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:
- Factory Act regulations
- 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:
- Ethical/Branded Pharmaceutical Manufacturing Company
- Generic Pharmaceutical Manufacturing Company
- OTC (Over the Counter) Pharmaceutical Manufacturing Company
- Pharmaceutical Distribution and Hospital Supply Manufacturing Company
- Pharmaceutical Manufacturing Export Company
- Pharmaceutical Manufacturing Import Company
- Derma Products Manufacturing Company
You have number of option in pharmaceutical Manufacturing. You can set-up single section/unit or an start-up all sections together.
- Tablet/Capsule Manufacturing Section
- Liquid/Syrup Manufacturing Section
- Parenteral (Liquid/Dry Injection) Section
- Ophthalmic/Eye/Ear/Nasal Drop Section
- Powder (Protein powder, Medicated powder etc) Section
- Inhaler/Spray Section
- Surgical/Medical Device Section
- Suppositories Section
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:
- 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
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.
- Third party manufacturing
- Contract Manufacturing
- Loan license manufacturing
- Own marketing and Distribution Channel
Space and Area required:
The manufacturing plant should have adequate space for:-
Read here: Business Plan for Pharmaceutical manufacturing company? Area Required and Machinery details per section…
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).
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.