A petition was filed in the Supreme Court to revive the 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.
The petition filed by Amulya Ratna Nanda, IAS (retired), All India Drug Action Network (AIDAN), Low Cost Standard Therapeutics (LOCOST) and Medico Friend Circle, represented by advocate Pragya Ganjoo and advocate Satya Mitra, urged the Supreme Court to push the ‘reluctant’ Union 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.
The petition said these PSUs, once revived, should be granted “full autonomy” as envisaged in the Javid Chowdhary report of 2010 to ensure their complete revival and smooth functioning in the future.
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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 petition. In that hearing, the government had agreed to take action to revive the PSUs.
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“Unfortunately, that has not happened and these vaccine manufacturing facilities that were catering to 80-85% of the 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 up 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 part of the global effort by the World Health Organisation,” the petition informed.
According to the petition, following the liberalisation and privatisation policies, 17 PSUs were shut down by 2005. By 2007, only seven PSUs remained operational, it said. Two of these are State level PSUs and five Central level PSUs. Kings Institute of Preventive Medicine (KIPM, Chennai), a State level PSU, has not produced any vaccines in the past two decades. The only functional State level PSUs today is the Haffkine Institute and its commercial arm, Haffkine Biopharmaceuticals Co. Ltd., (HBPCL) in Mumbai.
The Central level PSUs are the Bharat Biologicals and Immunologicals Ltd, the Indian Institute of Immunologicals, the Central Research Institute (CRI) in Kasauli, the Pasteur Institute of India (PII) in Coonoor and the BCG Vaccine Laboratory (BCGVL) in Chennai, it said.