Criminal Revision No. 2650 of 2008 1 In the High Court of Punjab and Haryana at Chandigarh Criminal Revision No. 2650 of 2008 Date of decision: 26.11.2010 Gursewak Dass and others ......Petitioners Versus State of Haryana and another .......Respondent CORAM: HON'BLE MRS. JUSTICE SABINA Present: Mr.R.S.Bains, Advocate, for the petitioners. Mr.Satyavir Singh Yadav, DAG, Haryana. **** SABINA, J. The petitioners were convicted for an offence under Sections 27(b)(i), 27(c), 27(d), 28(A) and 22(3) of the Drugs and Cosmetics Act, 1940 (for short the Act )by the Chief Judicial Magistrate, Hisar vide judgment dated 6.6.2006. Vide order dated 8.6.2006, the petitioners were sentenced to undergo rigorous imprisonment as under:- Sr. No. Name of accused U/Section Punishment 1 Gursewak 27(b)(i) 2 years RI and to pay a fine of Rs.5,000/- Criminal Revision No. 2650 of 2008 2 Sr. No. Name of accused U/Section Punishment 27(c) 5 years RI and to pay a fine of Rs.5,000/- 27(d) 1 year1 RI and to pay a fine of Rs.1,000/- 28A 1 year RI and to pay a fine of Rs.1,000/- 22(3) 1 year RI and to pay a fine of Rs.1,000/- 2 Rajesh Sareen 27(b)(i) 2 years RI and to pay a fine of Rs.5,000/- 27(c) 5 years RI and to pay a fine of Rs.5,000/- 27(d) 1 year1 RI and to pay a fine of Rs.1,000/- 28A 1 year RI and to pay a fine of Rs.1,000/- 22(3) 1 year RI and to pay a fine of Rs.1,000/- 3 Ashwani Tully 27(b)(i) 2 years RI and to pay a fine of Rs.5,000/- 27(c) 5 years RI and to pay a fine of Rs.5,000/- 27(d) 1 year1 RI and to pay a fine of Rs.1,000/- 28A 1 year RI and to pay a fine of Rs.1,000/- 22(3) 1 year RI and to pay a fine of Rs.1,000/- All the sentences were ordered to run concurrently. Aggrieved by the same the petitioners preferred appeals, which were dismissed vide judgment dated 27.11.2008 passed by the Additional Sessions Judge, Hisar. Hence, the present revision petition. Criminal Revision No. 2650 of 2008 3 The contents of the complaint (Annexure P-1 ) read as under:- “1. That the complainant is appointed as an ‘Inspector’ Under Section 21 of the Drugs and Cosmetic Act 1940 (hereunder after referred to as the Act) for whole of Haryana State vide Haryana Govt. Gazette notification No. 1/5/82-IHB-III dated 8th January 1986 and has been posted and working as Distt. Drugs Inspector-I Hisar since 12.8.1987. 2. That the firm M/s Azad Medical agencies situated in Jain Gali, inside Nagori Gate, Hisar (accused No. 3) is a licenced firm for sale of drugs by way of wholesale, holding durgs licence No. 3552-OW/H and 3253-W/H on form 20B and 21B respectively granted on 28.2.89 vide letter No. 27/791-3-D-II-88/971 dated 28.2.89. This is a partnership firm having two partners namely Sh. Harvinder Kumar (accused No. 1) and Shri Munish Kumar (accused No. 2) as per the partnership deed dated 13th Jan 1989 of this firm. Sh. Harvinder Kumar also the experienced person of this firm. 3. That on 19.7.91, the complainant alongwith his peon Sh. Hari Ram visited the above said sale premises of the accused firm M/s Azad Medical agencies, Hisar, wherein, Sh. Harvinder Kumar, partner cum experience person of Criminal Revision No. 2650 of 2008 4 the firm was found present. The complainant disclosed his identity and purpose of his visit to Sh. Harvinder Kumar. During Inspection of the ship of the accused firm, the complainant found following drugs stocked by the firm other trade stocks for sale and distribution. i) 2x10x100 Capsules Chloramphenicol capsule IP Batch No. F-801 Mfd date June 90, Exp dated June 92, Mfd by M/s. Medicose, 487/61, Peeragarhi, DELHI-110041. These capsules (Blue/While colored shells) were contained in two PVC container (1x10x100 capsules in each) with label inside each polythene pack of 100 capsule and also outside the PVC Container. ii) 2x10x100 Capsules R.Clox, Ampicillin and Cloxacillin Capsules (blister pack) 1x10x100 Capsule contained in carton B. No. P-115 Mfd. Dated Oct 91 Exp dated March 