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IN THE COURT OF PRL. JUNIOR CIVIL JUDGE - CUM - JUDICIAL
MAGISTRATE OF FIRST CLASS, KAMAREDDY.
PRESENT:- SRI VENKATESH DURVA, ADDL. JUNIOR CIVIL JUDGE – CUM -
SPL. JUDL. MAGISTRATE OF FIRST CLASS
(MOBILE), KAMAREDDY,
FAC PRL. JUNIOR CIVIL JUDGE - CUM -
JUDICIAL MAGISTRATE OF FIRST CLASS,
KAMAREDDY.
C.C. No. 658 of 2019
Tuesday this the 25 th day of April, 2023
Between:- The State of Telangana through Drugs Inspector, Kamareddy.
...Complainant
//And//
1.M/s. Aagya Biotech Private Limited, 1.5 Km, Manglour – Saharanpur Road, Manglour, Roorkee, Dist. Haridwar – 247656, Uttarakhan(India) Represented by A-2 & A-3.
2.Mr. Aditya Arora Director, office address: M/s. Aagya Biotech Private Limited 1.5. K.M, Maglour – Saharanpur Road, Manglour, Roorkee, Dist. Haridwar – 247656, Uttarakhand(India) R/o. H.No. 557, South Civil Lines, Muzaffarnagar – 251001, Uttar Pradesh.
3.Mr. Archit Arora Director, Office Address: M/s Aagya Boitech Private Limited, 1.5 Km, Manglour – Saharanpur Road, Manglour, Roorkee, Distt. Haridwar – 247656, Uttarakhand(India) R/o. H.No. 557, South Civil Lines, Muzaffarnagar – 251001, Uttar Pradesh. …Accused Nos 1 to 3
This case is coming before me on 24-04-2023 for final hearing and disposal in the presence of Learned Assistant Public Prosecutor for the State and M.A. Muqueem, Learned counsel for accused Nos 1 to 3. Having heard both sides and upon perusal of the material available on record this court has delivered the following:-
JUDGMENT
1.The Drug Inspector, Kamareddy, filed the complaint against the
A1 to A3 for the offences alleged U/s. 18(a)(i) r/w 16 of Drugs and
Cosmetics Act,1940 punishable U/s. 27 (d) of the Drugs and Cosmetics
Act, 1940 with a prayer to punish A1 to A3 for the above noted offences.
2. The brief facts of the case are that :
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PW1 is a Drugs Inspector, Kamareddy, is appointed under section 21 of Drugs and Cosmetics Act, 1940 vide G.O.Ms. No. 71,
Health, Medical & Family Welfare(L2) Department, Dated: 25-05-2013 published in the Andhra Pradesh Gazette with the jurisdiction over entire state of Andhra Pradesh and was posted as Drugs Inspector,
Kamareddy(Sales), Nizamabad District vide proceeding RC.No.
11493/E1/1977, Dated 09-04-2013 of the proceedings of the Director
General, Drugs and Copy Rights, Drugs control Administration,
Vengalraonagar, Hyderabad. Further, the PW-1 was ordered by the
Government to serve as Drugs Inspector, Kamareddy District on and from the 11th day of October, 2016 vide G.O. Rt. No. 747, Health, Medical & Family Welfare(B1) Department, Dated. 11-10-2016. The PW2 is also a
Drugs Inspector, Nizamabad (Urban), Drugs Control Administration,
Nizamabad, as per the orders issued vide Proceeding RC. No.
1063/E/TS/2018-2, Dated: 12-06-2018 of the Director, Drugs Control
Administration, Hyderabad, Telangana State and is also FAC of Drugs
Inspector, Kamareddy as per the proceedings RC. No. 6630/E1/2018,
Dated: 25-09-2018 of the proceedings of the Director, Department of
Drugs Control Administration, Hyderabad.
A-1 is the firm holding Drug licenses in Form 25(bearing No.
5/UA/2017) & Form 28(bearing No. 5/UA/SC/P-2017) to manufacture for sale of drugs with validity for a period from 10-01-2017 to 09-01-2022 issued by the Drug Controlling & Licensing Authority(Mfg), Garhwal
Mandal, Uttarakhand. A-2 person is the Director of A-1 firm and A-3 person is the Director of A-1 firm.
