Last Updated on December 18, 2024 by The Health Master
CDSCO approval
The Drugs Controller General of India (DCGI) has cracked down on the illegal manufacturing and sale of an unapproved antibiotic combination:
Meropenem 1mg and EDTA for injection.
This highlights critical issues within India’s drug regulatory system.
Unapproved Drug Poses Safety Risks
The DCGI raised concerns after discovering manufacturers selling this injectable combination without mandatory CDSCO approval.
This classifies it as a “new drug,” requiring rigorous testing and safety evaluations before reaching the market.
Dr. Rajeev Singh Raghuvanshi, DCGI, emphasized the importance of regulations: “New drug safety is paramount”.
No new drug can be manufactured for sale without CDSCO approval from the Licensing Authority, as defined by the New Drugs and Clinical Trial Rules, 2019.
Key Points on New Drug Regulations:
- Rule 3: New drugs require approval by the Licensing Authority before manufacturing or sale.
- Rule 80: Manufacturing a new drug (API or formulation) necessitates an application (Form CT-21) and fee to the Central Licensing Authority.
This incident follows a similar situation last month, where the DCGI wrote state regulators to cancel product permissions for the same drug combination.
The reasoning? It falls under the category of a new drug, requiring CDSCO approval.
Unapproved Drugs: A Recurring Problem
This isn’t the first instance of unapproved drugs circulating in India.
Regulatory experts point to communication gaps between regional and central drug authorities as a contributing factor.
The Need for a Centralized System:
- The Drugs Technical Advisory Board (DTAB) proposed seeking State feedback on establishing a single licensing/approval authority.
- Centralized drug regulation discussions gained momentum after incidents of Indian-made medicines causing adverse effects abroad.
- Experts advocate for a single national portal where State drug regulators update drug license status and quality test results for central reference.
These measures aim to streamline the drug approval process, enhance communication, and ensure patient safety by preventing the sale of unapproved medications.
Citizen Role:
- Be cautious of unfamiliar medications.
- Verify a drug’s CDSCO approval status with the CDSCO website (https://cdsco.gov.in/).
- Report any suspected cases of unapproved drugs to the DCGI.
By working together, we can ensure a safer and more regulated pharmaceutical landscape 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.
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Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Revised Schedule M: The Role of Pharmaceutical Waste Management
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