EXPERT COMMITTEE SET UP FOR STRENGTHENING
& UPGRADING THE DRUG REGULATORY MECHANISM
SHATRUGHAN
SINHA DISCUSSES ISSUE OF SPURIOUS DRUGS WITH PHARMA INDUSTRY
RURAL DEVELOPMENT, PANCHAYATI RAJ
AND PUBLIC WORKS
Union Minister for
Health & Family Welfare, Shri Shatrughan Sinha has announced
the setting up of a broad based expert committee under the chairmanship
of Dr. Mashelkar to suggest concrete and time bound measures for
strengthening and upgrading the drug regulatory infrastructure.
Shri Sinha was addressing a meeting with leaders of Pharmaceutical
Industry here today. The meeting was called in order to have one
to one discussion about the nature and extent of the problem concerning
movement of spurious drugs.
Expressing concern
about reports of circulation of spurious/counterfeit drugs in
the market, Shri Sinha said that in the past few years the Health
Ministry has taken a number of initiatives like streamlining the
licensing procedure for manufacture and sale of drugs, new import
registration procedures for all drug products, revised bench marks
for Good Manufacturing Practices (GMP), computerization and networking
of all central and state drug control offices and drug testing
laboratories in the country to ensure safety efficacy and quality
of drugs as well as to harmonize regulatory requirements with
the changing global practices. He said the Ministry is also in
the process of taking up a capacity building project to augment
the drug testing facility in the country so that about one lakh
samples can be tested annually as against the present figure of
about 38,000 samples and also to reduce the time of testing to
less than one month.
Outlining the legal
requirements under Drugs and Cosmetics Act 1940 and Rules made
there under, Health Minister said the responsibility to ensure
manufacture of quality drugs and to check possible movement of
sub standard drugs rests primarily with the State Governments.
The infirmities in the enforcement system and lack of focused
strategy to preclude any possibility of manufacture and sale of
spurious or fake medicines is therefore likely to be taken advantage
of by criminal elements to push spurious drug products in the
supply chain. The Minister said in view of the complexity involved
in combating the heinous crime for which the main responsibility
lies with the States, he has taken up this matter with the Chief
Ministers.
Shri Sinha said that
the counterfeiting of any product including medicines has become
easier due to easy excess to modern packaging and printing technology.
In many cases such counterfeit or fake medicines may contain the
labeled active ingredient and routine analysis may not reveal
the fraud. Shri Sinha suggested a review of the corresponding
penal provisions in addition to making these offences cognizable
under the provisions of Drugs and Cosmetics Act. This would help
drug enforcement authorities in obtaining speedy police assistance
which is very critical to apprehend the criminal elements involved
in such clandestine activities. The Mashelkar Committee will look
into these aspects.
Shri Shatrughan Sinha
called upon the Pharma Industry to play a major role in checking
the menace of spurious drugs. He said the Pharma Industry has
a well developed and extensive marketing network which can be
effectively used to identify the weak links in the drug distribution
channel and which are suspected to connive with antisocial elements
in providing an opportunity to push spurious products. He said
that initiatives of some industry associations like Indian Pharmaceutical
Alliance to unearth spurious drug rackets need to be continued
with full vigor.
