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The Drugs Consultative Committee (DCC) has recommended to the central drug regulator to communicate with the state and Union Territory (UT) drug controllers on standard implementation of the Institutional Development Plan (IDP) on market surveillance and control, in line with the World Health Organisation's (WHO) National Regulatory Authority (NRA) assessment held last year.
The advice is with an aim to enable the States to implement the IDP recommendations in a uniform manner to continue the momentum in keeping up the standards as per the requirement of the international organisation.
The Committee, in its meeting held on June 17, looked into various recommendations of IDP with regard to the marketing surveillance and control function, which was proposed following the WHO NRA Assessment in 2024.
"The matter was deliberated with the DCC members along with the CDSCO proposal for compliance. The members agreed to take suitable action as proposed by CDSCO for the Institutional Development Plan (IDP) on Market Surveillance and Control function," said the minutes of the DCC meeting.
"DCC also recommended that a detailed letter from DCGI (Drugs Controller General of India) may be written to all the states/UTs Drugs Controllers in the matter along with the appropriate SOPs/Formats, etc. to enable the states to implement the action point in a uniform manner," it added.
The WHO, on October 15, 2024, said that a team of international experts led by the Organisation has affirmed that the National Regulatory Authority (NRA) of India and relevant institutions meet WHO published indicators for a functional vaccine regulatory system.
The WHO NRA re-benchmarking assessment, conducted from 16-20 September 2024, was aimed at assessing and documenting the status of the India vaccine regulatory system and re-benchmarking it against the WHO Global Benchmarking Tool (GBT), updating the institutional development plan of NRA and other relevant institutions, and measuring the maturity of the system.
Various regulatory functions are evaluated during the assessment, including General Overview of the National Regulatory System (RS), Registration and Marketing Authorization (MA), Vigilance (VL), Market Surveillance and Control (MSC), Licensing Establishments (LI), Regulatory Inspections (RI), Laboratory Testing (LT), Clinical Trials Oversight (CT) and NRA Lot Release (LR).
India retained Maturity Level 3 with highest marks in several functions, against the Global Benchmarking Tool (GBT) version VI with raised bars and stringency in comparison with the previous version used in the benchmarking in 2017.
The country needs to keep its momentum in terms of growth in regulatory capabilities in order to continue winning the future benchmarking activities of the Organisation.
The ministry of health and family welfare, announcing the results of the benchmarking assessment of WHO in 2024, said, "As for all NRA benchmarking, sustainability of the gains made in regulatory capacity is critical. For this purpose, the team which has just completed the assessment in India has drawn up a detailed Institutional Development Plan."
"The plan will outline additional activities to be undertaken to further strengthen regulatory capacity in India in the coming years," it added.
As part of the process, the WHO carries out assessment of the NRA of India comprising the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Central Drugs Laboratory, Kasauli; Adverse Events Following Immunization (AEFI) structures at the Central and States levels, Immunization Division, Pharmacovigilance Programme of India, and other relevant institutions engaged in the regulation, control and testing of vaccines.
Performance in the benchmarking is critical as it is a prerequisite for manufacturers to supply to countries through the Union Nations procuring agencies. A functional NRA is a criterion for WHO prequalification of vaccines.
India is a major vaccine producer that has 36 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries), which makes India a major vaccine supplier across the globe, said the government last October.
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