Do will Require Drug License for B2B Medicine Sale?

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 […]

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What are Drug and Cosmetic Act, 1940 & Rules, 1945?

The Drug and cosmetic Act, 1940 is an act to regulate import, manufacture, distribution & sale of drug and cosmetics.  The Drug and Cosmetic rules, 1945 made under the act prescribe statuary requirements for grant of license to manufacture for sale and distribution of drug to ensure safety, efficacy and quality of drugs manufactured and […]

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Steps involved to register the herbal medicine

Query: This is with regards to the herbal products and registration. I would like to know to steps involved to register the herbal medicine. Response: Herbal Medicines and Ayurvedic Medicines are synonyms in Indian Market. Herbal Medicines are manufactured by same way and under same manufacturing license as of Ayurvedic Medicines. Herbal Medicines could be […]

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Renewal Omitted: No Need for Renewal of Pharmaceutical Drug Licences and its Effect

With effect from new amendment in Drug and Cosmetic Act, 1945, you will not need for renewal of your drug license in future. If you have Retail/Pharmacy, Wholesale/Distribution, Loan or Manufacturing License Form* for pharmaceutical and cosmetic preparations then you will have no need to renew it. You only need to deposit license retention fee […]

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How many years the Schedule H1 Medicines Record To Be Kept Stored

Query: I have some queries 1. What are the details of a patient and doctors has to be noted and to be keep in record ? If possible please attache specimen sample2. For How many years the Schedule H1 Medicines Record To Be Kept Stored?3. Is only purchase bill of schedule H1 drugs is to […]

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Do Ayurvedic Products require any license to sell at own Clinic?

Query:   I am a BDS doctor, I want to sell ayurvedic drugs from my clinic do I need any licence or any Pan card etc.. How much investment required for PCD marketing company. Response: For selling Ayurvedic Products at your clinic, you will not require any drug license…Investment to start pcd marketing company depend […]

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Is there any need of Drug License for OTC products supply?

Query:   I saw your pharma blog website. I have gone through details. I have question. I want to start dealing in OTC Products as a supplier in Hospital. I have GST. I have registered as a proprietor. Some one told me , for OTC Products I don’t need any drug license. May I start dealing in […]

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Temperatures and Storage Conditions to be maintained in the Pharmaceutical Establishments

Query:   Myself ———–, a final year student of B.Pharma. I would like to setup a wholesale & retail business after I pass out. But unfortunately I have failed to acquire much guide regarding the temperatures that are required to be maintained in both the pharmacy retail shop & wholesale storage warehouse for storing medicines. […]

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How to register new Ayurvedic Formulation before launching in India?

Query:   Reference to your blog http://www.pharmafranchisehelp.com/where-to-register-your-pharmaceutical-ayurvedic-products.html, I’d like to know few things related to ayush laws. I am basically going to start my own Ayurvedic manufacturing plant and launch several ayurvedic products. I have few questions related to regulatory part:I want to formulate a dietary supplement with an imported ingredient, which is not currently in […]

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Excise Duty exemption for Pharma Companies

Query: We are small scale pharmaceutical manufacturing (formulations) company situated in rural area in Punjab. Please clarify the following with specific notifications 1) Turnover (sale upto 150 lakhs) for the purpose of excise to be calculated on 65% of MRP or based on actual billing price as per invoices. 2) VAT to be charged on 65% of MRP or […]

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