MINISTER OF STATE(INPEPENDENT CHARGE) OF THE MINISTRY OF STATISTICS AND PROGRAMME
IMPLEMENTATION AND MINISTER Of STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS
(SHRI SRIKANT KUMAR JENA)
(a) & (b): A survey to assess the extent of spurious drugs in the country was conducted in the year 2009 by the Ministry of Health, through Central Drugs Standard Control Organization. Samples were drawn from different stratum in various regions in the country. 24,136 samples of 52 brands of drugs belonging tc 9 therapeutic categories of 30 manufacturers from over 100 different Pharmacy outlets in different regions of the country and located in each stratum viz. Metros, big cities, district, towns and villages were collected. The survey revealed that the extent of drugs found spurious was 0.046% only. The report of the survey is available on the CDSCO website www.cdsco.nic.in.
(c): The Government, has taken following steps to check the menace of Spurious/ Sub-standard Drugs.
1. The Drugs and Cosmetics Act, 1940 was amended under Drugs &
Cosmetics (Amendment} Act 2008. Stringent penalties for
manufacture of spurious and adulterated drugs have now been
provided to make it deterrent for the antisocial elements to indulge
in manufacture of spurious drugs. Certain offences have also been
made cognizable and non-bailable.
2. Whistle Blower Policy has been announced 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. The details of policy are available at the
website of CDSCO (www.cdsco.nic.in).
3. Guidelines for taking action on samples of drugs declared spurious or
not of standard quality ;n the light of enhanced penalties under the
Drugs & Cosmetics (Amendment) Act, 2008 were forwarded to the
State Drugs Controllers for implementation.The guidelines are
available on the web site of CDSCO (www.cdsco.nic.in).
4. The inspectorate staff has been instructed to keep vigil and draw
samples of drugs for test and analysis to monitor the quality of
drugs moving in the country.
5. The State / UTs were requested to set up special Courts for trial of
offences under the Drugs and Cosmetics Act for speedy disposal of
cases. Some of the States have already set up designated special
Courts for trial of cases elated to spurious and substandard drugs.
(d): The Drugs and Cosmetics Rule, 1945 provdes that the supply by retail of any drug shall be made against a cash/credit memo which shall contain the following particulars:
(a) Name, address and sale licence number of the dealer,
(b) Serial number of the cash / credit memo,
(c) The name and quantity of the drug supplied.
Carbon copies of cash / credit memos shall be maintained by the licensee as record.
(e) & (f): In view of reply to (d), does not arise.
