New Delhi: The Drugs Consultative Committee (DCC) has once again called on the State and Union Territory (UT) Drugs Controllers to provide the information related to vaccine manufacturing and sales to the Central Drugs Standard Control Organisation (CDSCO) in order to meet the requirements of the expected global benchmarking of vaccines by the World Health Organization (WHO).
Even though the Committee has extended the request in its previous meeting held last year, many States have not yet provided the data to CDCO in response to the letter issued by the CDSCO in the matter, observed the latest DCC meeting held at the end of January, this year.
“Further, the committee was informed that the data submission is a continuous activity and updated data needs to be provided regularly as per checklist and SOP (Standard Operating Procedure) shared by CDSCO for manufacturing as well as sales premises for following the common practice on inspection process and preparation of uniform inspection reports among the States,” observed the Committee.
“Accordingly, all the State/UT Drugs Controllers were once again requested to provide the information at the earliest,” it added.
WHO follows a Global Benchmarking Tool (GBT) for assessment or benchmarking of a country with respect to various regulatory functions. This is a prerequisite for procurement of vaccines by United Nations (UN) agencies from Indian Vaccines manufacturers, and CDSCO along with other associated institutions like Central Drugs Laboratory, Adverse Events Following Immunisation (AEFI) surveillance system etc., are assessed by WHO.
The CDSCO has sought various information including list of officials in the respective department with details of qualification, experience before joining, current regulatory experience, training attended, which should be updated from time to time, number of inspections conducted in vaccine facilities, recruitment rules, plan and procedures, organogram with job responsibilities under QMS, risk based sampling plan and sampling of vaccines on basis of quarterly plan with guidance on same and submission of same with reports of vaccines storage facilities, among others.
In the previous meeting in the end of September, 2023, under the chairmanship of Drugs Controller General (India) [DCGI] Dr Rajeev Singh Raghuvanshi, the Committee noted that the WHO may plan the re-benchmarking of CDSCO very soon with respect to vaccines, once formally agreed by the Ministry.
Data from all states is required for the manufacturing as well as sales premises. It was stressed that the data is required in view of upcoming NRA (National Regulatory Agency) assessment, informed the Committee.
According to WHO, the standard evaluation of vaccines includes review of the manufacturing process, verification of compliance with relevant standards, sample lot testing and a site audit. Procedures are also in place to ensure a standardized approach for streamlined and expedited assessment, including reliance on the responsible NRA.
WHO vaccines prequalification works with NRAs that have been recognized as having a sufficient level of “maturity”, according to WHO’s GBT, says WHO.
NRAs play a vital role in regulatory oversight of vaccines intended for use in national immunization programmes. In some cases, WHO may agree to sign collaborative agreements or enter into a collaborative arrangement with certain NRAs whereby the prequalification process will be shortened or streamlined through WHO reliance on the NRA’s assessment, testing and inspection reports.
The WHO congratulated the Indian regulatory authority after successful assessment in 2017, declaring the NRA being “functional” with a maturity level of four, which is the highest level as per the definitions during the time for five functions and maturity level three in respect of four functions.
