Give vaccine emergency use authorisation after trials on sufficient sample size: Par Panel

Any vaccine against COVID-19 should be granted emergency use authorisation only after proper consideration and conducting its trials on a sufficient sample size, a parliamentary panel chaired by senior Congress leader Anand Sharma has recommended to the government.

In a report submitted Monday to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee on Home Affairs also said there was a need for a comprehensive public health law to keep a tab on private hospitals and check black-marketing of medicines.

The report comes even as the government considers applications of at least three firms seeking emergency approval to roll out their vaccines against the coronavirus 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 are being examined by the COVID-19 subject expert committee of Central Drugs Standard Control Organization (CDSCO).

The parliamentary committee report noted that the CDSCO has given no emergency use authorisation in the past, and suggested that all necessary and mandatory requirements must be duly fulfilled and all trial phases completed.

"Trials on small animals, human trials should be mandatorily undertaken on a sufficient sample size population…if at all emergency authorisation would be given, it should be given by Government with proper consideration and caution and this provision should be used in rarest of the rare cases," the report reads.

The report also noted that government hospitals bore the largest share of the burden of extending comprehensive healthcare during the pandemic, as private hospitals were either inaccessible or not affordable to everyone.

Therefore, more fund should be allocated to public hospitals to strengthen the public health Infrastructure so that they can equip themselves appropriately to handle such pandemics in the future, the committee suggested in the report.

It also recommended that learning from the experience of the pandemic, there is a need for a comprehensive public health act preferably at the national level with suitable legal provisions to support the government in keeping checks and controls over the private hospitals "as there have been reports about the selling of hospital beds by them".

"And also keep a check on the black marketing of medicines and product standardisation." At the same time, the panel said it is also necessary to make people aware through campaigns on cheaper and effective repurposed medicines to prevent them from panicking and spending a huge amount of money on expensive drugs.

"The committee recommends that good quality and affordable medicines be provided to everyone, especially at a cheaper or subsidised rate to the marginalised sections of the society especially at the time of Pandemic like COVID-19," the report reads.

(With PTI image)