Last Updated : Apr 23 2019 5:36PM     Screen Reader Access
News Highlights
Polling progressing peacefully for 3rd phase of Lok Sabha elections            Actor Sunny Deol joins BJP            SC issues contempt notice to Rahul Gandhi for his remarks on Rafale judgment            India adequately prepared to deal with impact of US decision on buying oil from Iran            IPL: Chennai Super Kings to face Sunrisers Hyderabad this evening           

National News

Mar 26, 2019
7:31AM

Government notifies Drugs and Clinical Trials Rules 2019

Representational pic
Health and Family Welfare Ministry have notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country. The new rules will change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.

These rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee. It has reduced the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country. 

The rules stated that in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved. It said the requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries to be specified by the Drugs Controller General with the approval of the government.

The new rules will ensure patient safety, as they would be enlisted for trials with informed consent. The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events. 

   Related News

PM’s Exclusive Interview to DD News

Live Twitter Feed

Listen News

Morning News 23 (Apr) Midday News 23 (Apr) News at Nine 22 (Apr) Hourly 23 (Apr) (1705hrs)
समाचार प्रभात 23 (Apr) दोपहर समाचार 23 (Apr) समाचार संध्या 22 (Apr) प्रति घंटा समाचार 23 (Apr) (1700hrs)
Khabarnama (Mor) 23 (Apr) Khabrein(Day) 23 (Apr) Khabrein(Eve) 22 (Apr)
Aaj Savere 23 (Apr) Parikrama 23 (Apr) Lok Ruchi Samachar 21 (Apr)

Listen Programs

Market Mantra 22 (Apr) Samayki 22 (Apr) Sports Scan 22 (Apr) Spotlight/News Analysis 22 (Apr)
    Public Speak

    Country wide 28 (Mar) Surkhiyon Mein 4 (Apr) Charcha Ka Vishai Ha 17 (Apr) Vaad-Samvaad 16 (Apr) Money Talk 16 (Apr) Current Affairs 22 (Mar)