What category would the pain relief spray fall under? Whether need to obtain a drug license?

Query:

I have gone through your website and found it quite informative. Let me introduce myself.. I’m an IT Entrepreneur based in Kolkata and I’ve been in business for the last 16 years. I have recently tied up with a scientist in US who has developed a revolutionary formulation for a pain relief spray which is far more effective than any of those presently available in India. This is based on feedback I have recieved on samples I had supplied to some known people.
I’m interested in introducing this pain relief spray in the Indian market. Obviously, the manufacturing would have to take place in India to make the business a viable proposition. Now, as a 1st step towards getting started, I would like to get some information on the following:-

  1. What category would the pain relief spray fall under and whether I need to obtain a drug license?
  2. How long would it take to obtain a manufacturing license?
  3. Whether I should look at outsourcing the manufacturing to a 3rd party and concentrate only on the marketing? However, in this event, how do I prevent my supplier from using the same formulation and supplying the product to a competitor?

Please advise.

Response:

  • If Your pain relief spray contain pharmaceutical ingredients then you have to obtain license. If Formulation is herbal or ayurvedic, you don’t need to take any marketing license but will need manufacturing licensepain-relief-spray. 
  • If you want to take manufacturing license, you can read all requirements to start pharma manufacturing here. If you want to get manufactured this formulation at third party basis, then you have to check whether manufacturers have approval for manufacturing this formulation or not. If Manufacturer don’t have approval to manufacture this formulation, then manufacturer has to apply to drug controller. In case it is new formulation and don’t have any approval in India at any company then you have to submit all safety and clinical data related to formulation to drug department for approval.
  • Easy way to stop your manufacturer to supply this formulation to competitors is to take patent of this formulation. Read procedure of patent here . Otherwise there is no way that you can prevent your supplier for making it for others.

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