Last Updated on January 13, 2025 by The Health Master
Drug Regulators
Drug Regulators of Madhya Pradesh Drug Control Administration (MP DCA) has taken a proactive approach and step to support and assist the pharma industry and for revised schedule M compliance.
An active and dedicated team of drug regulators has been constituted to provide all the guidance and support to pharma units for upgrading their facilities in compliance with revised schedule M.
Guidance and Support on site
This team of drug regulators will visit the pharmaceutical units across the state and will offer expert opinions on assisting and supporting them with compliance with the revised schedule M.
The aim of the proactive approach of the drug regulators is to streamline the compliance process and minimize hurdles that may come across during the manufacturing process.
Industry Response
Dr. Darshan Kataria, President of the Madhya Pradesh Small-scale Drug Manufacturers Association (MP SDMA), emphasized the commitments of the pharma industry to meet the new standards mentioned in the revised schedule M.
He also acknowledged the challenges faced by the pharma industry due to various technical and logistical hurdles.
He assured the drug regulators that all pharma units are actively in the process of complying with revised schedule M within the time frame.
Key points for Pharma Industry
- Understanding the revised Schedule M completely and all the guidelines and requirements to upgrade themselves.
- Submitting the required applications with explanations for extension of the timeline within time granted to them, i.e., three months from the date of the notification.
- Actively ask for the assistance, guidance, and support from the team of drug regulators designated for this purpose.
- Allocate adequate resources for the upgrade of the manufacturing facilities.
- Ensure timely procurement of all the necessary equipment and machinery from reliable suppliers.
What is Schedule M?
Schedule M outlines the Good Manufacturing Practices (GMP) for the pharmaceutical industry in India.
Why is revised schedule M necessary?
The revised schedule M aims to enhance the quality efficacy of the drug, which ultimately ensures patient safety, and upgrade the standard of drugs manufactured by the pharma manufacturers in India.
What support is offered by drug regulators of MP pharma manufacturers?
Drug Regulators of Madhya Pradesh Drug Control Administration (MP DCA) has taken a proactive approach and step to support and assist the pharma industry and for revised schedule M compliance.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Note: This article is for informational purposes only and should not be considered legal or professional advice.
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