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The country's top regulatory agency in the health sector will follow the Narendra Modi mantra of e-governance to bring more transparency and accountability while reducing red tape in clinical trials, drug approvals as well as manufacturing licences. The office of Drugs Controller General of India (DCGI) is preparing a plan to go online with all approval-related processes, etc, an official said.
This would enable companies to apply online for approval of their products and also upload required documents. Companies will be able to track their pleas on a daily basis, the official said.
E-governance will help the regulator and government maintain data related to drug approvals and clinical trials. Recently, the regulator and the health and family welfare ministry were rapped by the Supreme Court for lack of data management and monitoring in clinical trials and deaths that occurred during these.
The move is also in line with the key areas identified by health minister Harsh Vardhan. After the new government formation at the Centre early last week, Vardhan had said he would move fast to put in place e-governance systems in all government-to-citizen and government-to-business interfaces under the ministry. "Accountability standards will be fixed at the highest level and corruption will be checked at source with transparent systems."
The official said the minister in his first briefing had given instructions to follow e-governance model. He added the regulator's office was studying the models of US Food and Drug Administration, UK's Medicines and Healthcare Products Regulatory Agency and Canada drug regulator.
