GMP Compliance: In recent times, the micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector have found themselves at a crossroads, grappling with the government’s impending mandate for Good Manufacturing Practices (GMP) compliance.
Industry associations, representing the MSME sector, have voiced their concerns to the health ministry and drug regulators, apprehending that this stipulation may not only erode competition but also lead to a significant impact on the availability of crucial medicines.
The Veil of Uncertainty
One of the prevailing issues faced by the industry lies in the lack of clarity regarding the consideration of their feedback.
An anonymous member of an industry association highlighted this concern, stating that they are in the dark about whether their input has been taken into account and what the final notification entails.
Impending Implementation: A Daunting Task
Currently, only a modest 20% of the nation’s manufacturers comply with the stringent WHO GMP requirements.
With the impending enforcement of the revised Schedule M, a significant portion of these establishments may face the threat of closure if not provided with ample time and guidance.
In 2019, estimations indicated that each MSME unit would necessitate an investment ranging from ₹3-5 crore, along with a minimum of three years, to align with the revised Schedule M requirements.
It is imperative that the government consider these three years from the date of the final notification as the deadline for achieving full compliance.
This duration is indispensable for bolstering infrastructure, recruiting and training additional manpower, and implementing revised Standard Operating Procedures (SOPs).
The Essence of GMP Compliance
GMP compliance serves as the bedrock of quality assurance within the pharmaceutical industry.
They encompass a spectrum of controls, ranging from materials and methods to machinery, processes, personnel, and the environment.
By adhering to these standards, companies ensure that the products meet stringent quality benchmarks.
Minister’s Mandate: A Race Against Time
Union Health Minister Mansukh Mandaviya, in a recent announcement, set the wheels in motion for a time-bound implementation of the revised GMP.
Companies with turnovers exceeding ₹250 crore are slated to implement these changes within six months, while their smaller counterparts, with turnovers below ₹250 crore, will have a year to adapt to the new standards.
Conclusion: Balancing Compliance and Survival
As the MSME pharma sector stands on the precipice of transformation, it is imperative for stakeholders to strike a balance between compliance and the sustenance of their operations.
Adequate timeframes, coupled with comprehensive support and guidance from regulatory bodies, will be instrumental in ensuring a seamless transition towards GMP compliance, thereby upholding the integrity and quality of medicines for the broader populace.
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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