Category: Rules and Regulations
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Meaning of IP/BP/USP | Licenses Required For Selling Over the Counter Products
Query: We are into Processed Food product business and operating under private our private brand. Now we are looking to foray into OTC-Healthcare segment specifically with Antacids, Pain Relievers Gel/Spray & Vitamin tablet. So going through internet for a query whether Above mentioned products requires any type of wholesale allopathy drug license because we want…
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National List of Essential Medicines (NLEM) 2022
Alphabetical List of Medicines in NLEM 2022 5-aminosalicylic acid (Mesalazine/Mesalaine) 5-Fluorouracil 6-Mercaptopurine Abacavir Abacavir (A) + Lamivudine (B) Acetazolamide Acetylsalicylic acid Actinomycin D Activated Charcoal Acyclovir Adenosine Adrenaline Albendazole Allopurinol All-trans retinoic acid Alprostadil Amikacin Amiodarone Amitriptyline Amlodipine Amoxicillin Amoxicillin (A) + Clavulanic acid (B) Amphotericin Ba) Amphotericin B (conventional)b) Lipid Amphotericin Bc) Liposomal Amphotericin…
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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…