NEW DELHI: With the Covid-19 pandemic getting the Indian drug regulatory system working in a faster gear, a government panel on Friday considered all the measures taken for faster approval process and use these to overhaul the drug regulatory system, three sources in the know told Mint.
“The discussions revolved around what all measures the CDSCO (Central Drugs Standards Control Organization) took to make the whole system faster, and how we can apply these to normal times because a lot of industry officials had expressed satisfaction at the speed of the approval process," one of the sources said.
Among the measures that were discussed in the meeting was how the CDSCO’s manpower can be efficiently utilised to make the approval faster, while another measure under discussion was on giving clearances to clinical trials faster, a second official said.
While the discussions were on the broader contours, a few more meetings are likely, with a report expected to be tabled in front of the health ministry in June, the second official said.
The committee, chaired by health ministry’s officer on special duty Rajesh Bhushan, was constituted by the ministry through an order on 11 May.
“The issue of reforms in the Drug Regulatory System has been engaging the attention of the Government of India for quite some time now. Although requisite procedural changes have been carried out during the current Covid-19 pandemic and have worked quite well, it is felt that comprehensive changes in the drug regulatory regime should be carried out to reflect global best practices as well as domestic requirements and to streamline Central Drugs Standard Control Organization to make it more effective," the health ministry order said, a copy of which was seen by Mint.
Apart from health ministry, the panel comprised of bureaucrats from the Department of Pharmaceuticals (DoP) and Department of Biotechnology, as well as experts from Indian Pharmacopoeia Commission, Indian Council of Medical Research and All India Institute of Medical Sciences in Delhi.
Representatives from industry bodies, Indian Pharmaceutical Alliance and Indian Vaccine Manufacturers' Association, are also part of the panel.
The health ministry’s meeting comes on the back of prime minister Narendra Modi expressing concern in a meeting earlier this month that the India’s regulatory system for new drugs and vaccines needed to be faster, while having the highest quality and ethical standards.