Discussion continues on indemnity to Moderna: Doubts over the early arrival of Corona vaccine even after emergency approval; The condition of the company was – only if concession is given, we will send the vaccine to India

Emergency approval has been given to Moderna in India, but the government has not yet been able to decide on the condition of the company’s indemnity. If sources are to be believed, then discussions are going on on this condition of Moderna. In such a situation, a question mark has arisen over the country’s first international vaccine coming to India soon.

In fact, Moderna had made a condition that they would get the indemnity, only then they would send the vaccine to India. This indemnity frees vaccine companies from all legal liability. If there is any disturbance due to the vaccine in future, then compensation cannot be sought from these companies. Pfizer has also sought a similar exemption from the Indian government.

Exemption was given in many countries including America
In December 2020, a US court granted immunity from compensation to Pfizer-Mordana. That is, compensation cannot be sought from the company for the side effects caused by the vaccine. Actually, relief or indemnity from indemnity means a guarantee of indemnity against any loss. In countries like America and Britain, Pfizer-Moderna has got such exemption.

Understand the mathematics of indemnity in 3 questions and answers
1. What is the law on indemnity in India?
The legal provisions in this matter are very clear. The drug laws of India do not provide for legal protection or indemnity while approving any new drug or vaccine. If any medicine or vaccine is to be given indemnity, then the accountability will become of the government. This will be mentioned in the clause of the contract between the government and the supplier.

2. Do other vaccines available in India have accountability?
– Yes. The Indian drug regulator has not granted indemnity to companies for all the three vaccines approved so far – Covaxin, Covishield and Sputnik V. Here the rules for clinical trials are clear. If a volunteer dies or suffers serious injury during the trials, he gets compensation.

3. Impact of indemnity on people?
In the absence of indemnity, foreign companies can increase the prices of vaccines. By giving indemnity, the government can negotiate the price and quantity of the vaccine. It will boost India’s vaccination campaign. The biggest advantage of this will be that the vaccine will be available to the children. Since, Pfizer and Moderna’s vaccine is being administered to children above 12 years of age in some countries including the US. The government is thinking of buying 5 crore doses, which can also be used on children.

Country’s first international vaccine
Moderna is being called the first international vaccine in India because it will be imported directly. It will not be manufactured in the country. At the same time, Coveshield is being made by Serum Institute in the country and Covaxin is being made jointly by Bharat Biotech and ICMR. Russia’s Sputnik-V will be manufactured by Dr. Reddy’s Laboratories in India. Dr. Reddy’s Laboratories is the Indian partner of the Russian Direct Investment Fund (RDIF), the developer of Sputnik.

The government also changed the policy
Moderna and Pfizer are among the companies that appealed to the Indian government to do away with the requirement of local trials after allowing emergency use. But Cipla will have to test 100 people. However, before getting approval in India, the foreign vaccine had to be tested on 1500-1600 people first. But on April 15, the government changed the policy to limit it to 100 people.

India now has 3 vaccines and one powder
Currently, CoveShield and Covaxin are being used in the vaccination drive in the country. Russia’s Sputnik-V is also being used. Apart from this, DRDO has made 2-DG medicine for the prevention of Kovid. Its emergency use has also been approved. It is a powder, which is dissolved in water.