ender process. However, when the quality analysis of those private NABL accredited labs was carried out in , the committee realised that certain required parameters not being followed and hence decided to do all the tests in the central and state-run laboratories. We have received 5000 samples which will be submitted before the end of this year besides our routine tests. Earlier, we used to conduct 2500-3000 tests in a year, which has been doubled now.”
He informs that two months backs the Indian Pharmacopoeia Laboratory (IPL), Ghaziabad, had received the WHO pre-qualified QCL certification which is the first government laboratory which has obtained this certification.
Following the steps of IPL, Singh is gearing up for the Mumbai lab as well. Presently, the CDTL, Mumbai is conducting tests of various samples like import / export samples from airports / port trusts, registration samples, new drugs samples from DCG(I) office, Zonal Survey samples from Zonal and Sub Zonal office of CDSCO, legal samples (Form 18) through central drug inspector, medical devices samples, proficiency testing samples, CGHS samples and other miscellaneous samples. He informs that presently the lab received more than 5,200 samples under drugs survey for drugs safety India through NIB, Noida under the directions of Ministry Health & Family Welfare through CDSCO for checking the NSQ / spurious drugs moving in the country. The analysis of these samples is going on simultaneously with war footing on time bound manner. Singh informs, that “We are in the process of applying NABL accreditation and later we will go for the WHO pre-qualified QCL certification in CDTL, Mumbai.
Singh while replying as to how such accreditation and recognition will be beneficial to the industry says, “With the NABL (ISO / IEC 17025:2005) accreditation, we will be in a position to call our lab a globally recognised one which will assure all quality measures.”
According to an industry source, Drug Information Association (DIA) conducts an annual meeting of their worldwide members for a minimum of three days in one of the major cities in the US. Members who take part in the meeting are normally from academia, companies, regulatory bodies and pharmacy students. It is an accepted body of a neutral status and thus provides a neutral platform for all the regulatory experts from various countries to interact and exchange views on regulatory advancements on the global front. It is invariably attended by US FDA, EDQM, EMA and other regulatory authorities of various countries who mingle with these prominent people and exchange ideas and update themselves every year.
