Punjab-Haryana High Court
Gursewak Dass And Others vs State Of Haryana And Another on 26 November, 2010
Author: Sabina
Bench: Sabina
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. Name of accused U/Section Punishment No. Gursewak 27(b)(i) 2 years RI and to pay a fine of 1 Rs.5,000/-Criminal Revision No. 2650 of 2008 2
Sr. Name of accused U/Section Punishment No. 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/-
Rajesh Sareen 27(b)(i) 2 years RI and to pay a fine of
2 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/-
Ashwani Tully 27(b)(i) 2 years RI and to pay a fine of
3 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. Name of Drug Mfd Exp Date Mfd by Four Sample No date portion No. .
1. Chloamphenical June June 92 Medicose Four GLS Capsule IP 90 487/61 equal 72/91 Peweragarhi portions Delhi each of 1 x 100 caps were made R.Clox Ampicillin Oct.90 Mar 92 M/s Rikar Four GLS and Cloxacillin Organics (I) equal 73/91 Capsules B. P.Ltd.487/81 portions No.P-15 A Peerigarhi each of Delkhi 5 x 10 caps were made 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 average fill weigh per capsule is 275.26 mg. Therefore 2.7 kg blend powder will be sufficient for production of app.9810 capsules only. Hence the yield of this batch should not be more than 9810 capsules, in case if all the filled capsules are good and there is absolutely no wastage of powder during filling the machine or otherwise. But the firm has sold 9800 capsules to M/s Rikar Organics Delhi, besides 100 capsules kept as control samples and 40 capsules used for test or analysis purpose, a total of 9940 good capsules. There is absolutely some manipulations either in the records or the manufacturing operations.
16. Similarly the firm M/s Rikar Organics (I) Pvt. Ltd. Delhi has in its reply dated 7.8.1991 stated that the drug in question was manufactured by M/s Medicose, Delhi and was marketed by them but there are many documentary and circumstantial evidences which indicates involvement of this firm in the manufacturing Criminal Revision No. 2650 of 2008 21 activities while this firm is only holding the wholesale drugs licence.
a) The firm got printed lables and supplied to M/s Medicose, Delhi. Some of the over stamped labels were even found in the premises of this firm on dated 7.8.1991 clearly indicate their misutilization by this firm. The firm could not produce any record of any kind relating to these labels and other printing materials. The firm had got printed 2000 labels of Capsules IP B. No.F801 Mfd.by M/s Medicose, Delhi for a batch size of 9800 capsules having 100's packing and requiring only approx. 100 labels. No further batch of this product was manufactured by M/s Medicose Delhi, indicates misuse of these spare labels.
b) The firm M/s Rikar Organics (I) Pvt. Ltd. Delhi had supplied this drug in packing of 1x10x100 (10 Polythene bags contained in a PVC container with label pasted on outside) while it had received this product in 100's polythene packings. This change in packing is not authorized to the stockist and firm where the firm M/s Rikar procured these extra label for pasting Criminal Revision No. 2650 of 2008 22 on PVC container, in a matter of concern and there is nothing on records in this regards.
c) The firm did not produce the office copy of its invoice No.R 001 dated 3.4.1991 and also the current sales records. But on the other hand Sh.Sham Sunder Singla in its statement before the Drugs Inspector Delhi had submitted the sales details of 9800 capsules which were purchased by them from M/s Medicose Delhi. The name of M/s Azad Medical Agencies , Hisar from where the complainant took samples of drug in question does not figure in the sale details. However, on perusal of the signatures made by Sh.Sham Sunder Singla MD of the firm M/s Rikar Delhi on the photocopy of invoice No.R-001 dated 3.4.1991, it appears that these signatures tallies with signatures already present on the photocopy and also on the statement dated 7.8.1991 of Sh.Sham Sunder Singla indicating the manipulations and alterations made by the firm in the sales records. Inhibition of the firm in producing sale records on the spot on 7.8.1991 also add to the above presumption.
d) The firm M/s Rikar Organics (I) Pvt. Ltd. Delhi Criminal Revision No. 2650 of 2008 23 was found possession in discriminated documents/ labels/ cartons/ literature etc. belonging to different products, some of which were taken into possession also indicates that some undesirable illogical activities was being run in the premises which was having the wholesale drugs licence. The firm did not submit any reply or any documents as was directed by the complainant on 7.8.1991 and also afterwards by registering letters by rather the firm had left the premises, without complying/fulfilling the legal requirements under the Act. Thus from these above said documentary and circumstantial evidence, there are sufficient ground to conclude active participation of this firm in the manufacture, stock and sale of spurious, substandard adulterated and misbranded drug capsules IP Batch No.F-801 M/s Medicose, 487/61A, Peeragarhi Delhi-41. 17. Hence in view of the above, accused No. 1 to 3 have contravened the following provisions made under the Act:-
i) Section 18 (a) (i) of the Act red with Section 16 (1) (a), 17A, 17B and 17 of the Act and Rule 96 Criminal Revision No. 2650 of 2008 24 of the Rules punishable U/s 27 (b) (i), 27(c) and
(d) of the Act.
