(a) whether there have been increasing incidents of circulation of substandard and fake drugs in some cities & towns;
(b) if so, the reasons therefor;
(c) whether according to survey made by ASSOCHAM, fake drugs worth 4000 crores are
sold in the country;
(d) if so, the details thereof and the reaction of the Government in this regard; and
(e) the steps taken to stop the circulation of substandard and fake drugs?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE
(SMT. PANABAKA LAKSHMI)
(a) & (b): There are no reports of increased incident of circulation of substandard
and fake drugs in certain cities and towns. A study of the samples of drugs tested all
over the country in the last 3 to 4 years reveals that 7 to 8 percent of samples were
reported to be not of standard quality and out of this 0.2 to 0.3 percent were found
to be spurious.
(c) & (d): Spurious and misbranded drugs are commonly called as fake drugs.
ASSOCHAM has published certain facts and figures indicating the quantum of counterfeit,
spurious and contraband goods including pharmaceuticals. However authenticity of the
claims can not be confirmed.
(e): The major steps taken by the Government to combat the circulation of substandard
and spurious drugs are given below:
1. The Drugs and Cosmetics Act 1940 is being amended in pursuance of the recommendation
of the Expert Committee setup under the Chairmanship of Dr. R.A. Mashelkar, Director
General and Secretary CSIR . It is proposed to provide for stricter penalities, provision
for special courts for speedy trial of drug related offences, compounding of offences
authorizing the police also to file prosecution for drug related offences and making
all drug related offences cognizable and non-bailable.
2. Government of India has also launched a 5 year World Bank Aided Capacity Building
Project for Food Safety and Quality Control of Drugs with a total project cost of
Rs.354.25 crores. Extensive assistance is being provided to State Governments to
augment their drug testing facility by way of equipments, manpower, training and
civil works under the project and a strong IEC campaign for the education of the
consumers has also been initiated.
3. Schedule – M has been amended to make it at par with International standards and
it is mandatory for the manufacturers of drugs to comply with the requirement for
quality control of product manufactured by them.