Last Updated on October 2, 2024 by The Health Master
DCOIWA
In a commendable move to align Indian drug manufacturing with global standards, the Drug Control Officers (I) Welfare Association (DCOIWA) is set to conduct a workshop titled ‘Risk-based Inspections‘ (RBI) at Manufacturing Sites on December 17 in Ahmedabad, Gujarat.
This workshop is part of a series organized by DCOIWA across states where pharmaceutical industries thrive.
The Genesis: DCGI’s Proactive Approach
The initiative for RBI was spearheaded by the Drug Controller General of India (DCGI), Dr. Rajeevsingh Raghuvanshi, earlier this year.
Endorsement of the DCGI Initiative
G Koteshwar Rao, the president of DCOIWA, expressed full support for the DCGI’s initiative.
The workshop’s theme, ‘RBI,’ reflects this collaborative effort to ensure the safety and quality of pharmaceutical products.
DCOIWA’s Workshop Chronicles
Sources reveal that the upcoming workshop in Ahmedabad marks the seventh national workshop organized by DCOIWA in the last two years.
Previous workshops were held in Jaipur, Agartala, Raipur, Srinagar, New Delhi, and Hyderabad, indicating the broad reach and impact of these initiatives.
Event Highlights: Ahmedabad Workshop Schedule
The Ahmedabad workshop will commence with participant registration at 9 AM, followed by the inaugural session at Hotel TGB on S G Highway.
Dr. Hemant G Koshia, Commissioner of the Gujarat FDA, will grace the event as the chief guest, with Dr. SP Adesara, former FDA commissioner, as the guest of honor.
DCOIWA’s Gujarat chapter president, VD Dobariya, national president G Koteshwar Rao, and program coordinator Dipika Chauhan will also address the audience.
From 11 AM to 1 PM, the Joint Drugs Controller General at the CDSCO, Dr. S Eswara Reddy, will deliver the keynote address.
Post-lunch, Dr. A Ramakrishnan, deputy drugs controller at CDSCO Hyderabad office, will speak on ‘Good Regulatory Practices.’
The workshop will conclude with Dr. A H Zala, general secretary of DCOIWA Gujarat chapter, expressing gratitude at 2 PM.
A Glimpse into Workshop Objectives
Koteshwar Rao shared that the workshop anticipates the participation of approximately 200 enforcement officials from central and state regulatory departments.
The primary aim is to enhance the knowledge and standards of drug regulatory officers nationwide.
Currently boasting 1,241 members from all states and union territories, DCOIWA plays a crucial role in this collective endeavor.
Insights from CDSCO: Audits and Anomalies
Sources from the Central Drugs Standard Control Organization (CDSCO) report that the national drug regulator has conducted audits in 270 companies.
Notably, 226 show-cause notices and 78 stop-production orders were issued, uncovering critical anomalies.
One alarming revelation was that some companies neglected to test the raw materials used in formulation making.
This issue will be a focal point of discussion at DCOIWA’s workshop.
Upholding Pharmaceutical Integrity
In conclusion, DCOIWA’s commitment to elevating drug manufacturing standards is evident through its series of workshops.
These initiatives, coupled with the collaborative efforts of regulatory bodies, aim to ensure the highest quality and safety of pharmaceutical products in India.
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.
FAQs
1. Why is risk-based inspection crucial for the pharmaceutical industry? Risk-based inspection is essential to identify and mitigate potential risks in drug manufacturing, ensuring the production of safe and high-quality pharmaceuticals.
2. How can pharmaceutical companies benefit from the DCOIWA workshops? Pharmaceutical companies can gain valuable insights into regulatory practices, quality standards, and address potential issues highlighted in the workshops.
3. What role does the DCGI play in shaping drug manufacturing standards in India? The DCGI takes a proactive role in initiating measures to align Indian drug manufacturing with global standards, as seen in the risk-based inspection initiative.
4. How can regulatory officers enhance their knowledge through DCOIWA workshops? Regulatory officers can participate in workshops to stay updated on the latest industry standards, regulatory practices, and collaborate with peers to address common challenges.
5. How does DCOIWA contribute to maintaining pharmaceutical integrity in the country? DCOIWA plays a pivotal role in organizing workshops and programs that aim to uplift the knowledge and standards of drug regulatory officers, ensuring the integrity of the pharmaceutical sector in India.
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