Modi orders drug regulatory system overhaul to reduce red tape
At a Tuesday meeting to discuss India's drug discovery, testing, and vaccine response to COVID-19, Prime Minister Narendra Modi reportedly suggested drug regulatory reforms. According to Hindustan Times, PM Modi said that the regulatory system for new drugs and vaccines in India was "creaky and cumbersome" adding that there was a need for an overhaul. Here are more details.
What happened during the meeting?
The meeting was attended by 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, et al. After the meeting, the PMO said over 30 Indian vaccines are in different stages of vaccine development, with few going on to trial stages.
'Modi stressed on highest quality, ethical standards, and highest speeds'
A senior government official present at the meeting told HT, "The Prime Minister underscored that we not only had to have the highest quality, ethical standards but also the highest speed." Another official told the publication that Modi had addressed concerns about the regulatory system adding that there was a need for an overhaul at "warp speed."
What are the issues with India's drug regulatory system?
While in the United States and Europe, human trials can be conducted on an emergency basis, drug companies in India could take months to even start animal testing. An official told HT that even if Gilead Sciences' Remdesivir turns out to be a successful drug against COVID-19, the red tape in India would not allow the drug to be accessible to patients soon enough.
Companies should take pride in manufacturing API, said Modi
Reportedly, when a participant at the meeting addressed India's dependence on one country for supply of active pharmaceutical ingredients (API), PM Modi said companies need to take pride in manufacturing API as opposed to relying on other nations. Officials also told Modi that they were looking at repurposing existing drugs and developing new ones for the treatment of COVID-19.
