Last Updated on January 14, 2024 by The Health Master
Drug Quality and Safety
In a proactive move aimed at addressing ongoing concerns about drug quality and safety as well as ensuring consistent enforcement of regulations, the government is taking a comprehensive approach.
This approach involves the implementation of a set of measures to ensure uniformity in documentation, enforcement, and market surveillance across the country.
Uniform Documentation and Licensing Approval
One of the key components of this strategy is the uniform implementation of document- and dossier-based approval for licensing pharmaceutical drugs nationwide.
This approach aims to standardize the approval process and enhance the quality of drugs manufactured in the country.
In the 61st meeting of the Drugs Consultative Committee (DCC) held in June 2023, the committee extensively discussed and endorsed the concept of document-based licensing.
They also proposed the development of a specified checklist or format that could be uniformly adopted throughout the country.
The checklist, currently used for approving new drugs by the Central Drugs Standard Control Organisation (CDSCO), may be adapted with necessary modifications in line with the Drugs Rules of 1945.
Recommendations by DCC
After thorough deliberation, the DCC recommended the following actions:
- Implementation of dossier or document-based licensing for drugs uniformly across the country.
- Development of a standardized checklist for document submission by applicants, based on the CDSCO’s checklist for subsequent new drugs.
- Issuing a directive by the Drugs Controller General (India) advising State Licensing Authorities to implement document-based licensing consistently nationwide.
Enhancing Market Surveillance
The DCC acknowledged that the current system of testing approximately 1 lakh drug samples faced challenges due to the absence of a comprehensive common database and a lack of coordination among various States and Union Territories.
To address this issue and improve the monitoring of drug quality, the DCC recommended:
- Developing a guidance document for drawing samples of drugs, cosmetics, and medical devices in consultation with stakeholders
- Initiating joint risk-based inspections of drug manufacturing sites across States and Union Territories.
Optimizing Resource Allocation
Recognizing the need for efficient resource allocation and better product quality, the DCC emphasized the importance of consistent compliance with good manufacturing practices (GMP).
To achieve this, they recommended:
- Conducting inspections using a risk-based approach, considering factors such as inspection history, product risk, past inspection findings, and the presence of not-of-standard-quality (NSQ) drugs.
Addressing Concerns About Drug Quality and Safety
These decisions come in response to growing concerns about Drug Quality and Safety in India, both for domestic consumption and export.
The central drug regulator is committed to addressing these issues through coordinated efforts and standardized procedures.
In conclusion, the central drug regulator is taking significant steps to ensure the quality and safety of pharmaceutical drugs in India.
By implementing uniform documentation, licensing, and inspection procedures, they aim to enhance drug quality and strengthen regulatory oversight, ultimately benefiting both consumers in India and international markets.
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.
DCGI issues advisory on this fake Cancer Injection
Revolutionary Weight Loss Drug, KDS2010, shows promise in Clinical Trials
Delhi High Court prioritizes hearing on ban on Cough Syrup
Drug alert: WHO issues urgent Alert over fake liver drug in India and Turkey
Delhi High Court upholds inclusion of Medical Devices as Drugs under…
Barcodes: Extension of Barcode Rules to Safeguard 11 APIs
Understanding the crucial role of Aspirin in Heart Attacks
Drug recall: Digoxin Tablets recalled due to label mix-up
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:
