Madhya Pradesh Government joins the queue for sourcing vaccine supplies from foreign pharma companies post High Court's nod
Amid the acute shortage of vaccines in government and private hospitals in Madhya Pradesh, the state government is looking to procure one crore COVID 19 vaccines. The MP government informed Madhya Pradesh HC about its decision to float a global tender for sourcing vaccines from big pharma companies abroad.
The MP government hopes that the move will attract the likes of Pfizer, Johnson & Johnson, Moderna to participate in the process and aid the process of filling the gaps in supply.
However, there are several states in the country like Maharashtra, Goa, Punjab among others who are trying to negotiate a deal with international pharma companies for vaccine supplies.
Pharma companies not keen on negotiating with state governments
International companies are reluctant to supply vaccines to the state governments. In fact, companies like Pfizer and Moderna have made it clear that they will only get into supply agreements with the central government citing policy considerations.
Although the PIL filed by Advocate Sunil Gupta points to a stringent drug approval procedure for international pharma companies’ hesitancy in supplying vaccines to states, there is more to the story than meets the eye.
Foreign Vaccine manufacturers demand indemnity, Indian government thinks otherwise
Foreign vaccine manufacturers are seeking an indemnity against even the remotest possibilities of mishap that might arise. Vaccine manufacturers have been able to distribute the vaccines much faster where they have been offered such legal protection.
On the other hand, the Indian Government is of the view that agreeing to the demands of a no-fault liability clause would mean extending the same terms and conditions to Indian vaccine manufacturers. Although talks between global pharma giants like Pfizer and the Indian government are on the anvil, an amicable solution has still not been reached. This has been a hindrance for foreign pharma companies in supplying vaccines to the vast Indian market.
India's lax regulatory approval process
As pointed out earlier, India has a stringent regulatory regime when it comes to granting approvals. Although the government has agreed to fast-tracking the approval process, there is some groundwork to be done. For instance, there have been controversies in the past over granting lack of transparency in the clinical trial process. In fact, the DCGI has received flak in the past over the lack of clarity on granting waivers from the clinical trial process.
In fact, the clinical trial process for approving Covaxin made headlines. Questions were raised on account of its rushed approval and clearance.
With vaccine drives halted, pressure mounts on the central government to find solutions to the shortage of medicines
With more and more states floating global tenders and the slack response from pharma companies in return, the pressure on the central government is mounting each day as it looks to find out ways to deal with the alarming vaccine shortages. The trouble only accentuates further when one considers that vaccination drives in several places have been halted due to the government’s inability to meet the overwhelming and unprecedented demand for covid vaccines.
While High Courts are green lighting the tender process to invite global tenders, it remains to be seen what impact the judiciary will be able to make considering the lack of willingness shown by major global pharma companies in dealing with state governments over vaccine supplies.