I am here presenting my next blog on the topic "DRUG LEGISLATION IN INDIA".
Manufacture of modern drugs in India started by the end of 19th century. Initially, Bengal Chemical and Pharmaceutical works at Calcutta, was established by Acharya P. C. Ray in the year 1901 & Alembic Chemical works was established at Baroda by prof. T. K. Gajjar (1).
During 1920-1930 a number of reports of harmful substitutes and adulterants were identified to be marketed in place of genuine drugs.According to Indian Medical gazette there was no control over the manufacturing sale and distribution of drugs in India. As there were no restrictions on quality of drugs that are being imported, unscrupulous manufacturers abroad took advantage and flooded the Indian markets with adulterated & spurious drugs.(2)
As a result of such frauds, the British Government was forced to initiate action for drug legislation. (2). Sir Haroon Zaffer moved a resolution on March 9, 1927 in the council of states recommending to the Governer General "to take immediate steps to control the craze of medicinal drugs by legislation for standardization of preparation and sale of such drugs."(1) In every civilized country the sale of foods and drugs is control by law, but in India there were no such restrictions. To avoid this Lt. Col. H. A. J Gidney in the legislative council demanded for the control of adultarated drugs. On september 4, 1928 he moved for leave to adjourned the house for the consideration of the "Gigantic Quinine fraud". The local press and even the pharmacuetical journal of England supported the agitation.(1)
In response to such agitations, Drugs enquiry committee constituted under the chairman ship of Col. R. N. Chopra as Chairman , Shri C. Govindan nair as secretary and Dr. B. Mukharjee as assistant secretary.(2)The main objectives of this committe were-
* To enquire & check the quality of drugs, that are being imported, manufactured and sold.
* To suggest remedial measures in preventing adulteration.
The committee submitted its report in 1931. Until 1937 British rulers do not act on this report . In 1937 import of drugs bill was introduced with limited reference to import and later it was withdrawn due to public criticism. Finally in the year 1940 The Drugs Bill was introduced in the Parliament, based on the recommendation of D. E. C and after in-depth deliberation The Drugs Act, 1940 was enacted which was latter amended to the Drugs and Cosmetics Act, 1940.(2) Later on, Drugs Enquiry Committee & Health Survey and Development Committee lead foundation for The Pharmacy Act, 1948.(2)
IMPORTANT MILESTONES IN DRUG LEGISLATION OF INDIA-
1857,1878 - Opium act enacted
1919 -- The position Act enacted.
1940 - Drugs Bill introduced in Parliament and Drugs act later amended to Drugs & Cosmetic Act
1946 - Indian Pharmaceutical Codex (I.P.C) published.
1947 - The Indian Nursing Council Act enacted.
1948 -- The Pharmacy Act, 1948 & The Dentists Act, 1948 enacted.
1954 -- The first B. Pharmacy Course approved by Pharmacy Council of India at Birla College, Pilani.
1955 -- First Indian Pharmacopoeia published.
1956 -- Essential Commodities Act enacted.
1960 -- Prevention of Cruelty to Animals Act passed
1962 -- Beginning of National Pharmacy week celebrations in third week of November every year.
1963 -- The Indian Hospitals Phrmacists assosciation (IHPA) was launched at Pilani, Rajasthan.
1970 -- First DPCO (Drugs Price Control Ordrer)
1985 -- The Narcotic Drugs & Psychotropic Substances Act enacted.
1986 -- Consumer Protection Act enacted.
References :
1.Text book of forensic pharmacy by C.k. Kokate and S.B Gokhale.pages 9-13
2. Text book of forensic pharmacy by N.K.Jain.pages 11,13 ,14,16,17
CDSCO is India's main regulatory body for pharmaceuticals and medical devices.it describes laws relating to drugs and cosmetics,notification and adverse drug reactions.it features licence and certification import of drugs and information to the patient.
It's main functions are * control of quality of imported drugs . * coordinate the activities of states drug control authorities and advice them for uniform action in the country. * lay down regulatory measures and standards of drugs. * grant approval of new drugs proposed to be imported into or to be manufactured in the country.
Under CDSCO there are many zones and sectors include:
*central drugs testing laboratory *regional drugs testing laboratory *Indian pharmacopoeial commission .
references: 1.www.cdsco.nic.in/html/CDSCO%20Contact%2025-9-08.htm 2.www.india-server.com/.../central-drugs-standard-control-35073.html3.www.joeant.com/DIR/info/get/18780/73764 -
It is high time that some gap-analysis is done in the legislated Acts and Rules to make it apt to the current situation.
Example: Registered Pharmacist certificate is given under Pharmacy Act to accord all privileges in practice of pharmacy.
Drug license is given under D & C Act to the Reg Pharmacist to SELL / DISTRIBUTE' drugs There is no term like 'CHEMISTS & DRUGGIST' in any Act.
We find all retail licensed outlets carrying bold board CHEMISTS & DRUGGIST!
A Reg Pharmacist cannot put up a board 'PHARMACY' unless he compounds and dispenses. Actual compounding and dispensing as defined in the Act is obsolete .
All pharmacists except the ones who are actually at the retail counter talks of patient counseling. But neither the Act says so nor the doctors expect the pharmacist to counsel. The patient on his part doesn't know what to expect from the chemist other than the dispensed drugs.
Legislation doesn't support the pharmacist but is in place to cow-down the pharmacist
