How to Start Pharmaceutical Company (Marketing & Manufacturing)?

Starting a Pharmaceutical company is a dream project for every pharma professional. But most of us haven’t start own pharmaceutical venture due to lack of knowledge and procedure to start pharmaceutical company. Here we will try to help you to start your own pharmaceutical company. This article we cover complete detail that is necessary to start pharmaceutical company.

We can divide pharmaceutical companies in two parts:

  1. Pharmaceutical Manufacturing Company
  2. Pharmaceutical Marketing Company

These are two basic types of pharmaceutical companies. These can be further divided into following parts based upon their marketing, sale and work basis irrespective of marketing and/or manufacturing type.

  1. Pharmaceutical Branded/Ethical Company
  2. Pharmaceutical Generic Company
  3. Pharmaceutical Franchise Company
  4. Pharmaceutical Pcd Company
  5. Pharmaceutical Specialty company e.g. Derma, ophthalmic, cardiac etc
  6. Pharmaceutical Export Company
  7. Pharmaceutical Import Company
  8. Pharmaceutical OTC company
  9. Pharmaceutical Distribution Company
  10. And many more

A manufacturing company can be marketing company at same time if they are doing own marketing also along with manufacturing. Manufacturing company also require to fulfill marketing company licenses and requirements to market, sell and distribute products.

There are different procedures to start marketing and manufacturing pharmaceutical company. In this article we will cover licences, procedure, documents, qualifications and requirements to fulfill criteria for marketing company and manufacturing company. First we will discuss about requirements, licenses required and Licencing authority for granting licenses for manufacturing company. Later in article will discuss about marketing/distribution/trading company.

How to start Pharmaceutical Manufacturing Company

Requirements:

  • Plant and Building (As per WHO:GMP and/or Your Country Law like in India, As per Drug and Cosmetic Act)
  • Technical Staff i.e. Approved Manufacturing Chemist and Approved Analytical Chemist
  • Machinery and Lab Equipment
  • Office Accessories
  • Machine Men and Workers
  • Electricity Supply
  • Water Supply
  • HVAC unit
  • List of medicines to be manufactured
  • Non Objection Certificate if required

Licences Required:

  • Company Registration (in case proprietorship you may skip this process)
  • Manufacturing License
  • Laboratory License
  • Wholesale Drug License
  • Goods and Service Tax Number

Licensing Authority for Manufacturing License:

Licensing Authority is a department and/or authorized person by government to grant, renew, issue and suspend license for any manufacturing unit. In case of manufacturing unit Drug Control Officer of concern state is a licensing authority for pharmaceutical manufacturing unit. Licensing Authority office is generally located at State Capital and/or Zonal basis for big states. You have to apply to licencing authority for granting of manufacturing license.

For new drugs, blood and blood products, IV fluids, vaccines and sera in India approval and licensing, Licensing authority is Drug Controller General of India.

How to apply?

Once you have completed all requirements and documents, you can visit to state drug control office for submitting your file for granting of manufacturing license. Most of state has started online application submission and/or some states still use manual file submission. You may have to visit number of times to licensing authority for it. Once you have submitted your application. Licensing Authority will intimate inspection schedule for your manufacturing unit through mail, phone and/or manually as applicable.

Inspection:

Inspection is conducted by joint team of State Drug Control Office and District Drug control office and/or with central drug authority. All facilities, technical staff detail, machineries and particulars are inspected according to submitted application and as per Drug and Cosmetic Act & Rules.

In case, all requirements and documents are find to be satisfactory, a license is issued by concerning drug authority for manufacturing of medicines in enclosed list with manufacturing license application.

 

Only Manufacturing License and Laboratory License processes are different for Pharmaceutical Manufacturing Company from Pharmaceutical Marketing Company. Remaining processes are same for both types of companies. Manufacturing Company also require wholesale drug license. Wholesale Drug License Procedure we have discussed in how to start pharmaceutical marketing company section below.

Remaining processes we will discuss later in article. Documents also we will discuss in end. You can skip to end to read documents required for each process. One of main critical step is trade mark registration. Trade Mark registration is important for protection of company name and brand names.

How to Start Pharmaceutical Marketing Company

Requirements:

  • Premises (Cemented and well furnished floor and walls, concrete roof etc)
  • Competent Person i.e. Pharmacist or Experience Person
  • Office Accessories
  • Freeze and Air conditioner if asked for
  • Electricity Supply

Licences Required:

  • Company Registration (in case proprietorship you can skin this process)
  • Wholesale Drug License
  • Goods and Service Tax Number
  • FSSAI Registration (In case of selling Food and Dietary Supplements also)

License Authority for Wholesale Drug License:

Licensing Authority is a department and/or authorized person by government to grant, renew, issue and suspend license for wholesale drug licence. In case of wholesale drug license Senior Drug Inspector and/or Drug Inspector of concern district is a licensing authority for pharmaceutical marketing company. Licensing Authority office is generally located at District Head quarter and/or combined for two or more districts in some regions. You have to apply to licencing authority for granting and issuing of wholesale drug license.

