All India Drugs Control Officers' Confederation (AIDCOC) has alleged that the Mashelkar committee had a predetermined approach while preparing the final report on comprehensive revamp of Indian drug regulatory system. Fearing that the committee has not taken congnizance of the representations on "central licensing" made by AIDCOC, the office bearers of the confederation submitted a fresh representation before the Union Health Minister Sushma Swaraj on Monday.

According the confederation, central licensing is a problem rather than a solution. "Manufacture, sale and distribution of drugs are all part of a composite activity. Therefore two agencies regulating these activities separately will create administrative and logistic problems. On the other hand for effective implementation of the regulations, implementation agency and monitoring agencies should be separate. It is therefore not desirable to centralize the manufacturing licensing", the representation said.

Speaking to pharmabiz.com, S W Deshpande, secretary general, AIDCOC opined that its high time authorities realized that committees and its reports would not substitute the basic need for adequate manpower and infrastructure. "Unless the Drugs Control Organisations are strengthened, the results cannot be achieved and the quality management will remain a distant dream", he cautioned. The issue of strengthening has to be reviewed in the context of not only numbers but the competency of the human resources and the review/monitoring mechanism, he added.

"The experiment of Central Licensing Approving Authority has not yielded desired results. It has in fact resulted in greater delay in the grant/renewal of licenses to blood banks than it used to be under state control. The reasons were inadequate manpower of CDSCO and diluted responsibility. The same situation would arise if it is extended to manufacturing facilities," warned Ravi Uday Bhaskar, president AIDCOC.

The confederation has said that that there is no need for centralization to ensure uniformity in implementation of drug laws. Establishment of separate intelligence branch, better coordination, training and incentives to officers can bring in uniform implementation of drug laws, they opine.

AIDCOC proposed the establishment of legal cum intelligence branch at all zonal offices of CDCSO with HQ at Delhi. "The DCGI should be the overall in-charge of such wing and the Deputy Drugs Controller at each zone should be declared as the nodal officer and in charge of the wing in his zone. He should be provided with police officers of the rank of inspector and sub-inspector under his direct control. The drugs inspectors having an aptitude for investigation work should be selected to work in intelligence branch. The officers from the state drug control organizations may be taken on deputation. Similar legal cum intelligence branch should be established at state level also", the confederation has said.

The central and state level intelligence branch should coordinate with each other for inter-state investigation. The zonal Deputy Drugs Controller (CDCSO) should be declared as the nodal officer responsible for effective co-ordination, AIDCOC said.