Bangalore District Court
The Assistant Drugs Controller vs M/S.Ciron Drugs & Pharmaceuticals Pvt on 19 November, 2016
1 CC.No.100-2013
BEFORE THE SPECIAL COURT FOR ECONOMIC OFFENCES:
AT: BANGALORE.
Dated this the 19th day November 2016
Present: Smt.PUSHPAVATHI V., B.A.L., LL.B.,
Presiding Officer, Special Court
for Economic Offences, Bangalore.
CC.No.100-2013.
Complainant: The Assistant Drugs Controller, O/c Assistant Drugs
Controller, Chikkamagaluru Circle, Chikkamagaluru,
Karnataka State, India.
.Vs.
Accused: 1.M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd.,
N-118, M.I.D.C., Tarapur, District Thane-401506,
Maharastra, India. Represented by A.2.
2.Keerthi T. Shah, Director,
M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd.,
N-118, M.I.D.C., Tarapur, District Thane-401506,
Maharastra, India.
JUDGEMENT
1. This complaint is filed u/s.200 of Cr.P.C., by the Complainant/ Assistant Drugs Controller, O/c Assistant Drugs Controller, Chikkamagaluru Circle, Chikkamagaluru, Karnataka State with a prayer to take cognizance against A.1 & 2 for the offence punishable u/s.27(d) of Drugs & Cosmetic Act, 1940 for violation of Sec.18(a)(i) of Drugs & Cosmetic Act, 1940 & Rules & to punish them in accordance with law. (Herein after referred as the "Act")
2. The brief facts of the complainant's case is that the complainant is an ADC appointed u/s.21 of Drugs & Cosmetic Act, 1940 vide Government 1 2 CC.No.100-2013 Order No.HFW/31/IMM/1998, dated:19.08.1998 & has been posted as Assistant Drugs Controller, Chikkamagaluru since 04.06.2010 having jurisdiction over entire Chikkamagaluru District, Vide Government Order No.CPÀÄPÀB53BLJAJA/2010 dated:01.06.2010 read with office order No.O¤EB147B¹§âA¢B 2010-11, dated:01.06.2010.
3. The complainant is a Public Servant U/s.21 of IPC & empowered to initiate this prosecution vide powers vested with him u/s.32(1) of the said Act.
4. The Chapter-IV of the Drugs & Cosmetics Act, 1940 came into effect in Karnataka from 1.4.1957 vide Gazette Notification No.LLH/10/MDH/ 57, Dated:22.3.1957 & S.18 of the said Act came into effect from 01.03.1959 vide Gazette Notification No.LLH/39/MDR/57 dated:
19.12.1958.
5. A.1-M/s.Ciron Drugs & Pharmaceuticals Private Limited is a Manufacturing Company situated at N-118, M.I.D.C., Tarapur District, Thane-401506, Maharastra, A.2 is one of the Director of the company which is possessing valid drug licenses in Form-28 renewed from 01.01.2007 to 31.12.2011 issued by the Joint Commissioner, Food & Drug Administration, Maharashtra State, Thane for manufacture and sale of Concentrated Vitamin-A Solution I.P., B.No.006025, M/D:01/2008, E/D:12/2009 and A.2 is responsible for manufacture of the said Not of Standard Quality drugs.
2 3 CC.No.100-2013
6. On 04.10.2008, C.w.2-Sri.A.P.Krishna Murthy, the then Assistant Drugs Controller, Chikkamagaluru Circle, Chikkamagaluru had drawn samples of Concentrated Vitamin-A Solution I.P., B.No.006025, M/D:01/2008, E/D:12/2009 manufactured by accused firm M/s.Ciron Drugs & Pharmaceuticals Private Limited from D.H.O., Drugs Stores, Chikkamagaluru in Form No.17 dated:04.10.2008 based on information of Drugs Controller for the State of Karnataka that Concentrated Vitamin-A Solution I.P., of various batches are declared as Not of Standard Quality by the Government of Analyst, Karnataka, Bangalore and hence Prohibitory Order in Form No.15 was issued for the remaining stocks, one sealed portion of sample was handed over to the D.H.O., Chikkamagaluru.
7. On 6.10.2008, C.w.2 sent one portion of the sample for the test and analysis to the Government Analyst, Drugs Testing Laboratory, Bangalore under Form No.18 dated:06.10.2008.
8. On 18.12.2008, C.w.2 received test reports in Form No.13 bearing No.MR.No.2000/08/MS/44/74 dated:15.12.2008 along with covering letter from the Government Analyst, Karnataka, declaring Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, M/D:01/2008, E/D:12/2009 manufactured by accused firm M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane, Maharastra as 'Not of Standard Quality' with respect to Assay of Vitamin-A. 3 4 CC.No.100-2013
9. On 18.12.2008, C.w.2 served a notice u/s.18A of Drugs & Cosmetic Act, 1940 to the D.H.O., Chikkamagaluru to disclose the source of acquisition of Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, M/D:01/2008, E/D:12/2009 manufactured by accused firm M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane, Maharastra.
