Last Updated on December 31, 2023 by The Health Master
National GMP Day
National GMP Day: In a groundbreaking move, the Indian Drugs Manufacturers’ Association (IDMA) collaborates with the government to introduce the inaugural National Current Good Manufacturing Practice Day (cGMP Day) on the 10th of October.
This visionary initiative aims to revolutionize the pharmaceutical landscape, addressing the pressing issue of substandard drugs emerging from India.
Paving the Way for Quality Assurance: The Genesis of cGMP Day
The pharmaceutical industry is no stranger to the alarming incidents of Indian cough syrups causing unfortunate fatalities, particularly among children in foreign countries.
In response to these critical events, the government has taken a definitive stance by mandating adherence to GMP guidelines for all drug manufacturers.
Daara Patel, the esteemed Secretary General at IDMA, underscored the significance of this day, emphasizing its pivotal role in raising awareness about cGMP guidelines.
He asserted, “The reputation of the Indian pharmaceutical industry has been tarnished by reports of substandard cough syrups abroad.
Our mission is to integrate GMP protocols into our industry’s best practices and standard operating procedures.”
The Essence of Quality: GMP Rules as Pillars of Excellence
In the pharmaceutical sector, quality is the linchpin that cannot be compromised.
GMP rules emerge as the bedrock of pharmaceutical manufacturing operations, serving as a shield against non-compliance and safeguarding the integrity of medicinal products.
cGMP: A Global Imperative Guided by WHO
Enshrined by the World Health Organization (WHO), Current Good Manufacturing Practice (cGMP) sets forth indispensable standards designed to elevate product quality.
It achieves this by enforcing stringent control measures across various facets, including materials, methodologies, machinery, processes, personnel, facilities, and the environment.
Currently, GMP, as outlined in Schedule M of the Drugs and Cosmetic Rule, is undergoing a significant revision to extend its applicability to all pharmaceutical firms.
A Sector in Transition: Upholding GMP Standards
India houses approximately 10,500 drug manufacturing units, yet only a mere 2,000 possess the coveted WHO GMP certification.
In a bid to galvanize the industry towards higher standards, the proposed amendment to Schedule M of Drugs and Cosmetics Rules, 1945, allows large corporations (with turnovers exceeding ₹250 crore) a six-month window, while MSMEs (below ₹250 crore) are afforded a 12-month grace period to integrate upgraded GMP standards.
Confluence of Expertise: Bridging Nations for Excellence
Anticipated participants in this momentous event include senior representatives from India’s health ministry, the United States Food and Drug Administration (USFDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), CDSCO, esteemed pharmacy institutions, and academia.
As of the time of writing, queries directed towards the health ministry remain pending.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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