NEW DELHI: The Union government has decided to waive off local clinical trials in case of new drugs indicated for life threatening diseases and diseases of special relevance to Indian health scenario like cancer and AIDS. The technical committee under the Directorate General of Health Services (DGHS) in a meeting held recently pointed out that it was desirable to expedite the development, evaluation, and marketing of new therapies intended to treat persons especially where no satisfactory alternative therapy exists. “Patients and clinicians are generally willing to accept greater risks from products that treat life threatening and serious diseases, than they would accept from products that treat less serious illnesses,” the health panel noted.
The experts also said that in such cases, conduct of clinical trial was also a complex, time consuming and costly affairs as such patients requires multiple therapy to manage the disease conditions. The experts, therefore, decided to waive off local clinical trials for such drugs. They are now shortlisting the list of such serious and life threatening diseases and the diseases of special relevance, where waiver of local clinical trial for approval of new drugs can be considered.
“It is a very valid concern affecting the interest of patients, at large, in the country. A cumbersome process of clinical trials on the drugs are already in use for years in the countries with highly developed regulatory system. We may not achieve anything substantially different from that already achieved in those countries,” the panel further said. Earlier, in respect of waiver of local clinical trial for approval of new drugs, the ministry has decided that such waiver can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs.
The panel had earlier also recommended that drugs which were already in the market in well-regulated countries with a good post marketing surveillance for more than four years, and which have a satisfactory report, may be permitted for direct marketing in India, subject to strict surveillance.
