The story so far : More than six months after the government announced it would fast-track clearances for foreign COVID-19 vaccines to India, the indemnity clause is still holding up the import of all American vaccines to India, including those manufactured by Pfizer, Johnson & Johnson and Moderna. Without specifying a timeline, a senior Health Ministry official said talks are on and that the “indemnity clause is also being discussed.”
What is indemnity and why is it needed?
Indemnity is a form of contract. It is not specifically provided for in any law or regulation related to the grant of approval for any new drug or vaccine in the country. If it all any indemnity is to be granted to any company in respect of a particular drug or vaccine, it can only be in the form of an indemnity bond executed on behalf of the government of India, or a clause or set of clauses in any contract that the government may sign with the supplier. There appears to be no precedent for any company getting such indemnity in India for any drug.
Section 124 of the Indian Contract Act, 1872, defines a contract of indemnity as one by which one party promises to save the other from any loss caused to the latter. Once the government of India grants such indemnity to the vaccine manufacturer or importer, it would mean that if a particular vaccine is perceived to have caused death or any lasting damage to a recipient, any claim of compensation arising from it will have to be met by the government, and not by the company. In the event of a court ordering payment, the company will be in a position to recover the amount from the government.
Is the demand for or grant of indemnity a standard practice?
Indemnity is essentially a contractual matter between the supplier and recipient, and therefore, a good deal of confidentiality is attached to such agreements. Pfizer’s global media relations head for Asia, Roma Nair, said the company had shipped more than two billion doses so far to 152 countries where the clause has been accepted and that indemnity talks with India were going on without a breakthrough yet. “In markets that do not have the legal or legislative protections that are available in the U.S, we work with governments to find mutually agreeable solutions, including contractual indemnity clauses,” she said.
Normally, it is the company applying for approval of a new drug or vaccine that submits itself to various conditions, processes and regulations. Approvals in most countries come with stringent conditions regarding conformity to national guidelines, quality standards, safety assessments and requirements regarding various phases of clinical trials. For imported drugs, a local clinical trial may not be required if it has been approved and marketed in countries specified by the Central Licensing Authority and if no major serious adverse events have been reported.
However, given the peculiar global situation arising out of the COVID-19 pandemic, and the shortage of vaccines faced by countries such as India, which urgently needs to inoculate hundreds of thousands of people, some vaccine suppliers may be in a position to set conditions.
What have the overseas companies got so far?
The Drugs Controller-General of India has already taken a big step towards fast-tracking the import of vaccines by dispensing with the need for local trials. Earlier, the Centre had decided that foreign-produced vaccines that had been granted emergency approval for restricted use by the regulators in the U.S., the U.K., the European Union and Japan, or those included in the WHO’s Emergency Use Listing, would be granted Emergency Use Authorisation in India. The condition was that there would be a post-approval parallel bridging trial. However, this condition has been waived and no bridging trial is now necessary. The significance of this exemption is that both the delay attached to such trials and the risk of adverse events to participants in those trials has been avoided.
The New Drugs and Clinical Trial Rules, 2019 set down stringent regulations for grant of approval as well as for trials. The Rules provide for payment of compensation by the sponsor of the trial or its representative to any participant who dies or suffers disability as a result of such trials. Exemption from these trials has reduced the risk to overseas manufacturers. However, the companies probably fear that they would still be liable under the ordinary law of tort, arising from future claims by anyone adversely affected after receiving the shot.
What does India gain by giving indemnity?
In the absence of indemnity, overseas manufacturers may load the risk onto the price of the vaccines, making each dose more expensive. By indemnifying the companies in respect of these vaccines, the government of India may be able to negotiate lower prices and higher volumes. It may help accelerate its national vaccination drive. On the flip side, the government may be forced to make it a level playing field for local makers too, by extending the indemnity to them, and thereby inviting upon itself the entire risk associated with more than a billion vaccine shots.