discussion on 'Drug regulatory Laws'

[Guest guest]

Dear Dr HeenopamaWell started.Go one by one.Will you provide some recent  developments in Drugs and Cosmetics Act ,1940.I shall be grateful to you if you please point out preference  in adaptability   of Schedule Y and OECD guidelines (  any parameter  for priority of  selection of protocols ) for toxicity studies of drugs  as per Indian drug  laws , if any.    

With regards,On Thu, Sep 1, 2011 at 1:41 AM, heenopamathakur <heenopamathakur@...> wrote:

 

A very goodmorning

to all the NetRUMians .I am Dr. Heenopama ,non-Pg SR under the expert guidance

of Respected Dr.V.Thawani sir,VCSGGMS & RC, Srinagar, Garhwal .I would be

moderating on `Drug Regulatory Laws' from 1st to 5th of

Sept.

This is

generally dealt with under Forensic Pharmacy.

This is my

very 1st effort on NetRUM so under your guidance ;I begin with my

discussion. Today I will just shed a light upon how the various laws came into

existence and became a foundation of todays' pharmacy.

                                                                                

 

Concept

of Law:

Jurisprudence-Study of fundamental legal

principles.

Ethics –science of human conduct(ideal moral

code/Positive moral code)

Thus

jurisprudence is related to positive morality as law may be considered the instrument through which positive

ethics tries to assert itself whereas ethics

lays down rules for ideal human conduct in the present and for

subordinating the individuals' requirement of society at large.

Functions

and Purpose of Law:

Law-an

instrument of society to establish justice.

The function

and purpose of Law is justice,stability and peaceful change keeping fair and

equal treatment to all in mind.

 

Evolution

of Law:

Discussed

under 4 headings.

1.Primitive

law:

Result of religious sanction with sphere limited and rules concerned with

property and inheritance on death.

Begins in simple way with introduction of technicality and fixation in

the middle period.Various codes like Code of Manu were formed.

 2.Middle law:

Gradual growth

of rigidity and technicality seen.

When

primitive law was embodied into code-ceasation of spontaneous development with harmonization

with society using 3 instruments-legal ictions,equity and legislation occurs.

3.Classical

law:

Blooming of

legal geniuses and development of a system mature enough to sustain the strain

of adaptation to overcome the deficiencies of primitive was done.

4.post

Classical Law:

With the

complexity of society :rapid development was inevitable.To deal with the new

situations statutes to deal with a particular problem or case were designed.

Statutes:

Expression of the

will of the legislature. Thus an Indian Statute an act of Central or State

legislature.

Forensic

Pharmacy:

Application

of Pharmaceutical knowledge to legal problems.

History

of Drug Legislation in India:

There were `The

Opium Act(1878),The Poison Act(1919) and The Dangerous Drugs Act(1930)' before

1940 still the drugs were exported in crude form and imported in finished form

during the pre-independence period without any control on drugs and anything

under the name of Drug could be made, sold or imported that might be completely

devoid of any therapeutic agent. India was more or less a trial ground or a

dumping ground during the British rule.

Thus the

need for control in drugs was realized by the leaders,common public,merchants'

chambers,medical people,research scientists and the press which took the form

of a strong agitation and as result of which `Drugs Enquiry Committee'(The

Chopra Committee)(1927) was formed under the chairmanship of Col.R.N. Chopra and

Dr.B.Mukherjee as Assistant Secretary was formed on whose(committee) recommendations

after a decade `The Drugs and the cosmetics act(1940)was passed and almost a

decade later `The Pharmacy Act(1948) came into existence.Thus

The Drugs

and cosmetics act -1940

The Pharmacy

bill -1945

The pharmacy

Act -1948-(act no.VIII of 1948)

The Drugs

and Magic Remedies(objectionable advertisements)Act-1954

The

Medicinal and toilet Preparations(excise duties) Act-1955

The

essential commodities Act -1955

The Drugs

prices(display and control) order-1966 repealed in 1970,1979,1987 and 1994

These came into

existence around 1940 ie events before and after 1940.

Future

trends

The Narcotic

Drugs and psychotropic Substances Act -1985(timely piece of legislation)

The

Pharmaceutical policy-2002 –provides measures for rationalization, quality

control and growth of drugs and Pharmaceutical industry in India.

THE

PHARMACY ACT(1948):

Broad

objective of regulating the practice of Pharmacy in India.

Extends to

whole India except the State of Jammu and Kashmir.

Pharmacy

council of India:

Central

council(ie Pharmacy council of India) constituted by the Central govt. and the

1st Central council was constituted in 1949.

Reconstituted

every 5yrs. and consists of:

A.Elected

Members:

1. 6 members

including at least 1teacher each in pharmaceutical chemistry,pharmacology and pharmacognosy

on the teaching staff of an Indian university or an affiliated college granting

a degree or diploma in Pharmacy.

Members

elected by UGC.

2.1 member

elected by the Medical Council of India from amongst its members.

3. 1 member

registered pharmacist to represent each state elected by State Council.