How to apply?

Once you have completed all requirements and documents, you have to visit District drug control office in your district for submitting your file for granting of wholesale drug license. Most of state has started online application submission and/or some states still use manual file submission. You may have to visit number of times to licensing authority for it. Once you have submitted your application online, you still need to submit your uploaded documents physically at licencing authority office . Licensing Authority will intimate inspection schedule for your premises inspection through mail, phone and/or manually as applicable.

Inspection:

Inspection is conducted by District Senior Drug Inspector and/or Drug Inspector. All facilities, competent person details and other particulars are inspected according to submitted application and as per Drug and Cosmetic Act & Rules.

In case, all requirements and documents are find to be satisfactory, a license is issued by concerning drug authority for sale, stock, exhibit and distribute of medicines for wholesale.

How to Register Company in India (Company Registration)?

There are four types of pharmaceutical companies mostly registered under Company Act.

  • One Person Company
  • Private Limited Company
  • Limited Liability Company
  • Public Limited Company

Each type of company has different requirements and eligibility. There are certain criteria fixed by Government of India for registration your company in any type. Ministry of corporate affair regulated company registration through Company Act 1956, 2013 and allied Acts. You can register your company through ministry of corporate affairs website.

Most of us will not take burden to apply for company registration by own self if we can get company registration consultants easily. Most of Chartered Accounts and Sale Tax/income Tax Advocates do this work with small consultancy fees. Search for CA and other agencies that deal in company registration nearby you and apply for company registration.

If you want to apply your own then you can visit at http://www.mca.gov.in/ and follow the process to apply for company registration.

How to apply for Goods and Service Tax Identification Number:

GST is essential in India for doing any type of business/trading but below 20 lac annual turnover, there is no requirement of GSTIN registration. GST registration is compulsory to obtain within 30 days after exceeding turnover above 20 lac. Unlike VAT, GST is valid in all states. It can be applied through portal provided by state government and/or center government.

Like company registration, you can outsource work of for GSTIN registration through CA and other agencies. If you want to apply for GSTIN by own then Go to www.gst.gov.in. There will be the two options: New User and Existing User. Click at New User, Enter your detail for apply GST, Enter you mobile number and Email Address of the authorized signatory of the business entity. This number and e-mail will be used for all future communication from the GST portal.

You will receive a OTP at mobile number and e-mail id you entered in previous step. Enter this OTP. After that follow all steps and enter information and scanned images of documents as mentioned in Provisional Registration form. After completion of this process, you have been successfully applied for GSTIN registration.

We will recommend you to let your CA do this work for you. They will charge some fees but it worth for work, they know better than you and us.

How to apply for Food Safety and Standards Authority of India (FSSAI) Registration

If you want to market food and dietary supplements along with medicines and drug then you also have to apply for FSSAI registration. This is a simple registration process which you need to apply online by visiting at FSSAI website. After applying application online, you also have to submit your documents manually at FSSAI officer’s office appointed by FSSAI department at district head quarter or at specific location. Office detail can be found at FSSAI website and/or contact number provided at their website.

This is applicable for marketing and selling of food & dietary supplements only. If you are a manufacturing food & dietary supplements then you have to apply for Food and Dietary Supplement manufacturing license at FSSAI website. This process is also online and has to submit documents at food officer’s office.

Documents and requirements are different for license and registration process. There are three type of categories under FSSAI.

  • Central License
  • State License
  • Registration

You can apply as per your need. If you are marketing, only registration could be ok but if you have large turnover you have to take state license from FSSAI. For manufacturing, you can opt for state license and/or central license as per your requirement.

Note: For granting FSSAI manufacturing license separate building and premises is necessary.

What will be Procedure and sequence to proceed for Starting Pharmaceutical Company

Important Step in starting Pharmaceutical Company

  • Taking Experience in pharmaceutical sector by doing job and/or indulge with any already established company/firm.
  • Take training if you don’t have experience in pharmaceutical sector
  • Choose Location of Business. Search for shop/building/premises for office, licenses and stock. It may be rented or owned but there should be adequate space as per government norm.
  • Research and Prepare list of all molecule and combinations, you want to manufacture and/or marketing.
  • Finalize Company Name and Brand Names of all products. Be sure these don’t resemble to any other company or brand already working in Market. Due to presence of thousand of brands and companies, it becomes difficult to choose unique name but you should try your best. Already registered or in process Trade Name and Company Name you can search at http://ipindiaonline.gov.in/tmrpublicsearch/frmmain.aspx. Trade name in class 5 and Company name at class 35.
  • Appointment of Technical and competent staff

Now we will discuss about documents required for licenses we have discussed above.

