Because of the increasing complexity
of modern pharmaceutical manufacture arising from a variety of unique drugs and
dosage forms, complex ethical, legal and economic responsibilities have been
placed on those concerned with the manufacture of modern pharmaceuticals. An
awareness of these factors is the responsibility of all those involved in the
development, manufacture, control, sale and marketing of quality products.
Over the past few years, there has
been increasing concern among the masses in regard to the progressively
deteriorating quality control of drugs and their irrational use. A host of
social, political, economic, legal and administrative factors have been
attributed to this grim scenario. Some of these factors are discussed as under.
1.0
SOCIAL FACTORS:
1.1
Lack of awareness
among masses in regard to Quality Control of drugs and about the difference
between misbranded, adulterated, spurious and sub-standard drugs.
1.2
Lack of awareness
among masses regarding legal aspects concerning quality control. For instance,
common people do not realize the significance of cash memos and do not demand
the same upon every purchase of drugs.
1.2.1 Consequences of non-issuance of Cash-memos:
i)
sale of spurious
drugs
ii)
overcharging of
taxes
iii)
sale of drugs
without prescriptions resulting into self-medication, drug-addiction, abuse
etc.
iv)
Failure of
enforcement agencies in getting such dealers convicted by the court of law.
1.3.
Lack of
informational inputs by common consumers in regard to sub-standard, spurious,
adulterated and misbranded drugs, resulting into failure of administration in
busting the rackets of spurious drugs.
1.4.
Lack of
complaints made by consumers to concerned authorities in the event of
ineffectiveness of a genuine formulation.
1.5.
People resorting
to self-medication and consultation by Medical Assistants, Compounders, fake medical practitioners etc resulting into
severe and even serious adverse drug reactions, ineffectiveness of medication,
improper diagnosis and inappropriate therapy
1.6.
Lack of
fundamental medical and health education at the basic high school level.
1.7.
Lack of
recognition of the distinction between qualified and non-qualified pharmacists
and the role that can be played by the qualified pharmacists in strategic and
scientific administration, preparation, sale, storage and distribution of drugs
and pharmaceuticals.
1.8.
Lack of
resistance on part of druggists, chemists and patients against unethical and
irrational prescriptions.
1.9.
Lack of
establishment of private, govt.-approved drug testing laboratories by qualified
pharmacists and related NGOs.
2.0
LEGAL FACTORS:
Drug services to common masses and related issues are
regulated through following laws:
» Drugs
and Cosmetics Act, 1940
» Drugs
and Cosmetics Rules, 1945
» Pharmacy
Act, 1948
» Drug
Prices Control Order, 1995
» Narcotic
Drugs and Psychotropic Substances Act, 1985
The existing provisions i.e., Section 274, 275 and 276
of IPC/CrPc related to drug offences are bailable and cognizable and are not in
consonance with the provisions of the Drugs and Cosmetics Act, 1940.
2.1
There has been no
major amendment in the Drugs and Cosmetics Act, 1940 since 1982, which was
passed with an objective to regulate the sale, storage, manufacture and
distribution of Drugs and Cosmetics.
2.2
There are several
loopholes in this Act that pave way for the safe passage of offenders.
2.3
Unlike Labour
laws, Act does not allow on-the-spot imposition of fines by inspectorate for
violating various norms like sale of drugs without prescription, not displaying
the license within premises, stocking of expired drugs within the premises,
absence of “qualified person” from the sales premises, stocking of physicians
samples etc. Inspectorate has to launch formal prosecutions for such petty
offences also. As a result, matters get dragged in lengthy judicial procedures
yielding very few convictions.
2.4 Section
27 of the Drugs and Cosmetics Act, 1940 lists out penalties for various
contraventions of the Act and Rules thereunder but at the same time authorizes
courts to impose a lesser sentence of imprisonment or fine in view of some
adequate or special reasons which unfortunately are not amply clear and
well-defined in the Act, resulting into reduction of punishments by courts on
clumsy and inadequate grounds to only a few hours of imprisonment and a fine up
to a few hundred rupees only. At present the offenders usually get bails and
the prosecutions normally take about 10-15 years for any judgements. In many
cases, the offender may get away with minor punishment whereas in all
likelihood, he continues to indulge in spurious drug trade during the period of
his trial.
2.4
Procedure
prescribed under Section 25 of D & C Act, 1940 for retesting of drugs is
faulty and provides an ample opportunity for the offenders to escape from the
jaws of law. The procedure is so cumbersome, tedious and lengthy that the drug
samples in question get expired even before it is retested or any prosecution
is launched against the offenders.
