What are the licenses required for a Hospital for Third Party Pharmaceutical Manufacturing Licensing?

Query:

First of all thank you for your extremely informative article “What is the difference between pharmaceutical loan licensing, third party manufacturing and pcd/franchise?”.

We are associated with a non-profit Hospital in West Bengal. We provide healthcare at lowest affordable cost to the poor and needy patients. We are in search of a system to reduce the cost of medicine as best as we can, certainly not compromising with the quality. In this regard I have gone through your above mentioned article. Now I have the following query:

What are the licenses required for a Hospital to get the medicines manufactured by Third Party Pharmaceutical Manufacturing Licensing? The Hospital will use those medicines under Generic Name, for own consumption only, and will not market to any other customer. Thank you and with regards,

 

Response:

Hospital or any other institution require third party manufacturing by owning wholesale drug license and GST number. If you want generic medicines, you don’t need to go through third party manufacturing. You can get generic medicines from any generic medicine manufacturers directly at very reasonable rates.

If you want to go into third party manufacturing. Read our article Third Party Manufacturing

Hope above information is useful to you…

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

how to start company and expand it more like MNC

Query:
I am M.tech in Biotechnology, currently working in pharmaceutical as Quality assurance, am hereby to sate that i am interested in pharmaceutical products so I want to start manufacturing pharmaceutical products. So I planed first to do marketing of pharmaceutical products with my company name and brand and if it runs well then I can plan to set up manufacturing unit. So i want your suggestions how to start company and expand it more like MNC companies. Kindly suggest me.

Response:
Process for starting pharma marketing company read here

For starting marketing company, you need to complete all documents as given in above link.

Starting marketing company with third party manufacturing is not a difficult process but most important prospect is selling that products. You can sell your company products from any marketing types we discussed in our article: Marketing types in pharmaceutical sector

For Expanding your company like Multi national companies,
  • First you have build a strong foundation.
  • Select area where you want to start in beginning.
  • Establish that area to expand your business in next area.
  • Expand step by step till you create good presence in market.
  • After that search for more investment in your company and cover many area’s in single time.
  • Slow and steady is best policy in beginning.

    Hope above information is useful to you.

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

Future of Pcd Pharma

Query:
I am planing to start work in PCD pharma Franchise. Please suggest me is it good in future or face in problem in future?


Response:

PCD pharma franchise is good option for sales and marketing professionals. If you are one of them , it is great option for starting pcd franchise marketing.
About Future of pcd marketing you can read in our article: Future of Pcd Franchise Marketing
Problems that you can face during franchise marketing as like:
Appointment of Distributors: It is an important aspect. If you have own wholesale drug license number and GST number then it’s not for you. But if you don’t have this necessities, then you have to appoint distributor for sale purchase and stocking of medicines. Appointing distributor will be an easy process if you are in sales or marketing and have good contacts with pharmaceutical distributors.

 

Building Good supply Chain: Read in detail at our article: How to develop a strong distribution network?

Prescription Generation: Most important foundation of pharmaceutical business. Most of Franchise marketing sale comes from prescription. This is the reason why most of franchise/pcd companies search for experienced sales professionals as their franchise/pcd partners. Read more at our article: How to sell through prescription?

Availability of products at essential counters: Here essential counter means chemist shops where a doctor’s prescription can possibly reach. Your all efforts will be useless if you can’t make availability of medicines at essential counters.

Regular Supply: You place order in company and they send you stock. You have stock for some times. But when your stock is about to finish, you have to re order the products. You have to consider transportation time and minimum re-order quantity to avoid out of stock situation. For regular supply, you also need company support because if out of stock problem occur from company hand then you situation automatically will become bad.

Corporation from Company Hand: Company matter the most. Company selection can make difference in your success and failure. Choose company with care. Read more about Which Pharma Franchise Company (PFC) or PCD Company will be best for association?

Payment collection: Business is money and money is business. A transaction doesn’t consider complete until payment is received. In Indian pharmaceutical market, payment collection from chemist is difficult process. Many chemists don’t give payment at time. So, you have to be careful while collection of payment.

