India plans cell for expediting new treatments and vaccines for emerging public health emergencies

New Delhi: The Central Drugs Standard Control Organization (CDSCO) plans to set up a crisis management cell of port offices, laboratories, state officials and it zonal chiefs to speed up the search for new treatments and vaccines for emerging public health emergencies.

According to a government document reviewed by Mint, these could include disease outbreaks, epidemics and the source of older pandemics such as Zika virus disease, Influenza H1N1 pandemic and the covid-19 pandemic.

Also read |  Bird flu among pigs should worry humans too

“To manage health crisis, a Crisis Management cell will be constituted which will comprise of Heads of zonal, sub-zonal, port offices/states/UT drugs control department, heads of laboratories. The cell would meet on regular basis during the crisis, or it would meet as and when required to strategize priorities and respond with regulatory agility,” the guidance document said.

“To facilitate the process, the cell would co-opt as many members as necessary, depending upon the nature and context of crisis. The crisis cell will also function to support Drugs Controller General (India), for giving inputs to the technical advisory committee of the crisis management group of disaster management cell, MOHFW,” it further said.

Push for fast-tracking

The document underlined that in order to prepare for health crises quickly, efficiently and in a coordinated manner, the development, evaluation and approval of vaccines, drugs and diagnostics should be fast-tracked in the management of health crises.

The note, while describing the role of regulatory authorities, said that all states should provide the necessary support for these mechanisms.

Also read |  India to undertake mega covid-19 study to help prepare for future pandemics

“It remains the responsibility of regulatory authorities to identify new medical products under assessment to participate in various collaborative initiatives in the regulatory field with each other and to facilitate the development and availability of the novel technologies wherever required,” it added.

The objective of the drug regulatory system is to ensure the availability of safe, effective and quality drugs, cosmetics and medical devices as per the Drugs and Cosmetic Act 1940 and Rules.

Holding key role

CDSCO along with state drug control departments have an important role for monitoring and mitigating shortages of medicine and device/diagnostics.

“This may include taking feedback from the industry on daily basis regarding the production of emergency drugs, devices, diagnostics and dispatch to distribution points, verification of the availability of API, excipients, Key Staring Material (KSM) for the uninterrupted production of emergency medical products,” it said.

Also read |  Inside the control room of MEA’s Covid-19 crisis management cell

For collection of data/information methodologies like survey at supply chain, hospitals, uploading of data in an online database system etc. may be adopted, the document said.

Queries sent to the health ministry remained unanswered.