Medication legislation and Drug regulations ~ Emergency medicine.Site

Medication legislation and drug Regulations

Content:

Legislation ?
Introduction
Pharmaceutical origin in INDIA
Drug enquiry committee
Implementation laws – Indian law
State act and committees
Drug legislation in USA

Legislation?

Law intends for regulation of various aspect of life.
These aspects might be social, economical and political.

Medication legislation is a mixed legislation, which overlappingly covers both social & economic aspects
To ensure that the patient receive drug of required quality, tested and evaluated for safety as well as efficacy for their intended use.
Pharmaceutical legislation is associated with the health of the society..

Introduction:

At the end of the 19th and 20th century use of allopathy system increases.
Drug of natural origin: veg, mineral oil, and animal.
At that time, profit is main motive -than service
Overdose of quinie In adequate dispensing & selling
Drugs are badly adultered
Instead of quinine, were badly adultered
Potent drugs like antimony, arsenic and digitalis marketed without any standards

Pharmaceutical origin in india:

In 1811 first chemist shop is opened by -Mr.Bathgate, who came to India with east India company in Calcutta. in 1910 they have started manufacture of tincture and sprits

In 1821 another firm, smith stain street & co. started apothecary shop and started manufacturing in 1918. In
1901 a small factory was started in Calcutta by Acharya P.C.Ray.

In 1903 prof T.K Gajjar opens factory at parel for the development of pharmaceutical units & alembic chemical works Ltd at Baroda.

Drug enquiry committee:

One representation from the Indian people the viceroy appointed a committee on 11th Auguest 1930, under the chairmanship of col. R.N. Chopra.
So this committee also called its vicerory committee/ R.N. Chopra committee/ Drug enquiry committee.
The report was published in 1931.

Reason for formation of Chopra committee:

Units were not sufficient to fulfil the requirement of Indian public.
Drug were imported -from UK, Germany and France.
During 1st world war cheaper drugs were imported into India, which increased the demand for indigenous drugs.
Unhealthy competition grew up & Indian market was flooded with inferior quality drugs.
Public pressurized government to introduce legislation to control import, manufacture distribution and sale of drugs.
There was no legal & effective control on pharmacy profession
So that the Indian government appointment a drug enquiry committee under the chairman of col R.N Chopra in 1931. this was known as Chopras committee

Drug enquiry committee recommendations:

90 recommendation with reports was submitted by the committee.

Important recommendations:
formation of central & state pharmacy council. Which would look after the educational and training of professionals. Councils would maintain the register containing names & addresses of the registered pharmacist.
Creation of drug control machinery at the centre & branches in all states.
Establishment of a well equipped central drug laboratory with competent staff & experts for an efficient & speedy working of control department. Small laboratories would work under its guidance.
Appointment of an advisory board to advice the government in making rules to carry out the object of the act.
Setting up of cources for training in pharmacy minimum qualification for registration as
Registration of every patent & proprietary medicines of undisclosed formula manufactured in India or imported from outside the country.

But implementation:

Drug bill act:.

Government was reluctant to implement the recommendation of DEC, & the public was pressurizing the government.
Ultimately in 1937, import of drug bill was introduced in legislative assembly to control the import of drugs.
However the manufacture, sale & distribution of drug was not include in bill.
Committee forced the government to include all these aspects.
As a result in 1940, drug bill was again introduced in assembly.
Drug bill 1940 was passed.

It came into force as drug act 1940, later on it was amended many times and at present the act covers provisions related to drugs, cosmetics, unani, ayurvedic, and homeopathic medicines

Drug and cosmetics act 1940:

The present drug and cosmetic act is an improved version of the Drug act 1940, the main objective of this act was to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.

The central government appoints the drugs technical advisory board to advise the central government & the state government on technical matters arising out of the administration of this act.

The central government made several rules entitled the drug and cosmetic rules 1945. these act and rules were amended from time to time.

Pharmacy act 1948:

he pharmacy act 1948 was passed in 1948 and was amended in 1959,1976, 1984.

Aim: To regulate the profession of pharmacy in India.
The central government constitutes a central pharmacy council of India consisting of following members:

six members from the teacher of pharmacy.

