Trial over, Axis back in business

HYDERABAD: It may raise a few eyebrows but the Drugs Controller General of India (DCGI) has lifted the suspension on Axis Clinicals Pvt Ltd, sister concern of Aurobindo Pharma Ltd, barely two months after barring the company from conducting Bio Equivalance and Bio Availability (BE/BA) studies at its Miyapur facility“We have conducted a detailed investigation and submitted a final reportThe DCGI is yet to give a final verdict but the suspension has been liftedThey (Axis Clinicals) are conducting studies as usual,” a senior official of the DCGI told ExpressWhen contacted, an Axis official confirmed the developmentFollowing reports that women from Piduguralla in Guntur district developed complications after undergoing drug testing at Axis, DCGI had ordered a preliminary investigationSubsequently, on June 25, it suspended the licence citing procedural lapsesIt also ordered an enquiry to examine all the studies Axis had conducted in the preceding two months to determine irregularities if anyAxis Cliniclas secured the DCGI approval to conduct BE/BA studies for generic anti-cancer drug Exemestane in January, 2010It then conducted a single-dose BE study sponsored by Mylan Inc on 48 healthy subjects between January 28, 2011 and February 18, 2011According to sources, the drug inspectors, in their preliminary report submitted to the DCGI and the Union Ministry of Health and Family Welfare last month, found that the Independent Ethics Committee (IEC) , appointed by Axis Clinicals, was not acting independently“It seems IEC is only giving approvals for all studies formally,” the report said.