How To Start A Pharmaceutical Manufacturing Company
This article covers the procedure to set up a pharmaceutical manufacturing company in India. you know pharmaceutical sector is most growing sector in all industry and there is lot of opportunity.
The profit ratio in pharma sector is very high in comparison to other sectors. So, that lot of people attract towards pharma sector. It is a highly sensible sector because it is related to life of human being. So, that there is lot of restriction, policies and guidelines, licensing follows in setup of pharmaceutical company. these limitations are very high in comparison to any other field manufacturing unit. Before starting a manufacturing unit you should have to understand the basics and in which section you want to start manufacturing. So, that selection is too much important in pharmaceutical manufacturing unit or pharmaceutical manufacturing company. Lot of capital and investment is required to setup a pharmaceutical manufacturing company in India.
A Pharmaceutical Manufacturing Company having lot of sections like
- Tablet
- Capsules
- Liquid
- Cream
- Injection
- Parenteral (Dry or Liquid Injections)
- Vaccines e.g for hepatitis,
- Opthalmic or Ear/ Eye/Nasal Drops
- Inhaler
- Spray
- Powder (Supplements and Pharma powders like protein powders, medicated powders)
- Suppositories Section
- Surgical
- Medical devices and Implants
- Blood Products Vaccines
- Cosmetic and Daily use products
Some regulations are present necessary for a pharmaceutical manufacturing company
- Factory Act regulations
- Good Manufacturing Procedure Requirements ( i.e. WHO: GMP, Schedule M or applicable in concern country)
- For export of medicine different approvals required from different authorities depend on the country requirement. But now a days PICS is mostly accepted by most of the countries.
Benefits of Pharmaceutical Manufacturing Company:
- Ethical/Branded Medicine Company
- Generic Medicine Company
- OTC (Over the Counter) Products And Medicine Company
- Pharmaceutical Distribution and Hospital Supply
- Export Of Medicines
- Import Of Medicines
- Medical Devices and Implants Like Use in ortho, dental , eye , heart surgery,
- Surgical Dressing Company Products Like cotton, crape bandage, bandage, syringes,
- Parenteral Fluid Companies Like manufacture DEXTROSE , RL , NORMAL SALINE, MANNITOL etc.
How to get the profit and benefit from pharmaceutical manufacturing company-
- Third party manufacturing
- Contract Manufacturing
- Loan license manufacturing
- Own marketing and Distribution Channel
Any pharmaceutical Manufacturing company required two type of cost i.e.
- Fixed cost
- Running cost.
Fixed cost means premises like building, land, infrastructure , manufacturing machines, packing machines and finishing-furnishing etc.
Running cost is monthly expense of company to run a unit like men power and salaries of staff, purchasing of raw material, rent, promotional and marketing expenses etc.
It’s very difficult to calculate exact investment theoretically because it depends many factors like area, cost of land, location, investment in the approvals for start a unit,type of product manufacture in company, country requirement, rent, machinery and equipment cost at that area, salary of employees and workers etc. For calculating these factor we should have to make a plan, which include the above factors and calculate the cost step by step. As a good businessman we should have calculate above factors for running a good manufacturing unit.
Tablets and capsules block:
Sieves, Blender, granulator, fluid bed dryer, colloidal mill, tablet compression machine, capsule filljng machine, coating pan/ auto coater, tablet packing machine(blister/ strip)
Liquid block:
Mixing tank, filling tank, filling and sealing line, visual inspection line, labelling and packaging machine.
Note: it is such a big topic that it is near to impossible to contain all the critical aspects in one answer. I have tried to give a brief idea about the process.
Selecting Unique Name, Types and Nature Of Manufacturing Units
For the name of pharmaceutical manufacturing company you shold have to choose a good, unique and catchy and simple to remember. Even you can use your existing company name if you have a pharma company. The name should be meaningful, attractive. After selecting a name, need to select the type of pharmaceutical manufacturing company or plant you want to open. The manufacturing companies can be a part of anyone or a combination of drugs. This includes
- Allopathy
- Ayurvedic
- Siddha
- Homeopathy
- Unani
Drugs and Cosmetics involving Allopathy, Ayurvedic, Siddha, Homeopathy, Unani manufacturing have to fill-in forms 25, 28, 25B, 25C,25D, 32 and 36. (The types of license and forms vary from state to state in India)
The manufacturing plant offers a wide range of dosage form. You can start by setting up a single section or unit or a different section of the dosage form. It depends on the what you want to start.
