Hg Koshia-6-6-09

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1-15 March 2009

'The pharma industry of Gujarat is facing no challenges' Recently promoted as Commissioner, Licencing Authority, Food and Drugs Control Administration (FDCA), Gujarat, H G Koshia has long been involved with the state's drug regulatory mechanism. Viveka Roychowdhury quizzes Koshia on the FDCA's initiatives What were challenges facing the pharmaceutical industry and Gujarat in particular, during your tenure in the FDCA? Presently the pharma industry of Gujarat is facing no challenges. The era of difficulty due to competition from tax free zones in the north is gradually getting relieved. The present infrastructures facilities enjoyed by the Gujarat drug industry are better with respect to roads, power, water supply and transportation. Technically competent and skilled staff is also an added benefit to the manufacturers of Gujarat drug industry. With linkages with the export business, quality reputation and updated technology, pharma sector is thriving towards new horizon of growth and development. Looking at the year ahead, what major regulatory changes is the government contemplating? What are your views on the moves of the government to centralise India's drug licensing system? The system for centralisation of drug licensing has its pros and cons as well. In the era of research, advance technology and globalisation, lot of new things from all around the world are coming up in the pharma industry which can be very well tackled by central licensing system. Moreover, the co-ordination, harmonisation and uniformity amongst the states and implementation and enforcement of Drugs & Cosmetics Act 1940 can also be monitored by the system of centralisation. Therefore, the system is a welcome move upto a limited extent. However, in order to safeguard the interest of small and medium enterprises (SME), it is necessary that the powers vested to the State Licensing Authority for conventional work be retained intact. Irrational Fixed Dose Combinations (FDCs) have become a health hazard for the consumer. What are the steps taken by the Gujarat FDCA to curb this practice? This is a sub judice matter. Some associations have already secured stay orders from the Chennai and Pondicherry High Courts. Under the circumstances, this department has to maintain the status quo for the implementation of High Court orders. Regarding the manufacturing, marketing and availability of 294 Fixed Dose Combinations (FDC), this department has already ensured that the manufacturing, marketing and availability of such drugs may not take place. The product licence of such combinations is also cancelled. All the manufacturing licensees of this additional product are already ordered to stop the manufacturing right from the date of the order of Drug Controller General (I). Thereafter this department is not issuing any such drug license. Similarly, what are your views on the attempts to define 'counterfeit drugs' by international agencies like the WHO's International Medical Products AntiCounterfeiting Taskforce (IMPACT)? The definition of counterfeit drug devised by international agencies like WHO, International Medical Products Anti-counterfeits' Task Force is somehow required to be given a second thought to match with the ethnic situation of India. The definition of counterfeit should be strictly and specifically differentiated in terms of labeling and quality. The provisions for counterfeit drug which is fraudulently mislabeled with respect to its original manufacturer should not coincide with the

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