The administration set up of the drug control department and the drug control laboratory in Tamil Nadu are undergoing modernization in tune to the demands of the modern day pharma business.
The drug-testing laboratory, attached to the present administration office, is undergoing upgradation, as part of a national programme funded by WHO through Central Drugs Standard Control Organization (CDSCO). Scheduled to be completed by end 2004, the lab is being modernized at Rs.2.2 crore to upgrade its infrastructure and testing facilities. A new separate building with modern infrastructure will be added to the existing laboratory with state of the art equipments to test samples. The facility will be also offered to other private players to test their samples. Currently the drug testing lab tests more than 6000 samples annually, and with the modernization, the number of samples tested could be increased marginally.
The drug control office is also undergoing automation. About ten systems have been installed with LAN connection, with connectivity to the Central Drug Administration. The automation process also envisages an online licensing system where the applicant can know the status of his application online. The online facility also has provisions for the manufacturers and the public to interact and access information from the drug control department. The officials of the department also have undergone training as part of automation process.
The programme is being implemented by the Chennai based software company ACCEL - ICIM Systems & Services, which has developed a user-friendly software to know the status of license applications. The system is helpful for the pharma industry and public to access any information and interact with the state drug administration.
According to the state government's policy note on health and family welfare, the state government has earmarked an amount of Rs.9.25 lakhs for providing equipments to the Drug Testing Laboratory, and provision of Computer etc., to the Office of the Director of Drugs Control at a total cost of Rs 2 lakh.
The Drugs Control Administration, Tamil Nadu has been functioning as a separate department since November 1981 with the Director of Drugs Control as its Head of Department. Under the administration, there are 13 Zonal Offices, including 4 in the City and 9 in the outskirts, each headed by an Assistant Director of Drugs Control, who is the Licensing Authority for the grant / renewal of Sale Licenses in the zone. The department has three Deputy Director of Drugs Control, besides a Joint Director of Drugs Control who co-ordinate with the 10 Senior Drugs Inspectors and 74 Drugs Inspectors in the state.
A Deputy Director of Drugs Control heads the Intelligence Wing of the TN drugs control administration. Besides, a mobile squad at Madurai headed by the Assistant Director of Drugs Control is functioning to attend to the complaints relating to spurious drugs.
The Drugs Testing Laboratory at Chennai came under the control of Drugs Control Administration since April 1982. The function of the lab is to test statutory samples of drugs drawn by the Drugs Inspectors under Drugs and Cosmetics Act. The total number of concerns selling drugs in Tamil Nadu as on 31-03-2002 is 32,345. The total No. of manufacturing concerns as on 31-03-2002 - Allopathic 1119, Indigenous Medicines 846, Cosmetics 227,Homeopathy 17 and Blood Banks 179.
Norms on licence for Ayurveda, Siddha and Unani firms
In order to grant license to Ayurvedic, Siddha and Unani firms, the department mandates to submit copy of qualification certificate of the technical staff, his/her declaration and copy of experience certificate, list of equipments provided with copies of purchase invoices, plan of the premises measuring 1200 to 1400 sq.ft., copy of rent receipt/rental agreement or evidence for the ownership, specimen labels, clinical trial report of each drug separately from two doctors ( Siddha or Ayurvedic as the case may be ) in triplicate, duly mentioning the curable diseases in Siddha, Ayurvedic terminology, the list of medicines/ingredients (both botanical and Siddha names) with reference to authoritative text from any one of the text books mentioned in the first schedule of the Drugs and Cosmetics Act 1940, method of manufacture, indications in Siddha/ Ayurveda terminology, copy of Partnership Deed/Articles of Association for the constitution of the firm etc. applied in Form -25 D.