Central Drugs Standard Control
Organization
Dte.GHS, Ministry of Health and Family Welfare, Government of India

 

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Laws Pertaining To Manufacture And Sale Of Drugs In India
    

HISTORICAL PERSPECTIVE

In the beginning of the current century Drug Industry was practically non-existent in India and pharmaceuticals were being important from abroad. The first world war changed the situation and not only were finished and cheap drugs imported in increasing volume, the demand for indigenous products also was voiced from all sides. With the clamour for swadeshi goods manufacturing concerns, both Indian and Foreign, sprang up to produce pharmaceuticals at cheaper rates to compete with imported products. Naturally some of these were of inferior quality and harmful for public health. The Government was, therefore, called upon to take notice of the situation and consider the matter of introducing legislation to control the manufacture, distribution and sale of drugs and medicines.

Two of the laws, The Poisons Act and the Dangerous Drugs Act were passed in 1919 and 1930 respectively. The Opium Act was quite old having being adopted as early as 1878. But to have a comprehensive legislation, which the rapid expansion of the pharmaceutical production and drug market required by the end of the second decade for its control, the Indian Government appointed, in 1931, a Drugs Enquiry Committee under the Chairmanship Lt. Col. R. N. Chopra which was asked to make sifting enquiries into the whole matter of drug production, distribution and sale by inviting opinions and meeting concerned people. The Committee was asked to make recommendations about the ways and means of controlling the production and sale of drugs and pharmaceuticals in the interest of public health. The Chopra Committee toured all over the country and after carefully examining the data placed before it, submitted a voluminous report to government suggesting creation of drug control machinery at the centre with branches in all provinces. For an efficient and speedy working of the controlling department the committee also recommended the establishment of a well-equipped Central Drugs Laboratory with competent staff and experts in various branches for data standardization work. Under the guidance of the Central Laboratory, it was suggested, small laboratories would work, in the provinces. For the training of young men and women, the Committee recommended the permission of Central Pharmacy Council, and the Provincial Pharmacy Councils, with registrars who would maintain the lists containing names and addresses of the licensed pharmacists.

The outbreak of the second world war in 1939 delayed the introduction of legislation on the lines suggested by the Chopra Committee which the Indian government contemplated and considered as urgent. However, the Drugs Act was passed in 1940 partly implementing the Chopra recommendations. With the achievement of independence in 1947 the rest of the required laws were put on the Statute Book. In 1985, the Narcotic Drugs and Psychotropic Substances Act was enacted repealing the Dangerous Drugs Act 1930 and the Opium Act of 1878.

At present the following Acts and Rules made thereunder that govern the manufacture, sale, import, export and clinical research of drugs and cosmetics in India.

   
  • The Drugs and Cosmetics Act, 1940
  • The Pharmacy Act, 1948
  • The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
  • The Narcotic Drugs and Psychotropic Substances Act, 1985
  • The Medicinal and Toilet Preparations (Excise Duties) Act, 1956
  • The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)
SOME OTHER LAWS
There are some other laws which have a bearing on pharmaceutical manufacture, distribution and sale in India. The important ones being:
  1. The Industries (Development and Regulation) Act, 1951
  2. The Trade and Merchandise Marks Act, 1958
  3. The Indian Patent and Design Act, 1970
  4. Factories Act

1. The Drugs and Cosmetics Act 1940.

The object of the Act is to regulate the import, manufacture, distribution and sale of drugs.

Under the provisions of this Act, the Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. The board can constitute subcommittees for the consideration of a particular matter.

2. The Pharmacy Act 1948

The Pharmacy Act was passed in 1948 and was amended in 1959, 1976 and 1984.

The aim of this law is to regulate the profession of Pharmacy in India.

Under the provisions of this act the Central Government constitutes a Central Pharmacy Council of India consisting of following members:

a) Six members from the Teachers of pharmacy.

b) Six members from practicing pharmacists or Pharmaceutical Chemists holding degree of diploma.

c) One member elected by the Medical Council of India.

d) The Director-General of Health Services.

e) The Director of the Central Drugs Laboratory.


f) The Chief Chemist, Central Revenues.

g) One member to represent each state elected by members of State Councils who shall be a registered pharmacist.

h) One member to represent each State Government who shall be either registered medical practitioner or a registered pharmacist.

The President and Vice-President of the Central Council of Pharmacy are elected by the members of the Council among themselves, hold office for five years and are eligible for re-election.

The conducting of courses of study for pharmacists, and the examinations in Pharmacy in the states are subject to the approval of the Central Council. Besides the Council has the responsibility to supervise the Education of Pharmacy in the States. Where it is found that the course of study is not in conformity with the Education Regulations, the Council may withdraw approval accorded to the course or the examination. The Central Council can approve qualifications granted by an outside authority for qualifying for registration under this Act.

State Pharmacy Councils

The Act makes it incumbent upon the State Governments to constitute State Pharmacy Councils with the following members:

a) Six members elected from amongst themselves by registered Pharmacists of the state.

b) Five members of whom at least two shall be persons possessing a prescribed degree or diploma in Pharmacy or Pharmaceutical Chemistry or members of the Pharmaceutical profession nominated by the State Government.

c) One member elected by the State Medical Council.

d) The Chief Medical Officer of the State.

e) The State Drug Controller.

f) The Government Analyst.

Registration of Pharmacists

The State Government has under the provisions of the Pharmacy Act to get a register of the State Pharmacists prepared and it is the State Pharmacy Council which has to maintain the register. The register shall contain the name and residential address of Pharmacist, the date of his first admission to the register, qualifications for registration, his professional address, the name of his employer and prescribed particulars.

3. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954

This Act is meant to control the Advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.

The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for:
a) the procurement of miscarriage in women or prevention of conception in women; and

b) the maintenance or improvement of the capacity of the human being for sexual pleasure;

c) the correction of menstrual disorders in women;

d) the diagnosis, cure, mitigation, treatment or prevention of any venereal disease. It is prohibited to directly or indirectly give a false impression regarding the true character of a drug or make false claim for it or to convey any false or misleading information in any material particular about it. No person shall import into or export from India any document containing advertisement of this nature.

Whoever contravenes the provisions of this Act shall, on conviction, be punishable with imprisonment which may extend to six months, with or without fine. In case of subsequent convictions the imprisonment can be extended to one year. The document, article or thing which contains the offending advertisement can be seized and confiscated.

If the person contravening any of the provisions of the Act is a company, every person who at the time the offence was committed was in charge of the business of the company shall be deemed guilty.

The prohibition under this Act does not apply to: a) any signboard or notice displayed by a registered medical practitioner including the treatment for any of the disease, b) any treaties or book dealing with any of the matters from a bonafide scientific standpoint, c) any advertisement related to any drug sent confidentially to any registered medical practitioners or to chemists for distribution among registered medical practitioners or to a hospital or laboratory, and d) Government advertisements.

4. The Narcotic Drugs and Psychotropic Substances Act, 1985

This is an Act to consolidate and amend the law relating to Narcotic Drugs, to make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances and for matters connected therewith.

Contents are provided and maintained by The Ministry of Health and Family Welfare