Documents Required:

Documents Required for Pharmaceutical Manufacturing License:

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

  • Covering Letter including introduction of applicant with address of the Plant and Administration office
  • Prescribed forms duly filled and signed by the Proprietor / Managing Partner / Managing Director
  • Fees challan in original remitting the required amount of fee in the Head of Account or Original Treasury Challan
  • Documents related to ownership of firm (Proprietorship/Partnership/Company)
  • Affidavit of Proprietor / Partners / Directors etc (Notarized)
  • Address Proof copy duly attested
  • Attested copy of ownership proof/rent agreement/lease deed
  • Affidavit of applicants, manufacturing chemist and quality control chemist
  • List of all technical staff along with photocopy of educational qualification and experience.
  • Blue print of Plan and layout of the premises showing the installation of Machinery and Equipment.
  • Design and layout of HVAC systems if applicable
  • List of medicines intend to be manufactured in manufacturing unit
  • Water Analysis Report
  • Electricity Connection Documents
  • NOC from competent Local Authority like Gram Panchayat , Nagar Nigam or Nagar Palika if applicable
  • Detailed list of Manufacturing Machinery and Lab Equipment with copies of purchase Bills. (As per Format)
  • 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)
  • Site Master File. (Refer para 29 of part I of Schedule M)

Affidavit formats, blue print format and other formats you can ask from drug control office

Documents Required for Wholesale Drug License:

Senior drug inspector and/or Drug Inspector can provide you full details of requirement for a whole sale drug license. Procedure and details for applying for D.L. number can be change according to government policies. Important documents are:

  • Application will be submitted in form no. 19 with other detailed information forms.
  • You or your partner (if any) either should be a registered pharmacist or Experienced Person or competent person. If you don’t have any of above qualification than you can appoint or hire a registered pharmacist or EP (Experienced Person) and make him authorized to handle all work on your behalf (Appointment letter will be submitted with application)
  • Premises size should have minimum of 10 square meter area (requirement of area may vary) and should have single premises.
  • Affidavits
  • Fees ( mode of fee and prescribed fee may vary)
  • Blue print or layout of Premises
  • Freeze purchase bill copy with complete address
  • Air Conditioner if applicable
  • Ownership or Rent agreement deed of premises.
  • Electricity bill of premises.
  • Affidavit of proprietor, partner, pharmacist, EP etc.
  • Firm registration receipt in case private limited firm. List of directors, address proof, article of association etc is also to submit with application form
  • Partnership deed if any
  • Any other documents as asked by local drug controller etc.

 

Documents for Company Registration:

  • DSC (Digital Signature Certificate)
  • DIN (Director Identification Number)
  • PAN (Permanent Account Number) Card
  • TAN (Tax Deduction and Collection Number)
  • Identity Proof (Electronic ID / Aadhar Card / Passport / Driving License)
  • Passport Photo
  • Address Proof (Bank Statement / Mobile Bill / Telephone)
  • Rent Agreement (Notarised: For rented property) or Ownership proof
  • Latest Electricity Bill
  • MOA(Memorandum Of Association) or/andAOA (Article Of Association)
  • NOC if required

Documents required for applying for GSTIN:

  • Digital Signature Certificate (Class II)
  • Address Proof of Business Entity
  • Proprietor/Partners/Directors Address Proof
  • Aadhaar Card, PAN and Image etc
  • Ownership Proof or Rent agreement
  • Partnership deed or memorandum of association/certificate of incorporation
  • Back Statement and Bank Detail

Qualification for Competent/Technical Staff:

Qualification of Technical Staff for Manufacturing Company

Manufacturing Chemist:

Minimum of Bachelor in Pharmacy with one and half year of experience in pharmaceutical manufacturing unit under supervision of approved manufacturing chemist

Or

Minimum of Bachelor in Sciences with three year of experience in pharmaceutical manufacturing unit under supervision of approved manufacturing chemist

Analytical Chemist:

Minimum of Bachelor of Pharmacy

Or

Minimum of Bachelor in Science with three year of experience in Laboratory of pharmaceutical manufacturing unit under supervision of approved analytical chemist.

Qualification and Eligibility for EP or competent person for Marketing Company

Person should have one of the below qualification or eligibility to be EP or competent person:

  • Registered pharmacist under state pharmacy council or
  • Minimum of one experience at registered wholesale drug licensed firm after graduation with salary in bank account and appointment letter, resignation letter & experience letter at firm’s letter head with duly stamped and signed

If you want to know about Investment then Read our Article: How much Investment requirement required to Start these Companies?

Hope this information is useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Have a quick look at other business opportunities in Pharma Sector:

 

How can a BAMS Doctor Start Ayurvedic Manufacturing Company?

One of our youtube viewer asked us about How a BAMS doctor can start Ayurvedic Manufacturing Company. Requirement for starting a ayurvedic manufacturing company is same as we have discussed in our article: How to start Ayurvedic Manufacturing Company?

but this article is specific for Bachelor of Ayurveda, Medicine and Surgery (BAMS) doctors.

An Ayurvedic Manufacturing unit requires two technical persons to handle overall manufacturing and quality. For manufacturing, a manufacturing chemist is required and for quality control, an analytical chemist is required. BAMS doctors are pre-approved manufacturing chemists for Ayurvedic manufacturing Unit under drug and cosmetic act. So they only require analytical chemist as another technical person.

