Pharmabiz
 

APDCA tightens regulatory measures

Sachin C Shastri, HyderabadThursday, March 15, 2007, 08:00 Hrs  [IST]

The Andhra Pradesh State Drug Control Administration (APDCA) is all set to tighten its grip on enforcement of regulations. According to the informed sources in the state drug control administration department, it has issued more than 120 stop production orders, while cancelled seven licenses on regulatory grounds. Besides, nearly 30-40 per cent of the units have upgraded their facilities with respect to Schedule M compliance. Though the department of drug control administration is running short of staff, measures have already been taken to enforce good manufacturing practices (GMP) compliance and other regulations. The APDCA has also requested the government to hire drug inspectors on regular basis, rather than on contract basis. The department is pressing hard for regular drug inspectors to monitor over 726 units apart from the loan licensees in the state. Of these units, nearly 140 units are in accordance with the World Health Organization (WHO) and the current good manufacturing practices (cGMP) standards, said reliable sources. With regard to spurt of minor cases of sale of counterfeit drugs in recent months, the APDCA has initiated raid and inspections in Hyderabad and the surrounding districts. In all, 1089 cases that have been filed with various courts in the state with respect to drug regulations, verdict on as many as 58 cases have been completed. Out of these 58 cases, the court has found 39 cases guilty. In the case of spurious drugs and surveillance, the state's score is 3 per cent, compared to the national average of 9 per cent. The department also has initiated steps to curb unethical blood donation practices in 216 blood banks in the state. As of now, the state has 39000 licensed medical stores, out of which 25000 are in the retail sector. Various measures have been initiated to maintain a balance between individual retail medial stores and retail chain operators. The officials are hopeful about 'out of the ordinary' changes and progress in the department under the current administration. Informed sources revealed that the APDCA would commence the testing of drugs in its new state-of-the-art drug testing laboratory, which is being developed at an estimated cost of Rs. 210 lakh on 13000 square feet area, shortly. Plans are also afoot to upgrade the existing infrastructure capabilities for which it expects to spend Rs.260 lakh. So far, the drug control department has been taking help of its existing laboratory for tests and examinations.

 
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