18. The accused No.4 to 8 have contravened the following provisions made under the Act.
i) Section 18(a) (i) of the Act read with Section 16(i) (a), 17 A, 17 B and 17 of the Act Rule 96 of the rules punishable U/s 27(b) (i), 27
(c) and 27(d) of the Act.
ii) Section 18-B of the Act by not furnishing the information to the Inspector, which is Punishable U/s 28A of the Act.
iii) Section 22(3) of the Act which is punishable U/s 22(3) of the Act.
19. The accused No. 9 and 10 have contravened the following provisions made under the Act:
i) Section 18(a) (i) of the Act read with section 16 (1) (a), 17 A, 17B and 17 of the Act and rule 98 of the Rules punishable .
ii) Section 28 (a) (vi) of the Act which is punishable U/s 27(d) of the Act.
20. Since the test report No.4409 dated 29.7.91 relating to drug Chloramphenical Capsules IP B. No.F- 801 Mfd. M/s Medicose, 487/61, Peeragarhi Delhi, has Criminal Revision No. 2650 of 2008 25 not been challenged, therefore, the facts stated therein are admissible in evidence as per Section 25(3) of the Act.
Therefore, it is requested that the prosecution complaint against the accused No.1 to 10 which the complainant to launch in this Hon'ble court by virtue of Section 32 of the Act may kindly be disposed of according to the provisions of the Act."
Learned counsel for the petitioners has submitted that the Courts below have erred in convicting and sentencing the petitioners under the Act. The Drug Inspector had filed the complaint without obtaining previous sanction from the competent authority and hence, no action could be taken on the basis of the complaint filed by the Drug Inspector. The petitioners were not manufacturers of capsules Chloramphenicol. In fact, the said capsules were being manufactured by M/s Medicose Delhi and the same were only being labeled by the petitioners on the instructions of the manufacturer. The samples of R. Clox Ampicillin and Cloxacillin capsules were manufactured by the petitioners but no charge was framed against the petitioners qua the said samples being of substandard quality. In fact, there was no report of the Chemical Examiner to the effect that the recovered samples, which were manufactured by the petitioners were of substandard quality. In support of his arguments, learned counsel has placed reliance on M/s Fizikem Laboratories Pvt, Ltd. and Criminal Revision No. 2650 of 2008 26 another vs. The Drugs Inspector, Karimnagar and another 2006 Crl.L.J.3090, wherein in para 13, it is was held as under:-
"In view of the fact that there is an express legal bar for institution of prosecution by the Inspector for the alleged offences, taking cognizance of the offence by the Magistrate suffers from incurable jurisdiction deficiency and continuing the same would result in abuse of process and unnecessary harassment to the petitioners."
Learned counsel has further placed reliance on Dr.Om Prakash Singh and etc. vs. State and another 2003 Crl.L.J.4276, wherein in para Nos. 9 and 10, it is was held as under:-
"9. Perusal of the impugned order shows that the learned M.M.did not deal with the contention raised by the counsel for the petitioner but referred to sub section (2) of Section 33-M which provides that no court inferior to that (of a Metropolitan Magistrate or of a Judicial Magistrate of the first class) shall try an offence punishable under this chapter and proceeded on the presumption that this section does not indicate that the sanction is a condition precedent for taking cognizance by court for offence under Chapter IV-A of Drugs and Cosmetics Act, 1940 and fell upon erroneous Criminal Revision No. 2650 of 2008 27 conclusion that sanction is not a condition precedent for taking cognizance by the court. In support of this view, the learned Magistrate placed reliance upon Jas Karan Singh vs. State 1974 Crl.L.J. 728. This judgment dealt with the provisions of Section 32 of the Act, which is part of Chapter IV and held as under:-
"Sanction is not a condition precedent for the taking cognizance by court of complaint for offence under the Act. Section 32 does not provide that sanction is condition precedent for taking cognizance of complaint. The word ' instructions' in Rule 51 is not synonymous with 'prior sanction'. It merely provides that the power to institute prosecution shall be exercised subject to instructions of controlling authority. The instructions contemplated by the rule can only be such as supplement the powers. It could not have been intended by rule-making authority that controlling authority could be executive instructions obstruct performance of duties imposed by the Criminal Revision No. 2650 of 2008 28 rule itself."
