THE MINISTER OF STATE FOR HEALTH & FAMILY WELFARE(SHRI DINESH TRIVEDI)
(a): Yes.In a survey conducted by Central Drugs Standard Control Organisation
(CDSCO), 24,136 samples of 61 fast moving brands of 9 therapeutic categories from the
sale outlets of different stratum (i.e. metro cities, Big cities, district Head
Quarters, towns and villages) were collected. The survey has revealed that the
extent of spurious drugs is 0.045% only.
(b): The manufacture of spurious drugs is an undercover and localized activity. Its
extent of availability has been found to be very low. It is therefore, not possible
to measure the impact in terms of losses occurred to original manufacturer.
(c): The following steps have been taken by Government to check the manufacture,
sale or marketing of spurious and sub-standard drugs in the country:
1. The Drugs and Cosmetics Act, 1940 has been amended under Drugs & Cosmetics
(Amendment) Act 2008 passed by the Parliament on 5th December 2008 and has come in
to force since 10th Aug, 2009. Under this Act stringent penalties for manufacture of
spurious and adulterated drugs have been provided. Certain offences have been made
cognizable and non-bailable.
2. A Whistle Blower Policy has been started by Government of India to encourage
vigilant public participation in the detection of movement of spurious drugs in the
country. Under this policy the informers would be suitably rewarded for providing
concrete information in respect of movement of spurious drugs to the regulatory
authorities.
3. The Port and Zonal Offices of the CDSCO are actively involved in the detection of
cases of the spurious drugs in the country.
4. A meeting with the Directorate of Revenue Intelligence, Commissioner Customs and
all the Port officers was held on 23-06-2009 to sensitize the concerned departments
about the import of fake drugs in the country and for taking action for absolute
confiscation and prosecutions in cases of import of spurious drugs.
5. In the 39th meeting of Drugs Consultative Committee (DCC), a statutory body under
the Drugs and Cosmetics Act, 1940, held on 10th December, 2008, the States were
requested to play pro-active role in assessing the extent of spurious drugs in the
country.
6. In the 40th meeting of DCC held on 29.6.2009, 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 adopted
for the purpose of uniform implementation of the Drugs and Cosmetic Act in the
country. The guidelines have been placed on the web site of CDSCO.
7. Under a Capacity Building Project through World Bank, assistance was provided to
upgrade testing facilities and to establish new drug testing laboratories to enhance
the capacity of the laboratories to test large number of samples.Under this project
23 States and 6 Central Drug laboratories have been strengthened.
(d)&(e): The manufacture and sale of drugs is under the purview of the State Drug
Control Authorities. The CDSCO, however, coordinate their activities for interstate
investigations. To strengthen the manpower of CDSCO for having extra vigilance in
operations against such activities, 169 posts of Drugs Inspectors for CDSCO have
been sanctioned against the present posts of 32 Drugs Inspectors.
