The manufacture and sale of spurious drugs is a clandestine activity generally indulged in by anti-social elements and carried out by unlicensed or sometimes by the licensed manufacturers to exploit the confidence enjoyed by certain fast selling branded drugs by making their imitations. The media and some organisations have been projecting the problem of spurious drugs in the country in a manner which does not provide a balanced perspective and has, therefore, caused serious apprehensions. These are unsubstantiated reports. For example, on the basis of an alleged WHO report, the media frequently reports that 35% of fake drugs produced in the world come from India. However, when enquired, the WHO has denied its authenticity. A survey conducted by the Government in 2009 to assess the extent of spurious drugs revealed that the extent of drugs found spurious was 0.046% only. ASSOCHAM’s report is not based on substantiated facts. The Government has taken a number of measures to check the problem of spurious and adulterated drugs in the country in the past in this regard and is also active in this direction, as follows:
(i) To specifically tackle the problem of spurious drugs, the Drugs & Cosmetics Act, 1940 was amended in 2008 by the Drugs & Cosmetics (Amendment) Act, 2008 for making the penal provisions under the Act more stringent so as to make it deterrent for the anti-social elements from indulging in these illegal practices. Certain offences have also been made cognizable and non-bailable. The Amendment also provided setting up of specially designated courts all over the country for speedy trial of offences under the Act. 14 States / UTs have already set up such courts.
(ii) The Central Government’s drug regulatory mechanism, the Central Drugs Standard Control Organisation (CDSCO) has been strengthened with additional manpower by creation of 216 additional posts at various levels since 2008. As against the total number of sanctioned posts of 111 in 2008 and 64 officers in position then, there are 310 posts in CDSCO now and 121 officers in position, including 65 Drug Inspectors. The selection of 90 more Drug Inspectors has already been completed.
(iii) Two Sub-zones of CDSCO (Hyderabad and Ahmadabad) have been upgraded to full zones and three new sub-zones (Bangalore, Chandigarh and Jammu) have been created to effectively cover the entire country under the active supervision of the CDSCO.
(iv) The Central Drugs Testing Laboratories have been strengthened with new sophisticated testing equipments. A new laboratory at Hyderabad has been constructed.
(v) The scheme of regular overseas Inspection of manufacturing facilities situated abroad has been initiated to ensure proper compliance of Manufacturing facilities before registering them for Import of Drugs from overseas. Two such inspections in China have already been completed.
(vi) A Whistle Blower Scheme has been initiated by the Government 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.
(vii) The inspectorate staff have been regularly instructed to keep vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country.
(viii) The Government has envisaged large scale capacity building of drug testing in the country during the 12th Plan including upgradation of existing labs, setting up of new labs, setting up of Mini labs at ports of entry, commissioning of Mobile Labs, special labs for medical devices and cosmetic, etc.
(ix) The Government has given special attention to strengthening and upgrading the infrastructure of States’ drug regulatory system which plays major role in enforcement of provisions of the Drugs & Cosmetics Act and hence in checking the problem of spurious drugs. A new Centrally Sponsored Scheme to help them during the 12th Five Year Plan has already been envisaged. The scheme includes strengthening of both the physical infrastructure and human resources. A new budget line has been opened and an initial token provision of Rs. 2 crores has been made in 2012-13 budget.