(In case of Siddha and Unani Medicines, technical person related to Siddha and Unani will be required)

Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs:

  1. An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with prescribed Fee.
  2. Subject to the conditions of Rule 157 under Drug and Cosmetic Act & Rule being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The licence shall be issued within a period of three months from the date of receipt of the application

Plant Specifications:

Plant should compile with conditions as specify in Schedule T under Drug and Cosmetic act & Rules.

Documents Required:

  • Application Form (Form 24-D).
  • Prescribed Fees
  • Requirement of schedule ‘T’ are to be fulfilled for which Departmental Inspection Team will conduct the inspection and submit its report on the prescribed Performa.
  • Technical Persons qualification documents. One is of BAMS doctor and One is of Quality section as discussed above.
  • Master Site Plan
  • Power Availability Certificate from Electricity Department.
  • List of Machinery/Lab. Equipments.
  • List of medicine to be manufactured.
  • Project Report.
  • Ownership proof or rent agreement

AYUSH department team will inspect premises as per norms prescribed in Schedule T. If all requirements are fulfilled, manufacturing license will be issued.

Area Required:

Area Required for setting up manufacturing unit is 1200 Square feet covered area with separate cabins or partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required.  You can read in detail at our article: How much Area required to start ayurvedic manufacturing plant.

Machinery and Equipment:

All the machinery and its part used in ayurvedic manufacturing is made-up of stainless steel. Machinery are in SS-304 and contact part should be in SS-316. To know in detail about machinery read our article: List of machinery used in Pharmaceutical and Ayurvedic Sector.

Laboratory Equipment:

An Ayurvedic manufacturing unit either establish own testing laboratory or unit can get testing done at government approved laboratories. Complete detail of laboratory equipment know here

Hope above information is helpful to you…

Requirements for Ayurveda, Sidha and Unani Quality Control Section: Equipment, Area etc.

Every Ayurvedic, Sidha and Unani manufacturing unit is required to set-up own quality control section or testing should be done through government approved testing laboratory. Tests should be conducted at per Ayurveda, Sidha and Unani pharmacopoeial standard. If tests are not available, tests should be performed under in-house specification or other information available. Work of quality control section is to verify all the raw materials, monitor in-process quality checks and control the quality of finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate expert.

Quality Control/Analytical Chemist: Quality control section will have a minimum of :

  • Expert in Ayurveda or Sidha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act 1970;
  • Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; and
  • Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University

The quality control section shall have the following facilities:–

  • Area for Quality control section should be minimum of 150 sq. feet.
  • For identification of raw drugs, reference books and reference samples should be maintained.
  • Manufacturing record should be maintained for the various processes.
  • To verify the finished products, controlled samples of finished products of each batch will be kept till the expiry date of product for 3 years.
  • To supervise and monitor adequacy of conditions under which raw materials, semi- finished products and finished products are stored.
  • Keep record in establishing shelf life and storage requirements for the drugs.
  • Manufacturers who are manufacturing patent and proprietary Ayurveda, Siddha, and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.
  • The record of specific method and procedure of preparation, that is, Bhavana, Mardana and Puta and the record of every process carried out by the manufacturer shall be maintained.
  • The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.
  • All raw materials will be monitored for fungal, bacterial contamination with a view to minimize such contamination.

List of equipment required for Laboratory in Ayurvedic Manufacturing Units.

(Alternatively, unit can get testing done from the Government approved laboratory)

CHEMISTRY SECTION

  • Alcohol Determination Apparatus (complete set)
  • Volatile Oil Determination Apparatus
  • Boiling Point Determination Apparatus
  • Melting Point Determination Apparatus
  • Refractometer
  • Polarimeter
  • Viscometer
  • Tablet Disintegration Apparatus
  • Moisture Meter
  • Muffle Furnace
  • Electronic Balance
  • Magnetic Stirrer
  • Hot Air Oven
  • Refrigerator
  • Glass/Steel Distillation Apparatus
  • LPG Gas Cylinders with Burners. Water Bath (Temperature controlled)
  • Heating Mantles/ Hot Plates
  • TLC Apparatus with all accessories (Manual)
  • Paper Chromatography apparatus with accessories
  • Sieve size 10 to120 with Sieve
  • Shaker
  • Centrifuge Machine
  • Dehumidifier
  • pH Meter
  • Limit Test Apparatus

PHARMACOGNOSY SECTION

  • Microscope Binoculor
  • Dissecting Microscope
  • Microtome
  • Physical Balance
  • Aluminium Slide Trays
  • Stage Micrometer
  • Camera Lucida (Prism and Mirror Type)
  • Chemicals, Glassware etc

License required to manufacture Diabetic Powder

Query:

Hi there

I have just seen your video on youtube on Ayurvedic manufacturing etc., which is very helpful

The reason I am writing to you is to enquire about a different kind of a licence and requirement. I will explain in detail so you can advice me.

