How covid-19 cut red-tapism

Coronavirus cases have crossed the two-lakh mark in India, and to keep up, government regulatory authorities have fast-tracked processes for development of vaccines and medication.

The process of taking research to the market has been shortened from 18 months to three weeks whether it is approval for clinical trials for new drugs or manufacture of oxygen and hand sanitisers.

A regulatory authority for vaccines and drugs, Central Drugs Standard Control Organisation (CDSCO) under the directorate General of Health Services (MoHFW), has fast-tracked all processes and cut red tapism significantly. “We are issuing manufacturing licences in three days, clinical trial approvals for vaccines and new drugs are given in two to five days, and applications for manufacture of oxygen are okayed in 24 hours. The need of the hour is to encourage solutions from innovators/ researchers and doctors to flatten the curve. We cannot be bogged down by prolonged processes during a pandemic,” Dr V G Somani, Drugs Controller General of India (DGCI) said.

In the last 70 days, the DCGI, the authority to give approvals to new drugs/vaccines and regulate clinical trials, has seen a flood of applications. CDSCO has approved 189 types of diagnostic kits, which includes 90 RT PCR kits and 99 rapid antibody kits on a fast-track basis. “Modalities have been revised across regulations and we have written to all state and Union Territory drugs controllers not to sit on applications. All this is done without compromising on rules,” Dr Somani said.

CDSCO is involved in collection and compilation of data of various critical drugs, including 152 drugs required in the management of covid-19 from the state/UT drugs controllers to ensure their availability. Besides, there is daily monitoring of hydroxychloroquine and formulation to ensure availability.

With delays and prolonged processes being the norm in these regulatory authorities, the DCGI’s response has come as a boon for doctors, researchers and innovators. “What would take 17 years sometimes to convert pure science to a drug for the citizen is now taking 17 days without compromising on any rules and regulations. In India, translational research was so costly and demotivating for innovators. The pandemic has changed all that. It now seems bench is sitting next to bedside both in medicine and research,” said Dr U S Vishal Rao, member of the consultative group to the Centre’s Principal Scientific Advisor.

Dr Jitendra Sharma, a pioneer in make-in-India medical devices, says there is now an alignment of critical units. “The different verticals in the regulatory authorities have all aligned and that is making the difference and resulting in shorter time for approvals. Six months ago the verticals did not bother about each other.”