Health groups irked by the SC order on vaccine PSUs

Around 65% of Tetanus Toxoid, 90% of BCG vaccine and 100% of Japanese encephalitis vaccines are procured from the private sector at increasingly higher prices each year

GN Bureau | February 19, 2018

#Public Sector Units   #Vaccine PSUs   #Health   #Supreme Court   #Vaccine  

Health groups have expressed their disappointment with a February 12 order of the supreme court, refusing to review or recall an earlier order disposing off a case against the mala fide suspension of the vaccine public sector units (PSUs) and government’s tendency to pamper private sector with public money.

The court relied only on the government’s claims regarding the revival and modernisation of the suspended PSUs and did not take into account the last rejoinder of the petitioners that highlighted the increasing diversion of purchase orders to private sector at ever increasing prices.

The groups are considering filing a fresh petition, as the court also said “in case there is any deficiency or neglect on the part of the government…, the petitioner shall be free to seek appropriate redress in appropriate proceedings at the appropriate stage.”

The decade-old public interest litigation (PIL) was filed by former union health secretary SP Shukla and representatives of the All India Drug Action Network (AIDAN), Low Cost Standard Therapeutics (LOCOST), Medico Friend Circle (MFC), and Society for Scientific Values (SSV).

Chief petitioner SP Shukla said, “We won half the battle with the revival of the suspended PSUs and their modernisation for compliance with good manufacturing practices (GMP), under the pressure of our court case and the report of the governmental Javid Chowdhury committee. But their production is yet to be restored to pre-suspension levels, the responsibility for mala fide suspension was not fixed, and even the recommendations of the Javid Chowdhury Committee have not been fully implemented.”

According to S Srinivasan of LOCOST, one of the petitioners, "The union government has not been buying vaccines from the public sector even after their revival. The government data show that the purchase orders to PSUs are declining and those to private companies are growing despite increasing prices. We highlighted all these issues in our last affidavit of 2016 to show that the Government of India is misleading the SC, but it was not taken into account before disposing off the petition.”

“We neither have a rational vaccine policy nor rational use of vaccines - for example, selective immunisation has disappeared from government policy. New vaccines and their combinations of doubtful efficacy and safety are being introduced in the universal immunisation programme. By shifting its procurement towards irrational cocktail vaccines made only by the private sector, the government is systematically reducing PSUs into component suppliers to the private sector,” said Mira Shiva of AIDAN, another petitioner.

N Sarojini from MFC remarked, “Due to lack of government orders, the revived PSUs are forced to find private buyers for survival. Prior to suspension, the public sector supplied 85% of all universal vaccines procured by the government. Today, over 90% of the government purchases are from private sector.”

On behalf of the SSV, Prof. N Raghuram stated, “Vaccines are prescription drugs but are being promoted like consumer goods through private immunization camps. It is unethical that all these dubious practices are being done in the name of children as they cannot decide the vaccines they need. Someone must give a credible answer to helpless parents’ question as to how many vaccines are adequate for a child.”


The public interest litigation, ‘SP Shukla and Others vs. Union of India’, was triggered by the sudden suspension of the last three surviving public sector vaccine manufacturing units under the union health ministry in 2008 by one of its own arms (Drug Controller General of India) citing non-compliance with good manufacturing practices (GMP), while another arm of the same ministry failed in its responsibility to invest in their modernisation and GMP compliance.

These units are: Central Research Institute (CRI), Kasauli; Pasteur Institute of India (PII), Coonor; and BCG vaccine laboratory (BCGVL), Chennai. Prior to suspension, they were jointly catering to 85% of the vaccine requirements of India’s Universal Immunisation Programme (UIP).

This PIL was admitted in the Supreme Court in February 2009. Over the years, the case highlighted the lack of a national vaccine policy and the government’s tendency to drift along the path laid by the private industry, such as in the introduction of dubious new and combination vaccines into the universal immunisation programme at exorbitant prices.

Under the pressure of this court case, in June 2009, the then UPA government set up a committee headed by Javid Chowdhury, former health secretary, who insisted on the revocation of the order suspending the PSUs and their revival for domestic production as well as modernisation for GMP compliance within 3 years (i.e., by 2013). As of today, only CRI became GMP-complaint and went into production in 2015. BCGVL just became GMP-compliant and is still in trial production, whereas PII-Coonor has not even built its GMP-compliant unit.

Under pressure from this PIL, the UPA II government also formulated a vaccine policy that legitimised its ongoing practices favouring the private sector, which continues to be followed by the current government.

Both UPA and NDA governments dragged on the case in the SC for over 7 years by seeking date after date. On October 2016, a three-judge bench headed by the chief justice disposed the case saying that the government has revived the suspended units and made them GMP compliant. On this day, a junior lawyer had requested a passover because senior advocate Colin Gonsalves representing the petitioners was occupied in another courtroom but this was not granted.

The last affidavit filed by the petitioners which showed that the government’s claims were half-truths seemed not to have been considered by the bench.  The judgment simply stated that “in case there is any deficiency or neglect on the part of the government in doing so, the petitioner shall be free to seek appropriate redress in appropriate proceedings at the appropriate stage.”

The petitioners filed petitions for review and recall of the order, by reiterating the substance of the last rejoinder affidavit against the Government’s claims and providing the cause list to show a genuine clash requiring the Senior Advocate to be in two courts at the same time. However, on 12 February 2018, a bench headed by Chief Justice Dipak Misra reiterated the earlier order and said that the court is not inclined to review or recall the previous order but can consider a fresh petition.



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