92 Mrd. Rikar Organics (India) Pvt. Ltd, 487/61A, Peeragarhi, Delhi-41. Out of these said durgs. The complainant purchased 4x100 capsules, chloramphenicol B.No. F-801 Mfd, Medicose, Delhi and 2x10x10 capsules Clox B. No. P-115 Mfd M/s Rikar Organics (I) Pvt. Ltd, Delhi, as mentioned as (i) and (ii), for test and analysis purposes. After writing down the details of Criminal Revision No. 2650 of 2008 5 these drugs in sample intimation form No. 17, vide the accused No. 1 Sh. Harvinder Kumar was intimated for collection of samples of these drugs, the complainant divided each of the above mentioned drugs in to four equal portions each as detailed below.:- S. No . Name of Drug Mfd date Exp Date Mfd by Four portion Sample No. 1. Chloamphenical Capsule IP June 90 June 92 Medicose 487/61 Peweragarhi Delhi Four equal portions each of 1 x 100 caps were made GLS 72/91 R.Clox Ampicillin and Cloxacillin Capsules B. No.P-15 Oct.90 Mar 92 M/s Rikar Organics (I) P.Ltd.487/81 A Peerigarhi Delkhi Four equal portions each of 5 x 10 caps were made GLS 73/91 The complainant then effectively and separately sealed all the four portions,l so made, of each of the said both drugs mentioned at S. No. 1 and 2, with his seal bearing seal impression DI GLS and then suitably signed and marked all these four portions of each of these drugs mentioned at S. No. (i) and (2) as sample No. GLS-72/92 and GLS- 73/91 respectively, all in the presence of Sh. Harvinder Kumar, who was then also asked to put his any seal or Criminal Revision No. 2650 of 2008 6 any other mark on the sealed portions of each sample No. GLS-72/91 and GLS-73-\/91 but he refused to do so and he only signed all these four portions of each samples in lieu thereof. A singed, written statement of the accused No. 1, Sh. Harvinder Kumar was obtained on sample intimation form No. 17. The complainant offered the sale price of these sampled drugs to Sh. Harvinder Kumar but a credit memo No. 2290 dated 19.7.91 for Rs. 988-00, was issued for the price of these sampled drugs by Sh. Harvinder Kumar. One sealed portions of each of these sampled drugs and a copy of sample intimation form No. 17, was then handed over to Sh. Harvinder Kumar on the spot against the acknowledgment of the receipt of same on form No, 17 itself. The price of these drugs were later on made to the firm by the office of Civil Surgeon, Hisar. 4. For rest of the quantity of Capsules IP Bno. F- 801 Mfd by M/s Medicose Delhi i.e. 16x100 Capsules, the complainant issued orders to the accused No. 1 on form No. 15 prescribed under the Act for non-disposal of the said drugs for a period of twenty days. A signed written statement of the accused No. 1 was obtained on form No. 15, a copy of form no. 15 was handed over to the accused no. 1 on the spot against the acknowledgment Criminal Revision No. 2650 of 2008 7 on form No. 15 itself. Inspection form was filled by complainant and was also signed by sh.Harvinder Kumar. 5. That on 19.7.91, one sealed sample portion of each of drug sample No. GLS-72/91, along with their original memorandum No. DI/91/1710 dated 19.7.9 and DI/91/1711 dated 19.7.91 respectively on form No. 18, as prescribed under the Act were, then sent to the Government analyst Haryana, Chandigarh by the complainant for test or analysis purpose by registered post parcel. One copy of these memorandum on form 18 bearing seal impression of the seal of the complainant, with which these samples in question were sealed, were also which these samples in question were sealed, were also sent by the complainant to Govt. Analyst Haryana Chandigarh, separately by registered Post. 6. That the complainant then received the test reports No. 4409 dated 29.7.91 and 4915 dated 21.8.91, both in triplicate in prescribed form No. 13 in respect of sample No. CLS-72/91 respectively, As per the test report No. 4409 dated 29.7.91, the drugs/Choramphenicol Capsules IP B.No. F-801 Mfd M/s