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NITI Aayog’s Expert Group recommends CDSCO to be made an independent regulatory authority

Our Bureau, New Delhi
Friday, September 13, 2024, 08:00 Hrs  [IST]

An expert group constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority.

The expert group report titled ‘Future Pandemic Preparedness and Emergency Response —A Framework for Action’, released by the policy think-tank, recommended giving autonomy to the regulatory body with well-developed approved Standard Operating Procedures (SOPs) for Accelerated Emergency Use Authorisation for innovative technologies and innovative products and provision for fast-tracking during pandemics, in an indicative timeframe of 12-24 months.

It has also been recommended for launching a mission on therapeutics and drug development during this timeframe.

"The existing Central Drugs Standard Control Organisation (CDSCO) to be made an Independent Regulatory Authority, with the Chief Regulator technically proficient and having special powers of making Rapid Regulatory Approvals. The Chief regulator is to be directly reporting to the Minister of Health and in the rank of Secretary to the Government of India," it said.

Regulation plays a vital role in developing new innovative products and making them available and accessible to the public, not only in the country but across borders. During Covid, a rapid response regulatory framework was developed, which facilitated the approval and authorisation of a number of products – vaccines and diagnostics, which were crucial for the Covid management strategy.

There were challenges faced in getting accelerated approvals and in the global harmonisation of regulatory protocols. Accessibility of innovative products could have been speeded up if we had a well-developed clinical trial network accepted by international regulatory authorities. Acceptance of regulatory data across National regulatory authorities also needed to be included, said the report.

It recommended that a well-harmonised regulatory system be developed with other globally recognised regulators for mutual acceptance of regulatory data. Accelerated approval pathways and protocols are to be prepared and pre-approved. Subject Expert Committees (SECs) should be strengthened with technical competence in different fields with a training programme for experts.

Besides, a strong clinical trial network and adaptive clinical trial methodology should be developed to expedite the development of drugs/devices/diagnostics. Also, the licensing of products/technologies process should be simplified and expedited. Inclusion/recognition of a few well-equipped district hospitals and the AIIMSs and INIs in the Clinical Trail Network is another step to improve pandemic response. A good example is the participation of district hospitals in the plasma trial for Covid.

Ear-marked clinical trial teams, with the required expertise to carry out robust clinical trials from appropriate organizations (such as the ICMR Clinical Trial Unit and AIIMS System) need to be identified for launching necessary trials on short notice. Further, this should not be mixed with regulatory trials, it added.

Presently, there is a need for competent human resources in IDSP units, RRTs, One Health surveillance and response, an all-hazard approach in CBRN, IHR, and laboratory techniques and IT infrastructure like PHEOCs to carry out epidemiological analytics at various levels.

In order to build a resilient supply chain, proper forward and backward linkages to be established for ensuring robust supply chains of all essential components and ingredients for development of countermeasures. There is also a need to develop capacities for indigenous manufacturing of consumables/equipment such as swabs, masks, PPEs, sanitisers, oxygen cylinders, ventilators, etc., for new pathogens. Also, there is a need to develop capacities for components for indigenous development and manufacture of diagnostics and vaccines –such as reagents, adjuvants, VVMs, etc.

It is important to have parallel systems in place for meeting supply chain constraints, such as an alternative source of oxygen supply through the steel industry, during the Covid-19 Pandemic. The requirements of different pandemics may be different. Each case scenario must be kept in mind while planning the supply chain.

It recommended development of strategies and guidelines for working with communities especially at the local level for managing PHEs and models for engaging with the private health sector for disease management and especially for ensuring surge capacities in the Indian context should be developed.

The report suggested that approval for a Special Pandemic Preparedness and Emergency Response Fund, setting up of an Empowered Group of Secretaries (EGoS), and institutionalisation of the Epidemiological and INSACOG framework and SOP for regional expansion, among others in a time frame of three to six months.

It recommended approval for a High-Risk Innovation Research Fund, establishing a Vaccine Science & Development Institute, initiating Priority Pathogen research through the Centre of Excellence Network and integration of all data portals, including ICMR and NCDC data, on a single platform and coordination, SOPs developed with scientific research bodies and relevant ministries, in six to 12 months.

In 12-24 months, it recommended for approval of a New Public Health Emergency Management Act, setting up an Epidemiological Forecasting and Modelling Network, setting up a National Biosecurity Biorepository Network, and having a well-established capacity-building training programme at all levels.

NITI Aayog has formed the expert group, headed by former Department of Biotechnology (DBT) secretary Dr Renu Swarup, in June, 2023, to look at the lessons learnt from within the country's response and global experience on the Covid-19 pandemic and offer a clear strategy and roadmap on what India's preparedness should be to handle any such and even more dangerous public health crisis in the future.

 




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