The Asian Age
No drug trials for fatal diseases
Committee says it is desirable to expedite the development, evaluation and marketing of new therapies intended to treat persons, especially where no satisfactory alternative therapy exists
In a significant move, the government has decided to waive off local clinical trials in case of new drugs indicated for serious, life- threatening diseases and diseases of special relevance to Indian health scenario like cancer, AIDS etc., where the likelihood of death is high. Observing that in cases of life- threatening diseases like cancer, AIDS etc., where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, the technical committee under the Directorate- General of Health Services ( DGHS), in a meeting held recently, pointed 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.
“In such cases, patients/ clinicians are generally willing to accept greater risks or side effects from products that treat life- threatening/ serious diseases than they would accept from products that treat less serious illnesses,” it noted. The experts 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 decided to waive off local clinical trials for cases where the existing therapy is approved in the well developed regulatory countries like the US, UK, Canada, Japan and Australia. The exerts 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. With such a cumbersome process of trials on drugs which are already in use for years in countries with highly-developed regulatory system, we may not achieve anything substantially different from that already achieved in those countries,” it said.