PROJECT ON :-

SPURIOUS DRUG

SUBJECT -SOCIO ECONOMIC OFFENCE

SUBMITTED TO- SUBMITTED BY

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Introduction

A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug,
if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it
wrongly claims to be the product of another manufacturer. The term „Spurious Drug‟ has been defined
under Section 17-B of the Drugs and Cosmetics Act, 1940, as amended by the Drugs and Cosmetics
(Amendment) Act, 1982. A stringent penalty for manufacture and sale of spurious drugs has also been
prescribed under the Act. Counterfeiting of commercial products, including medicines, is a global issue and
is reported in many countries. Circulation of spurious drug can lead to grave, adverse consequences on both
consumers (patients) and genuine manufacturers. According to State Drug Controller, the extent of
circulation of spurious drug is about 0.3 per cent. The Government is aware of the problem of movement
of spurious drugs in the market and has taken serious note of it1

Under the provisions of Drugs and Cosmetics (Amendment) Act 2008 and Rules thereunder, it is the joint
responsibility of Central and State Governments through their respective Drug Control Organizations to
regulate manufacture and sale of drugs as well as to keep surveillance over possible movement of spurious
drug

Mashlekar Committee

The apprehensions about the availability of safe and genuine medicines in India, is in a way causing concern
to the consumers within the country, on the other affecting the credibility of drug products from India.
Hence, the Government had set up an Expert Committee under the Chairmanship of Dr. R.A. Mashelkar,
the then DG (CSIR) in February, 2003 to recommend measures for strengthening the drug regulatory system
in the country as well as tackling the problem of spurious drugs . The Committee which submitted its report
in November, 2003 had recommended several changes in the penal provisions of the Drugs & Cosmetics
Act. The main recommendations of the Committee are as follows:-

i) Enhancement of penalty, for sale and manufacturing of spurious drugs that cause grievous hurt or
death, from life imprisonment to death.
ii) i Sale and manufacture of spurious drugs, which are not likely to cause consequences as stated in
(i) above, be made cognizable and non-bailable.
iii) There should be a penalty for those who are unable to produce documents in support of their
purchase.

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Report on Countrywide Survey for Spurious Drugs, Central Drugs Standard Control Organisation (CDSCO),

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iv) There should be a provision for compounding of minor offences so that these should be disposed
of expeditiously while prosecution is able to concentrate on serious cases in the appropriate courts.
v) Authorization of the police to file prosecution.

The Drugs and Cosmetics (Amendment) Act, 2008

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. Apart
from other provisions, the respective Bill sought to achieve the following objectives:

(i) To enhance the period of imprisonment for a term which shall not be less than ten years but which
may extend to imprisonment for life and shall also be liable to fine of ten lakh rupees or three times
the value of the drugs confiscated, whichever is more;
(ii) To provide that the fine imposed on the convicted person and realised from him under the said
clause shall be paid to the person who used such adulterated or spurious drugs and in case of his
death, to his relative;
(iii) To designate one or more Court of Session as Special Court for trial of offences related to
adulterated or spurious drugs; 14 States/UTs have already set up these special Courts
(iv) To make offences relating to adulterated or spurious drugs as cognizable and non-bailable in
certain cases;
(v) To confer upon the police officers not below the rank of sub-inspector of police and other officers
of the Central Government or State Government authorised by it to institute the prosecution under
the aforesaid Act;
(vi) To provide compounding of certain offences not being an offence punishable with imprisonment
only or with imprisonment and also with fine, etc

Drugs and Cosmetics (Amendment) Act, 2008 Guidelines for taking action on samples of
drugs declared spurious or not of standard quality in the light of enhanced penalties under
the Drugs and Cosmetics (Amendment) Act, 2008

The Drugs and Cosmetics (Amendment) Act, 2008 provides deterrent penalties for offences
relating to manufacture of spurious or adulterated drugs which have serious implications on public
health. It will help regulatory authorities to handle anti social elements involved in the manufacture

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 of such drugs and playing with human safety. The major categorization of not of standard quality
of Drugs is given below

Category A (Spurious and Adulterated Drugs)

Spurious or imitation drug products are drug formulations manufactured concealing the true
identity of the product and made to resemble another drug, especially some popular brand, to
deceive the buyer and cash on the popularity of original product. The product may or may not
contain the active ingredients. Spurious drugs are usually manufactured by unlicensed anti-social
elements but sometimes licensed manufacturers may also be involved. The adulterated drugs are
those drugs which are found to contain an adulterant/substituted product or contaminated with filth
rendering it injurious to health.

Category B (Grossly sub-standard drugs)

Drugs manufactured by licensed manufacturers and reported to have defects of serious nature to
affect the quality of the drug. These defects may broadly be like Tablets/Capsules failing in
disintegration test wherever prescribed; liquid preparations showing presence of fungus; and
vaccines failing in potency, etc. Category C (Minor defects) Drugs manufactured by the licensed
manufacturers found not of standard quality because of defects arising out of minor variations in
quality. Such defects may arise because of inadequate pre-formulation development studies, lack
of in process controls 6 Guidelines under New Penal Provision, Central Drugs Standard Control
Organisation, exercised by the manufacturer or unsuitable conditions under which drugs are stored
or transported. For examples broken or chipped tablets; presence of spot/discolouration/ uneven
coating; and change in colour of the formulation, etc

Whistleblower Scheme

Since spurious or fake drugs is a sensitive issue affecting the health of the citizens as well as the prestige
of the country‟s pharmaceutical trade interests, there is a sense of urgency in taking on the menace on
priority basis. In eradicating the menace a scheme has been devised by the Central Government for giving
monetary rewards to the whistleblowers who can take risk of providing the information about the
perpetrators 8 Ibid, pp. 4-6 -7- of such crime. The Reward Scheme provides for giving handsome rewards
to the informers who provide specific information to the designated authorities leading to the seizures of
spurious, adulterated, misbranded and not of standard quality drugs, cosmetics and medical devices. This

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Reward Scheme will be applicable to both the informers as well as the officers of the Central Drugs
Standard Control Organisation (CDSCO). In the fight against the menace of spurious or fake drugs, cost of
such social participation will be minimal given the proportion of damage inflicted by the perpetrators of the
crime on the health of the society and the economic progress of the country.

Conclusion

Any effective action against this activity would require continuous surveillance by the regulators and active
co-operation from the Law and Order Enforcement machinery in the States. The state drugs controllers
have been regularly requested to keep vigil -11- and draw samples of drugs for test and analysis to monitor
the quality of drugs moving in the country. The manpower and other infrastructure of the Drugs Control
Departments, both at the Centre and in the States / UTs are continuously being strengthened. The Central
Drugs Authority needs to be set up which would review the issuance of licenses for manufacture and sale
of drugs. Strengthening of existing and creation of new drug testing laboratories is essential to ensure the
quality of drugs being produced in India, whether used for domestic distribution or for export to other
countries