10. On 24.12.2008, C.w.2 received a reply letter from D.H.O., Chikkamagaluru that the said drug Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, M/D:01/2008, E/D:12/2009 was received from the Directorate of Health & Family Welfare Service, Bangalore.
11. On 30.12.2008, C.w.2 sent a letter along with a copy of the Test report to M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane, Maharastra vide acknowledgement.
12. On 12.02.2009, C.w.2 in compliance of Sec.25(2) & Sec.23(4)(iii) of the Act sent a letter dated:12.2.2009 along with a copy of Form No.13 bearing No.MR.No.2000/08/MS/44/74 dated:15.12.2008 and one sealed portion of Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, M/D:01/2008, E/D:12/2009 to Deputy Director (Nutrition), Health & Family Welfare Services, Anandarao Circle, Bangalore under RPAD.
4 5 CC.No.100-2013
13. On 02.12.2011, C.w.1 received letter from D.H.O., Chikkamagaluru enclosing copy of letter of Deputy Director (Nutrition), Health & Family Welfare Services, Anandarao Circle, Bangalore that Concentrated Vitamin A-Solution I.P., B.No.006025, M/D:01/2008, E/D:12/2009 was supplied by M/s.Circon Drugs & Pharmaceuticals Pvt., Ltd., District Thane, Maharastra vide invoice No.KTK/01/2007-08, dated:13.01.2008 and which was supplied by them to the D.H.O., Chikkamagaluru.
14. On 13.10.2008 D.H.O., Chikkamagaluru vide their letter dated:
13.10.2008 voluntarily handed over Concentrated Vitamin-A Solution I.P., B.No.006025, B.No.001016, B.No.002017 & B.No.003018 all supplied by M/s.Circon Drugs & Pharmaceuticals Pvt., Ltd., District Thane, Maharastra to C.w.2 which are declared as Not of Standard Quality.
15. On 23.12.2008 C.w.2 informed ADC Bangalore Circle-3 about voluntary collection of NSQ Drugs from D.H.O., Chikkamagaluru in reply to his letter dated:20.12.2008.
16. On 12.3.2009 & 20.7.2009 C.w.2 submitted report to the Deputy Drugs Controller, Regional Office, Mysore.5 6 CC.No.100-2013
17. On 20.5.2011 as per the direction of the Additional Drugs Controller, Bangalore vide letter No.DCD/Test/179/08-09, dated:03.05.2011 C.w.1 had handed over documents to C.w.4.
18. On 14.06.2011, C.w.3 & C.w.4-Sri.Jayanth Yadav, Drugs Inspector, Thane visited to M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane, C.w.3 enquired with the C.w.8-Brijeshkumar Yadav, Quality Assurance Manager of M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane & collected attested copies of manufacturing records, copies of licenses, test report and name of the Analytical chemist etc., along with a letter dated:14.06.2011 for the investigation. Then C.w.3 enquired about Sri.Rajendra Naik, Technical Staff for Analysis & Sri.Bishwajit Poul is the Manufacturing Chemist in M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane, but Sri.Brijeshkumar Yadav informed that both have resigned and left the Job about 2 years back, he also informed that M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., District Thane is a Limited Company and accused-Keerthi T.Shah is one of the Director and responsible person of day to day activity of said manufacture. C.w.3 handed over the investigation documents to C.w.1.
19. On 03.08.2011, C.w.1 reported to the Drugs Controller for the State of Karnataka about the investigation of the case and sought permission to prosecute against the said accused persons. The Drugs Controller 6 7 CC.No.100-2013 for State of Karnataka, Bangalore vide letter No.DCD/Test/179/2008-
09, dated:03.12.2011 gave permission to initiate prosecution, as such the complainant has filed this complaint against A.1 & 2 for violation of S.18(a)(i) which is punishable u/s.27(d) of the Drugs & Cosmetic Act, 1940 & hence, the complaint is filed. With these grounds prays to punish the accused No.1 & 2 for the offence said above.
20. On received this complaint, cognizance taken, registered the case, secured A.1 & 2, enlarged on bail. Copies of the complaint and other documents were furnished to them, the plea was recorded, where A.2 on his behalf & also on behalf of A.1 firm pleaded not guilty and claimed to be tried. Hence, the matter was posted for complainant's evidence where the complainant has examined as many as 7 witnesses i.e., P.w.1 to 7 and got marked Ex.p.1 to 25 & Mos.1 to 44 and closed their evidence. P.w.1 to 7 have been cross-examined by the accused counsel. On completion of prosecution evidence, the matter was posted for recording the statements of A.1 & 2 u/s.313 of Cr.P.C., where A.2 on his behalf & also on behalf of A.1 firm denied incriminatory evidence read over and explained to them in the language known to them & submitted that they have got no evidence & nothing to say, they did not choose to lead any defence evidence, hence the matter was posted for arguments.
