The main legal point established in the judgment is the mandatory compliance with statutory provisions regarding sample distribution and the right of the manufacturer or distributor to access the report and a part of the sample for defense.

JUDGMENT

Sureshwar Thakur, J. - The Drugs Inspector concerned, instituted a complaint under Section 18(a) (I) read with Section 17- A (f) against the accused named therein, for commission, of, offences punishable under Section 27(b)(i) and 27(d) of the Drugs and Cosmetics Act, 1940 ( hereinafter referred to as the Act) and Rules , of, 1945 made thereunder. In the complaint, it is alleged that, upon, the Drugs Inspector concerned, on 28. 3. 2008, inspecting the premises, of, one Sanjeev Kumar Gautam, Proprietor of M/s Gautam Medical Agency, Vill. Parnal, P. O. Nalti, Tehsil Ghumarwin, District Bilaspur, H. P. , hers observing, existence, of, lot of flake like particulate matter and suspended matter in the Dexa Injection 20 ml, B. No. SAP-1333, manufactured by M/s Anrose Pharma 147, Mauza Sansiwala Barotiwala Industrial Area. The Drugs Inspector, withdrew therefrom, sample(s), of the aforesaid drug, as, depicted in form-17, form-17 whereof is enclosed, with, the complaint, as Annexure PC, (i) AND thereupon divided, into four portions, the sample(s) withdrawn therefrom. From amongst four portions, of, the sample(s) drawn, from, the aforesaid drug, kept in the premises of M/s Gautam Medical Agency, (a) one portion was sent on 28. 4. 2008, on form-18, to, the Government Analyst, through registered post, for its analyses. Upon the aforesaid sample, sent to, the Government Analyst, for analyses, the latter in his report appended, as, Annexure PH with the complaint, made a declaration, of, the sample of the drug sent to it, for, analysis, not, conforming to its prescribed standard quality. Accused Sajeev Kumar Gautam, is the retailer of the apposite drug. Accused Dr. Saneh Goyal, is, the proprietor of M/s Sri Balaji Distributors,, Shop NO. 9, Sector 01, Divya Bhawan Complex Parwanoo, District Solan, H. P. , AND also is the distributor of the apposite drug. Accused Dr. Kewal Krishan is the proprietor of M/s Sri Balaji Medicos, Shop No. 3, Sector-01, Divya Bhawan Complex, Parwanoo, wherefrom whom, accused Sanjeev Kumar Gautam, purchased the apposite drug. Accused Ankit Agarwal and Anil Kumar Agarwal, are, the manufacturer(s), of, the apposite drug.

2. The apposite drug is a life saving drug. Provisions of Section 18 of the Act, read 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 a standard quality, or is misbranded, adulterated or spurious;

[(ii) any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;]]

[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 79 [the true formula or list of active ingredients contained in it together with the quantities, thereof];]

(iv) any drug which by means of any statement design or device accompanying it or by any other means, purports or claims 80 [to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;]

(b) [sell, or stock or exhibit or offer for sale,] or distribute any drug 83 [or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

(c) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 83 [or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chap