Absence of a regular state drug licensing authority in the Directorate of the Indian System of Medicines in Tamil Nadu is pushing drug units into a serious crisis in the state, according to the president of Tamil Nadu Ayurvedic, Siddha and Unani Drugs Manufacturers Association (TASUDMA), Dr Viay A Mehta.
The units fear this situation in the licensing department can hamper the very progress of establishment of the 16 crore Ayurvedic Cluster project in the state. TASUDMA had made a lot of efforts for the project and is now waiting for the clearance from the centre. Mehta said without a proper licensing system, Ayush Department would not recommend the units for forming the Cluster as at lest 15 firms need to have GMP certification.
From November last year, the Drugs Controller is not available in the office as some investigations are reportedly going on against him. An officer was appointed as the first drug licensing authority for Indian Systems after the formation of a special wing under the Commissionerate of ISM in January 2008, Dr Mehta told Pharmabiz.
"The last date of filing of applications for license renewal was one Month before December 31, 2008. More than 100 manufacturers could not submit applications, as there was nobody responsible to deal with the applications. The commissioner has engaged one lady ayurvedic doctor to accept the applications, but she is not technically qualified to handle them. So the manufacturers were unwilling to submit their original documents along with the applications," said the association president.
While appreciating the cooperation rendered to the industry by the commissioner, Dr Mehta said the current situation can adversely affect the production and thereby hitting the exports. No quality control endorsement, no chemist endorsement or not any other business activity is done in the factories. He said the industry people are struggling to get their licenses renewed. Only just 100 units got their licenses in 2005 and they need to be renewed for another three years.
As the president of the manufacturing association, he suggested there should be a hierarchical pattern of officers such as Drug Controller, Deputy Drug Controller and Assistant Drug Controller, besides appointing sufficient office staff. He said that now there are only two officials, who are on deputation, are looking after the cases of more than five hundred ISM manufacturers in the state. He added that shortage of qualified drug inspectors also causes delay in the day-to-day functioning of the industry.