21. Thereafter, heard the arguments. Perused the entire records, the points that arise for my consideration are :
7 8 CC.No.100-2013
Point No.1: Whether the complainant proves beyond all reasonable doubt that A.1-M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., No.118, M.I.D.C., Tarapur, Dist. Thane-401506, Maharastra, India is a firm, A.2 being one of the Director and responsible for day to day activity of the company, representing A.1 on 04.10.2008 found to be manufacturing and selling 'Concentrated Vitamin-A Solution I.P.', B.No.006025, M/D:01/2008, E/D:12/2009, which is 'Not of Standard Quality Drugs' and thereby contravened S.18(a)(i) of Drugs & Cosmetic Act 1940 and committed the offence punishable u/s.27(d) of Drugs & Cosmetic Act, 1940. ?
Point No.2: What order.?
22. My findings on the above said points are as under:
Point No.1: In the Negative, Point No.2: As per the Final orders for the following:
REASONS
23. Point No.1: P.w.3 Sri.A.P.Krishnamurthy, Tumkur has stated that during June-2006 to June-2010, he was working as ADC in Chikkamagaluru, on 04.10.2008, he received information from their Head Office that Concentrated Vitamin-A Solution I.P., is not of standard quality that the said drug is supplied to various districts through D.H.O., & had instructed to take proper steps and to investigate further. On 4.10.2008, he visited to D.H.O., Chikkamagaluru & drawn the samples of 8x100 ml of Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 mfd., by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Tarapur, Thane District under Form No.17 as per Ex.p.13. On the same day, he issued 8 9 CC.No.100-2013 prohibitory order to remaining batch of same drug manufactured by same company in Form No.15 as per Ex.p.14. On 06.10.2008, he sent the sampled drugs for analysis under Form No.18 as per Ex.p.15. On l8.12.2008, he received the report under Form No.13 from Government Analyst, Bangalore that the sampled drug is not of standard quality as per Ex.p.16. On the same day, he has issued a notice u/s.18A & B to D.H.O., Chikkamagaluru to disclose the source of acquisition of said drug as per Ex.p.17, he had enclosed the copy of Form No.13 along with the said notice. On 24.12.2008, they gave reply that the above said sampled drug is supplied by the Director of Health Services, Ananda Rao Circle, Bangalore as per Ex.p.18, but they did not furnish any invoice, but had submitted that they have not received such invoice and they would furnish soon after they receive. On 30.12.2008 the copy of the Form No.13 is sent to manufacturer with covering letter through RPAD as per Ex.p.19, the same was served, the said acknowledgement is at Ex.p.20. As D.H.O., did not give invoice for more than 2 months, he sent 3rd portion of sampled drugs along with the Form No.13 to Director of Health Service, Ananda Rao Circle, Bangalore through RPAD as required u/s.23 & 25 of the Drugs & Cosmetic Act as per the office copy of the letter Ex.p.21, the same was served, the said acknowledgement is at Ex.p.22. On 23.12.2008, he reported this to ADC, Bangalore through letter as per Ex.p.23. On 20.7.2009 a detailed 9 10 CC.No.100-2013 report was submitted to DDC, Mysuru through letter as per Ex.p.24. On his transfer, he handed over files to one Mr.Bhaskar.
24. During cross examination of P.w.3, he has stated that he did not drawn sample in presence of independent witnesses, he has not drawn panchanama at the time of sample drawn, he did not pay the cost of sampled drugs, he says as he drawn the samples from District Health and Family Welfare Office, the Government Institution, he did not pay cost, he did not furnish sampled portion to labeled manufacturer.
25. P.w.3 has denied that he never send any intimation to manufacturer, the accused did not aware of the drugs sampled are not of standard quality, he never drawn sample, for statistical purpose, he has created documents.
26. P.w.5 Dr.K.B.Eshwarappa, Dy.Director, Medical, Directorate of Health & Family Welfare, Ananda Rao Circle, Bangalore in his chief examination has stated that during June-2007 to June-2012, he was working as D.H.O., Chikkamagaluru, on 04.10.2008 ADC visited their stores & collected concentrated Vitamin-A Solution I.P., labeled as B.No.6025 under Form No.17. The ADC issued prohibitory order for remaining stocks of said drug, he received notice dated:18.12.2008 along with the test report declaring the said drugs is not of standard quality as per Ex.p.13, 14, 16 & 17, the ADC has collected remaining 42 bottles of said drugs. He received notice dated:18.12.2008 to disclose the 10 11 CC.No.100-2013 acquisition of above said drugs, he replied on 24.12.2008 stating that they are procured from Directorate of Health & Family Welfare Service, Bangalore as per letter Ex.p.18. In the reply dated:24.12.2008, he had undertaken to hand over invoice, so on 2.12.2011, he handed over the copy of invoice as per Ex.p.3, letter received from Dy.Director, Nutrition, Bangalore is as per Ex.p.25 along with covering letter Ex.p.2, the samples are marked as Mo.1 & 2.
27. During cross-examination of P.w.5, he has stated that no independent witnesses were called during sample taken, no independent witnesses were called during panchanama drawn, he has not received any complaint against accused.
28. P.w.5 has denied that on Mo.1 & 2 no signatures, no drugs sampled in his presence on 04.05.2008, to support I.O., he is deposing false.
