The state drug authorities in Kerala have expressed concern over the proposal of converting the present CDSCO (Central Drugs Standard Control Organization) into the CDA (Central Drug Authority). They are apprehensive that with just four regional offices and very few enforcement staff, the CDA cannot do practically anything with regard to licensing, endorsement of additional products etc. of thousands of pharma manufacturers.
In the suggestions submitted to the Parliamentary Standing Committee on Ministry of Health which visited the four southern states recently, the drug authorities in Kerala have raised doubt that whether the present CDSCO will be sufficient to be converted to the designated CDA. "The present CDSCO with four regional offices and very few enforcement staff can do practically nothing with regard to licensing, endorsement of additional products, etc", they said.
Till a few years back, CDSCO didn't have much work. Now they are responsible for import registration, clinical trials, pharmacovigilance, new drug approval, joint licensing of LVP, vaccines, medical devices, blood banks, etc. The sad part is that the staff strength has decreased instead of increasing over the years. One of the most vital departments dealing with very confidential matters is mostly run by contractual staff and consultants. "So, if the central government wants to equip the CDSCO with licensing powers of the CDA, they need at least one office in each state and ten times the present staff strength", the drug authorities in Kerala said.
The memorandum also suggested that to convert the present CDSCO as licensing authority for manufacturing licenses is neither advisable nor practical. The CDSCO does not have the infrastructure and expertise to grant licenses. An experiment with four offices and 30 field staff will only be a child's play.
The example of licence approval of blood bank and IV fluid, even without any responsibility, has proved the inefficiency. There is not only non-uniformity among different states, but also within the same state. Different Drug Inspectors of the CDSCO have different standards while inspecting blood banks and manufacturing units. There is inordinate delay in just approving the licenses. It takes six months to one year to get back a license approved by the CDSCO. What will be the case when all manufacturing licences are issued by CDSCO. Progress can be achieved only through delegation and de-centralization. On the contrary, we are on the reverse track, the memorandum said.