerning state
  • After acceptance of file, Drug authority will conduct physical inspection before granting manufacturing license
  • Apply for Wholesale Drug License (Wholesale Drug License is also necessary for a pharmaceutical unit in India for receiving, stocking and selling of finished pharmaceutical goods)
  • Apply for Goods and Service Tax (GST) Registration (GST registration is necessary for commercial activities)
  • NOC for any other department if required 

Different types of unit/s you can start with below procedure:

You have number of option in pharmaceutical Manufacturing. You can set-up single section/unit or an start-up all sections together.

For starting pharmaceutical/Cosmetics/Ayurvedic/Siddha/Unani products manufacturing company/business, you require to obtain manufacturing license from concerning authority of applicable state. Procedure and requirements may vary state to state or with amendments in Drug and Cosmetic Act/Rules. You should refer Drug and Cosmetic Act/Rule at regular basis for accurate requirement and procedures. You can also visit concerning department website of particular state for complete information.

Drug and Food Administration grants the manufacturing licences in Form 25, 28, 32 and 36. (Type of Forms and licenses may vary state to state) We are providing general requirements and documents required to start pharmaceutical manufacturing unit. Layout plan and location of manufacturing unit is most important part for getting approval for starting manufacturing.

Requirements for Grant or Renewal of Manufacturing License:

List of Documents required to obtain pharmaceutical manufacturing drug license: (May vary state to state):

  • Covering Letter (Introduction of applicant with address of the Plant and Administration office and his requirement)
  • Prescribed forms duly filled and signed by the Proprietor / Managing Partner / Managing Director/ Person declared as responsible under Section-34 / Person Authorized by the Board of Directors accompanied by Company Board Resolution along with prescribed fees
  • Fees challan in original remitting the required amount of fee in the Head of Account or Original Treasury Challan
  • Attested copies of partnership Deed / Memorandum and Articles of Association (Notarized)
  • Documents related to ownership of firm (Proprietorship/Partnership/Company)
  • Declaration of the Proprietor / Partners / Directors etc. in Affidavit (Notarized) 
  • Attested Copy of Ration Card or Passport or Electoral Card / Bank Account Details in support of proof of residential address of the responsible person
  • Attested copies of Rent / Lease deed in case of Rental premises
  • Affidavit form of applicants, manufacturing chemist and quality control chemist regarding obtaining any license earlier, Prosecution and conviction if any under drug and cosmetic Act/Rules
  • List of all technical staff along with photocopy of educational qualification and experience.
  • Declaration of the owner of the premises if premises owned by the applicant firm or company with the documentary evidence of ownership like Registered sale deed etc and or proof of allotment of the site and or building along with latest property tax receipt.
  • Plan and layout of the premises showing the installation of Machinery and Equipment. Preferably a Blue Print approved by Licensed Engineer and signed by the applicant who signed in the statutory form
  • Design and layout of HVAC systems if applicable
  • List of applied items with formula
  • Water Analysis Report
  • NOC from competent Local Authority like Gram Panchayat , Nagar Nigam or Nagar Palika if applicable
  • Documents regarding electricity connection
  • Detailed list of Manufacturing Machinery and Quality control Equipment with copies of purchase Bills. (As per Format)
  • Appointment letter, consent letter and photocopy of approval of the approved manufacturing chemist and Analytical Chemist If not, Application for approval of Technical Staff in the prescribed format with enclosures of consent letter, copies of qualification certificates, experience certificates of proposed technical staff along with earlier approvals. 
  • Permission obtained from the Municipal Authorities/ Panchayat authorities / Certificate in conformity with Factories Act for construction and starting the Unit
  • Permission from the Health Authorities / Pollution Control Board clearance of the area for setting up the manufacturing facility
  • Clearance from Drugs Controller General (India), New Delhi in case of new drugs (Either Bulk drug or Formulation) – New Drugs as defined under Rule 122 E of Drugs and Cosmetics Rules 1945
  • Site Master File. (Refer para 29 of part I of Schedule M)
  • Letter of the loan license applicant addressed to the principle unit and consent letter of the principle unit in case of loan license

Read Related:
Who is Manufacturing Chemist? Definition, Job Responsibilities, Qualification etc
Who is Analytical Chemist? Definition, Job Responsibilities, Qualification etc

Additional requirements in case of renewal:

  • Drug Licence with list of products approved in the last licensing period.
  • Consolidated List of the Products
  • Production particulars for the last Licensing Period (As per Format)
  • Declaration regarding the changes in the premises, constitution, (Directors/ Partners), Technical Staff of the firm/ Company
  • Original labels

After getting drug manufacturing license number you are eligible to start manufacturing of pharmaceutical products. Along with drug manufacturing license, you have to obtain wholesale drug license number and tax identification number for stocking, sale and distribution of drugs and medicines.

