Last Updated on November 4, 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.
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Dissolution test: Importance in Pharma Industry
9th Advanced GMP Workshop organised: IPA
Gujarat FDCA and IDMA Join Forces for GMP Compliance Training
Venus Remedies gets GMP certificate from Libya: A Gateway to African Markets
October 10: National GMP Day – A Turning Point
8th Advanced GMP workshop organized by IPA
GMP Compliance for MSME Pharma Companies: Challenges and Perspectives
Clotrimazole Cream Price Dispute: Govt upholds NPPA’s Ceiling Price
Telangana DCA takes action on 15 Medical Stores for Violations
Govt to amend MDR to include QMS requirements for Class A Medical Devices
NPPA orders Price Cut on these Cancer Drugs
9th Advanced GMP Workshop organised: IPA
DTAB recommends key amendments of MDR, 2017
USFDA approval granted for Diltiazem Hydrochloride extended-release capsules
Drug alert: 67 drug samples declared as NSQ in September 2024
Govt rejects review applications from 5 Pharma Companies on pricing of Metoprolol
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