That on 13-10-2017, PW-1 inspected the premises of M/s.
Krishna Medical and General Stores, situated at D. No. 4-4/1,
Thimmanagar Road, Pitlam(V& M), Kamareddy District, in the presence
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of PW-3 and has picked up following quantities of two(02) different drug samples for the purpose of test or anlysis vide Form-17.
Quantity: 4 x 5 x 10 Tablets of “Nucet cold NF
Tablets(Paracetamol, Phenylephrine hydrochloride & Levocetirizine
Dihydrochlordie Tablets)” of Batch No. T-1704198, Mfg. Hydrochloride &
Levocetirizine Dihydrochloride Tablets)” of Batch No. T-1704198, Mfg.
Date: 04/2017, Exp. Date: 03/2019, Mfd by A1 firm.
Quantity: 4 x 5 x 10 Tablets of “ACENAC-MR ( Aceclofenac,
Paracetamol & Chlorzoxazone Tablets) “ B.No. AMR -1701, Mfd Date:
Apr. 2017, Exp Date: March, 2019, Mfd by: Concord Drugs Limited,
Khasra No. 165/3, Nalhera Anantpur, Paragana: Bhagawanpur, Tehsil
Roorkee, Distt. Haridwar, Uttarakhand(India).
As required U/s. 23(3) of the Act, PW-1 divided each of the above two(02) different drug samples into four(04) equal portions and sealed, after placing them in polythene covers, with sealing wax. PW-3 has signed on all the sealed portions of the sample and affixed his shop stamp on all the sealed portions of samples. PW-1 issued a copy of Form 17 & Form 17-A, and also a sealed sample portion from each of the said two(o2) drug samples, to PW3 under his acknowledgment.
On 18-10-2017, PW-1 forwarded one sealed portion from each of two(02) drug samples to the Government Analyst, Drugs Control
Laboratory, Hyderabad through registered post. Each sample portion is wrapped with Form 18 memorandum addressed to the Government
Analyst for analysis of the samples. Another set of Form 18 memorandum for the two(02) samples, containing the specific impression of seals used in sealing the sampled drugs, are put in a sealed cover and delivered to the Government Analyst by registered post.
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On 14-08-2018, PW-1 received certificate of test of analysis in
Form 13 vide Report No. 297/NRS/DCL/2018, Dated: 30-07-2018 in tripilicate along with a covering letter for the sample of Nucet cold NF
Tablets”(Paracetamol, Phenylephrine hydrocholordie & Levocetirizine
Dihydrochloride Tablets)” of Batch No. T – 1704198 by registered post.
The Government Analyst declared that sample of “Nucet cold NF
Tablets( Paracetamol, Phenylephrine hydrochloride & Levocetirizen
Dihydrocholoride Tablets)” of Batch No. T -1704198, Mfg. Date 04/2017,
Exp. Date: 03/2019, Mfd by: M/s. Aagya Biotech Private Limited, 1.5 km,
Manglour – Saharanpur Road, Manglour, Roorkee, Distt. Haridwar – 247656, Uttarakhan(India)” as NOT OF STANDARD QUALITY(NSQ) for the reason that sample does not comply with respect to Assay Content of
Paracetamol(i.e., 236 mg) as it is not within the limits(i.e., 292.5 mg – 357.5 mg) of the label claim(i.e., 325 mg).
On 16-08-2018, as required under the provisions of Section 23(4)(ii) of said Act, PW-1 deposited a sealed sample portion of the above said NSQ drug in this Hon’ble Court of Judicial First Class
Magistrate, Kamareddy, along with Form-13 report bearing No.
297/NRS/DCL/2018, Dated: 30-07-2018(in Original) before which proceedings are instituted in respect of drug. Correspondingly, this
Hon’ble Court has allotted CPR No. 365/2018, Dated 15-09-2018 for the
said NSQ drug sample.
