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STATE GOVERNMENT TESTING LABORATORIES, CENTRAL DRUG LABORATORY:
It is undisputed fact that in India Test Reports issued by Government Analyst(s) whether belonging to State Lab. or CDL in form 13 of Rules and / or Test Report issued by the Director CDL, Calcutta in form 2 of Rules solely forms the basis of initiating either administrative action under rule 85 of Rules for suspension/cancellation of licence or for institution of criminal prosecution.

These laboratories are required to give opinion whether the drug is of or not of Standard Quality as defined in the Drugs and Cosmetics Act and Rules framed there under.

The apathy of these so called laboratories whose findings decide the fate of Industry and Trade is as under:

Mashelkar Committee Final Report 2003:
1. Out of 31 States/UTs, only 17 drug testing laboratories were found to be functioning. Out of 17 States having their testing laboratories, only 7 were reasonably equipped / staffed, while the others were poorly staffed and did not even have the bare minimum equipment. (Page 2).
2.   The limitations in testing of drug samples in the government labs. are related to the absence or lack of sophisticated instruments, lack of trained analysts, lack of commitment, lack of reagents, non-validated methods, shortage of funds, inadequate number of staff and in many cases a combination of  more than one of  these constrains.(Page 91).

OTHER ISSUES:
(i)   None of these government labs. including the CDL have ever been audited what to talk about audit at regular interval.
(ii)  There is no arrangement for training at regular interval of government analysts and other junior analysts engaged in testing of drugs.
(iii)  The quality of chemicals and reagents are procured without any quality assurance and vendors list is not approved.
(iv)   Absence or lack of reference books, other text books and current literature.
(v)    Absence or lack of reference standards.
(vi)   Lack of capability / Capacity and skill to interpret standards prescribed and provisions of the Act and Rules and there is no practice of imparting training in this regard.
(vii)   Absence or lack of sophisticated equipments and trained expert technical staff to handle those equipments.

The entire ‘Act’ has been prepared for the purpose of proper enforcement of the Drugs and Cosmetics Act. There also we find that it is the Drugs Inspectors who have to perform several duties enumerated under the various provisions of the Act. The primary idea is that no substandard drug shall be sold in the market and no one will sell even a genuine drug without a licence. This is the essence of the provisions of the Drugs and Cosmetics Act.

To enforce this central idea various provisions of the Act have been made and officers are appointed primarily for the purpose of enforcement of this Act. (1988 Drug Cases 70 Bombay High Court, DB, State of Maharashtra Vs Laxmichand Varhomal Chugani, Para 12)

As the title of section 18 suggests, it is prohibitory provision.  The Oxford dictionary meaning of ‘Prohibition’ is- the action of forbidding something, specially by law’

Section 18(a)(i) as amended by Act of 68 of 1982 w.e.f. 1.2.1983 reading as under-

18  Prohibition of manufacture and sale of certain drugs and cosmetics: From such date as may be fixed by the State Government by Notification in the official Gazette in this behalf, no person shall himself or by any other person on his behalf-

(a)     manufacture for sale (or for distribution), or sell, or stock or exhibit (or offer) for sale, or distribute-

(i) any drug which is not of standard quality or is misbranded, adulterated or spurious;

(ii) any cosmetic which is not of standard quality or is misbranded or spurious.

S. 27 as amended in the year 1982 w.e.f. 1.2.1983 reading as under:

27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.—whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,

(a) any drug deemed to be adulterated under section 17A or spurious under section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees;

(b) any drug—

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or

(iii) without a valid licence as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than five thousand rupees:
Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five thousand rupees;

(c)   any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than five thousand rupees:
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year;

(d)    any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made there under, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine:
Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment imposes a sentence of imprisonment for a term of less than one year.

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