The  Union health ministry will soon approve 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) previously treated with an oxaliplatin containing regimen, Trastuzumab emtansine is indicated for the treatment of patients with HER2-Positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Trastuzumab and a taxane.

According to sources, the Technical Committee in its meeting held recently under the chairmanship of Dr Jagdish Prasad, Director General of Health Services (DGHS), gave its green signal to these drugs for manufacture/ import for marketing in the country without any local clinical trial.  In fact, the Technical Committee after detailed deliberation agreed to the recommendations of the subject expert committee (SEC) for marketing authorization of these drugs without conducting local clinical trial.

“There is an unmet need as a second-line therapy for metastatic colorectal cancer. The firm has conducted clinical trial in other indications as part of global clinical trial which showed no difference in the pharmacokinetic parameters in 14 Indian patients and there was no safety issue”, the SEC recommended on  Aflibercept.

“In view of the fact there is no therapy available for this condition and in the interest of public, Committee recommended for the permission to import and market for the subject drug may be granted subject to condition 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 SEC recommended on the drug  Trastuzumab emtansine.

After agreeing to these recommendations, the Technical committee submitted its recommendations to Apex Committee which is the highest authority in this matter.  The Apex Committee, in its meeting held recently under the chairmanship of Union health ministry, recommended that the Technical Committee should specifically mention if these three cases fall under the five laid down criteria for waiver of local clinical trial in Indian populations for approval of new drugs 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.