Extension Announced for Compliance with Revised Schedule M of Drugs Rules, 1945
The Ministry of Health.....
The Ministry of Health and Family Welfare has announced a proposed extension for small and medium drug manufacturers to comply with the revised Schedule M of the Drugs Rules, 1945.
The amendment, introduced in December 2023, outlines new guidelines titled “GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS.”
In response to manufacturer concerns, the Government has decided to extend the compliance deadline, providing additional time for adherence to the updated standards.
The revised compliance deadline will be effective from January 4, 2025.
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FSSAI Issues Notification for Quarterly Submission of Rejected and Expired Food Items Data
The Food Safety and Standards.....
<p style='margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;font-size:11.0pt;font-family:"Calibri","sans-serif";' id="isPasted"><span style='font-family: Cambria, "serif"; font-size: 18px;'>The <strong><span style='font-family:"Cambria","serif";font-weight:normal;'>Food Safety and Standards Authority of India (FSSAI)</span></strong> has issued a notification mandating the <strong><span style='font-family:"Cambria","serif";font-weight:normal;'>quarterly submission of data on rejected and expired food items</span></strong><strong>,</strong> along with details of actions taken for their <strong><span style='font-family:"Cambria","serif";font-weight:normal;'>disposal or auctioning</span></strong><strong>.</strong></span></p>
<p style='margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;font-size:11.0pt;font-family:"Calibri","sans-serif";'><span style='font-family: Cambria, "serif"; font-size: 18px;'>Food Business Operators (FBOs) are advised to compile and maintain accurate records to ensure timely submission once this provision is activated on the <strong><span style='font-family:"Cambria","serif";font-weight:normal;'>FoSCoS portal</span></strong><strong>.</strong></span></p>
<p style='margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;font-size:11.0pt;font-family:"Calibri","sans-serif";'><span style='font-family:"Cambria","serif";'><span style="font-size: 18px;">This requirement will be effective from <strong><span style='font-family:"Cambria","serif";font-weight:normal;'>December 16, 2024</span></strong></span><strong><span style="font-size: 18px;">.</span></strong></span></p>
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PESO Issues Notification on Phasing-Out of Electrical Detonators
The Petroleum and Explosives.....
<p style='margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;font-size:11.0pt;font-family:"Calibri","sans-serif";line-height:normal;' id="isPasted"><span style='font-size: 18px; font-family: Cambria, "serif";'>The Petroleum and Explosives Safety Organisation (PESO) has issued a notification advising manufacturers to align their production processes with the phasing-out target for electrical detonators by March 2025.</span></p>
<p style='margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;font-size:11.0pt;font-family:"Calibri","sans-serif";line-height:normal;'><span style='font-size: 18px; font-family: Cambria, "serif";'>Effective April 1, 2025, the manufacture, possession, and import of electrical detonators will be completely banned throughout the country.</span></p>
<p style='margin-top:0cm;margin-right:0cm;margin-bottom:8.0pt;margin-left:0cm;font-size:11.0pt;font-family:"Calibri","sans-serif";line-height:normal;'><span style='font-size: 18px; font-family: Cambria, "serif";'>Manufacturers are urged to comply with this directive to avoid legal repercussions and ensure a smooth transition away from the use of electrical detonators.</span></p>
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