29. P.w.1 Sri.J.Bhaskaran, ADC, Bangalore Circle-4, Bangalore in his chief examination has stated that during June-2010 to June-2012, he was working as ADC, Chikkamagaluru, he took charge from Mr.K.P. Krishnamurthy, the then ADC Chikkamagaluru on 7.6.2010, on the directions of Addl. Drugs Controller, State of Karnataka, he gave required investigation papers to Sri.Basavaraj Asangi, ADC, Bangalore Circle-3 to investigate at manufacturer level as per the letter Ex.P.1, he after investigated the case along with report returned back the investigation papers. Thereafter he received a letter from District Health and Family Welfare Office, Chikkamagaluru that drug in 11 12 CC.No.100-2013 question Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 mfd., by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane, Maharastra is purchased from M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane, he had enclosed invoice as per Ex.p.2 to letter Ex.p.3. On going through the record, he found investigation was completed. So, he wrote a letter to D.C., State of Karnataka on 3.8,2011 for sanction to prosecute against accused persons as per Ex.p.4. On 3.11.2011, he received sanction as per Ex.p.5. On 9.12.2011, he filed complaint before Addl. JMFC., Chikkamagaluru as per Ex.p.6. The accused had manufactured not of standard quality and had violated Sec.18(a) which is punishable u/s.27(d) of Drugs & Cosmetic Act, 1940, the two sample bottles of Concentrated Vitamin-A Solution I.P., are marked as Mo.1 & 2. 42 bottles of Concentrated Vitamin-A Solution I.P., handed over by District Health Officer, Chikkamagaluru marked as Mo.3 to Mo.44.
30. During cross-examination of P.w.1, he has stated that he did not sent legal sample to Drugs Controller at the time of obtaining sanction.
31. P.w.1 has denied that the sanction is not in accordance with law, he has filed false case without applying mind, A.2 was not responsible for day to day affairs of the company as on the date of offence.
32. P.w.1 has admitted that the I.O., has not obtained any signatures of any person either accused or colleague or panchas on Mo.1 to Mo.44. 12 13 CC.No.100-2013
33. P.w.2 Sri.Basavaraj Asangi, ADC, Bangalore Circle-5, Bangalore in his chief examination has stated that during July-2009 to May-2012, he was working as ADC, Circle-3, Bangalore, he was entrusted by D.C., State of Karnataka to join Mr.Ajay Mudugal, Drugs Inspector, Circle-3 to collect some documents from the manufacturer of drug Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 mfd., by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane, Maharastra which was declared as not of standard quality and to hand over the same to P.w.1, before going to manufacturer, he collected copies of Form No.13, Form No.17 & Stock transfer note from P.w.1. Thereafter, he along with Drugs Inspector, Circle-3 & Sri.Jayanth Yadav, Drugs Inspector, Thane, Maharastra visited manufacturer's place on 14.6.2011, one Mr.Brjesh Kumar Yadav, Quality Assurance Manager was present. On their request, he handed over attested copies of renewal licence valid upto 31.12.2011, product permission copy, copy of articles of association & copy of analytical report, copies of name & address of directors, he handed over these copies of P.w.1 as per Ex.p.8 to 12. The covering letter given by Mr.Brjesh Kumar Yadav enclosing documents handed over to him as per Ex.p.7.
34. During cross examination of P.w.2, he has stated that the Managing Director of M/s.Ciron Drugs was not present when they visited, the analytical report collected from manufacturer was showing drugs was 13 14 CC.No.100-2013 standard quality. Mr.Ratanshi T.Shah, Mr.Kirti T.Shah, Mr.Samer R.Shah were 3 directors as per Memorandum of Articles & Articles of Association. On the basis of delivery challan, he came to conclusion that Mr.Kirti T.Shah was responsible for affairs of company, there are no other documents to show he was responsible for business of company.
35. P.w.2 has denied that any person of the company can put his signature to delivery challan.
36. P.w.4 Smt.Pramila N.D., Scientific Officer cum Government Analyst in Drugs Testing Laboratory, Bangalore in her chief examination has stated that from-2008 to 2013, she was working as Scientific Officer cum Government Analyst in Drugs Testing Laboratory, Palace Road, Bangalore, she received Concentrated Vitamin-A Solution I.P., on 20.10.2008 for test from Mr.A.P.Krishnamurthy, ADC, Chikkamagaluru, she subjected the said drug to analysis as per the I.P. 1985, she found the drug was not of standard quality with respect to assay for Vitamin- A, she gave the report in Form No.13 as per Ex.p.16.
37. During cross examination of P.w.4, she has stated that she do not remember whether he has seen any signatures on sample portion, the drug was kept in room temperature i.e., 25 degree Celsius. He has not enclosed copies of Protocol Test, she says she applied I.P., 1985, hence copies of protocol test is not enclosed with Form No.13. She 14 15 CC.No.100-2013 has not produced copy of notification to this court as to her appointment, she has not even enclosed the same to Form No.13.
38. P.w.4 has denied that the drug was not kept in required temperature, due to which test report varied in its result, she has issued false report.
