Category: Rules and Regulations

  • Schedule J: Diseases which a drug may not purport to prevent or cure

    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 J: Diseases which a drug may not purport to prevent or cure.- No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J.  No drug may…

  • Schedule G: List of substances included

    This article covers name of active pharmaceutical ingredients (api) come under Schedule G, Warning, pdf download link etc. 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 G Warning: Products or Substances that are included in this list should mention below lines at label: ‘Caution: It is dangerous to take this preparation except under medical supervision’ – conspicuously printed and surrounded by…

  • Schedule D, D(I) and D(II): Import of medicinal substances in India

    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 D:   Schedule D describe the requirement and formalities to import medicinal substances in India. Some Highlights of details covered under Schedule D is: 1. Substances not intended for medicinal use All provisions of Chapter III of the Act and rules thereunder subject to the condition that if the substance is imported in…

  • Schedule E and Schedule E(1): Poisonous Substances under Ayush System

    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 E was omitted in 1982. Schedule E(1) contains the list of poisonous substances under Ayurvedic (including Siddha) and Unani System of Medicines. Schedule-E (Omitted) Schedule-E(1) List of poisonous substances under the Ayurvedic (including Siddha)  and Unani Systems of Medicine Ayurvedic System:  Drugs of vegetable origin: Ahipena (Papaver somniferum Linn.)  Arka  (Calotropis gigantea (linn.)R.…

  • Schedule B : Fees Required to Pay for test or analysis by CDL/SDL

    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 B: Schedule B Describe the Fees required to pay for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Few Tests that are covered under Schedule B are as Follow: Section 1:  Drugs Required for use of Animals Microbiological Tests and Assays Identification Tests Physical Tests Assay Polymorph Tests Drugs…

  • Schedule A: Forms, applications and Licenses

    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 A: Schedule A describes the format of form used for various licenses and approvals under Drug and Cosmetic Act & Rules. FORM 1: Memorandum to the Central Drugs Laboratory FORM 2: Certificate of test or analysis by the Central Drugs Laboratory FORM 3-7: Omitted FORM 8: Application for licence to import drugs (excluding…

  • List of Banned Drugs for Manufature, Sales and Distribution in India

    There are number of drug that are banned for manufacture, sale and distribution in India. Here we are presenting a brief list of banned drugs in India for our readers: All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.  Amidopyrine  Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal. …

  • List of Refrigerated Drugs and Medicines

    Query:   I am B Pharma from Ahmedabad. I am will to setup wholesale/stockist for the refrigerated drugs. Will you please help me which drug come in these criteria and how to communicate with company’s . And what condition is required for those drugs   Response: Refrigerated drugs are the drugs/medications which are required temperature…

  • Do I need another wholesaler drug license for One Person Company?

    Query:   I would like to inform you that I have wholesale drug license for a proprietor firm with the name “—————–“.I also have registered recently an OPC with other name.Both the firm are owned under my name.Kindly clear do I need another wholesaler drug license for OPC to start third party manufacturing and marketing…

  • 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…