Secrets behind approval charges for Pharma Third Party Manufacturing

Query:  

I am very confuse about Start marketing Pharma company. Please guide about Third Party Manufacturing, Whole sale License & Brand name approval Cost.

I was various third party manufacturer are told about product permission cost is per Product of Rs.30000/-Approx. Kindly provide complete details of Product Permission Cost.

Response:

Read about third party manufacturing here

At present Brand name approval is not issued by drug department. Product permission at present is issued at generic names. Manufacturer gets approval at generic name of medicines like if a product with name “abc” having active ingredient paracetamol in it then manufacturer will get approval to manufacture paracetamol. Manufacturer have to take approval once and can manufacturer it for various brands. Most of manufacturer’s charge 1500 to 3000 per product as approval charges.

Above is for general products. If your product is a new molecule or contains any of new molecule in product or product is not approved from DCGI then manufacturer has to take approval from dcgi. That cost nearly 15000/- per product. That’s the work for manufacturer and in most of cases cost of approval is bear by manufacturer itself. In some special case, manufacturer don’t have approval of products and they charge from marketing companies for approval of products.

In you case may be your product come under dcgi approvals and manufacturer’s don’t have approval for products manufacturing. For approval they are asking to you about 30000/- per products approval.

Read in detail about pharma products approval here