Johnson&Johnson applies to India's drug controller for Phase3 Vaccine trials

New Delhi: Pharma company Johnson & Johnson has sought approval from the Indian drug regulator for Phase III trials of its single dose vaccine. In addition, the company has also requested an import license.

Johnson & Johnson corona vaccine:

Sources said that the company has demanded a meeting of the Subject Expert Committee constituted by the Central Drug Standards Control Organization for an early decision on the application.

The central government has last week decided to speed up the emergency approval of all foreign Corona vaccines.

Trial of corona vaccine in India:

This would include vaccines approved by the World Health Organization or regulators in the US, Europe, UK or Japan. According to sources, Johnson & Johnson applied to the Global Clinical Trial Division through the Sugam online portal on 12 April, while the cases of vaccine and other biologics go to the Biological Division.

The company has applied again on Monday. Johnson & Johnson vaccines can be stored at temperatures ranging from two to eight degrees for up to three months. Only one of its doses has been found to be effective in protecting Corona.

It is to be noted that the foreign vaccine has also been exempted from the condition of Breeze trial before use. Now companies like Moderna, Pfizer and Johnson & Johnson in the US will be able to export vaccines developed abroad to India.

Emergency use of covid vaccine:

Recently, Chairman of National Expert Group, Dr. VK Pal had said that exemption in Breeze Trial has been given only in view of the present situation of corona infection. Even after this, there will be no shortage in ensuring the effect and quality of the vaccine.

Foreign companies will have to initiate Breeze trials in India along with the emergency use of their vaccine and later the Controller General of India (DCGA) may formally allow its emergency use in India based on Breeze trial data.

A senior Ministry of Health official said that after getting permission to use in India, foreign companies can also start production in India by entering into an agreement with Indian companies. This will increase the supply of vaccine by leaps and bounds.

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