Notwithstanding the opposition by many state drug controllers and strong apprehension by some others, the DCGI office is going ahead with the proposal to centralize the issuance of Certificate of Pharmaceutical Products (CoPP) and model certificate of Good Manufacturing Practices for medicinal products, and got the proposal approved by the recent meeting of the Drugs Consultative Committee (DCC).
"As per agenda and the statement made by DCGI, the CoPP certificates or model certificate of GMPs would henceforth be issued by the central agency i.e. DCGI for the purpose of uniformity and compliance to WHO guidelines. The system of granting the certificates by CDSCO would be informed to WHO and the State drug control authorities accordingly," as per the approved minutes of the DCC meeting held recently.
Most of the state drug controllers have reportedly expressed strong resentment against the proposal. But, their observations were not included in the minutes of the meeting. However, it said, "Some of the State drug controllers were of the strong view that a status quo be maintained as large numbers of these certificates are being issued by them to fulfil needs of the drug industry for the purpose of export." The proposal will now be presented before the DTAB which has to ratify the same.
"DCGI briefed the members that WHO, under its guidelines (TRS No.823, 863 and 908), recommends the issue of CoPP and model certificate of GMP for medicinal products moving in the international trade by the National Regulatory Authority of the producing country. There is no provision under the Drugs and Cosmetics Act and Rules made there under for the grant of CoPPs. The grant of these certificates was delegated to the State Licensing Authorities by the CDSCO earlier in view of the shortage of man power in CDSCO," the minutes said.
It has been observed that the certificates issued by the States are many a time, at variation to the guidelines of WHO Certification Scheme. Even the prescribed formats are not adhered to. WHO in its guidelines does not recommend the use of WHO name or logo in the title of such certificates. WHO has written to the office of DCGI objecting to giving the title of 'WHO GMP Certificate' by the State Licensing Authorities. For the purpose of issuance of CoPP certificate, it is expected by WHO that the CDSCO has verified that medicinal products covered in the certificate are consistently produced by the firm and conform to the GMP and quality standards prescribed in WHO Technical Reports Series, according to the minutes.
"It is further observed that these certificates are being issued on the basis of interpretations which vary from State to State. The availability of large variants of such certificates creates confusion in the minds of regulatory authorities of importing countries. CDSCO is now being strengthened on a fast track basis with the pro active support of the Ministry of Health and Family Welfare. The zonal offices are being upgraded and expanded. The Central Government would therefore, be having enough manpower to handle the responsibility and grant COPP as per WHO norms and fulfil the international obligation effectively," it said.
DCGI informed that a considered decision has been taken that CoPP would be issued by the DCGI office for the purpose of uniformity and compliance to WHO guidelines, the minutes said, adding that drug controllers from Delhi and Maharashtra supported the proposal. DDC south zone Dr D Roy was also quoted saying that as such there will be no difficulty by the zonal offices to conduct independent inspections as per WHO norms and issue certificates in the prescribed formats to maintain uniformity.