Medicose, Delhi, was not standard quality, misbranded, adulterated and spurious within the meaning of section 16, 17, 17A and 17-B, of the Act, for the reasons mentioned in the test report. Criminal Revision No. 2650 of 2008 8 7. That on dated 21.7.91, the complainant alongwith his peon Sh. Hari Ram visited the sale premises of the accused firm M/s Azad Medical agencies, Hisar, wherein Sh. Harvinder Kumar, (accused No. 1) and Shri. Munish Kumar (accused no. 2) were found present. The complainant delivered one original copy of the test report No. 4409 dated 29.7.91 of the drug sample No. GLS -72/ 91 alongwith his office letter no. DI/91/1824 dated 31.7.91 to Sh. Harvinder Kumar (accused No. 1), wherein the firm was asked to disclosed the name, address and other particulars of the person from whom the drugs in question have been purchased by them as required u/s 18-A of the Act and was also show cause as to why an action under the act should not be taken against them for having stocked and hold the drug in question. The firm in its reply dated 31.7.91, disclosed of having purchased 2x10x10 Chloramphenicol Capsules IP B.No. 801 Mfd Medicose, from M/s Rikar Organics 9i) Pvt. Ltd. 487/16A, Peergarhi, Delhi, vide their invoice R-001 dated 3.4.91. The firm also stated in its reply that these drugs received through P.N. B and Okara Transport Co. G.R. No. 233 dated 4.4.91 photocopy of the ‘G.R.’ was also submitted by the firm. The complainant then, on the same day and time seized 16x100 Chloramphenicol Capsules IP B.No. F 801 Mfd by Criminal Revision No. 2650 of 2008 9 Medicose, Delhi which were under non-disposal orders issued on 19.7.91 after detailing this drug on form no. 18, in the presence of Sh. Harvinder Kumar (accused no. 1), Sh. Munish Kumar (accused No. 2) and a witness Sh. Durgesh Paul. The drugs were put in a carton and sealed by the complainant with his seal bearing impression DI/GLS. A written and signed statement of Sh. Harvinder Kumar was obtained on form no. 16. Sh. Harvinder Kumar, Sh. Munish Kumar, Sh. Durgesh Pal and the complainant signed the sealed packed and form no. 16. A copy of form 16 was handed over to Sh. Harvinder Kumar on the spot against acknowledgment on form 16 itself. Form 16 is filed in original sport memo was prepared and signed by both parties and the complainant. 8. That on 1.8.91, the sealed packed containing seized drug Capsules as stated above, was produced before the then Chief Judicial Magistrate, Hisar and also moved and application attached with the seizure from no. 16, requesting for custody orders of the seized drugs, as require U/s 23(5) (b) of the Act. The Chief Judicial magistrate, Hisar after signing the sealed packets form no. 16 passed the order for the custody of the sealed packet. 9. That on dated 7.8.91, the complainant alongwith, Criminal Revision No. 2650 of 2008 10 Sh. K.R. Jain, Senior drugs Inspector, Rohtak and Sh. S.K. Aggarwal, Drugs Inspector, Delhi administration Delhi visited the premises of M/s. Rikar Organics (i) Pvt. Ltd. 487/61A, Peeragarhi Delhi for investigations purpose. Sh. Sham Sunder Singla, who disclosed himself to be the Managing Director and authorised signatory of the firm was found present. The complainant disclosed his identity and purpose of visit to Sh. Sham Sunder Singla M.D. Of the firm. The complainant delivered his office letter No. DI/91/Special GLS-1 dated 7.8.91 alongwith one original copy of the report No. 4409 dated 29.7.91 and one sealed portion of sample No. GLS-72/91 in intact sealed condition to Sh. Sham Sunder Singla, in its reply dated 7.8.91 stated that the drug in question was manufactured by M/s Medicose 487/61, Peeragarhi Delhi and marketed by them. He could not produce the current sales records as well as the office copy of their invoice No. R-001 dated 3.4.91 claiming to be issued by their firm, when demanded by the complainant because of the non- availability on the