The scope of the Pharma industry in India is immense and this industry is a hub of opportunities for those looking out for new avenues of investments. India’s pharmaceutical exports stood at US$ 17.27 billion in FY18 and are expected to grow by 30% to reach US$ 20 billion by the year 2020. Hence investing in the Pharma
Industry in India can be a profitable venture. But taking up any venture calls for the whole set of legal formalities to comply with and investment.
Similarly, starting a PCD Pharma Company in India calls for compliance with a lot of rules and regulations and terms. Let’s take a glance at the step by step procedure of setting up a PCD pharma company

• Chalk Out your business plan

A business plan is a blueprint that will guide your business from the very initial stage through the establishment and eventually business growth. It is a must for all new ventures. The type of your business plan would depend upon your finance requirement. If you want to seek financial help from banks or financial institutions then go for Traditional business plan. In this plan and if not, then a simple one-page business plan for you would suffice.

• Plan your Finances 

  No company can be established without finance. So, knowing an estimated cost of establishment and the source to fund your business is very important.

1. Put together all the expenses that you would need to make in a spreadsheet (include property buying or leasing cost, licenses and permits, equipment and machines, infrastructure and building premise, market research, inventory, branding, insurance). Also add to it the working capital that you would need for running the business for at least a year (eg marketing and advertising, employee salaries, travel expenses, etc). Adding all these expenses would make you arrive at the figure of the initial investment required.
2. Next step is to look for Ways to Fund your business, it could be through your own equity or debt from banks or financial institutions.

 

• Business structure

In the case of above 2 partners and below 50 partners, a company can be registered under private limited company or limited liability company and for the single proprietor, one can go for a one-person company.

• Decide a good Business Name

The business name plays a vital role in all aspects and is a silent ambassador of your company. Decide Brand names of all products and make sure that these don’t resemble any other brand already existing in the market

• Documentation, Licensing & Certification

Commencing a Pharmaceuticals Company in India needs licensing and approvals from various different authorities. Most of them are a one-time investment which may last a lifetime, while some may require renewal after a certain time period.

1. Drug License Number: Drug license number is necessary for every company to start distribution or marketing in India.
2. Company Registration: In case of above 2 partners and below 50 partners, a company can be registered under private limited company or limited liability company and for the single proprietor, one can go for a one-person company.
3. Food Safety & Standard Authority of India (FSSAI): Annual registration required.
4. Trade Mark: Trade Mark registration is necessary to safeguard one’s intellectual property. Trademark registration can be obtained for a business name, brand name, logo, tagline or caption, etc.
5. GSTIN: Pharmaceuticals and medical supplies in India are taxed at four separate rates of Nil, 5%, 12%, and 18%.

 

• Set up your Business location

Including your office and a warehouse for storage. Ensure that all the premises that you select should have adequate space and are established as per Govt. norms.

• Products selection and development

One can start a pharmaceutical company by getting manufactured one, two or three products. One doesn’t need to go with a big product list. Product selection is an utmost important prospect. Do proper research and prepare a list of all the molecules and combinations, you wish to launch in the market. Understand the market’s need and look for currently running & latest molecules those creating good market demand.

• Finalize third-party manufacturers

Send quotation for minimum batch size and minimum possible rates to as many third-party manufacturers as possible (as it helps you crack the best deal). Select the best manufacturer who can assure you timely and quality services. Third party or contract manufacturers, manufacture products for you in their factories and save you from the hassle of running a whole manufacturing unit.

• Place Your order with the selected Manufacturer

and make sure to send affidavit (specifying that the brand name of the product belongs to you and you will be totally responsible for any brand name or trademark conflict and manufacturer will not responsible for any conflict in future with respect to brand name or trademark). Manufacturers also ask for a scanned copy of your drug license number and GST number.

• Make agreements/contract with them

specifying the agreed terms and conditions and the other details about the deal.

• Start Building your Team

Make sure that you hire experienced people. Appoint only registered pharmacists and carefully select the whole sellers or super-distribution companies who would push your product in the market in the best manner.  You would also need MR to visit and promote your products to doctors.

• Promotion and Marketing

of the products and brand name can really turn around the sale game and make a company earn huge profits.

1. Design a good logo for your brand and choose it wisely as a logo says a lot about a brand silently.
2. Packaging and Labelling do more than just protecting and storing a product. They play a vital role in promoting and developing the image of a brand in a  market.
3. Prepare visual ads, product cards, and promotional materials.
4. Design a good website and run ads on the internet.

 

The medication of Branded-Generic drugs is created to be same as of already existing and marketed patent drugs be it in dosage form, safety, strength, route of administration, quality, performance characteristics, effectiveness and intended use of the drug. Branded-Generic drug makers certainly bring competition to the drug market because of their low-priced drugs. But still, some patients prefer using patented ones instead of Branded-Generic ones. Let’s look at the myths our population has in their minds regarding Branded-Generic medicines.

Myth 1: Many of you must have had this question quite a few times in your mind despite Branded-Generic drugs being cheaper assure you same quality and effectiveness as of patent drug how?

The fact behind this is Branded-Generic drugs are cheaper as compared to patent drugs because in that case, the manufacturers did not have to spend on the expenses of developing and marketing a new drug. Whenever a company introduces a new drug into the market, the company has already spent a substantial amount of money on research, development, marketing and promotion of the drug. All that the Branded-Generic drug manufacturers have to do is a basic level of marketing of the new Branded-Generic drug. A patent is henceforth granted to the firm that developed that very particular drug which further gives the company an exclusive right to sell the drug as long as the patent is in effect.

Myth 2: Branded-Generic drugs compromise on quality standards in the production phase.

It’s not true. The fact is the production of all Branded-Generic drugs follow the same quality standards for making, testing and packaging of drugs as the patented manufacturers do. In fact, sometimes, many Branded-Generic drugs are produced in the exact same factory where the patent drugs were produced following the same measures and standards as the patented drugs had gone through.

Myth 3: Branded-Generic Drug makers sell their products at slashed prices.

The reason why Branded-Generic drug makers can sell their product at lower prices is that their drugs do not compromise in terms of quality with patent drugs. Branded-Generic drug sellers sell at a lower price because they do not have to recover anything like their initial investment in research and development, clinical trials nor do they have to spend millions on tv commercials and marketing campaigns as the patented drug producers typically do. All they have done is spent an amount on the basic level of marketing of the newly launched drug. The Branded-Generic drug manufacturers can thus pass these cost savings on to their patients.

Myth 4: Branded-Generic drugs are not as effective as patent drugs.

It’s not true. Branded-Generic drugs have to prove bioequivalency with the patent drug showing that the drug works in the same manner in the human body as a patent drug does. Sometimes, Branded-Generic versions of the drug have different colors, flavors, or combinations of inactive ingredients than the original medications but don’t need to worry they have the same medicinal effects as patented ones.
As the expense of healthcare services keeps on taking off over the rate of inflation, Branded-Generics are an uncommon source of healthcare savings. As the above rundown shows, there’s no distinction in the adequacy or quality manufacturing standards among Branded-Generics and patented drugs. Surely, they are both frequently created in precisely the same generation plant under the very same conditions. While you may not feel any distinction in your body, you can unquestionably feel it in your pocket.