More you can read at below links

Hope above information is useful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Do I need another wholesaler drug license for One Person Company?

Query:
I would like to inform you that I have wholesale drug license for a proprietor firm with the name “—————–“. I also have registered recently an OPC with other name. Both the firm are owned under my name. Kindly clear do I need another wholesaler drug license for OPC to start third party manufacturing and marketing ??
Also clear GST No.. Means whether two GST No. Or not.

Response:

Persons start marketing companies from two way: One by completing all formalities with the name of company like Wholesale Drug license, company registration, GST Number etc.

In second case, persons register company with another name and use drug license of other firms for sale, purchase and stocking of medicines.

First way is best way to start marketing company through third party manufacturing. You can also start with second option by using drug license of your firm. You have to make all transactions from you firm name. Receiving, dispatching, billing and stocking will be done through with your firm containing drug license number.

You will need two GST number. At your personal PAN card, only single GST number could be issue either for your firm name or company name. You need to issue PAN card of your registered company.

We will advise you to take wholesale drug license and GST number with your register company name and start third party manufacturing and marketing.

 

How to start business in Ayurvedic and Food Supplement Sector?

Query:
At the onset my sincere appreciation to your efforts in sharing vast knowledge through your website and encouraging willing persons to start their own business of pharma/ayurvedic marketing. It is rare to see successful businessmen to share knowledge and ‘secrets’ of their own domain.
1. I am planning to start my own marketing company and also sell products through online.
2. Planned product line:
Ayurvedic medicine
Cosmetic
Food supplements
Health foods
Organic foods etc.3. Would want to limit allopathic products to proteins, multivitamins, OTC products only.
I have following queries:
Query 1:
Is any DL or Food Licences required for “marketed by“…, for ayurvedic medicine and cosmetics, health foods and drinks, foods supplements, organic foods and other food products.

 

Response:

For sale and Marketing of Ayurvedic medicines and cosmetics(Not for medicinal use) Products, you don’t need any drug license number. For selling food supplements, you will require registration at FSSAI.

 

Query 2: Is it advisable to go “Marketed By” right from the beginning.

Response:

If you have some type of marketing experience in field or online then its ok to go in marketed by. If you are new then you should first take distribution of franchise of any company and start marketing first.

 

Query 3: What is the minimum investment required?

Response:

Investment depend at number of products, you launched as marketed by. You can presume fifteen to twenty thousand per products. But investment depend at cost per product. Read about Investment Required here

 

Query 4: How good is the idea to start online and personal selling before going through trade channel.

Response:
Selling online is good idea. It depend at your capacity to sell online. Selling online and through trade channel are two different thing. You need to concentrate at one thing with full attention. Read About How to Sell Online?

 

Query 5: What are minimum quantities or batches for various products – liquid, powder and capsule/tablet form in ‘private label’?

Response:
Minimum Order Quantity of liquid in Ayurvedic industry is 1000 pc plus packaging material security
MOQ for Powder is 1000 pc
MOQ for Tablets/capsule is 20000 cap/tab

 

Query 6: What is the cost of product approvals in ayurvedic, food supplement category?

Response:

Vary company to company and state to state. It is approximately 2000-3000/- per product

Query 7: What are minimum batch sizes supplied by you under ‘market by’ label?

Response:

As mentioned in point 5

Query 8: Terms and conditions for working with you as your distributor or pcd?

Response:

Flexible terms and condition based upon mutual discussion. Read about Term and Conditions Here

Read in detail about starting Food and Feed Supplement Company here
Hope above information is useful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Billing and Tracking Software for Pharmaceutical Companies, Distributors, Retailer and Hospitals

Here are the list of Accounting and Inventory Software for Pharmaceutical Companies, Wholesaler/distributor, Pharmacies and Patient record software for Doctors & Hospitals. Our clients face many problem during selection of software of his new firm. We decided to make a list of software that will help you to find you best suitable software for you…

 

1. Tally ERP 9: Advantage:
GST Ready

Powerful remote capabilities that boost collaboration
Easy to find qualified personnel
Easy to customise
Low cost of ownership via quick implementation, Tally Integrator, Support Centre.