39. P.w.4 has admitted that the Jr.Scientific Officer had prepared inventory report, on verifying that inventory report, she concluded Form No.13.
40. P.w.6 Sri.Mr.Brijeesh Yadav, Quality Assurance Manager, M/s.Suraj Chemical, Maharastra in his chief examination has stated that he worked as Quality Assurance Manager, M/s.Ciron Pharma for 12 years. On 14.6.2011 Mr.Ajay Mudugal, Mr.Basavaraj & Mr.Jayanth Yadav visited their company, they requested to furnish the details of the manufacturing records of 6 batches of Concentrated Vitamin Solution I.P., 100 ml., & licence details, product permission copy, memorandum of articles of association as per Ex.p.8 to 12. He confirmed the manufacturing of all the batches and also informed that A.2 is the Director and responsible for day to day affairs of the company, he handed over self attested copies of documents above said to P.w.2, the covering letter dated:14.6.2011 issued by him as per Ex.p.7.
41. During cross-examination of P.w.6, he has stated that he do not know the contents of the documents, he do not know whether samples have been collected by the Drugs Inspector.
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42. P.w.6 has admitted that he has just handed over the documents.
43. P.w.7 Dr.B.R.Jagashetty, Retired D.C., State of Karnataka, Bangalore in his chief examination has stated that from 1.5.2008 to 31.10.2013, he was working as D.C., & Controlling Authority for the State of Karnataka, based on report dated:3.8.2011 of the then ADC, Chikkamagaluru Circle & Investigation Officer, he had given permission to launch prosecution against accused vide letter dated:
3.12.2011 for the drug Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 mfd., by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane Maharastra for having manufactured and sold not of standard quality & he has issued sanction order as per Ex.p.5 & thereby violated Sec.18(a)(i) which is punishable u/s.27(d) of Drugs & Cosmetic Act, 1940.
44. During cross-examination of P.w.7, he has denied that all the facts and circumstances are not reflected in the sanction order without looking into records, he has given false sanction.
45. P.w.7 has admitted that the punishment section is not mentioned in the sanction order.
46. In support of oral evidence, the complainant has placed documentary evidence at Ex.p.1 to 25 i.e., Ex.p.23 is the letter dated:23.12.2008 to ADC, Bangalore Circle-3, Bangalore by ADC, Chickamagaluru that the drugs seized are kept in his custody and has sought information about steps taken regarding such drugs. Ex.p.24 is the O/c of Letter dated: 16 17 CC.No.100-2013
20.7.2009 of ADC of Chickamagaluru to Regional Deputy Drugs Controller, Mysore seeking directions to collect documents with regard to drugs in question through ADC, Bangalore Circle-3. Ex.p.1 is the Letter dtated:20.05.2011 written to Asst.Drugs Controller, Bangalore Circle-3, Bangalore by the ADC Chickamagaluru handing over the documents, photo copies of Form No.13, Form No.17, other two letters & invoice for further investigation at manufacturer level.
47. Ex.p.13 is the Form No.17 according to which Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 mfd., by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Tarapur, Thane District has been seized from the office of Stores of D.H.O, Chickamagaluru Circle, Chickamagaluru. Ex.p.14 is the Carbon copy of Form No.15 according to which the Prohibitory Order is issued, Ex.p.15 is the Copy of Form No.18 according to which the drug in question is sent to test, Ex.p.16 is the Form No.13 according to which subject drug is declared has not of standard quality, Ex.p.17 is the Notice issued by ADC, Chickamagaluru to D.H.O., Chickmagaluru to furnish the source of acquisition of subject drug. Ex.p.18 is the Reply of D.H.O., Chickamagaluru that the subject drug have been supplied by M/s.Circon Drugs & Pharmaceutical Pvt., Ltd., Ex.p.2 is the Letter dated:02.12.2011 by ADC, Chickamagaluru to the District Health and Family Welfare Office sending the letter of Directorate office regarding Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, 17 18 CC.No.100-2013 D/M:Jan/2008, D/E:Dec/2009 mfd., by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Tarapur, Thane District is supplied to District Health and Family Welfare Office, Chickamgagaluru. Ex.p.25 is the such copy of Letter dated:2.12.2015 of Dy.Director, Nutrition to the D.H.O., Chickamagaluru, according to which M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Tarapur, Thane District is the manufacturer and supplier of the drug in question to them and that they have supplied 21 boxes of drugs in question to D.H.O., Chickamagaluru. Ex.p.3 is the copy of consolidated Tax Invoice, according to which M/s.Circon Drugs & Pharmaceuticals Pvt., Ltd., have supplied drugs in question to the Directorate Office, Bangalore. Ex.p.19 is the Covering Letter issued by ADC, Chickamagaluru informing the General Manager M/s.Circon Drugs & Pharmaceuticals Pvt., Ltd., that the drug in question is not of standard quality, along with this letter copy of Form No.13 was also enclosed. Ex.p.20 is the Acknowledgement for having served the said letter to M/s.Circon Drugs & Pharmaceuticals Pvt., Ltd., Ex.p.21 is the O/c of Letter issued to D.H.O., along with one portion of sample and Form No.13 by ADC, Chickamagaluru. Ex.p.22 is the Acknowledgement for having served the said notice to the D.H.O., Ex.p.7 is the Report of Mr.B.K.Yadav, Quality Assurance Manager, M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane reporting that the Concentrated Vitamin-A Solution I.P., 100 ml., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 is manufactured by their 18 19 CC.No.100-2013 company, Sri.Bishwajit Poul was the Competent Technical Staff for Manufacturing, Manufacturing Chemist & Sri.Rajendra Naik was the Competent Technical Staff for Analysis and Approved Analytical Chemist during the year 2007-2008 as per licencese issued by the Licensing Authority. Ex.p.8 is the A/copy of Renewal Licence of M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane. Ex.p.9 is the A/copy of Product Permission Letter, Ex.p.10 is the A/copy of Articles of Association, Ex.p.11 is the A/c of Analytical Report, Ex.p.12 is the details of Name and Address of the Directors of M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane. Ex.p.4 is the Report by Asst. Drugs Controller Chickamagaluru Circle, Chickamagaluru to the Drugs Controller seeking sanction to prosecute the case against the accused. Ex.p.5 is the Sanction Order. Ex.p.6 is the Complaint.
