Congenital Defect in Drugs and Cosmetics Act 1940 - Indian ...

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Congenital Defect in Drugs and Cosmetics Act 1940
B.L.Dass 1 , R.N.Gupta 1 , A.K.Dorle 2
1
Birla Institute of Technology, Ranchi, 2 Nagpur University, Nagpur
Drugs & Cosmetics Act was introduced in our country in 1940
to regulate sale, distribution, manufacture, import etc., of drugs.
On seeing the reasons for its inception, several factors have
been revealed. Industrial commission appointed by British- India
Government in 1918 stated that adulteration of Drugs reached such
a position in India that it was doubtful that an Act could curb it 1 .
Certain events took place in British–India Legislative Assembly and
outside Assembly in between 1920 and 1940 regarding objective
of Government behind the enactment of “Drugs Act, 1940”.
On 19 th March 1921, Lieutenant Colonel H.A.J. Gidney
(Nominated; Anglo –Indians Member ) introduced a motion in the
British -India Legislative Assembly, in which, it was stated that
there were many Sub-standard drugs being imported in India, and
therefore it moved to impose a 20 percent extra taxation on the
import of certain dishonest quack drugs.
Six years later, on the 9 th of March 1927, the Honorable Sir
Haroon Jaffer moved a Resolution in the Council of State to
recommend the Governor-General in Council to take immediate
measures to control the craze for sub-standard drugs by a legislation
having provision for standards of drugs. He pointed out that the
market was flooded with drugs and chemicals of defective strength
and impure quality and those potent remedies like sera and vaccines
were being freely sold to the public, without their quality being tested.
He characterized the practice as a great menace to the public health
and called for the prompt intervention of the State by institution of
efficient safeguards, to ensure the quality; and the authenticity of
the medicinal preparations offered for sale; to the public.
The discussion followed a general consensus of opinion in favor
of a comprehensive “Act” to regulate the sale and manufacture
of drugs in country including the provision for standardization of
drugs and the assay of sera and vaccines. The Council of State
eventually adopted the Resolution in the following terms: (Drugs
Enquiry Committee 1930)
“This council recommends to the Governor-General in
Council to urge all Provincial Governments to take such
steps as may be necessary to control the indiscriminate use
of medicinal drugs and to legislate for the standardization of
the preparation” 2 .
On 4 th September, 1928 Leut.– Col. H.A.J. Gidney moved
an adjournment motion on a gigantic Quinine Fraud, in British
India Parliament. While moving the adjournment motion he said;
(Proceedings L.A. 1928.)
“Sir, I rise to ask your permission that this House do
adjourn with a view to consider certain facts relating to the
gigantic quinine fraud that is today the people of India are
being perpetrated throughout the length and breadth of India
and to which the people of India are being subjected…..It
is most terrible fraud that has been ever perorated on this
country and the unrestricted sale of this spurious drug has, I
submit, been largely responsible for the steady high mortality
from malaria” 3 .
He further spoke in the same debate: (Proceedings L.A.
1928).
“Because there is no Drugs Adulteration Act in India,
acts which even Egypt, Palestine Mesopotamia possess.
(An Honorable Member: “Who makes that quinine?”) This
spurious preparation of quinine is manufactured in England
and Germany and other places of Europe…..” 3
All these could not attract attention of the Government because
on political front the Government was in trouble, adjusting the after
effects of First World War. The independence movement and
Satyagrah, Swadesi movement, kept the Government busy on
that front. The British India Government neither had intention to
do something for the welfare of the people nor had it the time for
same. It awoke and became worried, when the business interest
of British Pharmaceutical Company came in danger, due to import
of drugs into India from countries other than Britain. Therefore,
they wanted to have some sort of Government control on import
of drugs in India. There were no standards defined for the drugs
and no legislation existed to control the menace of adulterated and
spurious drugs. This peculiar situation resulted in supply of grossly
sub-standard, cheap medicine in the market. The cry in press put
the Government in great embarrassment.
Honorable Member of the House (British –India Assembly)
Shri Pandit Laxmi Kant Moitra, spoke in the Assembly, on 4 th April
1940, while discussion on the “Drugs Bill” gave valuable information
regarding the reasons of introducing Drugs Act in the Legislative
Assembly. (Proceedings L.A. 1940).
“There is a chequered history behind the Bill to which
some reference has been made but from which have been
drawn entirely different consciences. Sir, as far back as 1927 in
response to the strong insistent demand of the public to have a
legislative measure to control of import, manufacture and sale
of drugs in this country, a Resolution was passed in the Council
of State. People expected that Government would forthwith
take steps to implement the Resolution. Nothing was done.
Three long years rolled by and in 1930 an incident occurred; an
incident which was of tremendous significance to the country,
to the medical profession and to the trade of drugs. There
was the withdrawal of recognition of Indian medical degrees
by the Medical Council of Great Britain, and consequently,
there was keenest resentment in this country, particularly in
the medical profession as well as in the trade of drugs. Sir, a
regular movement was started in this country with a political
complexion; a movement which was sponsored by the leaders
of medical profession all over India, including personages like
Dr. Sir Nilratan Sarcar, Dr. P.C. Roy, Dr. Deshmukh, Dr. Mehta
and Dr. Mudaliar. The cry was that the least India could do to
vindicate her national honor and self respect was to boycott
British drugs and medicinal preparations and to take to Indian
manufactured drugs from the countries other than Britain.
