The Drugs Consultative Committee (DCC) has recommended that the extension of Certificates of Pharmaceutical Products (COPP) and approval for inclusion of additional products should be given by the state licensing authorities only after recommendation by the CDSCO.

It has been observed that after joint inspection for COPP certificates as per WHO TRS, the COPP certificates after inspection are issued by the State Licensing Authority (SLA) for a period of two years. After completion of two years, the manufacturing firms apply for extension of COPP certificates for further six months (two times). In certain cases, the applicant applies without submitting the application to the office of CDSCO or the application for inspection is submitted near to expiry of second extension, according to the DCC.

It was also noted that after joint inspection for COPP as per WHO TRS, the COPPs as inspected are issued by the State Licensing Authority and list of which is also attached along with inspection report. Afterwards, the firm applies for COPP of additional products directly to SLA and COPP is issued by SLA without intimation to zonal/sub-zonal offices of CDSCO.

“The committee was informed that the staff strength of CDSCO is being continuously increased and the number of drug inspectors in each zone has been increased and as such there is no reason that zonal offices would not be in a position to conduct joint inspections regularly. As a principle, the joint inspections should not be bypassed,” the DCC said.

“The members agreed that in the cases of grant of extension of COPP certificates the applicant is required to make application for issue of WHO-GMP COPP well before the expiry of validity (i.e. two months) of certificates and joint inspection shall be carried out for issue/ reissue of WHO-GMP-COPP certificates. However, in cases where application for reissue of COPP is already made in time by applicant (with all the data) and where CDSCO has not been able to organize the inspection along with SLA within 28 days after the receipt of the complete application, then the extension may be granted to the applicant by the SLA for reasons of delay to be recorded in writing,” it said.

“The application for inclusion of additional products shall be made simultaneously to both SLA and concerned zonal/sub-zonal office of CDSCO. The application shall be accompanied by the list of applied additional products, product license copy, product summary sheet and Stability data of three batches accelerated/ real time with condition (temperature and relative humidity) and process validation data. Technical scrutiny of the application shall be done by CDSCO as per guidance document for functions and responsibilities of zonal, sub-zonal and port offices. The recommendations (of issuance or rejection or query) on application shall be forwarded to the applicant and SLA within 21 days,” it said.

“In case no recommendation (about issuance or rejection or query) is forwarded by CDSCO to the applicant and the SLA within 21 days, the SLA may conduct technical scrutiny of the application for appropriateness and decide on the issuance of the COPP and forward its decision to the manufacturer along with intimation to CDSCO indicating the reasons of grant of COPP in the particular case,” the DCC recommended.