India clears way for foreign-made Covid vaccines, invites applications
New Delhi/IBNS: The Indian government has decided to fast-track the emergency approval of foreign-made vaccines against coronavirus amid the whopping surge in infections across the country.
The decision comes as a part of the plan to increase the scale of vaccination.
The government wants applications from vaccine-makers in western nations and Japan.
"We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others...to be ready to come to India as early as possible," said VK Paul, chairman of the National Expert Committee on Vaccine Administration.
Vaccines, which are approved by the World Health Organization (WHO) or authorities in the US, Europe, the UK and Japan, "may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial", the health ministry said.
Such pharmaceutical companies will not need to conduct small, local safety trials for their vaccines before seeking emergency approval in India.
The national drug regulator has already granted permission for restricted use in emergency situations to Russia's Sputnik-V vaccine.
Limited doses of the vaccine will likely be available by the end of this month or early next month.
The countrywide vaccination drive started from Jan 16 onwards. Two vaccines have been approved for Emergency Use Authorisation (EUA) by the National Regulator i.e. Drugs Controller General of India (DCGI). These are “Covishield” manufactured by Serum Institute of India (SII) and “Covaxin” manufactured by Bharat Biotech International Limited (BBIL).
Several other vaccines are at various stages of clinical development within the country, read a government statement.