spot. He submitted that these will be produced within 15 days time in the office of the complainant. He further stated that all the manufacturing activities relating to the manufacture of this drug was done by M/s Medicose itself but the lable were got printed Criminal Revision No. 2650 of 2008 11 and supplied by them to M/s Medicose. He did not produced any plank/over-stamped label of this product, when demanded by the complainant. He stated that no stock of this drug was available with them. He pleaded ignorance about the contents of this drug and further requested that the sealed sample portion and the original copy of test report given to him, be supplied to the manufacturer M/s Medicose Delhi. He returned the sample portion and the original test report of drug in question to the complainant after putting his signature on the sealed sample portion. The forth sample portion retained in original packing was also shown to Sh. Sham Sunder Singla, who put his signature on this portion also. He also submitted certified Photostat copies of invoice No. 40 dated 4.8.90 for Rs. 18554-50 issued by M/s Medicose, 487/61, Delhi vide which their firm had purchased the drug in question. Sh. Sham Sunder Singla also singed the certified Photostat copies of invocie No. R-001 dated 3.4.91 claiming to be issued by M/s Rikar Organics (I) Pvt, Delhi to M/s Azad Medical agencies, Hisar. He could not produce copy of memorandum of article of association when demanded however, he mentioned some of the names of the directors of his firm. Spot memo was prepared by the complainant and was Criminal Revision No. 2650 of 2008 12 signed by Sh. K. Jain Senior Drugs Inspector, Rohtak, Sh. S.K. Aggarwal, Drugs Inspector Delhi Adm. And the complainant. Copy of this memo was delivered to sh. Sham Sunder Singla M.D. of the firm. The firm was also found in possession of number of cartons (empty) labels belonging to different products being manufactured by different companies and marketed by this firm. sh. Sham Sunder Singla handed over two empty overprinted carton of R-Clox 10x10 blister pack after putting his signatures on these which is their packing for 10x10 blue/blue capsules of R-Clox but he refused to sign the lables of Chloamphenical capsule IP over-stamped with B.No. F- 801 Mfd by Medicose 487/61 Delhi when these labels were found kept in a carton in folded condition in their premises. These labels were however taken in possession and were signed by the complainant, Sh. K.R. Jain and Sh. S.K. Aggarwa. Spot memo in this context was prepared separately and was signed by all these three officers. 10. That on dated 7.9.91, the complainant alongwith Sh. S.K. Jain and Sh. S.K. Aggarwal Drugs Inspector, Delhi administration Delhi visited the premised of M/s Medicose 487/61, Peeragarhi, Delhi -41 for conducting investigations into spurious Chloamphenical Capsule the Criminal Revision No. 2650 of 2008 13 drug in question. Sh. V.P. Singhal who disclosed himself to be the proprietor of this firm was found present. The complaint disclosed his identity and purpose of visit to Sh. V.P. Singhal. The complainant delivered letter No. DI/Special/GLS-2 dated 7.8.91 to V.P. Singhal properietor of the manufacturing firm M/s Medicose Delhi. The sealed sample portion and the original report as returned sh. Sham Sunder Singla M.D. of the firm M/s Rikar Organics Delhi. Were also rendered to Sh. V.P. Singhal who acknowledge their receipt in the office of said letter. In its reply dated 7.8.91, the firm M/s Medicose has stated that they had procured genuine raw material, got them tested, the produce was tested and sold to M/s Rikar Organics (I) Pvt. Ltd. Delhi in whole, under their invoice No. 40 dated 4.5.91. The firm submitted certified copied of their manufacturing, analytical, in process and sales records etc relating to the drug in question. It was also stated by the firm that Drugs Inspector Delhi had already