Well, I have made a Ayurvedic churn for Diabetes, this churna is not manufactured by me, what i have done is taken different  powders/churans in exact ratios and made one churan which is found to be beneficial in curing Diabetes. These different powders are bought from local market and all i do is mix them in specific ratio and make my churan for diabetes.

I am doing this process for a long time for the family, domestic purpose and not for commercial purpose. But now I want to do it on commercial basis, as I have read this is completely a safe medicine

My purpose will be to outsource the raw products (Churans/powder) from the market, mixing, packing in good quality packing and sell them in the market on a very nominal rate.

I am from ahmedabad, gujarat, and I have been to the local Ayush office here, but it was useless visit as they could not explain anything, but only explain something about loan/third party licence.

I read on google about this Loan//Third party licence, i think i would need such licence but do not know how to get one and from where to proceed.

Please if you can help in advising about —

  1. This loan/third party licence and also
  2. if I need to have a unit/shed from where I should be operating? As I am not manufacturing only mixing and assembling powers/churans.
  3. ALso on how can I get such and licence and what all douments etc is required

I would be highly grateful if you answer my questions

 

Response:

After reading your mail, we have concluded two option for you…

  1. Either you can make your as Food Supplement

or

  1. you can make it as Ayurvedic Product

For in both case you need to take manufacturing license. For food supplement, you need FSSAI license and for ayurvedic product, you need ayurvedic manufacturing license.

Read requirements and how you can take licenses by clicking at below link:

How to start Food Supplement Company?

How to start Ayurvedic Company?

As you mention, you are only mixing. That come under manufacturing process. When you take different ingredients and mix these into a finished preparation, that fall under manufacturing process and you will need a manufacturing license for it.

As you asked by Loan licensing and Third party manufacturing, these both processes involve when you get manufactured your product from another manufacturer but brand name and company name belong to you…

In simple words, product will have your company name and your brand name but will be manufactured by an another manufacturing unit which have a valid manufacturing license number.

Read About Third Party Manufacturing by clicking here

Hope above information is helpful to you…..

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How to start Pharmaceutical Manufacturing Unit in South Africa?

In this post, we will discuss about how to start Pharmaceutical Manufacturing Unit in South Africa. Topics Cover in this post are

  • Steps before Starting
  • Requirements
  • Sections
  • Procedure
  • Documents Required

Pharmaceutical Manufacturing Unit/Company Licensing and Registration is covered under MEDICINES AND RELATED SUBSTANCES ACT, 1965. Medicines Control Council Handles all process related to registration and licensing in South Africa. Every medicine that are imported, exported, manufactured and distributed in South Africa should be registered at Registrar of council.

Steps before Starting Pharmaceutical Manufacturing Unit in South Africa:

  • Apply to the Council for a licence to manufacture, import or export, act as wholesaler or distribute medicines, Scheduled substances or medical devices
  • Appointment of a technical person such as a pharmacist who will supervise and control the manufacturing or distribution of medicines and related substances
  • Appointment of an authorized person who resides in the Republic and responsible for all activity related to licensing procedure and interaction with council
  • Premises as per Good Manufacturing Practice arrangement

Requirements:

Manufacturing Sections

A Medicine manufacturing unit can have one or more section depend at nature and types of product to be manufactured. There is requirement of separate section to manufacture a particular dosage form to prevent contamination and following cGMP requirement. Every dosage form requires different type of machinery and equipment for manufacturing and processing. Few sections that are required in pharmaceutical manufacturing unit are as follow:

Procedure for applying for Pharmaceutical Manufacturing Unit License:

  1. Applicant has to submit application to registrar on a prescribed form provided by council
  2. Registrar will issue a written notice to applicant regarding documents to be submitted to council for granting license to manufacture medicine and related substances in reasonable time
  3. Council will inspect the business premises specified in application
  4. If the council is satisfied with all requirements and arrangement, council will issue license to applicant for manufacturing of medicines and related substances

Documents Required:

  • Documents related to Business Ownership
  • Registration of the responsible Pharmacist
  • Qualification certificates of staff responsible to manufacture, store, distribute and sell medicines and related substances
  • Copy of Local Area Plan of location of the Business
  • Floor plan of building in which business is situated
  • Blue print of Building and Premises
  • List of Machinery and Equipments and Inventory for it
  • Site Master File indicating procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines and related substances
  • List of medicines and related substances to be manufactured
  • Application and Inspection Fee Receipt

Hope Above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Related Post: How to start medicine distribution business in South Africa?

List of Pharmaceutical Companies in South Africa.

How to Start Pharmaceutical Manufacturing Unit in Pakistan?

Procedure for Grant of Drugs Manufacturing License in Pakistan

In this article, we will discuss about how to start Pharmaceutical Manufacturing Unit in Pakistan. The Drugs Act, 1976 of Pakistan regulates the import, export, manufacture, storage, distribution and sale drugs in Pakistan. The grant of licenses to manufacture drugs is regulated by Central Licensing Board (CLB) setup under section 5 of the Drugs Act, 1976.

