The Drugs Controller General (India) has asked all State drug controllers to collect the information on the closure of small scale pharma units following the amendment of the Drugs and Cosmetics Act enforcing the revised Schedule M guidelines in the country from July, 2005.
The DCGI has called for the information including the names of units along with their addresses closed since July 2005 due to non-compliance of Schedule M requirements after the Ministry of Micro, Small and Medium Enterprises (MSME) made a request in this regard in view of the proposed detailed survey to ascertain the extent of the impact of Schedule M.
MSME, the agency entrusted to conduct the survey as recommended by the Rajya Sabha committee on subordinate legislation, had informed the DCGI office that it did not have sufficient infrastructure and manpower to conduct the survey and had requested the assistance. Hence the DCGI, after taking up the matter with the DTAB, has instructed the State drug controllers to collect the data as they are the licensing authorities to enforce the Schedule M, sources said.
Apart from the information on the closed units, the DCGI has also asked the State authorities to gather data on the cases in which licences have been surrendered by the manufacturers. “It is also requested to provide information on the cases in which licenses have been suspended or cancelled by the authorities due to the non-compliance to revised Schedule M. Please indicate separately the cases in which licences remained suspended or cancelled and those where licences have been reinstated after due compliance,” the DCGI letter said.
“Names of drugs and pharmaceutical units which are partly compliant to Schedule M in respect of specific sections while licence for other categories has been suspended, cancelled or surrendered specifically due to non-compliance of Schedule M also be forwarded,’’ the letter said.
The DCGI has asked the State licensing authorities to collect the data on top priority basis so that information could be forwarded to the Committee on Subordinate Legislation, sources said.
The DCGI has called for the information including the names of units along with their addresses closed since July 2005 due to non-compliance of Schedule M requirements after the Ministry of Micro, Small and Medium Enterprises (MSME) made a request in this regard in view of the proposed detailed survey to ascertain the extent of the impact of Schedule M.
MSME, the agency entrusted to conduct the survey as recommended by the Rajya Sabha committee on subordinate legislation, had informed the DCGI office that it did not have sufficient infrastructure and manpower to conduct the survey and had requested the assistance. Hence the DCGI, after taking up the matter with the DTAB, has instructed the State drug controllers to collect the data as they are the licensing authorities to enforce the Schedule M, sources said.
Apart from the information on the closed units, the DCGI has also asked the State authorities to gather data on the cases in which licences have been surrendered by the manufacturers. “It is also requested to provide information on the cases in which licenses have been suspended or cancelled by the authorities due to the non-compliance to revised Schedule M. Please indicate separately the cases in which licences remained suspended or cancelled and those where licences have been reinstated after due compliance,” the DCGI letter said.
“Names of drugs and pharmaceutical units which are partly compliant to Schedule M in respect of specific sections while licence for other categories has been suspended, cancelled or surrendered specifically due to non-compliance of Schedule M also be forwarded,’’ the letter said.
The DCGI has asked the State licensing authorities to collect the data on top priority basis so that information could be forwarded to the Committee on Subordinate Legislation, sources said.
Posts
No comments:
Post a Comment