On 18-08-2018 as required U/s 25(2) of said Act, PW-1 forwarded the said report of Form 13( in original) to M/s. Krishna Medical and General Stores, Thimmanagar Road, Pitlam(V & M), Kamareddy Dist.
and also issued a notice vide Rc. No. 318/NSQ/D1/KMR/2018, dated: 18- 08-2018 to reveal the source of supply of the said batch of NSQ drug, under acknowledgement from PW-3.
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On the same day, PW-1 received a reply from PW-3 by revealing that his firm, namely “M/s. Krishna Medical and General Stores, Pitlam(V & M), Kamareddy dist. “ has purchased the said batch of drug”Nucet cold NF Tablets(Paracetamol, Phenylephrine hydrocholoride &
Levocetirizine Dihydrocholride Tablets)” of Batch No. T-1704198, Mfg.
Date: 04/2017 Exp. Date: 03/2019, Mfd by: M/s. Aagya Boitech Priavate
Limited, 1.5 km, Manglour – Saharanpur Road, Manglour, Roorkee, Dist.
Haridwar – 247656, Uttarakhan(India)” from M/s. Sree Adithyaram
Medical Agencies, D. No. 5-5-49, Vivekanananda colony, Kamareddy,
Kamareddy District vide Invoice No. D 0000004385, dated: 03-10- 2017(Qty: 60 x10 Tablets) & No. D 005290, dated 11-11-2017(Qty: 60 x 10 Tablets).
On 29-08-2018, PW-1 has also sent a copy of notice vide Rc. No.
318/NSQ/DI/KMR/2018, dated: 18-08-2018(which is addressed to M/s.
Krishna Medical and General Stores, situated at D. No. 4-4/1,
Thimmanagar Road, Pitlam(V & M), Kamareddy Dist.) to A-1 firm with an instruction to recall the subject batch of drug from the market, whomever it was supplied, along with copy of report of Form 13, dated:
30-07-2018 by registered post.
On 28-08-2018, as required U/s 25(2) & 23(4)(iii) of the Act, PW- 1 forwarded the said Report of Form 13 bearing No. 297/NRS/DCL/2018,
Dated: 30-07-2018(in original) issued by Government Analyst along with
a sealed sample portion of subject batch of drug besides with a request letter vide Rc.No. 318/NSQ/DI/KMR/2018, date: 28-08-2018 addressed to
M/s. Sreee Adithyaram Medical Agencies, D. No. 5-5-49, Vivekananda colony, Kamareddy, Kamareddy District to furnish certain information(like source of supply of subject drug, copy of purchase invoice, sales details, etc), U/sec. 18-A, & 22-(1)(cca) of the Act by registered post.
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On the same day, PW-1 received a reply letter signed date: 28- 08-2018 from M/s. Sree Adithyaram Medical Agencies, D. No. 5-5-49,
Vivekananda colony, Kamareddy, Kamareddy, District by submitting that the subject batch of drug was purchased from M/s. Vignesh Enterprises,
D. No. 3-5-1097/A, 1st Floor, Opp. Lane to Blood Bank, Narayanguda,
Hyderabad -29 vide Invoice No. RGST – 00903, dated: 20-09-2017(Qty:
100 x 10 Tablets), RGST-01055, dated: 06-10-2017(Qty 200 x 10
Tablets) & RGST-01179, dated 23-10-2017 (Qty: 200 x 10 Tablets) and also its sale details of the same to different parties(including M/s.
Krishna Medical and General Stores, situated at D. No. 4-4/1,
Thimmanagar Road, Pitlam(V& M), Kamareddy District. Vide two invoices.
On 29-08-2018, PW-1 addressed a letter vide Rc. No.
318/NSQ/DI/KMR/2018, dated: 29-08-2018 to M/s. Vignesh Enterprises,
D. No. 3-5-1097/A, 1st Floor, Opp. Lane to Blood Bank, Narayanguda,
Hyderabad -29 with a request to furnish certain information(like source of supply of subject drug, copy of purchase invoice, sales details, etc)
U/s. 18-A & 22(1)(cca) of the Act by enclosing the attested copy of
Analytical report of Form 13, Dated: 30-07-2018 by registered post.
On 10-09-2018, PW-1 received a reply letter, dated: 06-09-2018 from M/s. Vignesh Enterprises, D. No. 3-5-1097/A, Opp. Lane to Blood
Bank, Narayanguda, Hyderabad – 29 by submitting that the subject batch of drug was purchased from M/s. Intas Pharmceuticals Ltd, Sy. No.