2.5
Pharmacy Act,
1948 has become obsolete and redundant due to lack of adequate and proper
amendments from time to time. Even after 55 years of its enforcement, the Act
does not extend to the state of Jammu
and Kashmir
2.6
Narcotic Drugs
and Psychotropic Substances Act, 1985 though a strong, stringent and powerful
piece of legislation, is not being properly implemented in most of the states
due to lack of adequate enforcement staff and non-delegation of relevant powers
under the Act to the available manpower.
3.0
ADMINISTRATIVE FACTORS:
3.1
Insufficient
workforce and excessive workload.
3.1.1 Guidelines put forth by several committees prescribe
one inspector for every 100 drug sale outlets or every 25 manufacturing
establishments, whereas at state levels there are only 14 inspectors in 14
districts of J&K
State
3.1.2 There are only 32 inspectors with CDSCO whose capacity
is 72 inspections per year whereas the need is 2800 inspections annually @ a
minimum of two inspections per establishment per year.
3.1.3 The kind of budget the Drug Control Department
receives is somewhere in the region of Rs. 25 crore under non-plan and Rs. 10
crore under planned expenditure. With this kind of budget it is impossible to
do anything.
3.1.4 There are about 4000 manufacturing units of whom
hardly 20% are in the organized sector and account for about 145 in number, the
rest are in the small scale sector which are hard to be monitored by such a
meager inspectorate staff.
3.1.5 Number of prosecutions being launched is declining day
by day. The number of cases of sub-standard drugs etc coming to notice is only
about 11 % and even that is on a plateau. Based on the samples tested by the
state drug controlling authorities during the period 1995 – 2003, the extent of
sub-standard drugs varied from 8.19 to 10.64 % and of spurious drugs varied
between 0.24 % to 0.47 % whereas Confederation of Indian Industries (CII) has
recently revealed that spurious drugs comprise 18 % of total pharmaceutical
production in India causing revenue loss to the tune of whopping Rs. 4112
crores annually. This raises serious doubts about the quality and quantity of
testing by our government laboratories.
3.2
Lack of adequate
transportation, accommodation, communication and judicial assistance facilities
to the available inspectorate. In J&K, Drugs inspectors are not even
conferred Gazetted status making them incompetent to launch proceedings for
over-charging of drugs under the provisions of Drug Prices Control Order, 1995.
3.3
Standards of Good
Manufacturing Practices not being enforced properly by the state governments.
At present there are over 16000 licensed drug companies in India
3.4
No substantial
headway in the direction of upgradation and modernization of state as well as
centrally-run drug testing laboratories. Out of information provided by 26
states to the recently framed Mashelkar Committee, only 15 drug-testing
laboratories have been found to be functional and out of 15 state having their
own testing laboratories, only 7 are reasonably equipped or staffed for being
able to test all categories of drugs, while the other states are poorly staffed
and equipped and do not even have the bare minimum equipment. The total testing
capacity for the state and central laboratories is only 3500 samples per year
against a need for around 10,000 samples per year. Drug testing facilities in
the states badly need to be augmented and drug testing time needs to be brought
down to one month which in many states extends to six months.
3.5
The inspectorate
have to spend most of their time in courts pleading for various prosecutions
launched by them and they are left with
no time to conduct any secret probe against possible spurious drug rackets
functioning in their jurisdiction areas. There is urgent need to create
separate intelligence and legal cells in state as well as central offices with
adequate provisions of secret funds and incentives for informers. Further
special courts need to be designated to exclusively try the cases of spurious
drugs.
4.0
IRRATIONAL USE OF DRUGS:
4.1
Several
combinations and formulations available in the markets have been identified as
irrational by several expert groups.
4.2
Pharmaceutical
companies offer their brands at cheaper rates with huge margins for retailers
and exorbitant complimentary gifts and commissions for physicians. No definite
mechanism or regulations to curb unethical prescribing by doctors or to control
unjustified distribution of costly gifts by Pharmaceutical companies are in
place.
4.3
Decision on
setting up of National Drug Authority had been taken in 1994 but the same has
not been implemented till date, reportedly due to lack of infrastructure. NDA
was to be set up for monitoring the prescribing practices and evaluation of
their appropriateness for the purpose of guiding the medical professionals and
for achieving the aim of rational prescribing. Further it was envisaged that
NDA shall be levied with the task of monitoring the standard practices in drug
promotion and use, clearly identify those that are acceptable and prohibit
those which are unethical and against the consumers’ interests. Failure of the
government to establish NDA has been the biggest hurdle in the way of ethical
prescribing and rational use of drugs.
No comments:
Post a Comment