48. I have perused the entire evidence, the learned counsel for accused argues that at the time of sample drawn no independent witnesses were present and panchanama is not drawn, hence, the accused are fit to be acquitted. In support of his argument, he has relied upon the case law reported in 2007 (2) EFR 109 (SC) in a case between State of Goa Vs. Tejpal P. Pandia Proprietor and another, which reads as follows:
"Drugs & Cosmetic Act, 1940, Section.27 - Criminal Procedure Code, 1973, Sections.94 & 104 - Drugs Inspector visited the premises of the accused u/s.21
- Took sample of Franycetine Skin Cream stocked in the premises- Drug were manufactured by respondents - Found to be not conforming to the 19 20 CC.No.100-2013 standards in terms of Sec.16(1)(a) read with Second Schedule - Complaint filed - Evidence clearly reveals that search was not in accordance with Section.94 Cr.P.C., - Panchanama was not drawn as per Sec.104 Cr.P.C., - Facts on record clearly justified the acquittal - Appeal dismissed. "
49. Here in this case, as per the evidence of P.w.3 that he has visited D.H.O., Chikkamagaluru and drawn the samples for Concentrated Vitamin-A Solution on 04.10.2008. But, during cross-examination, he has admitted that the sample was not drawn in presence of independent witnesses & Panchanama is also not drawn at the time of sample drawn. In the above referred case, the Judgement of the acquittal was justified under similar set of facts that Drugs Inspector visited the premises of the accused u/s.21 of the Act, took sample of Franycetine Skin Cream manufactured by respondents and found to be not conforming to the standards in terms of Sec.16(1)(a) read with Second Schedule stocked in the premises, Complaint was filed on the ground that the evidence reveals that search was not in accordance with Section.94 Cr.P.C. Panchanama was not drawn as per Sec.104 Cr.P.C. In this case also the sample is not drawn under mahazar in presence of two independent witnesses & hence, the accused are fit to be acquitted.
50. The learned counsel for the accused further argued that the copy of Form No.13, one portion of the drug sampled were not handed over to accused as required u/s.23(4) of the Act & hence, the accused has deprived his right of challenging the report. So, he is fit to be 20 21 CC.No.100-2013 acquitted. In support of his argument, he has relied upon the case law reported in 2000 Drugs Cases 190 in a case between Sri.Kamlesh Purkait & another Vs. Sri.Sambhunath Dey, Drugs Inspector & Another, wherein it is held as follows:
"Drugs & Cosmetics Act, 1940 - Sections.23, 27 and 28A - procedure - to be followed - Non-compliance of the procedure - sub-section (4) of Section.23 of the Drugs and Cosmetic Act, 1940 directs the Drug Inspector the manner in which he is to dispose of the portions of sample taken by him and clause (iii) of the sub-section (4) of section.23 of the Act in specific terms provides that the Drug Inspector is to send the third portion of the sample to the manufacturer. When the statute has directed that the portions of sample are to be disposed of in a particular way the Drugs Inspector has to follow the said directions and he cannot act in a different way. Therefore, the Drugs Inspector is not complying with the said procedure has clearly violated the mandatory provisions of law provided in Clause (iii) of sub-section(4) of section.23 of the Act, thereby causing serious prejudice to the accused and vitiating the entire proceeding - the instant proceeding should be quashed on this score alone."