622/A/4, First Floor, Devarayamzal (V), Near Kompally, Shamirpet(M),
R.R. District vide Invoice No. 0716177540, dated: 30-05-2017(Qty:
17020 x 10 Tablets) 7 TS117502418, dated 29-07-2017(Qty: 13730 x 10
Tablets) and also its sale details of the same to different parties(including M/s. Sree Adithyaram Medical Agencies, Kamareddy, vide three invoices).
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On 25-09-2018, PW-1 addressed a letter vide Rc. No.
318/NSQ/DI/KMR/2018, dated: 22-09-2018 to M/s. Intas Pharmaceuticals
Ltd, Sy. No. 633/A/4, First Floor, Devarayamzal(V), Near Kompally,
Shamirpet(M), R.R. District, with a request to furnish certain information(like source of supply of subject drug, copy of purchase invoice, sales details, etc) U/s. 18-A & 22(1)(cca) of the Act by enclosing the attested copy of Analytical report of Form 13, Dated 30-07-2018 by registered post.
On 28-09-2018, PW-1 received a reply letter vide Ref. No.
RN/09/01/2018/INTAS, dated: 10-09-2018 from A-1 firm addressed to
M/s. Intas Pharmaceuticals Ltd by submitting that the subject batch of drug is being recalled/withdrawn from the market due to technical reasons and it was requested to collect all the unused stock distributed to different outlets. On 29-09-2018, PW-1 received a reply letter vide
Ref.No. AB/18/09/01, dated: 11-09-2018 from A-1 firm by submitting that it has issued a recall letter for the subject batch of drug vide Ref. No.
RN/09/01/2018/INTAS, dated: 10-09-2018 to M/s. Intas Pharmaceuticals
Ltd.
On 09-02-2019, PW-2 received through the DCA Office, nizamabad about the instructions of the Director, Drugs Control
Administration, Hyderabad, vide Memo Rc.No. 1495/Admn-STC/2018,
dated 04-09-2018 to complete the investigation and submit detailed
compliance report.
On 13-02-2019, PW-2 received a reply letter vide Ref. No.
INT/DI/19/01, dated: 12-02-2019 from M/s. Intas Pharmaceuticals Ltd, Sy.
No. 633/A/4, First Floor, Devarayamzal(V), Near Kompally, Shamirpet(M),
R.R. Dist. by submitting that the subject batch of drug was transferred from M/s. Intas Pharmaceuticals Ltd, Delhi – Meerut Road, Murad Nagar,
Gaziabad, vide Transfer challan No. 1002844919, dated: 25-05-
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2017(Qty: 17020 x 10 Tablets) & 1002853891, dated: 26-06-2017(Qty:
13730 x 10 Tablets) and also its sale details of the same to M/s. Vignesh
Enterprises, Hyderabad vide two invoices.
On 23-02-2019, PW-2 addressed a letter vide Rc. No.
318/NSQ/DI/KMR/2018, dated: 21-02-2019 to M/s. Intas Pharmaceuticals
Ltd., Delhi – Meerut Road, Murad Nagar, Gaziabad with a request to furnish certain information(like source of supply of subject drug, copy of purchase invoice, transfer details, etc) U/s. 18-B & 22(1)(cca) of the Act by enlosing the copy of reply letter, Dtd. 12-02-2019 of M/s. Intas
Pharmaceuticlas Ltd. Sy. No. 633/A/4, First Floor, Devarayamzal(V), Near
Kompally, Shamirpet(M), R.R. District by registered post.
On 23-02-2019, PW-2 addressed a letter vide Rc. No.
318/NSQ/DI/KMR, dated: 22-02-2019 by registered post to A-1 firm, by enclosing the copy of analytical report of Form 13, dated 30-07-2018, with a request to furnish certain information(like Manufacturing record &
Quality Control record of subject batch of drug, copy of manufacturing licenses & approval of subject drug, Constitution particulars of the firm and other particulars of Managing Director/Directors of the firm for day to day activities at the time of manufacture of the subject drug, copies of sales particulars of subject batch of drug and also sale invoice issued to
M/s. Intas Pharmaceuticals Ltd. Delhi – Meerut Road, Murad Nagar,
Ghaziabad) U/s. 18B and 22(1)(cca) of the Act. Further, A1 firm was instructed to recall the unsold stock of subject batch of drug, if available, from its supplier(s) (who supply their drug from A-1).
