Even as the Union Health Ministry is going ahead with the establishment of Central Drugs Authority (CDA) with 10 distinct divisions to handle regulatory matters related to segments like medical devices and biotechnology, All India Drug Control Officer's Confederation (AIDCOC) members at the state level are not completely confident of its success. Drug regulatory officials feel that a similar segmentation at the state level can only really help it function properly.
According to them, there should be specialization at the state level also. The drug inspectors in the field, who are ultimately the implementers of whatever rules and regulations are framed, should also be knowledgeable in their particular area of specialization, they feel. Taking note of the growing need to regulate medical devices, drug officials felt that their inspectors at the state level are yet to have the expertise to handle these situations.
"There should be provisions to outsource expert consultancy at the state level also. More courses that offer multi-skills like medical engineering should be introduced", they said.
AIDCOC had earlier opposed the government move to bring the powers to issue manufacturing licenses under the control of the central organization. However, it had supported the proposal to create an independent agency to deal with the whole regulatory services in connection with drug approval, manufacturing, marketing and trade, imports, clinical trials etc.