Last Updated on May 28, 2024 by The Health Master
Gujarat FDCA
To compliance with international quality standard, the Gujarat Food and Drug Control Administration (Gujarat FDCA) and the Indian Drug Manufacturers Association (IDMA) Gujarat Chapter have launched a significant training program.
This initiative targets 300 Gujarat-based pharmaceutical manufacturers, focusing on the effective implementation of the Revised Schedule M Guidelines.
Why is this Training Initiative Important?
Maintaining Credibility as the “Pharmacy of the World”:
Dr. H.G. Koshia, Commissioner of Gujarat FDCA, emphasizes the urgency of this program.
He highlights the need to equip manufacturers with the knowledge to implement the revised norms.
This ensures India upholds its reputation as a reliable source of high-quality pharmaceuticals.
Meeting Evolving International Regulations:
The Central Drugs Standard Control Organisation (CDSCO) has actively conducted training programs for regulators.
This collaborative effort between FDCA and IDMA ensures manufacturers stay updated on the changing international regulatory landscape, enabling them to cater to both developing and developed markets.
What are the Revised Schedule M Guidelines?
The revised Schedule M, notified in October 2018, aims to achieve three key objectives:
Ensuring Drug Quality:
The guidelines establish stricter standards for drug manufacturing, promoting better quality control measures.
Promoting Pharmaceutical Exports:
By adhering to these guidelines, Indian manufacturers can ensure their products meet international standards, facilitating smoother exports.
Building Trust in Indian Pharmaceuticals:
The emphasis on quality strengthens trust in Indian-made drugs, both domestically and internationally.
Key Requirements and Deadlines
The Union Health Ministry has mandated stricter compliance deadlines based on company size:
- Large Pharmaceutical Companies (Turnover > Rs. 250 Crore): Must achieve WHO-GMP certification within six months.
- Medium and Small-Scale Enterprises: Have a 12-month window for compliance.
A More Comprehensive Approach to Quality Assurance
The revised norms redefine “Good Manufacturing Practices” (GMP) as “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”
This broader term reflects a more holistic approach to quality assurance, encompassing all aspects of the production process.
Strengthening India’s Pharmaceutical Leadership
Dr. Koshia concludes by expressing optimism about the initiative’s impact.
He believes this collaboration will significantly enhance the quality and credibility of India’s pharmaceutical exports, solidifying the nation’s position as a global leader in the industry.
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.
Key Notes on Revised Schedule M: Must read
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
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
One App for All: Gujarat FDCA Simplifies Drug Licensing
Gujarat FDCA Takes Action with Inspections and License Revocations
Gujarat FDCA seized Fake Drugs worth Rs. 1.75 crore
Blast in Pharma Factory in Gujarat: A Tragic Unfolds
Gujarat FDCA: Obtain Online Non Conviction and Performance Certificates
Relief for Medical Devices: CDSCO Grants 3-Month Extension
USFDA approval granted for Edaravone Injection
Drug recall: Dr Reddy’s, Sun Pharma, Aurobindo recall these drugs due to this reason
NPPA revised Ceiling price of 6 scheduled formulations: May 2024
Indian Pharma Industry Gears Up to comply Revised Schedule M
CDSCO: Timely pay retention fee to Avoid Disruption in Medical Device licenses
NPPA fixed retail price of 4 formulations: May 2024
FSSAI Takes Action: Popular Beverage Mixes Reclassified on E-commerce Platforms
NPPA fixed retail price of 37 formulations: May 2024
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:
