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 Schedule Y Amendment: Application for Permission


 

 

 

Schedule Y refers to requirements and guidelines to be followed in order to attain permission of importing and/or manufacturing New Drugs to market or to undertake clinical trials in India.

 

  1. Application for a permit for importing or manufacturing new drug for sale or for a clinical trial.
  2.  

    The requisites for the application are as follows:

    1. Chemical and Pharmaceutical ingredients and their related information;

    2. Animal Pharmacology Information.

    3. Animal Toxicology Information.

    4. Human Pharmacology Information.

    5. Pharma Regulatory Status in other countries related to the drug, including restrictions imposed, if any,  on the consumption of the drug in other countries, like dose limits, exclusion of certain age groups, adverse drug reactions,etc.
    6. Full prescribing information should be submitted as part of the new drug application for marketing. The prescribing information (package insert) shall include following details: generic name; composition; dosage form(s), indications; dose and method of administration; use in special populations (such as pregnant women, lactating women, pediatric patients, geriatric patients etc.) ; contra-indications; warnings; precautions; drug interactions; undesirable effects; overdose; pharmacodynamic and pharmacokinetic  properties; incompatibilities; shelf-life; packaging information; storage and handling instructions. All package inserts, promotional literature and patient education material subsequently produced are required to be consistent with the contents of the approved full prescribing information.

    7. Complete testing protocol(s) for quality control testing together with a complete impurity profile and release specifications for the product. Samples of the pure drug substance and finished product are also to be submitted when desired by the regulatory authority.

     

  3. If the drug under consideration is imported for the purpose of trial, test or analysis, the application for import of small quantities of drugs for such purpose should also be made.
  4.  

  5. For drugs indicated in life threatening / serious diseases or diseases of special relevance to the Indian genetic conditions, the toxicological and clinical data requirements may be abbreviated, deferred or omitted, as seeked by the Regulatory Authority.

 

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