- Pfizer, Moderna among companies that requested government for waiver
- The government has pledged to vaccinate all of India by December
- Vaccinations have slowed down in many states because of a shortage of doses
New Delhi: The Drugs Controller General of India (DCGI) has done away with specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies – a big move likely to clear the way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement. In a letter, DCGI Chief VG Somani letter said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation. “In light of the huge vaccination requirements and the need for increased availability of imported vaccines,… it has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing,” he said.
Mr Somani added that for the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval brigding clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by the National Control Laboratory of the Country of Origin.
Earlier, vaccines that had completed clinical studies outside the country were required to carry out “bridging trials” or limited clinical trials on the Indian population to know how the drug works on people of Indian origin.
The scrutiny and review of their Summary Lot Protocol and Certificate of the analysis of Batch/Lot Shall be undertaken by CDL Kasauli for batch release as per standard procedures and the requirement of assessment of the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out further immunization programs, along with other procedures for filing of applications and timeline for processing of the applications, etc, as laid down in the notice dated 15.04.21 shall remain the same, Dr Somani said in the letter.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.