Approval, licensing and registration of factories:
After deciding the type and nature of pharma manufacturing company, you can go to start the legal procedure. It is compulsory for all companies to be registered with the registrar of companies under Companies Act, 1956 or Companies Act, 2013. In case you are a partnership firm, then register for Limited Liability Partnerships (LLP) under Partnership Act, 1932.
SSI / MSME / DIC Registration (MSME- Micro, Small and Medium Enterprises, SSI= Small Scale Industries)
MSME registration is purely optional for all factories and manufacturing companies. MSME certificate grants you wide opportunities and benefits. You can get loans easily under priority sector lending. You can pay less interest on loans, benefits of exemptions under tax laws and much more.
- Micro: Does not exceed Rs. 25 Lakh
- Small: Exceeds Rs. 25 Lakh but does not exceed Rs. 5 Crore
- Medium: Exceeds Rs. 5 Crore but does not exceed Rs. 10 Crore
Starting with land acquisition, you need to have permission from respective ministry. You have to apply for opening a manufacturing unit and submit mentioned fees and documents along with the blueprints. You have to also take permission from pollution board for the same.
Then the construction begins. You have to ensure that the rooms and blocks are logically constructed so as to facilitate a proper flow of materials( It is well taken care by the project management group). During this you can hire a architect for make the things easy.
After the construction is completed, establishment and validation of machines is necessary.
After the equipment and area validation is completed, you can start manufacturing (provide that you have taken permission to manufacture drug products from the state health and family welfare department). Requirement of machines depend upon the type of operations to be performed, different machines are required for different type operations. for e.g. – for tablet and capsule different machines required.
List of Important Documents :
- A copy of fee receipt or Bank challan.
- Details of the competent technical staff for manufacturing and testing of drugs and cosmetics (mention educational qualifications and experience certificates). A copy of consent/ approval letters for full-time employment.
- A copy of approved layout plan (as mentioned above).
- Rent agreement, purchase documents or documents showing the ownership of the premises.
- Purchase bills of equipment, machinery and other appliances.
- Copy of original Incorporation Certificate of manufacturing company, Partnership Deed, AOA & MOA (memorandum and article of Association)
- Full name and the authorized signatory of the authorized person or partners or directors.
- Permission from State Pollution Control Board for setting a manufacturing plant.
- Site Master File as per paragraph 29 of Schedule M.
- Letter of loan license (If)
- Municipality/ Panchayat authorizes conformity certificate (NOC certificate) to construct or start a manufacturing unit.
- In the case of New drugs (as mentioned in Rule 122 E of Drugs and Cosmetics Act 1945 you will need clearance from Drug Controller General of India.
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.
Steps to Acquire A Pharma Manufacturing License
Set of terms, condition, rules and regulations have been passed for setting up a pharma manufacturing factory in India. It has been done to provide quality, safe and pure formulations. The requirements may vary state to state. Here are the steps to get a manufacturing license:
- Fulfill requirements as per Drugs and Cosmetics Act 1940 for manufacturing premises.
- 3 blueprints of the layout plan of the premises have to be submitted to the concerned Licensing Authority. You will need to submit 4 copies in case you are manufacturing blood products and vaccines sera.
- The layout plan will be scrutinized by a panel of offers. An inspection can be carried for approval whether the layout is accordance to Drugs and Cosmetics Act 1940.
- Once the layout is approved, you will be given an approved copy of it.
The Pharmaceutical manufacturing companies required different requirements for allopathic, ayurvedic and neutraceuticals, unani, siddha , homeopathy. Once meet with a higher authority for better clarity about the full requirements that you will need to submit along with the form because requirements differ from state to state.
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