The Ministry of Health and Family Welfare on 27th October 2021 has published the Drugs (5th Amendment) Rules, 2021 to further amend the Drugs Rules, 1945.
Through this amendment, a new rule 90 which deals with the form of application in which the following sub-clause has been notified:
Rule 90(3): The license in Form 29 may be granted by the licensing authority within a period of seven working days from the date of receipt of the application duly completed in Form 30, and in case where no communication is received by the applicant from licensing authority within the said period of seven days, the licensing authority shall be deemed to have granted the license.
If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a license in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29. A license in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time.
