Drug Testing Laboratory

Every drug manufacturing unit having a drug manufacturing license shall maintain a laboratory for carrying out tests on drugs or raw materials used in the manufacture for sale of drugs.

Types of Drug testing laboratory applications and Licenses:
  • Form 36: Application for grant or renewal of approval for carrying out tests on drugs/ cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs /cosmetics
  • Form 37: Approval for carrying out tests on drugs/ cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs/cosmetics
  • Form 38: Certificate of renewal of approval for carrying out tests on drugs / cosmetics and raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs / cosmetics
  • FORM 39: Report of test or analysis by approved institution

Competent Technical Staff qualification:

The head of the testing unit shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate

For more detail follow schedule L

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