Grant Emergency Authorisation to Covid Vaccines Only After Enough Trials: Parl Committee Warns Govt

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On the eve of India getting it's first COVID-19 vaccine, Parliamentary Standing Committee on Home Affairs has warned the government against rushing through authorisation. The Anand Sharma-led committee, in its report, recommended that due diligence, enough trials and all other precautions be taken before emergency authorisation is granted. "The Committee recommends that while undertaking vaccine trials all necessary and mandatory requirements must be duly fulfilled and all phases must be completed. Trials on small animals, human trials should be mandatorily undertaken on a sufficient sample size population," the report stated.

The recommendation comes as the government considers applications of at least three firms who have sought emergency authorisation to roll out their COVID-19 vaccines in India. The Centre, last Tuesday, said the applications by Bharat Biotech, Serum Institute of India and Pfizer, filed with the Drugs Controller General of India (DCGI), are being examined by the COVID-19 subject expert committee of Central Drugs Standard Control Organisation (CDSCO).

The report titled 'Management of Covid-19 Pandemic and Coordination with State Governments' noted that no emergency use authorization has been given in the past by the CDSCO. Therefore, the committee recommends that if at all emergency authorisation would be given, it should be given by the government with proper consideration and caution and this provision should be used in rarest of the rare cases.

The multi-party committee, while calling for a comprehensive public health act, highlighted the enormous burden on health infrastructure which was exposed during the pandemic. Special focus was laid by the committee on lack of enough ICU beds.

"The Committee opines that the threat of COVID-19 has highlighted the huge disparity of infrastructure and services in public and private hospitals. There has to be sufficient capacity of beds available both in public/government and private hospitals," the report said .

It added that disproportionate availability of ICU beds in private and public sector hospitals was observed. The Home Affairs committee has recommended to the government to make private hospitals affordable for common people so that the burden doesn't fall on the public sevtor hospitals alone like it did during the outbreak of coronavirus.

The committee noted that after the onset of the pandemic, the largest share of the burden of extending comprehensive healthcare has been borne by the government hospitals "as private hospitals are either inaccessible or not affordable for everyone." It further noted that there is a need for a comprehensive public health law to keep a tab on private hospitals and check black-marketing of medicines.

The parliamentary panel also called for a complete overhaul of the Epidemic Diseases Act. "It should be revisited, updated and amended so that it is fully equipped to respond to the challenges posed by the unanticipated onset of pandemic/epidemic in the future," the panel said.

The panel also emphasised on the need for having proper data on migrant labourers and said the task of identifying the location and disbursing relief measures to migrants became difficult since there was statistics available.

The report was submitted to Rajya Sabha chairman and Vice President M Venkaiah Naidu on Monday.