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TN DC ignores DCGI directives; tops in issuing licenses for irrational combinations
CH Unnikrishnan, Mumbai | Tuesday, July 20, 2004, 08:00 Hrs  [IST]

The sub-committee appointed by the Drug Consultative Committee (DCC) to probe into the matter of irrational fixed doze combinations licensed by the state drug authorities, has revealed that the Tamil Nadu Drug Control Department issued the maximum number of such licenses in the country during the period 2000-'04.

Himachal Pradesh comes second in the list where the Drug Controller General of India (DCGI) has already taken a stringent penal action for an year ago.

However, the Tamil Nadu Drug Control Department, which issued more than 200 such licenses mostly during the last two years, is learnt to have ignored several notices sent from the office of the DCG of India in this regard.

When contacted, the current Tamil Nadu Drug Controller in-charge T Kannan said that since he has taken charge very recently after the retirement of the former drug controller, A Somnath, he is totally unaware of how many manufacturing licenses have been issued for combination drugs during the period in the state.

Though the DCGI had issued a circular in May 2002 to not to issue any new fixed dose combinations by state drug controllers in a bid to eliminate manufacturing and marketing of irrational drug combinations in the country, most states still continue issuing licenses.

Nevertheless, since there is no coordination between central and state departments in issuing manufacturing license for existing drugs, the central authority is helpless in restricting or cancelling the licenses issued by state departments. At the same time, once someone secures a manufacturing license for a new combination product from a state, he can sell the product all across the country.

According to sources in the Central Drugs Standard Control Organisation, (CDSCO) as the State Drug Control departments are not under the central health administration, the DCGI cannot interfere in the state DC's functioning beyond a certain limit. This lacunae in the de-centralized system often results in tussle between the state DCs and the CDSCO in such matters and thereby no control on proliferation of substandard and irrational drugs in the country.

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