Last Updated on January 6, 2024 by The Health Master
Download notification: The Union ministry of health and family welfare has notified an amendment in the Drugs Rules, 1945, adding 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 vide notification No. GSR 766(E) dt 27-10-2021.
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.”
The decision is expected to help industry to get manufacturing licenses for the purpose of examination, test or analysis faster.
A draft to the amendment was earlier notified on August 3, following consultation with the Drugs Technical Advisory Board (DTAB), 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.
The Central government has considered the objections and suggestions received from the public on the said rules, said the new notification. Following this, the Central Government, after consultation with the DTAB, made the rules to amend the Drug Rules, 1945, it added.
Licensing procedure for manufacturing of Drugs
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