THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)
(a)to(e): A statement is laid on the Table of the House.
STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO.201 FOR 7TH DECEMBER, 2012
(a)&(b): Cases of sale of spurious and substandard drugs have been reported by the State /
UT Drugs Control Authorities. A statement showing the number of samples tested, number of
samples declared not of standard quality, number of samples declared spurious, number of
prosecutions launched, number of persons arrested and the approximate value of drugs seized
State / UT wise during 2009-10, 2010-11, 2011-12 and from April-July, 2012 is enclosed at
Annexures 1 to 4.
The Central Drugs Standard Control Organisation (CDSCO) has not received any report of deaths
due to sale and marketing of spurious, sub-standard and expired drugs.
(c)&(d) The Government has no proposal under consideration for entering into international
co-operation and global treaty specifically to deal with the menace of spurious and substandard
drugs reaching the market.
(e) The Government has taken the following steps to check the problem of spurious /
sub-standard drugs.
1. The Drugs and Cosmetics Act, 1940 was amended by the Drugs & Cosmetics (Amendment)
Act, 2008 to provide for more stringent penalties for manufacture and trade of spurious and
adulterated drugs. Certain offences have also been made cognizable and non-bailable.
2. The Drugs & Cosmetics (Amendment) Act, 2008 has also enabled setting up of special
designated courts for speedy disposal of cases to deal with the cases of offences under the
Drugs and Cosmetics Act. 14 States/UTs have already set up these special Courts.
3. Guidelines for taking action on samples of drugs declared spurious or not of standard
quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008
were forwarded to the State Drugs Controllers for implementation.
4. 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.
5. The state drugs controllers have been regularly requested to keep vigil and draw
samples of drugs for test and analysis to monitor the quality of drugs moving in the country.
6. Overseas inspection of manufacturing sites abroad from where drugs are imported into
the country has been initiated. Such inspections have already been conducted in manufacturing
sites situated in China.
7. The manpower and other infrastructure of the Drugs Control Departments, both at the
Centre and in the States / UTs are continuously being strengthened.
