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.
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.
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.
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…
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