The Ministry of Health and Family Welfare vide its notification dated 3rd August 2021 has notified Drugs (Draft Amendment) Rules, 2021 to further amend Drugs Rules, 1945 and has invited Objections and suggestions from the public which shall be addressed to the Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in. within 30 days.
The Amendment is brought under rule 90 which deals with the form for application in which the following sub-rule 3 has been inserted:
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 in Form 30 duly completed, and in case where no communication is received by the applicant within the such stipulated period from licensing authority, such licence shall be deemed to have been granted.
If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, shall obtain a licence in Form 29.
The License shall 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.
