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NETWORKING DRUG ADMINISTRATION
P A Francis | Wednesday, October 30, 2002, 08:00 Hrs  [IST]

An efficient regulatory system is the key to healthy growth of pharmaceutical industry in any country. And such a system should have a proper networking and coordination between other offices to be a successful entity. In a country like India with a large number of state drug administrations, the need for a coordinated system is being felt much more. Drug authorities in the states and Union territories in India function almost independently now as far as enforcement of various drug regulations are concerned. Although they are expected to follow and implement all the Central drug laws, many key regulations are not being enforced just because there is no coordination and regular communication between the state drug authorities and the Central drug authority. One of the worst outcomes of this poor coordination between various state authorities and the DCGI is the proliferation of irrational drug combinations in the market. Despite the DCGI's sincere efforts to weed out the irrational combinations over the last many years, it has not met with any success. Drug companies continue to get manufacturing licences for irrational combinations from state drug administrations which are weak. Currently there is no practice amongst the state drug controllers to check with other state authorities whether they have already rejected an application for an irrational combination. Pharma companies know this weakness of the current system very well. Once a manufacturing licence is obtained, the product can be marketed throughout the country. There are cases wherein the states like Maharashtra, Gujarat and Karnataka had disallowed manufacturing licences for certain irrational combinations but subsequently licences were issued for the same combination by other states. Considerable delay in reaching notifications from the DCGI office and NPPA at state authorities is another serious problem in enforcing the Central orders at same time all over the country. Officials in state drug authorities find it often difficult to implement the orders of DCGI without actually receiving them. The association, representing officials of state drug authorities, is doing its bit to enlighten them about the need for a coordinated approach in enforcing drug laws during their routine meetings. But that has not brought any acceptable improvement in decision-making by officials of most of the states. The project initiated by DCGI, in this context, for linking all state level drug administrations, regional and Central offices of DCGI through a computer network is a great step forward in streamlining the drug control operations in the country. The networking project, executed by Hospital Services Consultancy Corporation, is expected to be completed within a year. A significant point to be noted here is that system has to be made fully tamper proof with adequate safeguards for breakdown

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