On 16-03-2019, PW-2 received a reply letter vide Ref. No.
B/19/03/01, dated: 05-03-2019 from A-1 firm by submitting that there is no unsold tock of subject batch of drug with its stocklist(i.e., M/s. Intas
Pharmaceuticals Limited) as well as in its finished goods store besides enclosing its certificate of analysis of subject batch of drug sample.
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On 20-03-2019, PW-2 received a reply letter, dated: 14-03-2019 from the Corporate House of M/s. Intas Pharmaceuticals Ltd., Gujarat by submitting that the subject batch of drug was purchased from A1 firm vide Invoice No. 000121, dated 07-05-2017(Qty: 42760 x 10 Tablets) &
No. 000202, dated: 28-05-2017(Qty: 6000x10 Tablets) and also its transfer details of the same from M/s. Intas Pharmaceuticals Ltd., Delhi –
Meerut Road, Murad Nagar, Ghaziabad(including to M/s. Intas
Pharmaceuticals Ltd., Sy. No. 633/A/4, First Floor, Deverayamzal(V),
Near Kompally, Shamirpet(M), R. R. Dist. vide Transfer challan No.
1002844949, dated: 25-05-2017(Qty: 17020 x 10 Tablets) & 1002853891, Dated: 26-06-2017(Qty: 13730 x 10 Tablets).
On 20-03-2019, PW-2 addressed a letter vide Rc No.
318/NSQ/DI/KMR/2018, dated: 19-03-2019 through registered post to A-1 firm, by enclosing the copy of list of Directors of A-1 firm downloaded from MCA website with a request again to furnish the same information sought in the earlier issued notice, dated 22-02-2019 and also to confirm the person(s) responsible for day to day activities of A1 firm.
On 28-03-2019, PW-2 received a reply letter vide Ref. No.
AB/19/03/02, dated: 25-03-2019 from its Authorized Signatory of A-1 firm by submitting that there is no unsold stock of subject batch of drug with its stockist(i.e. M/s. Intas Pharmaceuticals Limited) as well as in its finished goods store besides enclosing the following attested documents(i.e., Copy of Drug Manufacturing License in Form-25 & Form- 28 along with the list of additional products including the subject drug, “Paracetamol,Phenylephrinehydrochloride&Levocetirizine
Dihydrochloride Tablets”; Batch Manufacturing Record(BMR) and Batch
Packing Record(BPR) of subject batch of product: Sale Invoices vide No.
000121, dated: 07-05-2017(Qty: 42760x 10 Tablets) & No. 000202,
dated: 28-05-2017(Qty: 6000 x 10 Tablets) to M/s. Intas Pharmaceuticals
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Ltd., Delhi – Meerut Road, Murad Nagar, Ghaziabad and its payment details from M/s. Intas Pharmaceuticals Limited.
But the A-1 firm could not furnish the Constitution particulars of it along with the details of list of Directors/Managing Director responsible under the said Act for the day to day affairs of the company and conduct of business of the firm as on the date of manufacture of said batch of drug.
So, as per the available information on A-1 firm, A-2 and A-3 are found to be the Directors in it and shall be deemed to be guilty for the contravention of provisions of Act.
As per the section 18(a)(i) of the Act, no person shall himself or by any other person on his behalf manufacture for sale( or for distribution), or sell or stock or exhibit(or offer) for sale, or distribute any drug which is not of a standard quality(NSQ).
The said sampled drug i.e.,” Paracetamol, Phenylephrine hydrochloride & Levocetirizine Dihydrocholoride Tablets” is the drug within the meaning of section 3(b)(i) of the said Act. The subject batch of said drug was anlyzed by the Government Analyst, Drugs Control
Laboratory, Hyderabad and opined in the above mentioned report as that it is of NOT OF STANDARD QUALITY for the reason that sample does not comply with respect to Assay Content of Paracetamol(i.e., 236 mg) as it is not within the limits(i.e., 292.5 mg – 357.5 mg) of the label claim(i.e., 325 mg).
