As the Centre races against time to meet its target of vaccinating entire population by December-end, the Drug Controller General of India (DCGI) on Wednesday made it easier for companies to bring their vaccines to India, provided they are approved by specific countries and the World Health Organisation (WHO).
The DGCI has agreed to keep them out of the ambit of mandatory post-approval bridging trials and batch testing here.
The drug regulator has also made an exemption from the requirements for “well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines”. The move is expected to give push to rollout of foreign vaccines Like Pfizer and Moderna in India.
They had already been requesting the Government for waivers such as no need to undergo post-approval bridging trials for supply in the country.
However, experts said that India has been little late in this direction in view of rising global demands and disruptions in the supply chain of critical components which could stretch the wait for these foreign vaccines a little longer.
As per the notice issued on June 1 by Drug Controller General of India (DCGI) Dr V G Somani, the requirement of conducting post-approval bridging clinical trials “can be exempted” for Covid-19 vaccines with restricted use permissions from regulators like the USFDA, EMA (European Medicines Agency), the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency), Japan’s PMDA (Pharmaceutical and Medical Devices Agency) or those with a WHO Emergency Use Listing.
However, it added, a previous requirement that a safety outcomes assessment be conducted on the first 100 beneficiaries for seven days before the vaccine is rolled out for larger immunisation still holds.
Companies are also being exempted from the requirement that “every batch” of their vaccine be tested by the Central Drugs Laboratory (CDL) in Kasauli, provided “the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin”.
However, the notice said that scrutiny and review of the summary lot protocol and certificate of analysis of batches of these vaccines will still be undertaken by CDL to release them for use in the country.
The latest decision was taken “as per (the) recommendation of NEGVAC (the National Expert Group on Vaccine Administration for Covid-19),” said the DCGI.
‘Bridging trials’, means they “bridge” the gap between studies conducted in several regions, and are localised clinical trials that generate data in an India-specific context, thereby assessing the efficacy of a certain vaccine in Indian participants. This is important since certain pharmaceutical products react differently to Indian genetic makeup than how they might in American or European populations.
The decision, said the drug apex regulator, had been taken because of the “huge vaccination requirements in India in the wake of the recent surge in Covid-19 cases”.
Welcoming the DCGI’s decision, Dr Rahul Bhargava, Director, Hematology Division, Fortis Memorial Research Institute in Gurugram, Haryana said that the move could have been initiated a few months before and saved countless lives. But still better late than never. “We can expect the vaccination drive to be on a smooth track once we have enough jabs on the platter. Moreover, people will have a wider vaccine basket to choose from,” he added. Presently, Covaxin and Covishield are being offered under the national anti-Covid-19 jab programme.
The drug regulatory body also pointed out that although the “domestic manufacturing of Covid-19 vaccines is getting augmented”, the earlier order was being partially modified “to meet the national requirements”. Since the launch of the nationwide vaccination drive from January 16, around 3 per cent of the total population in India has been vaccinated. The Government has submitted before the Supreme Court recently that it plans to vaccinate the entire population by this year-end.
However, the notice said, scrutiny and review of the summary lot protocol and certificate of analysis of batches of these vaccines will still be undertaken by CDL to release them for use in the country.
The latest decision was taken “as per (the) recommendation of NEGVAC (the National Expert Group on Vaccine Administration for Covid-19),” said the DCGI.
The decision, said the drug apex regulator, had been taken because of the "huge vaccination requirements in India in the wake of the recent surge in Covid-19 cases".
Welcoming the DCGI’s decision, Dr Rahul Bhargava, Director, Hematology Division, Fortis Memorial Research Institute in Gurugram, Haryana said that the move could have been initiated a few months before and saved countless lives. But still better late than never. “We can expect the vaccination drive to be on a smooth track once we have enough jabs on the platter. Moreover, people will have a wider vaccine basket to choose from,” he added. Presently, Covaxin and Covishield are being offered under the national anti-Covid-19 jab programme.
The drug regulatory body also pointed out that although the "domestic manufacturing of Covid-19 vaccines is getting augmented", the earlier order was being partially modified "to meet the national requirements". Since the launch of the nationwide vaccination drive from January 16, around 3 per cent of the total population in India has been vaccinated. The Government has submitted before the Supreme Court recently that it plans to vaccinate the entire population by this year-end.