COVID-19 | SC wants to know Government policy to revive vaccine public sector units

Bench asks Government to file response to plea that urged the Supreme Court to push the ‘reluctant’ Union Government to put these PSUs to use in the time of dire need.

The Supreme Court on December 13 said it wanted to know the Government’s policy to revive vaccine public sector units, considering the dire need to ramp up the COVID-19 immunisation and utilise their full production capabilities by placement of purchase orders.

A Bench led by Justice D.Y. Chandrachud said the Government should file a response to a petition filed by Amulya Ratna Nanda, IAS (retired), All India Drug Action Network, Low Cost Standard Therapeutics and Medico Friend Circle, represented by advocates Satya Mitra and Pragya Ganjoo. The petition has urged the Supreme Court to push the “reluctant” Union Government to put these PSUs to use in the time of dire need, especially after public funds were once spent to make them Good Manufacturing Practices (GMP) compliant.

Solicitor General Tushar Mehta, for the Centre, said the issue was within the domain of policy.

“Yes, we would like to know what is the policy. So we shall like you to file a reply,” Justice Chandrachud addressed Mr. Mehta.

‘Grant full autonomy’

The petition said the PSUs, once revived, should be granted “full autonomy” as envisaged in the Javid Chowdhary report of 2010 in order to ensure their complete revival and smooth functioning in the future.

The plea said steps should be immediately taken “to revive vaccine PSUs by ensuring issuance of production licences to the remaining GMP compliant vaccine PSUs to utilise them for manufacturing all mass vaccination programmes, including COVID-19 vaccine, to meet on-going demand influx”.

“No PSUs should be excluded from producing any vaccine or from government vaccine procurement, as long as quality and affordability are ensured,” the petition submitted.

The petition referred to an order of the Supreme Court in October 2016 based on an earlier plea. In that hearing, the Government had agreed to take action to revive the PSUs.

Unfortunately, the plea said, the Government did not honour its commitment.

“Unfortunately, that has not happened and these vaccine manufacturing facilities that were catering to 80-85% of the country’s vaccine demand prior to their suspension continued to languish wastefully despite their modernisation and capacity expansion. This is acutely felt in the present times,” the petition said.

“India is home to the oldest vaccine PSUs, with 25 of them set up under the British Raj. By 1980s, 29 PSUs were set with the sole objective of self-reliance and self-sufficiency in vaccine production for the Universal Immunisation Programme introduced in 1986 to prevent mortality and morbidity amongst children in India as a part of the global effort by the World Health Organisation,” it said.

According to the petition, following the liberalisation and privatisation policies, 17 PSUs were shut down by 2005. By 2007, only seven PSUs remained operational in India, it said. Out of this, two are State level PSU and five Central level PSUs. Kings Institute of Preventive Medicine (KIPM, Chennai), a State level PSU has not produced any vaccines for the past two decades. The only functional State level PSUs today is the Haffkine Institute and its commercial arm, Haffkine Biopharmaceuticals Co. Ltd., in Mumbai.

The central level PSUs were Bharat Biologicals and Immunologicals Ltd., Indian Institute of Immunologicals, Central Research Institute in Kasauli, Pasteur Institute of India in Coonoor and BCG Vaccine Laboratory in Chennai, it said.

“The need for PSUs in every nation is an imperative essentiality that goes beyond just safeguarding health security of the nation but to test and to ensure that vaccines produced in both public and private sector in the country is regulated,” the petition noted.

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