‘Creaky and cumbersome’: PM Modi orders overhaul of drug regulatory system
At a late Tuesday afternoon meeting, Prime Minister Narendra Modi showered praise on academics, industry and start-ups for setting aside their reservations and joining hands to power India’s research to develop tests, vaccines and drugs for Covid-19. But PM Modi had one lurking concern.
This was about the ability of the regulatory framework to keep pace with industry and scientists. PM Modi, who has on occasions spoken how the bureaucracy and its systems weren’t able to keep pace, said India’s regulatory system for new drugs and vaccines was still “creaky and cumbersome” at the best of times. This, Prime Minister Modi told the meeting of top government officials, had to change. Fast.
“The prime minister underscored that we not only had to have the highest quality, ethical standards but also the highest speed,” a senior government official who was present at the meeting of the task force on coronavirus vaccine development, drug discovery, diagnosis and testing told Hindustan Times.
Among those who were present at the meeting were principal secretary to the PM PK Mishra, principal scientific adviser to the government K VijayRaghavan, advisor to PM Amarjeet Sinha, biotechnology department secretary Renu Swarup, Indian Council of Medical Research director general Balram Bhargava, Union health secretary Preeti Sudan and Rajesh Bhushan who will take over as health secretary three months later.
“This means we need to overhaul the regulatory system, that too at warp speed,” one official later told HT. He explained one aspect of the concern around the regulatory framework that the prime minister had articulated.
In the United States and Europe, there are provisions to conduct human trials on emergency clearance basis. In India, it can take drug companies months to even conduct trials on mice.
Besides, an official explained by way of an example, if a drug such as Remdesivir of Gilead Sciences turns out to be a success in the United States, it will take a considerable time to reach the medicine to Indian patients due to red tape in the entire system of drug approvals. “We really need to revamp the approval processes at the drug controller’s office,” he said.
In the course of Tuesday’s meeting, when a participant spoke about India’s dependence on one country for supply of active pharmaceutical ingredients (API), Prime Minister Modi underlined that companies need to take pride in manufacturing API also rather than relying on other countries. It should be a matter of pride… not just low costs, PM Modi said.
In the early part of the task force meeting, PM Modi was told that there were 30 Indian vaccines in different stages of development including a few that were going on to the trial stage. In drug development, officials told the meeting that they were looking at repurposing existing drugs to treat Covid-19 in addition to working on new drugs and linking a high performance computational approach with laboratory verification to keep research on the fast track.
An official statement issued after the meeting had stressed that the prime minister took note of the “extraordinary coming together of academia, industry and government”.