Sir, the movement began to gather volume and momentum.
Government suddenly woke up and thought that they also in
their turn should do something to counteract the agitation and
forthwith appointed the Drugs Enquiry Committee with Col.
Chopra as its President….” 4
*Email Id: roopgupta@sify.com
Pharma Times - Vol. 44 - No. 05 - May 2012 41

The same hypothesis was also forwarded by Chopra Committee
itself. The Report stated in its paragraph 34.
“Although, as already indicated, the appointment of the
Committee was the inevitable outcome of the pressure brought
to bear on the Government from different quarters, the motives of
the Government were questioned and the Committee itself was
viewed with suspicion when it was actually constituted. The distrust
found expression in the columns of a section of the press. The
appointment of the Committee unfortunately synchronized with a
period of intense political unrest in India.
Above facts, reveal the situation prevailing in 1930, when
Chopra Committee was put in action. It was also stated that the
British India Government was facing multidimensional, problems,
at that time. In short it can be enlisted as;
1. Public cry over dearth of quality medicines in market.
2. Resentment in medical professionals, on derecognizing Medical
Degree of India by British Medical
Council.
3. Urgent need to recapture Indian market after trauma of First
World War.
4. To counter Swadeshi Movement in India.
The appointment of Chopra Committee was a measure of
British Government to resolve the above problems. The Chopra
Committee submitted its report in 1931. The Report recommended
for a comprehensive legislation to regulate import, manufacture
and sale of modern and indigenous drugs. It has also enlisted
the main provisions of the Act. It is supposed as prototype of the
“Drugs Act, 1940”.
Time Selection for introduction of “Drugs Bill”
The Government put the Copra Committee Report in the cold
storage. In 1935 “Devolution Act” came into effect. The affairs of
health were put in the list of States. Most of the State governments
were led by the Congress Party. The credit of positive work on health
would have gone to the Congress Party. Neither it was acceptable
to the British-India Government nor did the Central Government
have intension to deliver good to the people of India.
After six years of submission of the Chopra Committee Report, in
1937, the Government placed a bill to regulate the “Import of Drugs”
into the Assembly as its prime concern was only to facilitated import
of drugs from Britain. It created big cry and resentment amongst
the people of India. The Assembly did not accept it and demanded
for comprehensive bill to regulate import, manufacture and sale of
drugs instead of a partial implementation of the Chopra Committee
recommendations. The Government of India withdrew “Drugs
Import Bill” in 1937 with a promise to re-introduce a comprehensive
bill. Again it was put into cold storage. Second World War broke
in August 1939. All state Governments, led by Indian National
Congress resigned in October 1939 due to participation of British-
India in war. The war made transportation of goods from Europe
to India difficult. In this situation British Pharmaceutical Houses
became desperate to save their industry and export earnings. As the
State Government did not exist, and peoples’ attention was fixed on
war, the British Government found it a right time to introduce “DRUG
BILL” in Legislative Assembly. The time warranted the Government
to get the bill passed by the House, with official majority in House,
as the elected members of the house had resigned. It had served
twin purpose of the Government of India;
1 It was an effort to safeguard the export of Pharmaceuticals from
Britain to India.
2 It projected the British India Government as welfare
Government.
This proposition finds enough strength from the conviction of
Honorable Member of the Assembly while speaking on the “Drugs
Bill” in The Assemble on 5th and 6 th , April 1940.
Honorable Members of the British India Legislative Assembly
Shri Pandit Lakshmi Kant Maitra, spoke in the Legislative Assembly,
during the discussion of the Bill on 5 th April 1940; (proceedings
L.A. 1940).
“…….My Honorable friend appealed that this Bill should not
be treated as a controversial measure. But, Sir, when we consider
the history of this legislation, and the fact that the representatives
of various interests concerned were not even shown the formal
courtesy of consultation, and the way in which it is sought to be
passed by this House, it raises in us the strongest suspicion that it
is not the purity or geniuses of drugs that is sought to be secured
by this Bill, but it is the import from other countries of under-strength
stuff that is going to be legalized and helped…” 6 .
The above mentioned facts revealed the reasons for insertion
of the “Drugs and Cosmetics Act 1940” clearly. The lack of
determination of the Act to eradicate menace of spurious and
sub-standard drugs resulted the weak provisions in the “Act” to
punish the unscrupulous traders and manufacturers of drugs. Due
to this congenital defect the “Act” lost the deterrence. It is noted
that even after much amendments still the dealer and manufacturer
were involved in bad practices since most of times they were being
acquitted. So it requires further strict regulations and its compliance
to control the menace of Sub-standard and Spurious drugs.
Reference:
1. Report of the Drugs Enquiry Committee 1930-1931: paragraph
492: page173.
2. Drugs Enquiry Committee Report, 1030-30:Chapter I; Page 1.
3. Legislative Assembly: 4 th September 1928; page 154.
4. Legislative Assembly: 4 th April: 1940; page 2198.
5. Drugs Enquiry Committee Report 1930-31: Section I chapter IV
paragraph 34.
6. Legislative Assembly: 5 th April: 1940; page 2212.
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Pharma Times - Vol. 44 - No. 05 - May 2012 42