10.There is a distinction and conspicuous difference in the language of Section 32 and Section 33-M. Section 32 provides that no prosecution under this Chapter shall be instituted except by an Inspector (or by the persons aggrieved or by a recognised consumer association whether such person is a member of that association or not). Section 33-M provides that no prosecution under this chapter shall be instituted except by an Inspector (with the previous sanction of the authority specified under sub-section (4) of Section 33(G). Sub section (4) of Section 33(G) provides the appointment of an authority by the Government under whom the Inspector shall be officially subordinate. Such an authority has been appointed by the Government by way of aforesaid notification and in this case is Sh.P.K.Mishra, the Director of Health Services.
So far as Sh.Suresh Kumar Sharma is concerned he has been appointed in the notification as an Inspector for the purpose of Ayurvedic drugs including Siddha. Even in Jas Criminal Revision No. 2650 of 2008 29 Karan's case, Supreme Court held that there is a difference between word "instructions" and words "prior sanction". These are two different connotations and have different meaning and import."
It has also been held in P.S.Singarayan vs. State by Drugs 2003 Crl.L.J. 2166 as under:-
"5. I have perused the material and on a perusal of the materials, I find that Ex.P-13, which was marked by the prosecution as a sanction order alleged to have been issued by the Director of Drugs Control, is not actually a sanction order, but only an order which contains the initials of some other persons. The prosecution did not even take the trouble of examining the person who depose that the materials were placed before the sanctioning authority and that the seal sanctioning authority, on a perusal of the materials was satisfied and pass an order granting sanction for the prosecution. In the absence of any such evidence from the prosecution side, the prosecution cannot rest content by marking a copy of the order which only contains the initials of some person, who is also not examined in Court. Criminal Revision No. 2650 of 2008 30 In view of the above, it is difficult to accept the contention of the prosecution that Ex.P-13 is a sanction order, since no order of sanction was marked and proved before the trial Court and Ex.P-13 is only a copy of the order containing the initials of some individual. I have, therefore, of the opinion that the prosecution is bad in law. Section 33-M of the Drugs and Cosmetics Act was not followed. The revision is allowed and the conviction and sentence imposed on the petitioner are set aside. Fine amount, if paid, shall be refunded to the petitioner."
Learned State counsel, on the other hand, has submitted that the Courts below had rightly convicted the petitioners qua offence committed by them.
After hearing learned counsel for the parties, I am of the opinion that the present petition deserves to be allowed.
Section 33-M of the Act reads as under:
Cognizance of offences.-
(1) No prosecution under this Chapter shall be instituted except by an Inspector with the previous sanction of the authority specified under sub-
section (4) of section 33G].
(2) No Court inferior to that of a Metropolitan Criminal Revision No. 2650 of 2008 31 Magistrate or of a Judicial Magistrate of the first class shall try an offence punishable under this Chapter.
Thus, as per the above provision, no prosecution shall be instituted except by an Inspector with previous sanction of the competent authority. Admittedly, in the present case, the complaint has been filed without obtaining previous sanction of the competent authority.
Vide amendment w.e.f 1983, it has been instituted that no prosecution under the Chapter shall be instituted except by an Inspector with previous sanction of the competent authority. Thus, since the complaint had been filed in this case without obtaining previous sanction from the competent authority, the petitioners were liable to be acquitted.
A perusal of the complaint reveals that on 19.7.1991, the complainant recovered capsules of Chloramphenicol, R.Clox Ampicillin and Cloxacillin. It is mentioned in the complaint itself that Chloramphenicol capsules were manufactured by M/s Medicose, whereas, other capsules were manufactured by M/s Rikar Organics (I) Pvt.Ltd. (petitioners). The recovery of the drugs in question was made from M/s Azad Medical Agencies. As per the report of the Chemical Examiner, the sample of Chloramphenicol capsules was not of standard quality as defined under the Act. The petitioners were not the manufacturers of Chloramphenicol capsules. In these Criminal Revision No. 2650 of 2008 32 circumstances, they could not be held liable if the said samples were found to be of sub standard quality. The Courts below have erred in convicting and sentencing the petitioners for offence under the Act for manufacturing sub standard drugs as admittedly, the petitioners were not manufacturers of Chloramphenicol capsules.
Accordingly, this petition is allowed. The impugned judgment/ order of sentence passed by the trial Court and the impugned judgment of the Appellate Court are set aside. The petitioners are acquitted of the charge framed against them.
(SABINA) JUDGE November 26, 2010 anita