 

2. Marg ERP 9: Marg software is the Accounting & Inventory Software which gives you 100% control on your business. Due to easiness, flexibility, self-customization options and time to time up-gradations are the major reasons behind its success. Comprehensive ERP solution for multiple location sales, distribution & manufacturing business to manage their entire down stream supply chains. The loosely coupled solution helps you to manage your chain network and take informed decisions from anywhere with complete visibility on your Business. GST Ready

3. Pharma Soft: A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Of all QMS regimes, Pharma Soft Sol Quality Management System Software deals with quality and sustainability and their integration.

4. Medismo Pharma: Medismo On Demand Healthcare Mobile CRM lets you report from anywhere. MR’s can Track Doctor Previous Call History, Stop False Reporting via GPS Tracking. Use the power of Medismo Pharma Mobile CRM to track your Medical rep locations and travel expenses sitting in Head Office.

5. SAP: Whether you just added five employees or are on your way to the Fortune 500, SAP solutions for small businesses and midsize companies provide you with the ability to act on data-driven insights in the moment. GST Ready

6. hCue Pharma: Type of Software: Pharmacy Management System. Key features include Cloud, SaaS, Muti-Store Inventory Management, Point of Sale (POS), SSL Encryption, Fully Offline Mode, Real-time Analytics, Intelligent Dashboard, Digital Payments, Pharmacy Mobile App – Android – Tab, Mobile & Web platforms, Hardware backward compatibility, Online Refills Reminders.

7. Inova Software: Inova offers the best out-of-the-box solution for partnering professionals business development, alliance management, scouting, licensing and R&D with industry-specific best practices built right into the software.

8. Logic Pharma: Invoicing, Accounting, Purchasing, Power Features, Security Features, Analysis Reports, Operational Reports, Profitability Reports

9. Pharma Care: Pharma Care is accounting software for Retail / Wholesale Medical business. It has unique features to satisfy all the special requirements of medical stores like billing, inventory management etc.

 

10. Medeil Plus: Medeil – Plus is Fully automated Pharmacy Management Integrated Modules for Invoicing, Merchandising,Purchasing, Receiving etc.

 

11. Kareo EHR: Kareo Clinical is surprisingly easy to use. Easy is to write notes and prescriptions, code encounters, and manage patients in our fully integrated, cloud-based EHR.

12. Open EMR: OpenEMR is the most popular open source electronic health records and medical practice management solution. ONC certified with international usage, OpenEMR’s goal is a superior alternative to its proprietary counterparts.

13. Open MRS: OpenMRS is a software platform and a reference application which enables design of a customized medical records system with no programming knowledge (although medical and systems analysis knowledge is required). It is a common platform upon which medical informatics efforts in developing countries can be built.

14. Free Med Forms EMR: The FreeMedForms project is a high quality medical software suite released in open source. This project is international, free, community driven and totally independent.

15. Go Frugal: Pharmacy software for single & chain stores providing valuable insights, strategic decision-making. You can also manage batch & expiry of drugs, home delivery tracking & management, integrated drug index book and many more time-consuming tasks with ease

16. Meditec: Accelerate care delivery with MEDITECH’s Web Ambulatory—a complete web chart that gives physicians instant access to all patient records and relevant information across the continuum, in one place.

17. Mircle Pharma: ERP Software for Pharma Retailers, Chemists, Druggists, Medicine Shops and Wholesalers, Hospital Dispensaries, Ayurvedic Medicine Dealers, Homoeopathy Drug Stores, 24 hour medical shops to maintain their stock accurately, Manage Financial accounts perfectly and generate customer invoices beautifully.

18. Pharma Assist: PharmAssist Solutions delivers you complete control of your buying decisions, driving efficiency into your business and freeing up your valuable time. If you want the power of a multiple linked to the speed and adaptability of an independent join the ever growing PharmAssist Solutions network of independents and benefit from this unique technological offer.

