Last Updated on January 9, 2024 by The Health Master
The Union ministry of health and family welfare has notified a draft amendment in the Drugs Rules, 1945, vide GSR No. 533(E) dt 03-08-2021 Draft Drug (Amendment) Rules 2021, to add a provision for deemed approval of license to manufacture drugs for examination, test or analysis, if the authority does not communicate it in seven working days from the date of receipt of application.
According to the Draft Rules notification, the ministry has substituted the Form 29 under the Rule 90, sub-rule 2, where it discusses the forms to be submitted to get the license, along with a fee of Rs. 250, with Form 30. The Rule 90 deals with application for license to be made to the licensing authority appointed by the state government.
After the Sub-Rule so amended, it has inserted a new Sub Rule, stating “(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 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 license shall be deemed to have been granted.”
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
The decision is expected to help industry to get manufacturing licenses for the purpose of examination, test or analysis faster.
The draft was notified on August 3, following consultation with the Drugs Technical Advisory Board, to inform all persons likely to be affected with the amendment. It also said that the draft rules shall be taken into consideration on or after the expiry of a period of 30 days from the date on which the draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period will be considered by the Central Government.
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