Steps taken by the Central Government to check the problem of Spurious / Sub-standard Drugs

A nationwide survey to assess the extent of spurious drugs in the country was conducted in the year 2009. 24,136 samples of 62 brands of drugs belonging to 9 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. The survey revealed that only 0.046% of the drugs were found spurious. Survey was related to spurious drugs only which are manufactured clandestinely. The survey did not have reference to assess the losses occurred to the original manufactures on account of this malpractice. 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% only.
The cases of spurious, substandard and expired drugs are investigated by the State Drug Control Departments for violation of the provisions of the Drugs & Cosmetics Rule as and when detected and action is taken by them as per the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945. 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. The inspectorate staff keep strict vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country.

The Central Government has taken following steps to check the problem of Spurious / Sub-standard Drugs:

1. 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.

2. The Drugs & Cosmetics Act, 1940 has been amended by Drugs & Cosmetics (Amendment) Act, 2008 for making penal provisions under the Act more stringent.

3. The Drugs & Cosmetics (Amendment) Act, 2008 also enabled establishment of special designated courts for trial of offences related to spurious and adulterated drugs. 14 States / UTs have already set up such courts.

4. A 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 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 above information was given by the Union Minister for Health & Family Welfare, Shri Ghulam Nabi Azad in a written reply to a question in the Lok Sabha on February 22, 2013.