19. Practice Suite: medical billing software is uniquely designed to meet the demanding needs of medical practices, healthcare businesses, and billing services, for both ambulatory and non-ambulatory medical billing.

Eye/Ear/Nasal Drops Manufacturing and Eye Ointment Plant

Eye and Ear are most sensitive parts of our body. A minor mistake can become serious problem, so everyone should be careful during manufacturing and use. Here we are going to discuss some important inputs regarding manufacturing of eye/ear and nasal preparations. Strict aseptic and sterile conditions is required in manufacturing of these preparations. For knowing documents and licensing procedure for Eye/Ear manufacturing click here

 

Technical Staff:

Non Technical Staff:

  • Machine Operators
  • Helpers

Types of Eye/Ear/Nasal Preparations

  • Single Dose Preparations
  • Multiple Dose Preparations

Dosage form of Eye/Ear/Nasal Preparations:

  • Drops
  • Lotions
  • Ointments
  • Washes
Section Required:

  • Warehouse
  • Washing Section
  • General Production Section
  • Weighing, mixing and Transfer Section
  • Sterilization Section
  • Filling Section
  • Capping and Sealing Section
  • Labeling and Packaging Section

Equipments and Machinery Required for Eye/Ear/Nasal Drops:

  • Wax mixing vessel
  • mixing vessel / storage vessel
  • Transfer pumps
  • Vacuum pumps
  • Autoclav
  • Dry Heat Sterilization equipments
  • Eye/Ear/Nasal Drop Filling Machine
  • Capping and Sealing Machine

Procedure for manufacturing of Eye/Ear/Nasal Drops:

  • Dispensing of raw material (Active ingredient, Excipients, preservatives, vehicle etc)
  • Accurately Weigh and measured quantity should be dispensed
  • Sterilized Plastic or glass containers are used for filling drops
  • Prepare a solution of vehicle with adding active ingredients, preservatives, excipients and other substances
  • Make-up volume by adding more vehicles
  • Filter this solution for removing any foreign and suspended particle
  • Clarified solution is filled into final container
  • Next step is sterilization. Sterilization involves autoclaving, Filtration (membrane filter 0.22 µg pore size into sterile containers using strict aseptic technique) and dry heat sterilization (For non aqueous preparations)
  • Cover the container with breakable seal and Seal the container
  • Now sealed container go for labeling and packaging

Equipments and Machinery Required for Ointments:

  • Wax mixing vessel
  • mixing vessel / storage vessel
  • Transfer pumps
  • Vacuum pumps
  • Semi Automatic Tube Filling Sealing & Coding Machine
  • Automatic Tube Filling Sealing & Coding Machine
  • Sealing Machine
  • Labeling and Packaging Machine

Procedure for Manufacturing of Eye Ointments:

  • Dispensing of all ingredients included active ingredients, Liquid Paraffin etc
  • Small sterile collapsible tubes is used for filling of eye ointments
  • Prepare a sterile ointment base
  • Finely powdered active ingredient / sterilized concentrated solution incorporated into sterile ointment base
  • Fill the ointment into sterile tube
  • Seal, label and send for packaging

What could be the reason behind launching of two thousand ruppes currency notes?

Indian economy contains best brains in World. We are not enough to predict any thing but in democracy everyone has right to represent own views. RBI will have enough evidence to launch two thousand currency notes. Here we will try to assume few aspects that may be behind this decision.

Government can’t remove black money in single process. It would be series of processes. Few has been implemented and many is going to be implemented. We have to study the pattern of last 2 year’s finance related decision to take some idea about processes. First government emphasizes to open bank account under Jan Dhan Yojana. Under this scheme huge number of accounts has been opened. Then Government give a time limit for declaration of black money and suddenly Government bans 500 and 1000 currency notes. If we study these processes deeply, we find it like Sizing/Sieving/filtration phenomena.

In Sieving, numbers of sieve are used to classified different size of particles. Particles of biggest size are collected at upper sieve and particles of finest size are collected at lowest sieve. Banning of 500 and 1000 currency notes are definitely a sieve in sieving process. It is of any of one sieve that will separate particles of any particular size from others but it may be top most but can’t be lowest sieve. Lowest sieve is to come.