B. Nominated

Members:

1. 6 members

including at least 4 persons possessing degree or diploma in pharmacy and

engaged in the practice of pharmacy or pharmaceutical chemistry,nominated by

the Central govt.

2. A

representative each of UGC and AICTE.

3. 1

registered pharmacist to represent each state nominated by the State

govt./union territory administration.

The

Pharmacy(amendment)Act(1976) provided that for 5 years from 1/9/1976(which coincidentally

happens to be the same date as today),the govt. of each Union territory would, instead

of electing a member (underA.3 above) nominate 1 member eligible for

registration to represent that territory,under this category.

C.

Ex-officio members:

1. The Director

General of Health Services.

2. The

Director of Central Drugs Laboratory.

3. The Drugs Controller of India.

-- Anand Chaudhary, Ph. D.Associate Professor ,Deptt of Rasa Shastra (Ayurvedic Pharmaceutics) & Regional Coordinator,North Zone,Regional Pharmacovigilance Centre for Ayurvedic Drugs

Faculty of AyurvedaInstitute of Medical Sciences Banaras Hindu UniversityVARANASI 221005Cell 9452074480

 http://anandchaudharybhu.blogspot.com/

[Guest guest]

Goodmorning everyone!Continuing with the session on thelast day-The narcotic drugs and psychotropic substances act,1985:Objective:Formed from Article47 ofconstitution of India, which provides the state shall endeavour to bring about prohibition of the consumptionexcept for medicinal purpose ,of intoxicating drugs injurious to health in considerationwith/guidelines by the international conventions like:(a)single convention on narcoticdrugs 1961 as amended by the 1972 protocol(b)conventions on psychotropicsubstances 1971.©united nations convention againstIllicit traffic in Narcotic Drugs and psychotropic substances,1988.Provisions:(a)The cultivation ,production,manufacturepossession,sale,purchase,trans[portation,warehousing,consumption,inter-staemovement ,transshipment and import and export of narcotic drugs andpsychotropic substances is prohibited, except for medical or scientific purposes and inaccordance with the terms and conditions of any license ,permit orauthorization given by the govt.(section 8).( the act empowers the centralgovt. to regulate the cultivation, production, manufacture, Import, export,sale, consumption ,use etc of narcotic drugs and psychotropic substances(section9).©State govt. empowered to permitand regulate possession and inter-state movement of opium, poppy straw ,themanufacture of mechanical opium and the cultivation of cannabis excludinghashish (section 10).(d)the act categorically prohibits ,anyactivity related to engaging in or controlling any trade whereby narcotic drugsor psychotropic substances are obtainedoutside India and supplied to any person outside India except with the previousauthorization of the central govt.(section 12)(e) The central govt.is empowered todeclare any substance ;based on an assessment of its likely use in themanufacture of narcotic drugs and psychotropic substances as a controlledsubstance.(section 9-A).(f)Assests derived from drugstrafficking are liable to forfeiture(chapter V-A).(g)Both the central and state govt.are empowered to appoint officers for the purposes of the act (sections 4,5 & 7).section 4(3) of the act envisages the creation of a central Authorityto coordinate the activities of the various central and state agencies involvedin drug law enforcement ,to implement Indias' obligations under various international organizations andauthorities in foreign countries in the prevention and suppression of theillicit traffic in narcotic dfrugs andpsychotropic substances.(h) chapter V of the NDPSact(sections 41 to68) sets out the powers as well as the procedures for the investigationof offences under the act ,whichincludes power to issue warrants ,to enter and search premises, to stop andsearch conveyances, to seize narcotic drugs and psychotropic substances,to takestatements and to arrest persons suspected of having committed anoffence,punishable under the act.Offences and penalties:Chapter IV (sections15 to 40)setsout the penalties for offences under the Act.These offence sare essentially related to violations of the variousprohibitions imposed under the act on the cultivation ,production,manufacture,distribution ,sale ,import and export etc. of narcotic drugs and psychotropicsubstances. All these offences are triable by special courts and the punishmentsprescribed range from imprisonment of 10-20 years for 1st offencesto 15-30 years for any subsequent offences together with monetary fine.In addition ;any person directly involvedin trafficking narcotic/ harbouring a person involved in trafficking /abets/is aparty to a criminal conspiracy ,including a criminal conspiracy to commit anoffence outside India ,is also liable to the same scale off punishments.The act was amended in May 1989 tomandate the death penalty for second offences relating to contraventionsinvolving more than certain quantities of specified narcotic drugs and psychotropicsubstances.Incase of possession for personalconsumption/trafficking-the punishment is between 6mnths -1yr. and applicablewhen:i)The quantity of drug possessed issmall as specified by central govt.ii)The onus is on the accused toestablish that the drug in question was meant for personal consumption and notfor sale ,distribution etc.the powers to search, seize ,arrestetc. inherent in the act are subject to both the substantive and proceduralsafeguards mandated by the `code of criminal procedure', in relation, inter-alia,to the presence of independent witnesses at a search, the drawing up of searchlists or panchnamas, and the constitutional obligation to produce an arrestedperson before a judge within 24 hours etc. contd........