New Delhi: Welcoming the updated guidelines detailing the functions and responsibilities of the zonal, sub-zonal, and port offices issued by the Central Drugs Standard Control Organization (CDSCO), the Indian Rubber Gloves Manufacturers Association (IRGMA) has urged the government to take stringent measures to implement the order effectively to stop the import of substandard gloves in the country.
The CDSCO issued the new Guidance Document for Functions and Responsibilities of Zonal, Sub-zonal, and Port offices on September 12. The guidelines were last released in 2011, and the recent changes include the introduction of new rules and regulations and the online system through the SUGAM portal, which necessitated the revised order in line with the procedures followed in CDSCO offices.
Guidance documents for Zonal, Sub zonal and Port offices were prepared in 2011 and implemented since then. It sets out the nature of work that Zonal, sub-zoneal, and port offices generally carry out and the guidelines about the policy that should be followed in disposing of work and duties.
Recently, there have been many changes in the procedures of Zonal, Sub-Zonal, and Port Office activities due to the introduction of new rules and regulations, online systems through the SUGAM portal, and delegation of some activity to the state Drugs Authority, etc.
Hence, it was needed to amend/revise the guidance documents in line with the recent procedures followed by the zonal, sub zonal and port offices.
In order to undertake the revision of guidance documents for zonal, sub-zoneal, and port offices, a team was constituted via order ref. no. GBT /RS /SS /NRS /2023-24 dated.26.12.2023.
The team submitted the draft document with respect to their responsibilities for the preparation of the first draft by a team comprising officials from CDSCO.
The guidance drafted and reviewed was shared with all officials (DDC (I) level) of CDSCO HO/Zones/Sub-Zone/Port offices to provide comments/suggestions/inputs if any, and the same was deliberated on 02.09.2024 virtually with all CDSCO Zonal, Sub-Zonal, and Port offices and CDSCO (HQ) officials.
Accordingly, revised and finalized guidance documents for Zonal, Sub-Zonal, and Port offices (revision: 01, 2024) are prepared to ensure uniform procedures in the execution of various regulatory processes by Zonal/Sub-Zonal and port offices of CDSCO.
Speaking on the new CDSCO guidelines, IRGMA General Secretary Man Mohan Singh Gulati said, “The new guidelines issued by CDSCO are a welcome step. However, the implementing authorities, including ADCs posted at ports, must be made aware of the document to effectively control the import of substandard bulk-packed gloves.”
The association has long been demanding the Quality Control Order (QCO) for gloves to keep substandard imports at bay and urged the government to expedite its process. This will not only help Indian manufacturers but also contribute to the union government’s Make in India initiative to achieve self-sufficiency and reduce dependence on other countries.
The IRGMA general secretary added that the new CDSCO guidance document will bring uniformity, transparency, predictability, and accountability to all offices, incorporating risk-based inspections as part of the organization’s technical functions.
The risk-based inspection guidelines outline uniform enforcement procedures for onsite inspections to evaluate compliance with quality systems and infrastructure, adhering to nationally and internationally accepted Good Manufacturing Practice (GMP) standards.
The guidelines also set timelines for processing various applications in the medical devices sector, including procedures for granting licenses to manufacture drugs for examination, testing, or analysis under the New Drugs & Clinical Trials Rules, 2019, and the issuance of No Objection Certificates (NOCs) for cargo clearance at CDSCO port offices, among other matters.
According to the guidelines, each drug inspector will collect at least ten samples each month, comprising nine samples of drugs (APIs, excipients, and formulations) and one sample of cosmetics or medical devices. Each inspector shall maintain data on sampling and submit it to their controlling authority monthly to facilitate the execution of the sampling plan. The inputs from the monthly sampling data will be used to plan the next month's sampling strategy.
To view the updated guideline for the functions and responsibilities of the zonal, sub-zonal, and port offices of the Central Drugs Standard Control Organization (CDSCO), click the link below:
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