Former Karnataka drugs controller Dr BR Jagashetty is of the opinion that there is a need to have an Indian Drug Administrative Service (IDS), on the lines of Indian Administrative Service (IAS), Indian Foreign Service (IFS) and Indian Police Service, to create a new band of qualified and dedicated personnel to man the drug regulatory system in the country.
This cadre can be employed not just at the Central government but could be deputed to different states depending on the need. The position would exercise focused drug administration including framing and implementation of policy in consultation with the related ministries. Further, such a system would create a proper hierarchy and bring in a systematic reporting structure which is uniform to both centre and state, Dr Jagashetty said.
Besides, the CDSCO needs to be given a facelift and apart from other reforms it should be renamed as either Central Drugs Administration (CDA) or National Drugs Administration (NDA) to propel faster clearances in a transparent and efficient manner. The present environment demands well-organized administration with ample focus on not just regulations but also on creations of a new job opportunities in drug administration, stated Dr Jagashetty.
Dr Jagashetty, who was also the erstwhile chairman of the DCC sub-committee for Amendments to Drugs & Cosmetic Rules constituted by DCGI, feels that Indian drug regulatory authority which scrutinizes the worlds’ third largest manufacturing base of pharma products by volume and 14th in value terms needs to have a more powerful image.
“CDSCO needs a transformation beginning with its name. It needs to be recognized as a formidable administrator. This is where CDA or NDA title could bring in a whiff of newness and innovation. It is also seen to be more appropriate in the current context of developments after India’s adoption of a dynamic Intellectual Property Regime that has proven attractive for foreign direct investments (FDI). However from a global perspective as India gather its momentum in the world markets, a National Drugs Administration (NDA) would be more appropriate, Dr Jagashetty told Pharmabiz.
The former Karnataka drugs controller also viewed that enforcements of norms could be issued and audited by CDA or NDA but its implementation can be entrusted to the state drugs control departments because health comes in the Concurrent List given under Part XI of the Constitution of India which allows dual control by centre and state authorities. For instance, if there is any ambiguity when the state drugs control department issues a license like the fixed dose combination approvals, the CDA or NDA could have the power to cancel the same which is contrary to the current practice. However, the execution of this rule mandates suitable amendment to D&C Act.