Thus, the total investigation reveals that A-1(represented by A2 & A3) is found with Manufacture, sale of subject batch of its drug(i.e., “Nucel cold NF Tablets(Paracetamol, Phenylephrine hydrochloride &
Levocetirizine Dihydrochloride Tablets)” of Batch No. T -1704198, Mfg.
Date: 04/2017, Exp. Date: 03/2019, whose sample was declared as NOT
OF STANDARD QUALITY w.r.t Assay Content of Paracetamol. Thereby
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violated section 18(a)(i) r/w section 16 of the said Act and punishable
U/s. 27(d) of the Act.
3.After filing the charge sheet, this Court has taken cognizance for the offences u/sec. 18(a)(i) r/w 16 punishable u/sec. 27(d) of Drugs and Cosmetics Act, 1940, against A-1 to A-3.
4.On appearance, copies of case documents were furnished upon
A1 to A-3 provided U/s. 207 Cr.P.C and A2 and A3 are examined U/sec.
251 of Cr.P.C and the substance of the accusation read over and explained to A1 to A3 on that they denied the same and claimed to be tried. Hence matter was posted for the trial.
5. In order to prove the case the prosecution got examined PW1 to PW3 and got marked Exs.P-1 to P-29 and also material object i.e.,
MO.1.
6.After completion of prosecution side evidence, the accused
Nos.1 to 3 were examined under section 313 of Cr.P.C by explaining the available incriminating material against them, for which the accused persons denied the same and reported evidence on their behalf. On behalf of the defence, DW1 was examined and exhibits Ex.D1 to D3 are marked.
7.The learned APPO and the learned counsel for the Accused
Nos.1 to 3 filed the written arguments. Heard arguments of both sides at length.
8. Now, the point that arises for determination is:- a. Whether PW-1/The Drug Inspector, Kamareddy/R. Srilatha who allegedly lifted the sample and sent the same for analysis to the
Government analyst and carried out investigation and Whether
PW2 the complainant /The Drug Inspector/Sri B. Praveen who allegedly carried out further investigation and filed the complaint, were validly appointed Drug Inspector as contemplated u/sec. 21(a) Drugs and Cosmetics Act?
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b. Whether Government analyst who analyzed the sample of the subject drug and issued form No. 13 i.e., Ex.P-6 analytical report was validly appointed Government analyst in pursuance of the provisions of section 20 of the Drugs and Cosmetics Act, 1940?
c. Whether report of Government analyst Ex.P-6 has been proved legally and whether Ex.P-6 has legal sanctity and same can be acted upon and can be read in evidence especially when the author of Ex.P-6 i.e., Government analyst is not examined at the trial?
d. Whether there is breach of mandatory rule 45 of the Drugs and
Cosmetics Rules, 1940?
e. Whether PW-1/Drug Inspector, who lifted the sample and investigated the case has complied with the mandatory provisions of section 25(2) of the Drugs and Cosmetics Act, by not delivered the signed copy of analytical report/Ex.P-6 to the accused No.1/Manufacture?
f.Whether the complaint has filed belatedly after life time/self-life of the drug expired will leads to the serious prejudice to the accused or not?
g. Whether the prosecution established that the accused No.2 and 3 were incharge of and responsible for the day to day business affairs of the accused No.1 firm as on the date of commission of alleged offence?
h. Whether the sample drug was stored within permissible temperature i.e., as per direction of the manufacturer as mentioned on the label of the drug and whether there is any violation of mandatory provisions of Rule 65 (17) of Drugs and Cosmetic Rules ?
i.Whether there is any violation of valuable statutory right of the accused given U/s. 25 (3) of the Drugs and Cosmetic Act?
j.Whether the evidence available on record is sufficient to record conviction for the offences punishable U/s. 27 (d) of Drugs and
Cosmetics Act, 1940 against A1 to A3 beyond all reasonable doubt?”
