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CDSCO revises guidance document for functions & responsibilities of zonal, sub-zonal & port offices
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Gireesh Babu, New Delhi
September 18 , 2024
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The Central Drugs Standard Control Organisation (CDSCO) has revised the guidance document for functions and responsibilities of its zonal, sub-zonal and port offices after almost 13 years, updating the adding procedures including for Risk Based Inspection (RBI) of drug manufacturing sites.
The guidelines, prepared and implemented in 2011, is updated now considering many changes in the procedures of zonal, sub zonal and port office activities due to introduction of new Rules and regulation, online system through Sugam portal and delegation of some activity to State Drugs Authorities etc, said Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi.
The document was prepared by a team constituted by the Organisation in December, 2023, and the draft document was reviewed and comments and suggestions were gathered from all of its senior officials, he added. The new document comprises over 1,100 pages as compared to the 2011 guidance document of around 480 pages.
The new guidance document, which is for internal work procedures within the CDSCO offices and its Headquarters for bringing uniformity, transparency, predictability and accountability of all offices, has added risk based inspections as part of the technical functions of the Organisation.
It elaborates that the functions and duties of the zonal and sub-zonal offices include scrutinising the application and participating in the joint inspection for grant/retention of license for manufacturing or risk based inspection at least once in three-year as per the orders issued on October 27, 2017.
The document incorporates the guidance document issued for risk based inspection, released by the CDSCO in March, this year, along with the other guidance documents issued during the recent months.
The Chapter on risk based inspection elaborates that the guidance document is to provide uniform enforcement procedures for onsite inspections to evaluate compliance of the quality system and infrastructure with nationally and internationally accepted GMP standards, based on the reference document as prescribed in the D&C Act & Rules and WHO-GMP/TRS guidelines.
When there is one or more critical or six major deficiencies or above, the site is considered to be operating at an unacceptable level of compliance with GMP guidelines. This would attract administrative (Show cause notice followed by Stop production order, Cancellation of product permission, Cancellation of manufacturing license) and/or legal enforcement actions (prosecution) as necessary and this action will continue till satisfactory resolution of the non compliance after joint verification by CDSCO & state.
When there are less than six major deficiencies, the site shall submit a compliance report after rectification of deficiencies and the same shall be verified for determination of compliance to GMP. When there are other deficiencies only, the site is considered to be operating at an acceptable level of GMP compliance, and the manufacturer is expected to provide CAPAs for all deficiencies.
Considering that the new guidance document comes after the medical devices sector has attracted more attention from the regulator, the document also elaborates on the procedures to be followed for licensing of manufacturing of class C & D devices and in-vitro medical devices, among others. It also sets timelines for processing of various applications in the medical devices sector, and procedures including grant of license to manufacture drugs for the purpose of examination, test or analysis under the New Drugs & Clinical Trials Rules, 2019, and NOC to be granted for cargo clearance at port offices of CDSCO, among others.
Each drugs inspector shall collect at least 10 samples in a month comprising nine samples of drugs (API, excipient and formulations), one sample of cosmetics/medical device. At least one sample of vaccine should be collected by each drugs inspector, quarterly. Each drugs inspector shall maintain data of sampling and shall submit to their controlling authority on monthly basis for execution of sampling plan. The inputs from the monthly data of sampling shall be used for planning of next month’s sampling plan.
The documentation required for various procedures, including grant or revalidation of CoPPs, grant or renewal of blood centres, for grant and retention of license for vaccines has also been expanded, in some cases extensively. For instance, the documents required for grant/retention of license for vaccines has been expanded from 16 in the 2011 guidance to 56 documents now.
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