How to Register Pharmaceutical and Ayurvedic Products before Launching in Market?

Query:I am ———, looking for the launching the Pharma/Ayurvedic products in Indian local market manufactured by Indian Manufacturer it self.
Want your guidance on below points;

  • Is it require to register the pharma/Ayurvedic products manufactured in India itself prior to market. 
  • If yes, then who will apply for the registration (Marketing company or Manufacturer) 
  • Approximate time & fee’s require for the registration. 

Looking for your response.

Response:
Point 1:

Pharma/Ayurvedic Products could be registered in two form. One is under Drug department for pharmaceutical products or Under Ayush Department for Ayurvedic Preparations. This process is known as Approval. Second is Brand Name Registration under Intellectual Property Act. This process is known as Trade Name or/and Brand Name Approval.
Every Manufacturing companies charge nearly 2000/- per product as approval charges. This process is done by manufacturing companies. Few years back, drug department (Pharmaceutical Products) provides approvals with both brand names and generic names(Salt/s name). But that brand name approval was misused by companies during trade mark registration and . Then drug department changed their guidelines and started providing approval by only generic names. This became very useful to manufacturing companies and they didn’t require any approval separately for every brand it manufacture. Now Manufacturer has to take generic name approval once and can manufacturer approved combination for any marketing company without any further approval. That is manufacturer work to get approval of any salt or combination to manufacture it before manufacturing it.
Ayush department (Ayurvedic Products) provides manufacturing approval for combination of herbs in case of patented and proprietary Ayurvedic medicines. Necessary supporting documents regarding efficacy, safety and other combination justification have to be attached with product approval file. For approval of these, department has issued particular guideline. If a Ayurvedic manufacturer wants to manufacture a already approved formulation for any marketing company then only brand name approval file has to be submitted to Ayush Department. Ayurvedic products that come under classical preparations don’t need any documentation support to get approval for manufacturing by Ayurvedic manufacturer and is to be issued by Ayush department without any objection. Marketing companies don’t need to take brand name approval for classical preparation becuase it’s not possible to change in classical name, composition, indication etc at label. Only Logo of marketing company and marketed by address could be changed.

Now come to brand name, Brand name registration under trade mark is your responsibility. It comes under Controller General of Patents Designs and Trademarks. You can get registered your trade name( brand name) at nearest office of controller office. Read more about registration of brand name in this article: trade mark registration. Brand name is your property and manufacturer will not have any responsibility or ownership related to your products name.

Point 2:

Registration and Approval to manufacture any salt/molecule and combination of molecules is responsibility of manufacturing company but charges will be paid by marketing company if any new or/and special product approval is required. And Registration of brand name and all conflict related to resemblance of brand name with other companies products is marketing company responsibility.

Point 3:
Most of Manufacturers have common molecules or combinations pre approved for manufacturing or they are already manufacturing many molecules or combinations for other companies. If you have new or different molecule or combination that is not approved for manufacturing by manufacturer. Manufacturer could take approval within month if drug department has no objection to manufacture it.

In case of Ayurvedic products, Ayurvedic manufacturing companies can only manufacture pre approved herbs combinations. If they want to manufacturer any new combination of herbs, they have to follow process as per ayush department guidelines. Generally they need clinical trial report of atleast three months approved by minimum of two registered BAMS doctors or as per guidelines.

Trade Mark registration is long process. It takes not less than 1.5-2 years. But you have to apply once. Other process is done by trade mark office. Your brand name will registered if it will cleared all formalities related to their guidelines. At present fees is —-/- per products.

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

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