Indian Pharma Industry Faces Regulatory Scrutiny

This revelation comes from risk-based inspections conducted since December, revealing significant discrepancies in manufacturing practices.

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Drug Medicine Pharma manufacturing Factory Industry Unit
Picture: Pixabay

Last Updated on December 31, 2023 by The Health Master

Indian Pharma Industry

In a recent development, India’s drug regulator has taken a stern stance against Indian pharma Industry, with 76 out of 237 inspected entities ordered to cease manufacturing due to poor standards.

This revelation comes from risk-based inspections conducted since December, revealing significant discrepancies in manufacturing practices.

Understanding the Inspection Process

Phase-wise Insights

The Central Drugs Standard Control Organisation (CDSCO) and state regulators conducted inspections in four phases.

Audit, Inspection, Documents , medicine FDA
Picture: Pixabay

Shockingly, out of the 237 manufacturing units scrutinized, 179 received show cause notices, leading to the cancellation of licenses for 15 firms.

The severity of the situation is underscored by the discovery that over 15% of the samples drawn from these units were not of standard quality.

Key Issues Unearthed During Inspections

Data Integrity Concerns

News18 reports common observations in the latest round of inspections, highlighting issues of data integrity.

This revelation raises questions about the reliability of the data submitted by these pharmaceutical companies.

Critical Lapses

Among the critical lapses identified were the lack of a dedicated section for potent products, vendor qualification shortcomings, failure to follow Standard Operating Procedures (SOPs), and insufficient freedom granted to technical staff.

These lapses indicate a systemic failure in adherence to quality control measures.

Must read: How to prepare SOPs in the Pharma Industry

Insights from Previous Inspections

Consistent Challenges

The inspections revealed a recurring issue of food supplements being manufactured in the same premises, indicating a persistent challenge that demands attention and rectification from the pharmaceutical industry.

Ground Reality and Regulatory Response

Regulator’s Perspective

A presentation by Chandrashekhar Ranga, deputy drugs controller of CDSCO, highlighted that these risk-based inspections served to bring regulators face-to-face with the ground reality of the pharmaceutical industry.

Overall Impact and Future Actions

Audit Results

Since July, a total of 299 firms, including 72 private testing laboratories, underwent scrutiny during the four phases of inspections.

However, the regulatory actions weren’t limited to manufacturing units alone.

Seventy-two public testing labs faced audits, resulting in 39 receiving show cause notices, nine being ordered to stop testing, and five issued warning letters.

Cumulative Regulatory Measures

A senior government official disclosed that, overall, 218 firms received show cause notices, 76 faced stop manufacturing orders, 15 experienced license cancellations, and 40 were issued warning letters.

These measures indicate the gravity of the situation and the need for swift corrective actions.

Inspection Criteria and Future Precautions

Selection Parameters

The inspection sites were chosen based on six parameters, including a national survey by the National Institute of Biologics, reports from CDSCO and state labs, data from international regulatory agencies, information from intelligence sources, and data from all 130 oxytocin injection manufacturers.

Insightful Statistics

Ranga’s presentation emphasized that risk-based inspections in 2016 and 2022-2023 showed alarming figures: 423 sites with two or more failures, 319 sites with three or more failures and spurious cases, and 100 sites with five or more failures and spurious activities.

Conclusion

In conclusion, the pharmaceutical industry in India is at a critical juncture, facing rigorous scrutiny from regulatory bodies.

The findings of the inspections highlight systemic issues that demand immediate attention and rectification.

The industry must prioritize quality control measures to ensure the safety and efficacy of pharmaceutical products.

FAQs

FAQs
Picture: Pixabay
  1. Q: How many firms faced regulatory actions as a result of the inspections?
    • A: A total of 218 firms received show cause notices, 76 were ordered to stop manufacturing, 15 had their licenses canceled, and 40 received warning letters.
  2. Q: What were the common observations during the inspections?
    • A: Common observations included issues of data integrity, lack of a dedicated section for potent products, vendor qualification shortcomings, and failure to follow SOPs.
  3. Q: How many manufacturing units were inspected in total?
    • A: A total of 237 manufacturing units underwent scrutiny, with 76 ordered to cease manufacturing due to poor standards.
  4. Q: What parameters were used for selecting inspection sites?
    • A: Inspection sites were chosen based on a national survey, reports from regulatory agencies, intelligence sources, and data from oxytocin injection manufacturers.

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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