What will be next step, no one in condition to predict? High dimension notes are major reason of money accumulation due to easy storage and produces black money. Then how can government launch 2000 rupees currency notes after knowing all possibilities. Persons who have taken such a major step to remove black money from India can take such a silly step of launching 2000/- currency note. There will solid reason behind it or it may be part of next filtration process.

To understand it we can take an example, when some phone get spoiled what you do first. You purchase a second cheap hand phone or use an old phone available with you till you have enough money to buy new phone. That may be in case of current situation. Two thousand currency notes may be launched only for preventing currency crises and maintain enough money into market. Two thousand currency notes bears less manufacturing charges and can easily fill the currency distribution gap easily.

Why 2000 currency Notes?

  • If our prediction is correct, 2000 currency notes are going to be banned as soon as government meets new currency distribution target and economy becomes stable. Two thousand currency note’s launching decision is unpredictable and will be launched after going into deep discussion. There will be much reason behind it.
  • First and most important reason is to completely destroy value of 1000 rupees currency notes. Government want to create mind set, there isn’t any currency related to one thousand. This will helpful in removing any possibility of 1000 rupees circulation in market.
  • Second reason, two thousand rupees note’s manufacturing cost is half if we calculated manufacturing cost of two one thousand notes. Government will prevent manufacturing cost in only one case i.e. only to prevent currency crises. When this purpose will be sorted out, Government can taken step to demonetize newly launched two thousands notes.
  • Third, Persons who have black money and from any mean he will successful to convert it with new currency. He will definitely store it in form of 2000 rupees currency notes. At that time 2000 rupees currency notes banning will act as narrow sieving.

What it will be going to happen, we don’t know but what is happening is seemed to be good for our country future.

What will the effect of Demonetization at Pharmaceutical Sector?

What is Demonetization?Demonetization is an act of stripping a currency unit of its status as legal tender. Demonetization means when a country bans or replace its own currency to new currency of any value to fight against corruption and black money.

What will the effect of Demonetization at Pharmaceutical Sector?

First we talk about effect of Demonetization at new and upcoming Entrepreneurs in pharmaceutical Sector. Every Pharma sales and marketing professional know how to sell into pharmaceutical sector?

A new entrepreneur faces much type of difficulties during his start-up journey. One of main problem that are faced by them is cash bribe donated by big pharma companies in pharma ocean. You may be best idea for selling your product but you aren’t able to stand against cash transactions and money power. After demonetization, big pharma companies may have better resources than new comers but all entrepreneurs will have same cash strength irrespective to resources. It will be huge advantage for all new entrepreneurs. Not only in Pharma sector, but also in all sectors it will be applicable.

Cash is going to be out for a small period of time but it will  leave long term affect at our habits. Business is going to be easy with legal money but is going to be difficult with illegal money.Other Effects at Pharmaceutical Sector:

  • Rates of Medicines: As cash flow is going to diminish, all transaction will be done through banks and online. There will be accurate profit earning report at all steps. No one can take much profit as he has to show it in his ITR. It will indirectly cause cheaper medicines followed by legal invoicing & billing habits.
  • Prescribe for Cash: Prior ethic codes in pharmaceutical market have banned benefits taken by doctor from pharmaceutical companies in form of tours, conferences, gifts etc. Now demonetization will directly affect prescribe for cash habit. No cash, No Prescription is going to change forever. It will not only cause loss to big pharma companies but also for small entrepreneurs who were used to of this habit of generating prescriptions for them.
  • More regulated market: Only bank transaction will regulate pharmaceutical market at higher extent. Only twenty thousand rupees transactions are allowed to pay as cash against invoice. If no one will have cash then who will transact in cash. Every retailer and distributor transactions could be regulated by Government. There will be more control of drug department at every purchase and sale you conduct. Most of Retail and distribution transaction will be done through banks only.
  • Implementation of New Rules and Regulations: It will become easy for government to implementation of new rules and regulation as market is going to be more regulated. Without bill medicine availability were major concern for government to implement banning of illegal drugs and medicines.
  • Knowledge and Innovation based market: With removal of cash from industry, new innovations in pharmaceutical sector will be initiated. There will be requirement of new study and scientific proofs to convince doctors to prescribe medicines.

