DRUG REGISTRATION SERVICES

RULE 37. Packing of Patent or Proprietary Medicine

Under Rule 37 of Drug and Cosmetic Rules, 1945 provisions are laid out concerning packing of patent or proprietary medicines and its import in India for retail sale in the country.

Importers intending to import such products need to apply for a permission in prescribed forms to CDSCO. Such an application needs to be made at least 3 months prior to the planned import.

As per the rules, Patent or proprietary medicines shall be imported in containers intended for retail sale Provided that such medicines may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission

Checklist of Documents
  1. Covering Letter explaining the Purpose
  2. Copy of Valid Manufacturing License
  3. Import License or Permission to Import
Why NKG for Drug Regulatory Services

NKG team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.

    get compliant now!

    Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or brand owner, one is already engrossed in various business aspects prior to launch of a brand in India. If a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues  as well as supply chain disruption. 

    CONTACT US FOR YOUR REGULATORY NEEDS.




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