The Union health ministry is considering a proposal for providing local clinical trial waiver for two cancer drugs Aflibercept and Trastuzumab emtansine on the plea that there is an unmet need for these drugs in the country.

While Aflibercept is indicated for patients with metastatic colorectal cancer (MCRC) Trastuzumab emtansine is indicated for the treatment of patients with HER2-Positive.

According to sources, the new drug advisory committee (NDAC) of the ministry has already given their approval for manufacture/import for marketing these drugs in the country without any local clinical trial.   The NDAC has given its recommendation to the technical committee, another high-level panel formed by the ministry on clinical trials.

“The committee recommended for import and marketing subject to condition that firm should conduct a structured India specific phase IV trial after getting approval by this office”, the NDAC in its recommendation on Aflibercept said, accepting the company's submission that there is an unmet need as a second-line therapy for metastatic colorectal cancer.

“In view of the fact there is no therapy available for this condition and in the interest of public, the committee recommended for the permission to import and market for the subject drug may be given subject to conduct of adequately powdered phase IV clinical trial with a review of data in 2 years. The phase IV protocol should be duly approved by the CDSCO”, the NDAC said in its report while recommending local clinical trial waiver for Trastuzumab emtansine.

The technical committee in its 17th meeting held on August 4 discussed the issue threadbare in the light of the fact that Prof. Ranjit Roy Chaudhury committee report, which was accepted by the health ministry, says that “The waiver of Clinical Trial in Indian population for approval of new drugs, which have already been approved outside India, 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”.

Earlier, the apex committee in its meeting held on 24.01.2014 had also recommended that waiver of local clinical trial of such cases should be granted only under the criteria as already decided by the ministry viz national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy. In case local clinical trial waiver is required for any other category, the matter should be brought before the committee for consideration along with the recommendations of the technical committee.

The technical committee in its meeting held on August 4 under the chairmanship of Dr Jagdish Prasad, Director General of Health Services (DGHS) observed that both the drugs are indicated for the treatment of different types of cancer. However no oncologist was present in the meeting. Hence, the committee deferred the proposal to next technical committee.