Health ministry to tighten drug regulations

February 25, 2013 | Monday | News | By BioSpectrum Bureau

Health ministry to tighten drug regulations

Health minister calls for stringent laws to check spurious drugs

Health minister calls for stringent laws to check spurious drugs

The union health minister, Mr Ghulam Nabi Azad recently revealed that a new scheme has been prepared by the central government for providing assistance for strengthening of state drug control departments during the 12th Five Year Plan. The minister further stated that, the Drugs and Cosmetics Act, 1940 has been amended by Drugs and Cosmetics (Amendment) Act, 2008 for making penal provisions under the Act more stringent. The Drugs and Cosmetics (Amendment) Act, 2008 also enabled establishment of special designated courts for trial of offences related to spurious and adulterated drugs. So far 14 states/UTs have already set up such courts.

Mr Azad also stated that whistle blower scheme has been initiated to encourage vigilant public participation in the detection of movement of spurious drugs in the country. Under this scheme the informers would be suitably rewarded for providing concrete information in respect of movement of spurious drugs to the regulatory authorities.

"Strengthening and up-gradation of infrastructure and facilities of Central Drugs Standard Control Organization (CDSCO) is an continuous and on-going process depending upon increase in responsibilities and consequent workload. Since 2008, 216 additional posts in the CDSCO have been sanctioned," the health minster mentioned while speaking in the parliament on February 22, 2013.

Mr Azad also reiterated that only 0.046 percent of the drugs were found spurious in a survey by the drug controllers' office. This nationwide survey to assess the extent of spurious drugs in the country was conducted in the year 2009 by the health ministry. Survey was only related to spurious drugs which are manufactured clandestinely. The survey did not have reference to assess the losses occurred to the original manufactures on account of this malpractice. About 24,136 samples of 62 brands of drugs belonging to nine therapeutic categories of 30 manufacturers from over 100 different pharmacy outlets in different regions of the country were drawn from different strata in various regions in the country. Further, on the basis of the information collected by the state drug control departments, the number of samples of drugs declared as not-of standard quality has been found to be around 4.75 percent only.

"The manufacture of spurious drugs being a clandestine activity can be curbed only through continuous surveillance and surprise inspections by the state drug control departments," said Mr Azad.

 

 

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