You are hereREAD ONCE | POWER CORRUPTS : ABSOLUTE POWER CORRUPTS ABSOLUTELY
READ ONCE | POWER CORRUPTS : ABSOLUTE POWER CORRUPTS ABSOLUTELY
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years,
retired from own Industry (2004),
Founder President of M.P.Pharmacy Graduates’ Association (MPGA),
Ex President: M.P.Pharmaceutical Manufacturers’ Organisation (MPPMO),
Founder President : M.P. Small Scale Drug Manufacturers’ Association (MPSDMA),
Ex President Indian Pharmaceutical Association, M.P. State Branch, Indore (IPA),
Ex Vice Chairman Confederation of Indian Pharmaceutical Industries (SSI) (CIPI)
Recently submitted thesis for award of Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
Absolute monarchies are those in which all power is given to or, as is more often the case, taken by, the monarch. Examples of absolute power corrupting are Roman emperors (who declared themselves gods) and Napoleon Bonaparte (who declared himself an emperor).
"Absolute power corrupts absolutely" arose as part of a quotation by the expansively named and impressively hirsute John Emerich Edward Dalberg Acton, first Baron Acton (1834–1902). The historian and moralist, who was otherwise known simply as Lord Acton, expressed this opinion in a letter to Bishop Mandell Creighton in 1887:
"Power tends to corrupt, and absolute power corrupts absolutely. Great men are almost always bad men."
The scope of this article is limited on the issue “Whether the legislature intended to impose punishment on the Firm / Company and its directors/partners/officials in the event of a drug/batch reported as Not of Standard Quality (NSQ) by the Government Analyst (GA) and/or Director, Central Drug Laboratory, Calcutta, CDL, alleging offence u/s 18(a)(i) r/w sec. 27(d) of the ‘Act’”
The author is of the firm view that based on legal propositions; the answer to the scope of the article is “BIG NO”.
Object of Act & Rules: Drugs are potent things. Modern scientific discoveries of recent years have vastly added to their numbers. With the growing consciousness of the people in their efficiency the need had arisen that the State see to it that the drugs of standard quality and purity are put in the market; that there is no misbranding and fraud and to preserve the public health, they do not impair any fundamental rights of life, liberty or property
In recent years there is a trend that FDA officials in the country very conveniently, without observing provisions of law, in abuse of powers vested in them and contrary to the guidelines prescribed by the Drugs Consultative Committee launch criminal prosecution against the concerned firm/company with directors/partners and many a times on technical staff alleging contravention of section 18(a)(i) punishable u/s 27(d) of ‘Act’ in the event of particular drug, alleged to be manufactured by the firm/company being reported as NSQ by either Government Analyst or Director, CDL.
Let us examine various relevant provisions of Law:
Qualifications of Govt. Analysts and Drugs Inspectors, Licensing Authority and Controlling Authority:
Government Analyst: Graduate/Post graduate in Medicine orScience or Pharmacy or Pharmaceutical Chemistry with experience in testing of drugs of a specified period (Rule 44).
Drugs Inspector: Degree in Pharmacy or Pharmaceutical sciences or Medicine with specialization in Clinical Pharmacology or Microbiology with experience in manufacture, testing of drugs of a specified period (Rule 49).
Licensing Authority: Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or Microbiology with experience in manufacture or testing of drugs for enforcement of the provisions of the Act for a minimum period of five years (Rule 49-A)
Controlling Authority: Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in Clinical Pharmacology or Microbiology with experience in manufacture or testing of drugs for enforcement of the provisions of the Act for a minimum period of five years (Rule 50)
It is interesting to notice that none of above qualifications and/or experience requires experience in interpretation of standards of drugs, capacity/capability to understand the provisions of Act / Rules. There is no provision in the law for imparting compulsory training in this behalf before such persons are actually given charge of the field. More so there is no arrangement either in the Law or in practice for training of such persons at regular intervals. They are just appointed on the basis of qualifications/experience prescribed and overnight they become BOSS of Industry and Trade.
It is also irony that in few States head of FDA does not meet qualification/experience prescribed and such officials are fully involved in enforcement of the Act/Rules.
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