The Central Drugs Standard Control Organisation (CDSCO) has been facing the problem of limited manpower for regulatory function which despite expansion in responsibilities over the years. The problem is sought to be addressed partly by placement of some technical staff on contractual basis with external support.
The inadequate manpower is even more acute in the State level. A large number of sanctioned posts are lying vacant in both enforcement and the laboratories. A manifestation of the lack of manpower is the substantial backlog running into months for issuing fresh and renewal of licenses, according to a senior official in the Union Ministry of Health.
In addition to lack of adequate and trained manpower there is an absence of uniformity in institutional and implementation arrangements. It is estimated that 19 States and Union Territories have full time Drugs controllers while 12 States/Union Territories have appointed directors of Health Services who carry out other duties also, apart from looking after Drugs Administration.
As the fiscal situation in many of the States limits filling of the existing vacancies, some States are now attempting innovative approaches such as contracting-in or contracting-out of some non-core regulatory functions to improve efficiency.
The drug departments of all levels should look at filling up of all sanctioned posts, rationalise the number of labs and distribution of staff positions across labs and creation of minimum essential technical posts. The departments have a major role in the adoption of GMP by small and medium scale pharmaceutical manufacturers.