visited on 1.8.91 for this investigation purposes and he had sealed the control sample of this drugs maintained by them. A copy of their reply dated 1.8.91 to drugs Inspector Delhi was also submitted by the firm to the complainant. Sh. V.P. Singhal put his signature when the forth sealed sample portion in original packing (rectangular plastic Criminal Revision No. 2650 of 2008 14 pack) was shown to him. He also produced the control sample being maintained by their firm for inspection to the investigation team, who (all three officers) signed the control sample. There was seen apparent differences in the overprinting pattern/style in Batch No. MPG dat, Exp date, MRP etc of the lable of the control sample and that of the forth sealed sample portion. Sh. V.P. Singhal further informed that they had supplied these in a packing of 110's capsule (99x100 polythene sealed bags with label) and not in any rectangular plastic container of 1x10x100's pack. This fact is also clear from the invoice No. 40 4.5.90 of Medicose firm had mentioned 98x100's as the quantity. Sh. V.P. Singhal admitted that the labels were supplied by M/s Rikar Organics (India) Pvt. Ltd. Delhi, which were over-stamped for Batch No., Mfg date, Exp date, MRP coding by them. The investigation team also signed the label of the control sample being maintained by M/s Medicose Delhi. Sh. V.P. Singhal concluded his reply with the statement that the sample taken for analysis by the complainant is not a product manufactured by their firm. The complainant prepared spot memo which was signed by all these three officers, a copy of which was delivered to Sh. V.P. Singhal of M/s Medicose. Criminal Revision No. 2650 of 2008 15 11. That the complainant vide his office letter No. DI/91/1964 dated 22.8.91 directed M/s Rikar Organics (i) Pvt. Ltd. Delhi, to produce the sales records of their firm and also the office copy of their invoice No. R-001 dated 3.4.91. Receiving no reply another letter vide No. DI/91/2229 dated 19.9.91 (both by registering AD post) was also sent to M/s Rikar Organics 9I) Pvt. Ltd. Delhi, which was received undelivered form postal authorities with comments on it 'LEFT'. 12. That the complainant received letter No. MED/S/91 dated 20th Aug 91 in reference to complainant letter No. DI/Special/GLS-2 dated 7.8.91 firm M/s Medicose 487/61m, Peeragarhi, Delhi. In this letter the firm has listed many differences between product manufactured by them and the sampled drug. He has also pointed out differences in the test reports issued by their quality control departmental and the one issued by Govt. Analyst Haryana Chandigarh. He also indicated that M/s Rikar Organic Delhi had sold his drug at a rate of Rs.725/- per thousand capsule as per invoice No.R-001 dated 3.4.1991, whereas, the drugs supplied by them has a MRP of Rs.61/120 per 100 capsules. He had again concluded that their firm had manufactured a standard product and not the substandard/spurious one having Criminal Revision No. 2650 of 2008 16 Mfd. Dated June 90 and Exp June 92 this impugned batch of capsules was never manufactured and sold by them to M/s Rikar Organic (I) Pvt. Ltd. Delhi for distribution. 13. That no reply was received from the firm M/s Rikar Organics (India)Pvt.Ltd. 487/61A, Peeragarhi, Delhi inspite of repeated written reminders issued by the complainant to this firm. 14. That the statement of Sh. Sham Sunder Singla Managing Director M/s Rikar Organics (I) Pvt.Ltd. Delhi and the sale statement of the drug in question as submitted by him to Sh.S.K.Aggarwal Drugs Inspector Delhi administration Delhi on dated 7.8.1991 was received by the complainant from the office of drugs controller, Delhi Administration Delhi (Photocopy of the sake invoices and the statement of Sh.S.S.Singla dated 7.8.1991 addressed to the Drugs Inspector, Delhi, Adm. Delhi). The managing director while giving details of the sales have not included the name of the accused firm M/s Azad Medical agencies in his sale statement. He had stated that they had got printed 2000 labels of this drug from their printer M/s Surbhi Printer, Tilak Nagar but the printer's bill or challan was not produced/shown by MD. The firm had Criminal Revision No. 2650 of 2008 17 only purchased 9800 capsules of IP and were sold to three firm only. The firm, however, did not produces any sales records of office copy their sales memo No.R-001 dated 3.4.1991 to the complainant, when it was demanded from firm for verification purposes on 7.8.1991. 