The Central Licensing Board (CLB) comprises of desired members including experts from the fields of Manufacturing and Quality Control of Pharmaceuticals, Professors of renowned universities, representatives of Health Departments Government of Punjab, Sindh, Khyber Pakhtun Khwa, Balochistan and a Law expert.

Procedures and Requirements may be change with change in Rules and Regulations as per Government of Pakistan.

Types of Licenses:

  • License to manufacture by way of Formulation
  • License to manufacture by way of Basic Manufacture
  • License to manufacture by way of Semi Basic Manufacture
  • License to manufacture by way of Repacking
  • License to manufacture by way of Experimental purpose

A pharmaceutical manufacturing unit (facility) can possess more than one licenses depending upon the nature of activity being under taken by the manufacturer / licensee

Requirements:

Manufacturing Sections

A Pharmaceutical Manufacturing Unit is used to manufactured different dosage form. Different dosage form manufacturing requires different machinery and different sections for preventing contamination and following GMP protocols. Few sections that are required in pharmaceutical manufacturing unit is as follow:

Documents for manufacturing License:

  • Application on Prescribed Form-1
  • Fee Challan Copy
  • Legal Status of firm (For proprietorship firm: – name and address of proprietor, for partnership firm: – name and addresses of partners, for company: – name and address of company and directors)
  • Premises details including layout plan of the factory
  • Section-wise equipment and machineries details for manufacture and quality control
  • Qualification and training of Production-in-charge and Quality-in-Charge, and other technical staff for manufacturing and quality control department
  • List of drugs to be manufactured including name, class/es of drugs and dosage form/s of the drug

Procedure for granting of Pharmaceutical Manufacturing License in Pakistan:

The salient features of the procedure for grant of a license by way of formulation / basic/ semi basic/ re-packing are as under: –

  • First submit an application Central Licensing Board for establishment of a pharmaceutical unit.
  • Area FID/Field Officer of Drug Regulatory Authority of Pakistan (DRAP) will inspect proposed site if fulfillment of pre requisites documents finds in submitted application.
  • Filed Officer will recommend or reject for establishment of pharmaceutical unit as per requirements under Schedule B of the Drugs (Licensing, Registering and Advertising) Rules, 1976 framed under the Drugs Act, 1976
  • Application will be processed to competent authority for site approval.
  • Competent authority will communicate with applicant if site is compile with provisions of rule otherwise application will be rejected.
  • For approved site, applicant is required to submit layout plan, drawn inline with cGMP requirements etc.
  • If layout plan is found as per cGMP requirement, the same is processed for the approval of competent authority. The approval is communicated to the applicant for construction of the facility.
  • After complete construction of unit, applicant has to submit application for grant of Drug Manufacturing License (DML) on prescribed Form-1 along with necessary documents.
  • If application is fulfill all formalities then inspection is carried out by constituted panel.
  • If inspection is found to be as per rules and regulations, constituted panel will placed report before CLB in its meeting.
  • After that CLB passes its order on the recommendations of the panel report.
  • License at Form-2 will be issued in case of approval of Drug Manufacturing License for five years which is subject to renewal further such time period till suspended and/or surrendered.
  • The procedural requirements for other types of Drug Manufacturing Licenses are similar as that of the Formulation, with some variations of conditions depending upon the type of the license.

Related: List of Pharmaceutical Companies in Pakistan

Site Master File for Manufacturing Units for Pharmaceutical Industry

Manufacturer Licensee has to submit site plan of manufacturing premises to drug authority along with application form for granting of medicine, medical devices and related products manufacturing license. Site plan has to be submitted in a form “Site Master File”. this may be applicable for Ayurvedic Manufacturing Unit, Homeopathic manufacturing unit, cosmetic manufacturing and Nutraceutical Manufacturing unit also.

Site Master File is a document containing specific and factual Good Manufacturing Practices about the
production and/or control of pharmaceutical manufacturing preparations carried out at the
licensed premises.

In simple words, a Site Master File is a document by which one can simply understand complete plant layout, working environment, work flow chart, processes and quality policies in brief. This document gives idea how manufacturing and analytical process will work, who will handle each process, how will quality be maintained, how will quality be assured, who will handle complain and recalls etc.

A Site Master File should easily highlight complete details in brief. A Site Master File generally has following information:

  • General Information Section
  • Personnel’s Section
  • Premises Section
  • Equipment Section
  • Sanitation Section
  • Documentation Section
  • Production Section
  • Quality Control Section
  • Loan License Manufacture and Licensee Section
  • Distribution, Complain and Product Recall Section
  • Self Inspection Section
  • Export of Drugs Section

General Information:

  • Brief information of the firm
  • Pharmaceutical manufacturing activities as permitted by the licensing authority
  • Other manufacturing activities, if any, carried out on the
  • Type of products licensed for manufacture with flow charts mentioning procedure and process flow
  • Number of employees engaged in the production, quality control, storage and distribution
  • Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis
  • Short description of the Quality Management System of the firm
  • Products details registered with foreign countries.

