What are Over the counter Products? How to start OTC (Over the counter) related products distribution?

What are the OTC products in pharmaceutical industry:

OTC products ( also known as over the counter products) which can be sell out without prescription by pharmacies or chemist. These products doesn’t come under schedule”H” drugs. Most commonly otc products are protein powders, multivitamins, pain gels, fungal infection creams etc. These products also includes cosmetic, food supplements and Ayurvedic/Herbal products.

At present anyone can get anyone medicine from chemist but this practice is not ethical. All schedule ” H” drugs can’t be sell out without prescription of registered medical practitioner. Only medicines out side schedule H can be sell as OTC products.

Query related to Otc products:
Query 1: How to start OTC products distribution in own brand?
Query 2: Which type of products could be promoted as OTC in pharmaceutical market?

Query 1-A:
I am looking to start OTC (Over the counter) related products distribution in our brand. Please info me. how should I start?

Response:
Please find the steps for starting your otc products company:

Step 1: Choose Company Name
Step 2: Choose molecules list and their brand names of products you want to launch in otc.
Step 3: Apply for drug license number and TIN number
Step 4: Apply for Trade mark registration of Company Name and Brand Names( Optional – Skip in starting)
Step 5: Private Limited Company registration (Only applicable If two or more than two partners is starting company)
Step 6: Third party manufacturing of your products

Above details is of documentations and licenses. Other than these, you may require to set-up your office and staff

After that you can start distribution and marketing of your brands. OTC products ( Over the counter products) are the products which don’t require medical practitioner’s prescription to sell medicinal products to the customers by chemist or pharmacies in pharmaceutical market. Your main customers are patients or person who are in need of that products. Chemist and pharmacies also play important role in otc marketing. They play important role in changing customer’s mind set and some time they substitute other brand with your brand. Your relationship and links will also provide you support during your distribution. Start otc distribution from your known chemists first.

OTC marketing is expensive and time consuming process. It requires advertising and promotion with good customer care support and good back up by sale team. If you don’t have much money for ad and promotion, you can start with door to door marketing till you start to earn enough for advertisement and promotion.Here Door to door marketing means chemist/pharmacies to chemist/pharmacies marketing. Chemist Chemist will give to customer and if customer will get good result, it will get back to chemist with same packing or brand name. This is the first sign of otc when customer start to ask for your brand. Customer demand create otc branding.

If you have good amount of money, you can invest it for advertisement and promotion of your products. Start with small advertisement budget and increase it as it produces results. You should have proper home work and plan for otc distribution. If you don’t have then there is minimal chances of success. You have to be patience during this process because it is time consuming process. It takes time to capture market in otc segment. You can start with single product or launch few products but in starting start with minimum products in otc section.

Query 1-B:

Thanks for your valuable information . We have tin, cst & drug licence .We are looking start with two products .
In allopathic:
Aceclofenac + Paracetamol tab
Diclofenac gel
In ayurveda – We looking pain relief gel and cough syp
From where we can manufacture. How can we get minimum quantity.

Response:

Any Pharma Third party manufacturing company can provide you these two pharma products. They are very common products and We think, these will be available to every manufacturer. For aceclofanac + paracetamole, you don’t have to invest more but for diclofenac gel, you have to invest in lami tube. Most of lamitube manufacturer make not less than 10000 tube at single time. Packing material investment will be high for gel segment. Packing material detail you can read here

In Ayurvedic Products, cough syrup will have less investment and pain relief gel will also follow the same lami tube procedure. We have own ayurvedic third party manufacturing plant and can arrange for Ayurvedic Third party manufacturing of your Products.

Pharma Third Party manufacturing service we provide but we don’t have own pharma manufacturing facility. We facilitate products manufacturing from other manufacturers.

Query 2-A:
First of all thanks for making such page for help in pharma.
I am running a pharma PCD company.
I want to know that is there any special govt. Permission required to advertising my OTC combinations.
I have pain relief gel, cough syrup in my product list.
Can I display their posters at medical stores and other places.

Response:
Thanks for your appreciation too. Your appreciation is our motivation.

For advertisement of otc products, you don’t need any prior permission from Government but your product doesn’t fall in Schedule “H” Category. You can’t advertise products bearing Schedule “H” warning. These products can’t be sell out without prescription of registered medical practitioner.

Pain relief gel is not Schedule H product. You can promote it without any prior government approval but in case of Cough, you will have to check composition of your cough syrup. If it contains molecule or molecules which comes under schedule H, you can’t advertise it. You can advertise cough syrup having non schedule H molecules like Torex and Benadryl etc.

Other than above, in case of video advertisement, you have to seek A-certification from authority look after advertisement and commercial advertisement in India. For advertisement at new paper and book, you not need any prior approval. For products other than schedule H drugs and medicines, you can display postures at medical stores and other places.

Query 2-B:
Thanks for your valuable support.
One little more advice required is that, please go thru the attached artwork of my pain relief gel.
However schedule H is not written on the same but warning is there.
Please advice is any amendment is required in the same or not for running as OTC,

Response:

You can sell it as OTC products.
You could amend two line:
You can amend: Direction of Use and Warning: Not for veterinary use
At OTC product, one should write minimum of matter . Mention only which is must. Highlight only that part of product to which customer want to see. Other parts should not be highlighted.

Hope above information was useful to you…

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

6 Replies to “What are Over the counter Products? How to start OTC (Over the counter) related products distribution?”

  1. As suggested above i had all the basic requirements to start OTC products,now iam searching for third party manufacturer and i have the following concerns,Could you pl. clarify

    1.Once we identify the third party manufacture is it required to register third part manufacturer name in the manufacturing license ?

    2.Can we mfg multiple pdt under one third part manufacturer
    3.Is ti required to generate any stability data when we started first batch manufacturing at the identified third party?

  2. 1. Third party manufacturer will have own manufacturing license. You have to mention that manufacturing license number and name/address of manufacturing company at packaging of products along with your marketed by address.

    2. You can manufacture any number of products from one third party manufacturer.

    3. Generally Certificate of Analysis (Test Report) is required. Stability data is required mostly in case of new molecules.

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