CDSCO’s Warning: 52 Drugs Nationwide Found Substandard

The revelation of substandard drugs aligns with a drug alert issued by CDSCO in November

December 25, 2023

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CDSCO Central Drug Standard Control Organisation — CDSCO

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Last Updated on January 2, 2024 by The Health Master

Substandard

The Central Drugs Standard Control Organisation (CDSCO) has recently brought to light a critical lapse in pharmaceutical quality control in Himachal Pradesh, India.

Shockingly, 14 Drugs and injections manufactured by 12 pharmaceutical industries in the state have failed to meet established quality standards.

This revelation, made during the first week of December and the last week of November, exposes a serious threat to public health.

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The Failed Drugs and Their Impact

The list of substandard Drugs includes crucial treatments for cancer, heart disease, infection, fever, vomiting, gastric issues, edema, cholesterol, pneumonia, and stomach worms.

These lapses in quality control pose significant risks to patients relying on these medications for their well-being.

Origin of the Lapses

Himachal Pradesh, particularly Baddi, Barotiwala, and Nalagarh, stands as the biggest pharmaceutical hub in Asia.

The CDSCO’s findings raise questions about the manufacturing processes in these key locations, bringing attention to the need for rigorous oversight and regulation.

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Timeline of the Drug Alert

The revelation of substandard drugs aligns with a drug alert issued by CDSCO in November.

This timeline underscores the importance of timely alerts and the need for a proactive approach in ensuring the safety and efficacy of pharmaceuticals.

Nationwide Ramifications

The fallout extends beyond Himachal Pradesh, as 52 Drugs from various states, have come under scrutiny, including:

Maharashtra,
Madhya Pradesh,
Uttarakhand,
Punjab,
Gujarat,
Uttar Pradesh,
Rajasthan
Telangana,
Andhra Pradesh,
Chennai,
South Korea.

The CDSCO’s investigation points to a broader issue affecting the pharmaceutical industry at large.

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Regulatory Response

In response to the alarming findings, the state drug controller has taken swift action, issuing notices to the pharmaceutical companies involved and instructing them to recall the entire batch of the implicated drugs.

Assistant drug controllers have been mobilized to conduct joint inspections, emphasizing the urgency of the situation.

Nature of Failed Drugs

Among the substandard drugs, three lacked proper labeling, one was misbranded, and a product from a Mumbai-based company was identified as fake.

These specific issues highlight the diversity of problems in the pharmaceutical supply chain, underscoring the need for comprehensive solutions.

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Legal Actions

To combat the menace of substandard drugs, 13 individuals involved in the manufacturing of fake Drugs have been arrested.

These legal actions send a strong message about the commitment to eradicating such practices and ensuring the safety of pharmaceutical products.

Confirmation of show-cause notices

State drug controller Navneet Marwah has confirmed the issuance of show-cause notices to pharmaceutical companies and has instructed the immediate recall of the entire stock of the concerned batches.

These measures indicate a zero-tolerance approach to lapses in pharmaceutical quality control.

Pharmaceutical Landscape in Himachal Pradesh

Baddi, Barotiwaala, and Nalagarh collectively form the largest pharma hubs in Asia, with Himachal Pradesh being the pharmaceutical manufacturing hub of the country.

The state contributes a substantial 35.0% to India’s pharmaceutical demand, with leading pharma giants establishing their units in the region.

Proposed Laboratory

In a bid to enhance pharmaceutical quality control, an ultra-modern laboratory assisted by the National Institute of Pharmaceutical Education and Research (NIPER) is proposed to be set up at Baddi.

This initiative aims to elevate the standards of drug manufacturing and testing, ensuring the production of safe and effective medications.

Contribution to Pharma Demand

Himachal Pradesh’s pivotal role in meeting pharmaceutical demand in India cannot be overstated.

With almost all leading pharma giants having a presence in the state, the CDSCO’s findings raise concerns about the broader implications on the national pharmaceutical landscape.

CDSCO’s Ongoing Actions

As investigations continue, the CDSCO remains vigilant in uncovering any additional lapses in pharmaceutical quality control.

The focus is on implementing stringent measures to rectify the issues identified and prevent similar occurrences in the future.

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

Q: How did the CDSCO discover the lapses in pharmaceutical quality control?
- A: The lapses were exposed during a drug alert issued by CDSCO in November, highlighting the importance of timely regulatory measures.
Q: What actions has the state drug controller taken in response to the substandard Drugs ?
- A: The state drug controller has issued show-cause notices, instructed the immediate recall of affected batches, and initiated joint inspections of pharmaceutical industries.
Q: How significant is Himachal Pradesh in the pharmaceutical landscape of India?
- A: Himachal Pradesh contributes 35.0% to India’s pharmaceutical demand and serves as the manufacturing hub, hosting major pharma giants.
Q: What legal actions have been taken against those involved in the manufacturing of fake Drugs ?
- A: Thirteen individuals have been arrested, signaling a strong legal response to curb the production and distribution of substandard drugs.
Q: What measures are being taken to enhance pharmaceutical quality control in Himachal Pradesh?
- A: An ultra-modern laboratory, assisted by NIPER, is proposed to be set up at Baddi, aiming to elevate standards and ensure the production of safe medications.

Click for Guidance documents for industry