Personnel:

  • Organisational chart showing the arrangement for quality assurance including production and quality control;
  • Qualification, experience and responsibilities of key personnel;
  • Outline for arrangements for basic and in-service training and how the records are maintained;
  • Health requirements for personnel engaged in production; and
  • Personnel hygiene requirements, including clothing.

Premises:

  • Simple plan or description of manufacturing areas drawn to scale;
  • Nature of construction and fixtures/fittings;
  • Brief description of ventilation systems. More details should be given for critical areas with potential risk of airborne contamination (schematic drawing of systems). Classification of the rooms used for the manufacture of sterile products should be mentioned;
  • Special areas for the handling of the highly toxic, hazardous and sensitizing materials;
  • Brief description of water system (schematic drawings of systems), including sanitation;
  • Description of planned preventive maintenance programs for premises and of the recording system.

Equipment:

  • Brief description of major equipment used in production and Quality Control Laboratories (a list of equipment required);
  • Description of planned preventive maintenance programs for equipment and of the recording system; and
  • Qualification and calibration including the recording systems and arrangements for computerized systems validation.

Sanitation:

  • Availability of written specifications and procedures for cleaning manufacturing areas and equipment.

Documentation:

  • Arrangements for the preparation, revision and distribution of;
  • Necessary documentation for the manufacture;
  • Any other documentation related to product quality that is not mentioned elsewhere (e.g. microbiological controls about air and water).

Production:

  • Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters;
  • Arrangements for the handling of starting materials, packaging materials, bulk andfinished products, including sampling, quarantine, release and storage;
  • Arrangements for the handling of rejected materials and products;
  • Brief description of general policy for process validation.

Quality Control:

  • Description of the quality control system and of the activities of the Quality Control Department. Procedures for the release of the finished products.

Loan licence manufacture and licensee:

  • Description of the way in which compliance of Good Manufacturing Practices by the loan licensee shall be assessed.

Distribution, complaints and product recall:

  • Arrangements and recording system for distribution;
  • Arrangements for the handling of complaints and product recalls.

Self Inspection:

  • Short description of the self-inspection system indicating whether an outside, independent and experienced external expert was involved in evaluating the manufacturer’s compliance with Good manufacturing Practices in all aspects of production.

Export of drugs. –

Hope above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

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How to start Factory in India?

If you are going to start any Pharmaceutical, Ayurvedic, Cosmetic and Food & dietary supplements manufacturing unit and that requires more than ten workers then you have to register your manufacturing unit under Factory Act, 1948 also along with required licenses and documents required for starting pharmaceutical manufacturing unit, Ayurvedic Manufacturing Unit, Cosmetic Manufacturing Unit and/or Food & Dietary Supplements Manufacturing Unit.

First we will understand definition of Factory, workers and manufacturing process under Factory Act, 1948.

What is Factory?

“Factory” means any premises including the precincts thereof

  • whereon ten or more workers are working, or were working on any day of the preceding twelve months, and in any part of which a manufacturing process is being carried on with the aid of power, or is ordinarily so carried on, or
  • whereon twenty or more workers are working, or were working on any day of the preceding twelve months, and in any part of which a manufacturing process is being carried on without the aid of power, or is ordinarily so carried on

Who is a Worker?

“worker” means a person [Employed, directly or by or through any agency (including a contractor) with or without the knowledge of the principal employer, whether for remuneration or not], in any manufacturing process, or in cleaning any part of the machinery or premises used for a manufacturing process, or in any other kind of work incidental to, or connected with, the manufacturing process, or the subject of the manufacturing process [but does not include any member of the armed forces of the Union];

What is Manufacturing Process?

“Manufacturing process” means any process for

  • making, altering, repairing, ornamenting, finishing, packing, oiling, washing, cleaning, breaking up, demolishing, or otherwise treating or adapting any article or substance with a view to its use sale, transport, delivery or disposal, or
  • Pumping oil, water, sewage or any 3 other substance; or
  • Generating, transforming or transmitting power; or
  • Composing types for printing, printing by letter press, lithography, photogravure or other similar process or book binding; or
  • Constructing, reconstructing, repairing, refitting, finishing or breaking up ships or vessels;or
  • Preserving or storing any article in cold storage

Approval, licensing and registration of factories:

State government is authorized to make rule under factory act, so approval. Licensing and Registration process and requirements may vary state to state. Contact your state Concern Inspector under this act for detailed information regarding setting up factory in concern state.

1. State Government may makes rules:

  • Requiring, the submission of plans of any class or description of factories to the Chief Inspector or the State Government.

(aa) Requiring the previous permission in writing of the State Government or the Chief Inspector to be obtained for the site on which the factory is to be situated and for the construction or extension of any factory or class or description of factories

  • Requiring for the purpose of considering application for such permission the submission of plans and specifications;
  • Prescribing the nature of such plans and specifications and by whom they shall be certified;
  • Requiring the registration and licensing of factories or any class or description of factories, and prescribing the fees payable for such registration and licensing and for the renewal of licences;
  • Requiring that no licence shall be granted or renewed unless the notice specified in section 7 of this act has been given.