Six members from practicing pharmacists or pharmaceutical chemists holding degree of diploma.
One member elected by the medical council of India.
The director general of health services
The director of central drugs laboratory.
The chief chemist, central revenues.
One member to represent each state elected by member of state councils who shall be a registered pharmacist.

Drug and magic remedies act1954:To control advertisements regarding drugs:

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;

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.

Whoever contravenes the provisions of this Act shall, on conviction, be punishable with imprisonment which may extend to six months, with or without fine.

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

d) Government advertisements.

Narcotics and psychotropic substance act 1985:

In 1985 was introduced in the Lok sabha in august 1985 and subsequently passed by both the houses of parliment. It comes into force on 14th November 1985
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
To relax restrictions placed by the Act on Essential Narcotic Drugs (Morphine, Fentanyl and Methadone), making them more accessible for use in pain relief and palliative care. Contained measures to improve treatment and care for people dependent on drugs.
Removed the NDPS Act's imposition of a mandatory death sentence in case of a repeat conviction for trafficking large quantities of drugs.
Increased the punishment for "small quantity" offences from a maximum of 6 months to 1 year imprisonment.
There are some other laws which have a bearing on pharmaceutical manufacture, distribution and sale in India the important ones being
The act has been amended three times in 1988,2001, and most recently in 2014.

Prevention of trafficking illicit narcotics and psychotropic substance:

law passed in 1988 by the Parliament of India.
The Narcotics Control Bureau (NCB) is the chief law enforcement and intelligence agency of India responsible for fighting drug trafficking and the abuse of illegal substances
There exists a published list that mentions the names of all substances banned or controlled in India under the NDPS Act – 237 line items. as ganja, cocaine, heroin etc. are mentioned as such. Cultivation/production/manufacture, possession, sale, purchase, transport, storage, consumption or distribution of any of the following substances, except for medical and scientific purposes and as per the rules or orders and conditions of licenses that may be issued, is illegal and a punishable offense.

Other Acts:

Prevention of food adulteration act, 1954 and rules.
The industries (development & regulation) act, 1951.
The industrial employment (standing order) act 1946 and rules.
Industrial dispute act, 1947.
Factory act,1948.
The Indian patent and design act 1970.
The trade and merchandise mark, 1958.
Shops and establishment acts of respective states.

Indian drug regularity (CDSCO):

Medicines in India are regulated by CDSCO - Central Drugs Standard Control Organization under Ministry of Health and Family Welfare.
Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair.
Under Retail and Distribution: - Drugs classified under 5 heads
1. Schedule X drugs – Narcotics
2. Schedule H and L - Injectables, Antibiotics, Antibacterial
3. Schedule C and C1- Biological Products-example Serums and Vaccines
Under Manufacturing Practice
1. Schedule N - List of the equipment for the efficient running of manufacturing wing, qualified personnel
2. Schedule M

Functions of CDSCO;

Approval of new drugs and clinical trials
Import Registration and Licensing
Licensing of Blood Banks, LVP's, Vaccines, r- DNA products & some Medical Devices
Amendment to D &C Act and Rules
Banning of drugs and cosmetics
Grant of Test License,
Personal License,
Testing of Drugs

State act:

Bengal:
Bengal municipal act 1884
Bengal food adulteration act 1999
Bengal excise act 1909
Madras:
Madras prevention of adulteration act 1919
Uttarapradesh:
United provinces municipal act 1916
Punjab:
Pure food act 1929
Municipal act 1911
Bihar and orissa:
Bihar and orissa municipal act 1922
Prevention of adulteration act 1919
Excise act 1914

Drug legislation in USA:

1.Food and drug act 1906:

The first significant regulation was enacted in 1906 with the passage of the Pure Food and Drug Act. As its name implies, this act prohibited altering or mislabeling medications.

2.Opium exclusion act of 1909:

In 1909, opium was prohibited from being imported under the Opium Exclusion Act.

3.Harrison narcotic act of 1914: restricting the use of various opiates and cocaine.

4. Drug, and Cosmetic Act (1938):

The US Food and Drug Administration (FDA) was given enforcement authority for rules requiring that new drugs were safe and pure
The FDA remains the federal agency responsible for approving new medications and removing unsafe medications from use.
Approval of a new medication typically takes several years. Occasionally, breakthrough medications for life-threatening

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