After ban of 500 & 1000 rupees currency notes, who will be the major suffer in pharmaceutical industry and who will be major gainer in sector?

For knowing the answers of above questions, we have to find who can have more black money in pharmaceutical sector. Pharmaceutical sector is operated through a chain of distribution channel such as

Pharmaceutical sector is one of the most profitable business and we have a good amount of black money possessing in lockers or bed or bags. Everyone in this chain will have some amount of black money. How to guess who will have more money in this circle? Company’s owners will have definitely great amount of money but they have highly paid CA and accounts, they can manage its some part though some transactions. C&F/Distributors/Stockiest will also have money with them. They can also adjust with some minor transactions. Now we come to retailers/chemists/pharmacies. Small chemist earn only as much as he can survive but big retailers earn huge money and without providing any bill to consumers. Most of chemists don’t even have sale tax number. They don’t have proof of any income. How they will manage? That’s the matter of thinking. They sell generic medicines at mrp getting hundred to thousand times profit. If talk about doctors, then we have many logics to explain many things. More than 80% doctors write prescription against cash. Now what happen to that deposited cash because you can’t exceed income from your last year income tax return.

What is the problem in depositing excessive cash in your account?

At every currency change and depositing, Income Tax Department and Government will have strict attention. Be sure before depositing money in your firm current account that you have enough cash in your account books. You can deposit cash in hand in your account as per your last sale tax return. Income you have shown in your return will be the basis of cash you can deposit in your account.

What to learn from this Demonetization by new Entrepreneurs?

Most important thing is Honesty is Best Policy. Businesses and persons who pay tax at time and declare their incomes accurately will not face any effect. Only persons who accumulate money by not paying tax and wrong means are only facing problems. Also remember, Change is only true in this World. Life and Business are also changeable. Sudden setbacks and surprises will be common things in entrepreneur journey. Prepare yourself for all unexpected things.

What category would the pain relief spray fall under? Whether need to obtain a drug license?

Query:

I have gone through your website and found it quite informative. Let me introduce myself.. I’m an IT Entrepreneur based in Kolkata and I’ve been in business for the last 16 years. I have recently tied up with a scientist in US who has developed a revolutionary formulation for a pain relief spray which is far more effective than any of those presently available in India. This is based on feedback I have recieved on samples I had supplied to some known people.
I’m interested in introducing this pain relief spray in the Indian market. Obviously, the manufacturing would have to take place in India to make the business a viable proposition. Now, as a 1st step towards getting started, I would like to get some information on the following:-

  1. What category would the pain relief spray fall under and whether I need to obtain a drug license?
  2. How long would it take to obtain a manufacturing license?
  3. Whether I should look at outsourcing the manufacturing to a 3rd party and concentrate only on the marketing? However, in this event, how do I prevent my supplier from using the same formulation and supplying the product to a competitor?

Please advise.

Response:

  • If Your pain relief spray contain pharmaceutical ingredients then you have to obtain license. If Formulation is herbal or ayurvedic, you don’t need to take any marketing license but will need manufacturing license pain-relief-spray.
  • If you want to take manufacturing license, you can read all requirements to start pharma manufacturing here. If you want to get manufactured this formulation at third party manufacturing basis, then you have to check whether manufacturers have approval for manufacturing this formulation or not. If Manufacturer don’t have approval to manufacture this formulation, then manufacturer has to apply to drug controller. In case it is new formulation and don’t have any approval in India at any company then you have to submit all safety and clinical data related to formulation to drug department for approval. Read about new drug here.
  • Easy way to stop your manufacturer to supply this formulation to competitors is to take patent of this formulation. Read procedure of patent here . Otherwise there is no way that you can prevent your supplier for making it for others.