The Union health ministry has accorded local clinical trial waiver to the drug company  Sandoor to import and market the paediatric acute lymphoblastic leukaemia drug Clofarabine in India.   The ministry's approval in this regard came after the company pleaded that Clofarabine is an orphan drug for rare disease for which there is no therapy in the country.

According to sources in the Union health ministry, the high-powered Apex Committee on clinical trials, constituted by the Union health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country, deliberated on this issue and approved the waiver of local clinical trial to Clofarabine.

In fact, the Apex Committee under the chairmanship of secretary, ministry of health, was concurring with the recommendations of the Technical Committee, which is another committee constituted by the health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country.  The Technical Committee had earlier agreed the local clinical trial waiver to Clofarabine on the condition that the drug should be manufactured in India.

The firm Sandoor then approached CDSCO for the re-examination of the condition imposed to manufacture the drug Clofarabine of Sandoor in India, as a part of clinical trial waiver.

In the application, the firm stated that in line with the guidelines issued by Prof. Ranjit Roy Chaudhary Committee, Clofarabine is an appropriate candidate for clinical trial waiver. Since Clofarabine can be clearly categorized as "orphan drug for rare disease and drug for conditions/disease for which there is no therapy". Clofarabine has been granted an orphan drug designation for treatment of paediatric acute lymphoblastic leukaemia in US, EU, Australia, South Korea and Japan.

Furthermore, the firm also stated that since the product is an orphan drug and the consumption cannot be more than a few hundred vials a year, hence it is also not feasible to set up manufacturing of this product in India.

The Technical Committee deliberated the issue in detail and opined that the condition to manufacture in India, while agreeing for waiver of local clinical trial, was a suggestive condition. As the consumption cannot be more than a few hundred vials a year, hence firm may be allowed to import and market the drug in the country.

The Apex Committee in its 19th meeting held on 24-12-2014 deliberated upon the proposal and concurred with the recommendations of the Technical Committee.