The Supreme Court has admitted a PIL (public interest litigation) against the central government for cancelling the manufacturing licenses of three PSU vaccine institutes and other related issues. The PIL was filed by SP Shukla (former special secretary in the Union ministry for health and family welfare), Mira Shiva of the NGO AIDAN, Srinivasan of LOCOST, KL Chopra of SSV and Sarojini of MFC.
Colin Gonsalves, the advocate from Human Rights Law Network who appeared for the petitioner, said that the Supreme Court will issue a notice to the govt before beginning the hearings.
The Union health ministry had in January last year suspended the manufacturing licenses of CRI Kasauli, PII Conoor and the BCG Vaccine Laboratory Chennai for non-compliance of good manufacturing practices (GMP) as per the WHO standards.
The petitioners through the PIL prayed the court to issue a writ of mandamus or any other appropriate writ, order or direction to the Respondents to setting up a Commission of Experts of this Court to enquire into the facts stated in this petition and any other matter incidental and relevant thereto and thereafter make a report to this Court and to include therein a draft vaccine policy and further to make recommendations as to the steps that ought to be taken to ensure that essential vaccines are both available and affordable to the vast masses of India.
The petitioners also prayed for an order directing the Respondents to forthwith restart production of vaccines at Pasteur Institute of India, Coonoor, Central Research Institute, Kasauli and BCG Vaccine Laboratory, Chennai and to take whatever steps that are required to ensure commencement of production.
The petitioners prayed for an order directing the Committee of Experts set up under prayer clause 1 above to forthwith report to this Court within a specified time as to whether the arrangements made between the Pasteur Institute of India and various private firms, it is in genuinely in the public interest and if not so, what steps ought to be taken.
The petitioners prayed to the court to issue a Writ of Certiorari, or any other appropriate writ or order or direction quashing and setting aside the order dated 15.01.2008 of Respondent No.9.
In the PIL, the petitioners argued that the closure of these three PSU vaccine units could have been avoided if the government had taken timely action to upgrade the shortfalls in WHO GMP compliance. In any case, compliance with WHO-GMP is mandatory only for exporting vaccines or buying them through the UNICEF vaccine procurement system and not for indigenous manufacture/purchase/immunization.
The govt (and DGCI) also had the option of suspending only exports till the PSUs became GMP compliant and meet the huge indigenous demand, rather than suspending production altogether, especially since there was no complaint on the product quality of the vaccines produced in those PSUs. Indeed China, Netherlands and other countries have effectively exercised this option to protect their PSUs and indigenous public health needs from the vagaries of international regulation, the petitioners argued in the PIL.