Category: Rules and Regulations
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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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Does Small quantity require Ayurvedic manufacturing license?
Query: If I want to manufacture Ayurvedic product according to Ayurvedic doctor for dispense purpose only, not for sale. Does it require manufacturing license ? Please guide me. Response: An Ayurvedic doctor has permission to manufacture Ayurvedic product as per his need, not for sale without any manufacturing license. If you are doctor or…
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Schedule U: Manufacturing records
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule U: Schedule U describes the particulars to be shown in manufacturing record. Following details are included in Schedule U: 1. Particulars to be shown in Manufacturing Records: Substances other than Parenteral Preparation in General Parenteral Preparations 2. Records of Raw Materials 3. Particulars to be recorded in the Analytical Records Tablet and…
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Schedule M: Good Manufacturing Practice
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule M: Schedule M describes Good Manufacturing Practices and Requirements of Premises. Schedule M provides the insights to achieve the objectives listed in schedule, each licensee shall evolve appropriate methodology, system and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production…
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Schedule K:Exempted Drugs, Conditions and extent of exemption
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule K: Schedule K describe the exempted drugs, conditions and extent of exemption from all the provisions of Chapter IV of the Act and the Rules there under subject to the conditions. The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the…