Scope of Pharmaceutical Manufacturing Unit:

Space and Area required:

The manufacturing plant should have adequate space for:- 

(i) Receiving and storing raw material
(ii) Manufacturing process areas 
(iii) Quality control section 
(iv) Finished goods store 
(v) Office 
WHO GMP certificate is required by all manufacturing unit to show its quality and standard manufacturing facilities. Most of customers will ask you about GMP certificate. Here we are mentioning general documents required to apply for it:

WHO GMP Certificate:Documents required :
Application in the Form of covering letter.
Document of the country where the products are to be exported.
List of Products to be exported in duplicate.
Stability studies of 3 batches of the product for which COPP is required(Both real time and accelerated).
GMP Certificate:Documents required :
Application in the Form of covering letter.
Xerox copy of the licence and latest valid renewal certificate.
Xerox copy of list of approved products.

Read about Complete about Schedule M and Good Manufacturing Practice by clicking at below Link: http://www.cdsco.nic.in/writereaddata/ScheduleM(GMP)6.pdf

Qualification of Manufacturing Chemist and Analytical Chemist:

Manufacturing chemist should have-

  • Bachelor of pharmacy with one and half year of experience in pharmaceutical manufacturing/Analytic and duly registered under drug control department
  • Bachelor of sciences with three year of year and duly registered under drug control department.

Read Pharmaceutical Manufacturing Unit Project Report including area, investment, location etc

Next Page: What is the requirements and Challenges one has to face to start Pharmaceutical Manufacturing Unit?

31 Replies to “How To Start Pharmaceutical Manufacturing Company in India?”

  1. hi, i want to start a new manufacturing plant in india gujarat for that i need whole detalies like invesment area required and process to start.

  2. I am plan to set up a pharma formulation manufacturing unit in Vasanthnarasapura industrial area, Tumkuru, karnataka. I am looking for a credible partner who has manufacturing or marketing expertise and who can invest. If interested kindly reply to rmanoharrao@gamil.com

    Thanks and Rgds
    Manohar

  3. I am a pharmacist living in Tanzania ,i am very interested with your website ,and i would like to ask for your help ,as I am looking for a guideline which can help me understanding the procedures and process for opening pharmaceutical manufactures company .

  4. We are India Based Website and having knowledge related to Indian market. We are sure, there may be similar requirements for starting pharma manufacturing company in Tanzania too except few ones. You can clarify more doubt from drug department located in Tanzania.

  5. Dear sir, this is from international (chemical supplier and trading company). i want to start my own pharmaceutical manufacturing unit in india. so please give me Quotation for new machineries cost and Registration cost for new unit. i am waiting for your response.

  6. I read all your details "about the company, it was very good.

    I look forward to the pleasure of being an agent for your company in Yemen Aden. If you do not have an agent in Yemen before
    I want new steps as you can see.
    I am a hardworking and motivated. Product and prices and want to know your company's certificate

  7. Sir, I am a B.Tech graduate from a reputed central university..I am interested only to serve underprivileged people of the country and my nation.So, I want to start my own pharmaceutical company and make avail the medicines to those who r poor n unable to purchase.. in cheap rate. Sir,please guide me how to start n how much cost it comes …. Waiting for Ur kind and honest reply.

  8. Dear sir,

    I want to start pharmaceutical manufacturing plant in surat.My qualification is B.Pharma with 10 yrs experience in tablet & capsule manufacturing and packing

    Advise me for manufacturing type of third party or loan license

    How will i get orders from market

  9. Sir I want start Small Scale company in Dhule District Maharashtra but i confusion in small scale which one is better Sterile or Tablet Capsule production and how many are total cost of product

  10. These registration when to get – I mean we apply registration after or before buying the machines, construction of building, are all respective items.

  11. @Rajesh Ramoliya
    For third party and Contract manufacturing orders, you need to contact marketing companies for it. You can choose number of marketing tools like e-mail marketing, sms marketing, tele marketing and/or direct approach personally to marketing companies for orders.

  12. Dear sir / madam,
    I am pharmacist i am doing job in pharma industry since last 2 years in F & D department.
    I want to be start up the business in pharma field as manufacturing unit.
    Please suggest me which type of formulation is best to grow up the business.
    I thinking about pharma business but i want your suggestion please send me your comment on my mail id.
    Thanks & regards,
    Prashant Patil
    prashant25sent@gmail.com

  13. Hi,
    I am Rangacharyulu. I want to setup a new generic manufacturing facility dedicated to Australian market in Vizag SEZ. Please let me know the land required, machinery required and their approximate costs for the same.
    my mail id is rajagopal002@gmail.com and I am available on 8017047678

  14. Hi i am kavin, its my first occasion to commenting anywhere, when i read this post i thought i
    could also create comment due to this good piece of writing.

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