2. If on an application for permission referred to in [clause (aa)] of sub-section (1) accompanied by the plans and specifications required by the rules made under clause (ii) of that sub-section, sent to the State Government or Chief Inspector by registered post, no order is communicated to the applicant within three months from the date on which it is so sent, the permission applied for in the said application shall be deemed to have been granted.

3. Where a State Government or a Chief Inspector refuses to grant permission to the site, construction or extension of a factory or to the registration and licensing of a factory, the applicant may within thirty days of the date of such refusal appeal to the Central Government if the decision appealed from was of the State Government and to the State Government in any other case.

Process for Approval, licensing and registration for factory

Here occupier means any person who is owner, director, manager or any authorized person for running a factory. He has to give prior notice at least fifteen days before begins  to occupy or use any premises as a factory, sent to the Chief Inspector a written notice containing

  • The name and situation of the factory;
  • The name and address of the occupier; the name and address of the owner of the premises or building (including the precincts thereof) referred to in section 93;
  • The address to which communications relating to the factory may be sent;
  • The nature of the manufacturing process
  • The total rated horse power installed or to be installed in the factory, which shall not include the rated horse power of any separate stand-by plant;
  • The name of the manager of the factory of the purposes of this Act;
  • The number of workers likely to be employed in the factory;
  • The average number of workers per day employed during the last twelve months in the case of factory in existence on the date of the commencement of this Act.
  • Such other particulars as may be prescribed.

Hope above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

WHO Good manufacturing practices for pharmaceutical products

GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification.

GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products.

Under WHO-GMP: 

1. All manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications;
2. Qualification and validation are performed;
3. All necessary resources are provided, including:
  • sufficient and appropriately qualified and trained personnel i.e. Manufacturing Chemist, Analytical chemist, supervisor etc,
  • adequate premises and space,
  • suitable equipment and services,
  • appropriate materials, containers and labels,
  • approved procedures and instructions,
  • suitable storage and transport,
  • adequate personnel, laboratories and equipment for in-process controls;
4. Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided;
5. Procedures are carried out correctly and personnel are trained to do so;
6. Records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is implemented;
7. Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;
8. The proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practices (GDP);
9. A system is available to recall any batch of product from sale or supply;
10. Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence
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What is BIHRT? Is it legal to compound and manufacture BIHRT in India

What is BIHRT?

 

Bioidentical Hormone Replacement Therapy. BIHRT is the use of supplemental doses of hormones that have a chemical structure identical to the hormones that the human body naturally produces.

Query:

I have a query regarding the regulatory requirements of compounding pharmacies in India.
Do Bioidentical hormones come under the category of Ayurvedic medicines. Is it legal to compound and manufacture BIHRT in India as many wellness clinics are doing it already.
I would be obliged if you could help me with this query.

Response:
Bioidentical Hormones are Chemical Compounds that are similar to Body natural hormone. These are manufactured synthetically and FDA do not approve the word BIHRT. These are not Bio identical to hormones but totally synthetic and chemically prepared and come under Pharmaceutical Hormonal section and requires same criteria for selling, prescribing and manufacturing as of other natural and synthetic Hormones. They are manufactured under strict manufacturing regulations.If Wellness clinics are doing it. They shall be performing it under registered Dermatologists prescription and under guidance of registered pharmacist only. Proper licensing and approval is required from Drug Control Department. For compounding of any pharmaceutical product at pharmacy require prior approval from Drug Department.

Most probably chances are wellness clinics are using packed or finished good preparations of these hormones manufactured by pharmaceutical manufacturing companies under proper licensing and approval. Compounding possibilities at own pharmacies are very less in their pharmacies. In India, number of compounding Pharmacies are very less at present. Most of pharmacies only dispense medicines, not involve in compounding.

If you want to establish a compounding pharmacy then you will require a pharmacist. Compounding of any pharmaceutical preparation is underdone only against prescription of medical practitioners specified the reason of compounding i.e. unavailability of particular drug or shortage in market or commercial available drugs are not suitable with patients requirements. If similar product is available in market then compounding of that product can’t be done. Along with pharmacist, A area of ten square meter with additional space of six square meter for compounding of medicines per pharmacist and for addition pharmacists, two square meter per each pharmacist is required. And you have to apply for pharmacy license specifying compounding of drugs.

As per our knowledge, compounding of medicines are restricted to solid or liquid dosage form that don’t required any special environmental or temperature conditions i.e. sterile or low temperature storage etc. Hormones are sensitive preparations and could be spoiled at some temperature variation. Hence compounding of BIHRT is not legal in India. Only licensed manufacturer can manufacture it. But you can confirm it from Drug authorities while you will apply for compounding pharmacy license.

Hope Above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com
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