How To Set Up A Pharmaceutical Manufacturing Plant In India – Looking for a legal procedure to set up a Pharma manufacturing factory in India? Want the steps to start a pharma manufacturing company in India? Pharma manufacturing is one of the popular ways to attract good benefits. If you have good investment and capital creation power then pharma manufacturing is the best. In this article, we are going to share our insights on how to set up a pharmaceutical manufacturing plant in India.
Steps To Start Your Own Pharmaceuticals Manufacturing Company and Plant In India
Pharma industry is one of the fastest-growing industries in India. Our Indian pharma industry boosts 3rd largest generic manufacturing. The generic drugs share 72 percent of the total production. Here take a look at the steps on how to setup a pharmaceutical manufacturing plant in India.
Selecting Unique Name, Types and Nature Of Manufacturing Units
Select a unique name for your manufacturing company. You can use your existing company name if you already have a pharma company. The name should be catchy, attractive and simple to remember. Make sure that you use a unique name for you manufacturing company or plant.
After fixing a name, you need to select the type of 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 and Unani. Here is a list of types of manufacturing companies in India:
- Ethical/ Branded Pharma Manufacturing Company
- OTC (Over The Counter) Pharma Manufacturing Company
- Generic Pharma Manufacturing Company
- Pharma Manufacturing Export Company
- Pharma Manufacturing Import Company
- Derma Medicines and Products Manufacturing Company
- Pharma Distribution and Hospital Supply Manufacturing Company
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 upon you which one you want to start. The unit section includes the following:
- Medical/ Surgical Device
- Ophthalmic or Ear/ Eye/Nasal Drops
- Parenteral (Dry or Liquid Injections)
- Powder (Supplements and Pharma powders like protein powders, medicated powders)
- Spray/ Inhaler
- Suppositories Section
- Tablets/ Capsules
Registration Process Of Manufacturing Plants in India
Once you have decided the type and nature of pharma manufacturing company, let’s start with 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.
The type of entity whether Small, Medium or Micro, get environmental clearances, you can benefit yourself by registering for MSME certificate. The MSME certificate can be provisional or on a permanent basis. Applying for the provisional certificate is advisable if you are newly opening a manufacturing unit or factory. Status of the enterprise for manufacturing industry under MSME Act:
- 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
Steps To Acquire A 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.
Licensing of Manufacturing Company or Plant
Licensing is important. The grant of Drug and Cosmetic manufacturing license is important. Food and Drugs administration provides manufacturing license. The licenses need to be approved by the Central Licensing Approving Authority i.e. Drug Controller General of India. The payment of necessary fees can be made through the available mode of payment i.e. bank challan.
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)
- Blood & Blood Products Vaccines & Sera fill-in form 28C & 28D.
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 and machinery.
- 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, Delhi.
The Pharma manufacturing industries lay different requirements for allopathic, ayurvedic and neutraceuticals. The submission of a list of drugs related to them differs (this could be in the case from state to state). Make sure you ask a higher authority for better clarity about the full requirements that you will need to submit along with the form.