15. Thus as per the test report No.4409 dated 29.7.1991, which is admissible in evidence as per Section 25(3) of the act a substandard, spurious, adulterated and misbranded drug Chloramphenical capsules IP B.No. F 810 Mfg by M/s Medicose, 487/61, Peeragarhi, Delhi, which is a life saving drugs is a drug of choice for the treatment of typhoid and is extensively used in the management of various microbial infestation has entered in the market for issue in the ailing human beings and has been manufactured, sold and stocked through and by the hands of accused No.1 to 10. the firm M/s Medicose 487/6 Peeragarhi, Delhi in its reply submitted to the complainant on dated 7.8.1991 and afterwards has stated that they have not manufactured this sampled drug which has been found to be spurious, adulterated and misbranded by the Govt.Analyst, Haryana. But there are certain documentary evidence which provides way for the Criminal Revision No. 2650 of 2008 18 possible involvement of the manufacturer introduction of spurious drugs or these may be the utmost negligence on the part of manufacturing firm M/s Medicose. Some of such worth mentioning observations are as below: a.) M/s Medicose Delhi has labeled this product Chloramhenical Capsules IP B. No. F801 Mfd. By M/s Medicose Delhi by using the printed labels which were supplied by M/s Rikar Organics Pvt. Ltd. Delhi. Since labeling of the products is a part of the manufacturing operation and as per the "Good Manufacturing Practice" as described under the act, access to labels etc. Should be restricted to authorized personnel only . Each and every printed label has to be a accounted for. Unused, coded or spoiled lable has to be destroyed and recorded. In present case M/s Rikar Organic (I) Pvt. Ltd. Delhi not being the manufacturer of this drug in question, had got the lables printed at his own and supplid to M/s Medicose, which in turn used these lables after over stamping. Under these circumstances it is evident that M/s Medicose, Delhi has tatally failed to complying with the provisions under the Criminal Revision No. 2650 of 2008 19 Act and misutilising of these labels with or without consent for ulterior motive cannot be ruled out. B) The supply of this produce Chloramphenical Capsules IP B.No.F- 801 Mfd. By Ms/ Medicose Delhi in polythene bag packing with label inside (without any container with lid or seal) does not fit into the requirement as per the Indian Pharmacopoeia. The manufacturer should have supplied these drugs in proper pack keeping in mind the nature and category of the finished product. c) From the records submitted by M/s Medicose Delhi, it is evident that the firm has committed number of mistakes e.g. The raw material IP purchased by this firm does not bear any expiry date or manufacturing date on it. How the manufacturer has assigned 2 years expiry to its finish product prepared from the raw material of unknown expiry, is a matter of concern. Similarly the specimen label has not been attached with the batch production record of the drug in question. d) The firm had prepared a batch of 10,000 Criminal Revision No. 2650 of 2008 20 capsules of Chloramphenical Capsules IP B. No. F 801 Mfd.by Medicose, Delhi by blending or raw material with adjuvant making the blend kg. As per the analysis report as well as the wt. Variation. As per record of the firm the