The Tamil Nadu government on Wednesday announced that it will float global tenders to procure COVID-19 vaccines to inoculate those between the ages of 18 and 44 in the state. The decision came after the state government said that the doses allocated by the Union government are not enough to cover the entire population in the said age group. Several other states have also made similar announcements on global procurement of vaccines, including Andhra Pradesh, Karnataka, Telangana, Maharashtra, Odisha, and Uttar Pradesh.
Does this however mean that these states can procure vaccines like Moderna and Pfizer, which have not been approved by the Union government for use in India yet? Or will they have to stick to the currently approved vaccines — Oxford AstraZeneca (Covishield), Covaxin, Sputnik V, and Johnson & Johnson?
As per the Union government’s April 13 announcement regarding conditional approval for foreign manufactured vaccines, the decks are already cleared for state governments to buy these vaccines, says Murali Neelakantan, Principal Lawyer with Amicus. On April 13, the Union government announced that vaccines which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing), may be granted emergency use approval in India, with a post approval bridging clinical trial in the country. It added that the first 100 beneficiaries of such foreign vaccines will be assessed for seven days after the vaccination for safety outcomes before it is rolled out for further immunisation programmes within the country.
“This means that all vaccines approved in the US, UK, EU, Japan and WHO overseas, will not require approval in India and they can be directly imported. The only thing that they will need to do is get a license under the drugs act and have them tested (every batch) in the government lab in Kasauli before releasing it for public use,” Murali says.
This is the route that has been taken to authorise the Russia-made Sputnik for mass vaccination programme in India. Sputnik is currently being imported by Dr Reddys and is being tested at the Central Drugs Lab (CDL) in Kasauli.
“The reason that we have to test every batch is because every batch is different. This is biological and not a chemical substance. Therefore each batch has to be tested. This is not unique for imports. Even for domestic vaccines, every batch sample is sent to CDL and tested. So it is consistent,” Murali explains.
Mathew Idiculla, Research Associate, Centre for Law and Policy Research says, “Health is under the control of the state government. So the states have all the right to enter into global procurement agreements and other similar deals by themselves,” adding that the only question is whether the states can procure drugs and vaccines because the authority rests with a Union government body.
Mathew points to a press release issued by the Union government that said, “The division of vaccine supply — 50% to Government of India and 50% to other than Government of India channel would be applicable uniformly across for all vaccines manufactured in the country. However Government of India will allow the imported fully ready to use vaccines to be entirely utilized in the other than Government of India channel.”
Pointing to the wordings in the statement, Mathew says, “The question now is, how do you interpret that? If you have a broad interpretation that says that these vaccines (Moderna, Pfizer) are ready and have gotten approval from the World Health Organisation (WHO) and many other countries, then the state will assume that they can buy those vaccines for their people.”
“It is a bit vague as it says it is 'fully ready' and not 'fully ready and approved for use in India'. Whenever things are a bit vague, it usually gives the state government the leeway to interpret it in its favour and say that they are going ahead and procuring things based on their right to do so,” he adds.
In a statement released on Wednesday, Chief Minister MK Stalin said that the Union government is providing vaccines for those above 45 years of age and pointed out that it has tasked the state governments with the responsibility to vaccinate those in the age group of 18-44 years. “Accordingly, about 13 lakh doses of vaccine have been set aside for Tamil Nadu. This number is not enough to vaccinate those in the 18-44 age group, therefore Tamil Nadu government has decided to import vaccines through global tenders. This government will expedite the process for the global tendering and vaccination of everyone in the 18-44 age group,” it added. In the tweet announcing this decision, Chief Minister Stalin also said that these vaccines will be procured by the state government at the lowest prices.
Apart from Tamil Nadu, states including Maharashtra, Odisha, Uttar Pradesh, Telangana, Andhra Pradesh and Karnataka have announced that they will import vaccines directly from global countries, as per reports.