51. The learned Sr.APP argues that according to the evidence of P.w.3, he sent third portion of sampled drugs along with Form No.13 to the Director of Health Service, Ananda Rao Circle, Bangalore through RPAD as required u/s.23 & 25 of the Drugs & Cosmetic Act as per the office copy of the letter Ex.p.21, the same was served, the said acknowledgement is at Ex.p.22 & argues that third portion of sample and copy of Form No.13 is served on the person from whom the drugs has been sampled and they have complied Sec.23(4) of the Drugs & 21 22 CC.No.100-2013 Cosmetic Act and has referred Sec.23(4)(iii) of the Act, Procedure of Inspectors reads as follows:
"S.23(4):The Inspector shall restore one portion of a sample to divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows:
i) One portion or container he shall forthwith send to the Government Analyst for test or analysis:
ii) The second he shall produce to the court before which proceedings, if any, are instituted in respect of the drug (or cosmetic): and
iii) The third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18-A."
52. I have perused Sec.23(4) of the Drugs & Cosmetic Act, according to this, third portion of the drugs sampled and Form No.13 should be served on the person if any, whose name, address and other particulars have been disclosed by the person from whom the sample is drawn under section 18-A. But as per P.w.3 himself, third portion of the sample and copy of Form No.13 has been served to D.H.O., Chikkamagaluru where they have sampled the subject drug. As same PW1 who continued investigation has stated that the District Health & Family Welfare Office, Chikkamagaluru had replied to the notice issued u/s.18A of the Act that the drugs in question is Concentrated Vitamin-A Solution I.P., labeled as B.No.006025, D/M:Jan/2008, D/E:Dec/2009 has been supplied by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., Thane, Maharashtra. According to Ex.P.18 22 23 CC.No.100-2013 the reply to the notice issued to District Health and Family Welfare Office, DHO has replied that the drugs have been supplied by M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., but according to Ex.p.21 the O/c of Letter issued by ADC, Chickamagaluru to D.H.O., one portion of sample and Form No.13 is served on District Health and Family Welfare Office. Here, actually the Investigation Officer had to serve Form No.13 & third portion of sample drawn to the M/s.Ciron Drugs & Pharmaceuticals Pvt., Ltd., whose name has been disclosed by D.H.O., Chikkamagaluru as from whom the drugs has been procured, but it has not been done so. From this it is clear that the prosecution has not complied Sec.23(4) of the Drugs & Cosmetic Act. For this reason applying the principle laid down by the Hon'ble High Court of Calcutta in the Judgement referred above & also the provisions u/s.23(4) of the Drugs & Cosmetic Act. 1940 the accused is fit to be acquitted.
53. The learned counsel for the accused further argues that the complaint is filed after shelf life of the drug, the accused lost opportunity to challenge the report. So, the accused is fit to be acquitted. In support of his argument, he has relied upon the case law reported in 2015(1) Drugs Cases (DC) 2, Andhra Pradesh High Court, in a case between M/s.Johnson & Johnson Ltd., & Others Vs. State of Andhra Pradesh & Another, wherein the Hon'ble High Court of Andhra Pradesh has held as follows:
23 24 CC.No.100-2013
"Drugs & Cosmetics Act, 1940 - Section.27(d) - Petition is filed to quash proceedings in CC.No.1085 of 2011 - the main points urged on behalf of petitioners are firstly, the prosecution is liable to be quashed for want of valid notification from the State Government as envisaged under the provisions of the Act. It is contended that P.Nagaraju has no jurisdiction over the place from where samples said to have been lifted and as per the provisions of the Act, there should be notification from the State Government, prescribing local limits of the area, for which, the Drugs Inspector is appointed - the Officer who lifted the sample has not followed the mandatory provisions of Section.25 of the Act - further contended that petitioners have lost the valuable right of sending second sample for analysis because the complaint is filed long after the expiry of the shelf life of the Drug - when right to analyze the second sample was lost due to inaction of the prosecuting agency, continuation of proceedings would amount to abuse of process of court.
Therefore, on a scrutiny of the material and on a consideration of facts and circumstances of the case, Court is of the view that continuing the prosecution against petitioners will be a futile exercise and would amount to abuse of process of court and that the powers under section.482 Cr.P.C., have to be exercised."
54. This Judgement is passed exercising power u/s.482 of Cr.P.C., by the Hon'ble Andhra Pradesh High Court. However, the ratio can be applied which is held that the complaint should be filed within the shelf life of the drug sampled is closed. Here in this case, the shelf life of the seized drugs is admittedly in the Year-2009. This case is filed in the Year-2013. This shows that the accused was not having opportunity to challenge the report after filing of the case. For this reasons also, I hold that the complaint is not maintainable.
55. The learned counsel for the accused further argues that the Gazette Notification of P.w.4-Smt.Pramila N.D., Scientific Officer is not 24 25 CC.No.100-2013 produced before the court & hence, the report of P.w.4 cannot be relied upon. In support of his argument, the learned counsel for the accused has relied upon the case law reported in 2007 Drugs Cases (DC) 3, in a case between M/s.Gaba Pharmaceuticals, Hyderabad and another Vs. State of A.P., wherein the Hon'ble Andhra Pradesh High Court has held as under:
"Drugs & Cosmetics Act, 1940 - Sections 20, 21 - non-compliance of - no Gazette Notification produced to show that the appointment of Public Analyst and Drugs Inspector - judgement set aside."
