Query: We are a trading firm and now started to deal in the medicine area. It says we need to have a drug license but as we are B2B traders. We have registered a business at a residential address. For medicines also we need to be directly exporting from the vendor’s location. We are not planning to store the medicines.
How to get the drug license in this case?
Response: In that case if you want to indulge into business activity like billing i.e. take purchase bills from vendors and provide your sales bill to your customer then you will need a drug license. Taking a purchase bill means you have purchased medicines. Whether you stock or not – doesn’t matter, it’s considered that you have received medicine at your location. When you will bill medicine from your firm having gst number at your location, it is considered that you have dispatched medicine from your location. So, you will require a drug license.
For doing this business you will require to take a wholesale drug license. Check all details of taking wholesale drug license here
In case if you don’t take a purchase bill and don’t issue a sale bill i.e. you directly provide an invoice to your customer from your vendor then you will not require a drug license.
Query: Actually, one more issue is there. We are only traders i.e. we have IEC code and not everyone in India we plan to purchase medical things have IEC code. They only have drug license. When we contact some vendors, they say yes maybe they can supply some items but they do not have IEC code.
We have an IEC code and a local wholesale vendor has a drug license. Can there be something that can be done in mid?
There are so many criteria for drug license that it’s really tough to have that. Like we have a query of Insulin and Insulin Syringe right now.
Response: We understand that issue but can’t do anything with rules and regulations. You need to have drug license or wholesale vendor having drug license need to have IEC. If you are getting problem in taking drug license then ask wholesale vendor to obtain an IEC. Taking IEC (Importer Exporter Code) is not a big issue and easily they can get it within a week….
Other than no mid-way is possible. For conducting business of medicine in India, there is requirement of drug license and for exporting from India, there is requirement of IEC. And these both should be at single firm who are going to conduct business, not at different firms.
Query: We are about to finalise a deal of PPS. It’s medical equipment. Does it also require drug licence? It has to be sent by air transport.
I have read this-
“To export Pharmaceutical Products, the exporters are required to obtain Certificate from wild life protection board and NOC from Drug controller under certain items of chapter 30 of HS code (HTS code).”
Only the drugs made of certain chemicals need a drug license. Yes?
Response: All medical devices fall under definition of Drug. So, you will require drug license for it.
Certificate from wild life protection board is for the herbs export and NOC from Drug controller means here approval of medicinal product, you are going to export i.e. COPP (certificate of pharmaceutical product)….
These are the things which are required to export and for NOC from a drug controller, you have to submit your drug licenses copy and dossier etc but first you need to conduct business within India i.e. purchase a medicine from a vendor. And for that you will need a drug license…
Almost all drugs require drug license, not made up of certain chemicals…
Hope above information is useful to you…