New Clinical Trial Rules to protect rights, safety of patients: ISCR

New Clinical Trial Rules to protect rights, safety of patients: ISCR

Pune: The New Drugs and Clinical Trial Rules, 2019 will protect the rights and safety of patients said the Indian Society for Clinical Research (ISCR).

Approved by the Ministry of Health and Family Welfare, ISCR stated the new rules will benefit patients.

ISCR president Dr Chirag Trivedi issued a statement which read: “The new rules seek to protect the rights, safety and well-being of patients while ensuring a strong scientific base for conducting clinical trials.”

“We hope this will lead to more stability and growth in clinical research being done in India which will ultimately ensure that our patients have access to faster and more effective treatment.”

Despite being the second populated country with highest disease count it spends less than 1.2 percent on clinical trials.

The ISCR said under the new Clinical Trial Rules, the approval time for drugs discovered in India or that which are researched, developed in India including proposed manufacturing, marketing in India is reduced to 30 days and for drugs developed outside the country, the approval time has been fixed to 90 days.

The approval validity of these clinical trials is determined as two years to initiate a study, extendable by one year, the ISCR president added.