Last Updated on November 12, 2024 by The Health Master
GMP Regulations
Indian pharmaceutical manufacturing sector is on the brink of a significant upheaval as stringent Good Manufacturing Practices regulations (GMP regulations) are set to take effect.
This impending change could force a large number of small and medium-sized pharmaceutical units to be in trouble, potentially disrupting the supply chain and impacting the affordability of essential medicines.
Upcoming GMP regulations
The upcoming GMP regulations, which are designed to align Indian pharmaceutical manufacturing with global standards, are expected to impact around 40% of small and medium-sized pharmaceutical units.
These businesses, which contribute significantly to the sector, may struggle to meet the stringent quality and safety standards required by the new regulations.
The Financial Burden on Small-Scale Manufacturers
One of the major challenges facing small-scale manufacturers is the substantial financial investment required to upgrade their facilities and implement the necessary quality control systems.
The cost of upgrading equipment, infrastructure, and technology can be prohibitive for many businesses, especially those with limited resources.
The Skill Gap and Workforce Challenges
Another significant hurdle is the shortage of skilled personnel in the pharmaceutical industry.
The high attrition rate of 25-30% exacerbates this problem, making it difficult for manufacturers to find and retain qualified employees.
Government Intervention and Industry Support
To address these challenges, the government has introduced various initiatives, including the revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS), to provide financial support to manufacturers.
Additionally, industry associations like the Indian Drugs Manufacturers Association (IDMA) and the Confederation of Indian Pharmaceutical Industry (CIPI) are working with the government to extend the implementation deadline and provide training and technical assistance to small-scale manufacturers.
A Delicate Balancing Act
While the government aims to improve the quality and safety of Indian pharmaceutical products, it must also consider the impact of these regulations on the industry’s sustainability.
Striking a balance between stringent regulations and supporting small-scale manufacturers will be crucial to ensuring the long-term health of India’s pharmaceutical sector.
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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