Drugs Controller General of India (DCGI)'s plan to establish a drug audit office in China for quality inspection of drug manufacturing units in that country to ensure that only quality products are sourced by Indian companies is yet to materialize.
As per the DCGI's plan, Central Drug Standards Control Organisation (CDSCO) was to open its first drug inspection office on March 1, 2013 in Beijing. In December last year, the DCGI decided to set up a permanent drug manufacturing audit and quality certifying office in China following increasing imports of drug inputs that had the potential to compromise the quality and safety of drug ingredients and intermediates being exported from China to India. Though several months have passed since then, no headway has been made in the project, mainly due to the staff crunch in the CDSCO.
As per the DCGI's plan, at least four Indian drug inspectors will be posted in China to examine manufacturing sites and check that these units are complying with good manufacturing practices. The proposed drug audit office in China will be equivalent to the audit office of US FDA and other representative offices of any foreign drug regulatory agency which operates in India and elsewhere.
The decision to establish drug audit office in China, which was already approved by the union commerce ministry, was taken by the union health ministry in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India made mandatory way back in 2003, it failed to bring the desired results as the inflow of inferior raw materials into the country refused to subside.
As part of its efforts to ensure that only quality products are sourced by Indian companies from abroad, the health ministry in 2011 started the process of auditing and inspection of manufacturing plants outside India. It has already sent two teams to China. The first delegation was sent to China in May 2011 in which the delegation had inspected five manufacturing units there. Though the delegation was to inspect six units, one unit did not allow the delegation to inspect their unit. The second CDSCO team was sent to China and inspected the manufacturing units there from February 11 to 22, 2012.