56. Here in this case, admittedly, P.w.4-Smt.Pramila N.D., who is examined as Scientific Officer has not produced the copy of Notification of her Appointment before the court. On the similar set of facts & circumstances, the Hon'ble Andhra Pradesh High Court has set aside the Judgement of conviction. So in this case, the report cannot be relied upon for the reason the gazette notification as to appointment of public analyst is not produced.
57. At the out set, in view of the sample is not drawn in presence of two independent witnesses under mahazar and in view of Gazette Notification of the officer who drawn mahazar & in view of report Form No.13 cannot be relied upon, the prosecution case appears doubtful. For the reasons said above, I hold that the prosecution has failed to prove beyond all reasonable doubts the allegations against A.1 & 2 & hence, I answer Point No.1 in negative.
25 26 CC.No.100-2013
58. Point No.2: In view of my findings on Point No.1, I proceed to pass the following order.
ORDER Acting u/s.255(1) of the Cr.P.C., the accused No.1 & 2 are acquitted for the offence u/s.18(a)(i) which is punishable U/s.27(d) of the Drugs & Cosmetics Act, 1940.
The bail bonds of accused No.1 & 2 stands cancelled. The samples of Mos.1 to 44 be released to the custody of complainant to dispose off the same in accordance with law. (Dictated to the Stenographer, directly on computer, typed by her, corrected and then th pronounced by me, in open court on this the 19 day of November 2016) PRESIDING OFFICER.
ANNEXURE:
ON BEHALF OF THE COMPLAINANT:
WITNESSES:
P.w.1 J.Bhaskaran, P.w.2 Basavaraj Asangi, P.w.3 A.P.Krishnamurthy, P.w.4 Smt.Pramila N.D., P.w.5 Dr.K.B.Eshwarappa, P.w.6 Brijesh Yadav P.w.7 Dr.B.R.Jagashetty.
DOCUMENTS:
Ex.p.1 Letter, Ex.p.2 Letter, Ex.p.2(a) Sig. of P.w.5, Ex.p.3 Copy of Invoice, Ex.p.4 O/c of Letter, Ex.p.4(a) Sig. of P.w.1, Ex.p.5 Sanction order, Ex.p.5(a) Sig. of P.w.7, Ex.p.6 Complaint, Ex.p.6(a) Sig. of P.w.1, Ex.p.7 Covering Letter dt:14.6.2011, 26 27 CC.No.100-2013 Ex.p.7(a) Sig. of P.w.6, Ex.p.8 A/copy of Renewal Licence, Ex.p.8(a) Sig. of P.w.6, Ex.p.9 A/copy of Product Permission Letter, Ex.p.9(a) Sig. of P.w.6, Ex.p.10 A/copy of Articles of Association, Ex.p.10(a) Sig. of P.w.6, Ex.p.11 A/c of Analytical Report, Ex.p.11(a) Sig. of P.w.6, Ex.p.12 Letter, Ex.p.12(a) Sig. of P.w.6, Ex.p.13 Form No.17, Ex.p.13(a) Sig. of P.w.3, Ex.p.14 Carbon copy of Form No.15, Ex.p.15 Copy of Form No.18, Ex.p.15(a) Sig. of P.w.3, Ex.p.16 Form No.13, Ex.p.16(a) Sig. of P.w.4, Ex.p.17 Notice, Ex.p.17(a) Sig. of P.w.3, Ex.p.18 Reply Letter, Ex.p.18(a) Sig. of P.w.3, Ex.p.18(b) Sig. of P.w.5, Ex.p.19 Covering Letter, Ex.p.20 Acknowledgement, Ex.p.21 O/c of Letter, Ex.p.21(a) Sig. of P.w.3, Ex.p.22 Acknowledgement, Ex.p.23 O/c of Letter, Ex.p.23(a) - Sig. of P.w.3, Ex.p.24 O/c of Letter, Ex.p.24(a) - Sig. of P.w.3, Ex.p.25 Letter from Dy.Director, Nutrition. Ex.p.25(a) Sig. of P.w.5.
MATERIAL OBJECTS:
Mo.1 - Sample Bottle of Concentrated Vitamin-A Solution I.P., Mo.2 - Sample Bottle of Concentrated Vitamin-A Solution I.P., Mo.3 to 44 - Sample Bottle of Concentrated Vitamin-A Solution I.P., ON BEHALF OF THE ACCUSED:
Witnesses & Documents: Nil.
(PUSHPAVATHI V.) PRESIDING OFFICER SPL.COURT FOR ECONOMIC OFFENCES, BANGALORE.27 28 CC.No.100-2013
A.1 is Co., rep. by A.2, A.2 absent, E.P allowed.
(Judgement pronounced in open court vide separate order) ORDER Acting u/s.255(1) of the Cr.P.C., the accused No.1 & 2 are acquitted for the offence u/s.18(a)(i) which is punishable U/s.27(d) of the Drugs & Cosmetics Act, 1940.
The bail bonds of accused No.1 & 2 stands cancelled.
The samples of Mos.1 to 44 be released to the custody of complainant to dispose off the same in accordance with law.
P.O., 28