Clinical research entities asked to register by April 1

All clinical research organisations in India will have to get registered with the country's drug regulatory authority by April 1, in what could bring more transparency and accountability to the clinical research industry in India.

Online registration of clinical research organisations is now functional on the SUGAM portal, the Drug Controller General of India (DCGI) said in an order dated March 4. Applications for registration should be submitted only through the SUGAM portal, it said.

The SUGAM portal allows filing of applications for licences, permissions and approvals from the drug regulator.

"The government's aim is to expedite clinical trials of novel medications and vaccines, and to bring in more transparency," said a person in the know.

With this, the government will also be able to have a repository in place regarding the organisations which are into clinical research, the person added.

Clinical research organisations are companies that provide services for clinical research and development. They work with pharmaceutical, biotechnology and medical device companies.

India accounts for only 3-4% of global clinical trials, raising concerns over the country's limited contribution to global clinical research, a pharma expert said.

According to experts, once a preferred destination for conducting trials, India has now been taken over by China. "There has been a lot of hype that India is the hub of clinical trials and that Indian patients are guinea pigs for drug assessment. However, in recent times the number of clinical trials being conducted in India has shown a steady decline. While India was a preferred destination for foreign multinational companies sometime back, China is now fast taking over," said a senior official.