In a significant decision aimed to avoid delay in the introduction of new drugs in the country indicated for serious/life threatening diseases like cancer, AIDS, etc and diseases of special relevance to Indian health scenario, the union health ministry has decided to approve waiver of local clinical trial to these new drugs which have already been approved in the well developed regulatory countries like USA, UK, Canada, Japan & Australia.

The health ministry's decision in this regard came in response to a letter written by the CDSCO some time ago.

“DCG (I) has raised a very valid concern affecting the interest of patients at large in the country. With such a cumbersome process of clinical trials on the drugs which 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. In light of this, we may consider approving the above proposal. However, the matter being technical, this needs to be discussed in the Technical Committee”, the ministry observed.  

The proposal was then placed before the Technical Committee. The committee deliberated the issue and agreed with the proposal stating that, this is already provided in the Drugs & Cosmetics rule. However, committee stated that instead of accepting it, in general, the list of such serious /life threatening diseases and the diseases of special relevance to the Indian health scenario, where waiver of local clinical trial for approval of new drugs can be considered, may be developed by the experts.

Earlier, in view of the recommendations of Parliamentary Standing Committee in its 59th report on approval of certain new drugs in the country without local clinical trials, the health ministry had constituted a committee under the chairmanship of Prof. Ranjit Roy Chaudhury which submitted its report to the ministry in August, 2013.

Acting on the recommendations of Prof Chaudhury committee, the ministry had earlier decided that local clinical trials waiver can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy.

Experts feel that conducting local clinical trial with new drugs indicated for serious/life threatening diseases like cancer, AIDS etc which are already approved in other country will not only delay its introduction, but also increase the cost of the new drugs which may not be in the interest of the patients suffering from such diseases especially where no satisfactory alternative therapy exists. Similarly, in case of new drug indicated for diseases which have special relevance to Indian health scenario, which are approved in other country like USA, UK etc conducting local clinical trials will delay the introduction of drug and cost of the drug.

Besides, experts are of the view 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, 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 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. Further, in such cases, conduct of clinical trial is also a complex, time consuming and costly affairs as such patients requires multiple therapy to manage the disease conditions.