Even as the Drug Controller General of India (DCGI) is going ahead with his decision to centralise the issuance of Certificate of Pharmaceutical Products (CoPP) and WHO GMP scheme from October 1, the state drug regulatory officials in the country are opposing the move as they think that the new system may create unwanted confusion.
The All India Drug Control Officers Confederation (AIDCOC), the association of state and central drug control officers in the country, has passed a resolution against the decision of DCGI and is looking for options to avoid centralisation of these certification programmes. The confederation has also conveyed its opposition on the matter to the DCGI, of late, according to Ravi Udaybhaskar, secretary general, AIDCOC.
The current system of conducting inspections jointly by the state and central drug regulatory bodies will ensure that the certification is also reported in the state drug control office. Since the state drug controller is issuing the drug manufacturing and sales licence, the records on WHO certifications should also be with them to avoid confusion in future.
"We appreciate that the DCGI is taking steps to strengthen the CDSCO with more staff. But they should focus on major issues like making rules, curbing presence of spurious drugs in the country and various other issues like licensing of fixed dose combinations and Schedule M. The WHO certification programmes are carried out smoothly at present through the dual agency system (both the state and the central regulatory agencies) and the latest move to centralise it is an unnecessary intervention from the CDSCO," said Udaybhaskar. He added that the confederation is checking out options to avoid centralisation of certifications.
The DCGI, through an order published last month, has notified the issuance of CoPP and WHO Scheme will be handled by the CDSCO and its zonal offices to bring in uniformity in procedures. The drug regulator has also informed the WHO and the state drug controllers about this procedural change. However, the state drug regulators allege that the decision was unilateral and was implemented ignoring the opposition of state drug regulators in the Drug Consultative Committee (DCC) meeting, which discussed the issue, in July, 2009.
The DCGI has been strengthening the CDSCO by appointing more staff for the last few months and according to regulatory sources, the CDSCO will have a staff strength of nearly 180 officers. However, the AIDCOC points out that the Rs 39000 crore-pharmaceutical exports is not affected by the current system of certification and further, a sudden change in the system may create confusion among both the state drug regulatory body and the industry, which in effect may affect the exports.