Dr Mashelkar's recommendation to have a central drug licensing system comes out of his honest assessment of India's highly disorganized and uncoordinated drug control administration that exists today. Currently, manufacturing licenses for drug formulations are issued by the drug controllers of various state and Union territories without any coordination or interaction between their counterparts in other states or DCGI. Most of these state drug controllers also violate the provisions of Drugs and Cosmetics Act when they issue licenses for combinations of new drugs. D&C Act clearly states that fixed dose combinations of new drugs have to be first cleared by DCGI before state authorities start issuing manufacturing licenses. Yet, even the relatively efficient state drug authorities have their own justifications to flout this provision. This is the primary reason for the existence of thousands of irrational and harmful combinations in the country today. For pharmaceutical companies, the current licensing system is of great convenience as it is easy for them to procure manufacturing licenses for any formulations. Even if a state drug licensing authority rejects an application for a manufacturing license on grounds of irrationality, the same could be obtained from another state and still market all over the country. This has been happening on a very large scale in the country today. CDSO and all state drug control officials know this fact very well.

Dr Mashelkar did not take much time to realize this ongoing mess in drug licensing system. Certainly if his recommendation of central drug licensing mechanism is implemented, monitoring and controlling of licensing could be far easier. It will also enable the Centre to bring some check on the growth of spurious drug manufacturing in the country with the end of the irresponsible licensing. It is almost impossible to make all state drug officials accountable while granting drug manufacturing licences under the existing system. The suggestion made by Ahmedabad based CERC, in this regard, to introduce a system making drug officials accountable for their lapses is significant. How feasible will be the newly proposed system in the current political climate is something the Central government has to think of. For the state governments, accepting a centralised system of drug licensing would mean losing some of their powers. Many of the state governments are yet to gauge the implications of Mashelkar's recommendation. In the interest of overall health of the public, the state governments should cooperate with the Centre for implementing a major reform like this. Some of the state drug control officials have already started airing protests against the Mashelkar's proposal. That appears to be more out of the concern that these state officials will lose their grip on the local manufacturing units. Even in a well-defined central licensing system, these state officials can have their roles clear. Once the concept of Central licensing is clear, many of these concerns of the state officials should disappear.