Last Updated on January 6, 2024 by The Health Master
Download notification No. GSR 839 dt 29-11-2021: The ministry of health and family welfare has issued a final notification No. GSR 839 dt 29-11-2021 for an amendment to certain rules under the Drugs Rules, 1945, omitting provisions for the issuance of duplicate copies of import licences or registration certificates if the original is damaged or lost.
Sub-rule three of Rule 24, under the Drugs Rules, 1945, refers to the procedure to obtain a duplicate licence while elaborating on the form and manner of application for an import licence. The sub-rule states that “A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this rule, if the original is defaced, damaged, or lost.”.
Besides, the sub rule seven of the Rule 24A, on the form and manor of application for registration certificate, states that a fee of three hundred US Dollars or its equivalent in Indian Rupees, shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
The final notification directs to omit “or for a duplicate copy of the license issued under this rules, if the original is defaced, damaged or lost,” from the Rule 24 and “or for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost” from the Rule 24A, shall be omitted from the Rules.
This comes at a time when the Ministry is bringing in changes in the regulations, simplifying them for ease of doing business, and moving most of the application and regulatory approval procedures to online with a plan to switch many of the processes mostly to digital over a period of time.
The draft of the amendment, which is named as the Drugs (6th Amendment) Rules, 2021, was issued on September 7, in the Gazette of India, inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public.
In the final notification, issued on Monday, the Ministry said that the objections and suggestions received from the public on the said rules have been considered by the Central Government. After consultation with the Drugs Technical Advisory Board (DTAB), the Ministry said, it has decided to make the rules further amend the Drugs Rules, 1945.
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