9. Point No. 1: Whether PW-1/The Drug Inspector,
Kamareddy/R. Srilatha who allegedly lifted the sample and sent
the same for analysis to the Government analyst and carried out
investigation and Whether PW2 the complainant /The Drug
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Inspector/Sri B. Praveen who allegedly carried out further
investigation and filed the complaint, were validly appointed
Drug Inspector as contemplated u/sec. 21(a) Drugs and
Cosmetics Act?
The learned APPO submitted in his written argument in this regard that the PW-1 is a notified Drug Inspector for the entire state and re notification every time they are transferred is not mandatory as they are posted only within the State jurisdiction, subsequent to the original appointment. There was no practice of notifying each and every transfer order of the Drug inspector, in the Gazette as on date. In support of prosecution contentions they relied upon Judgment of Hon’ble Bombay High
Court in State of Maharashtra V/s. Ghan Shyam K. Zaveri and another and also Hon’ble Supreme Court judgment in State of Andhra Pradesh V/s
Bharath Damodar Kale and another. Further, during the course of arguments the learned APPO vehemently argued that if the Drug Inspector are not validly appointed then their higher authorities or any other person will register the FIR against them. Since they are validly appointed by the
Govt., as such they empowered to do any inspection in their posting areas.
The learned defence counsel submitted that the PW-1/R.
Srilatha/Drug Inspector, who allegedly lifted the sample and sent for the analysis to Government analyst who allegedly investigate present case and
Sri B. Praveen/PW-2 who allegedly carried out further investigation and filed the complaint before this Court claimed that they were the Drug Inspectors,
Kamareddy Local area but to substantiate their claim they did not file any document to show that they were the Drug Inspector of Kamareddy, local area as they claimed. They also failed to produce any Gazette notification containing their appointment of Drug Inspector of the local area of
Kamareddy. The sample lifted of the local area of Kamareddy, but PW-1 did not produce any Gazettee notification suggesting that she was authorised to operate as Drug Inspector, as the local area of Kamareddy. Therefore, she was incompetent to lift the sample from Kamareddy local area and to investigate the case. Similarly, Pw-2 who allegedly carried out further investigation and filed the complaint before this Hon’ble Court claiming that he is Drug Inspector of Kamareddy but to substantiate to claim he did not file any document to show that he was Drug Inspector of Local area of
Kamareddy, therefore, he was not validly appointed Drugs Inspector of local area of Kamareddy in view of the settled law. Further, Pw-1 has filed gazette notification of her initial appointment as the drug inspector which is
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marked as Ex.P-2 but Ex.P-2 nowhere indicates duties and powers of Drug
Inspector tobe performed in the local area of Kamareddy. In support of his contentions the learned defence counsels relied upon following citations:
a. Hon’ble High Court A.P. Judgment in M/s. Gaba Pharmaceuticals,
Hyderabad, V/s State of Andhra Pradesh, 2007(2) Crimes 358 A.P.
High Court.
b. Hon’ble High Court of A.P Judgment in Johnson and Johnson limited,
H.P and another v/s State of Andhra Pradesh, 2015(2)(ALD) (CRL) 457
T.S & A.P. High Court.
c. Hon’ble High Court of State of Maharastra Judgment in State of
Maharastra V/s Chanda warkar and others.
d. Hon’ble High court of State of Andhra Pradesh in M/s. Chenna
Keshava Bandage and others V/s State of Andhra Pradesh, 2010(1)
ALT(CRL) 219 A.P. High Court.
Perused Ex.P-1 to P-3 and also Ex.P-18 to P-21. The Ex.P-2 and
Ex.P-18 are Gazette notifications showing PW-1 and 2 appointed as Drug
Inspectors for the entire State of Andhra Pradesh but these Gazette notifications does not show that Pws 1 and 2 authorised to act as Drug
Inspector for kamareddy local area.
On perusal of Ex.P-1, Ex.P-3, Ex.P-19 and Ex.P-20 and Ex.P-21 it clinchingly shows that PW-1 and 2 authorised to act as Drug Inspector,
Kamareddy. However, Ex.P-1, P-3, P-19, Ex.P-20 and Ex.P-21 are not official
Gazette notifications and they are G.Os and proceedings of the Director
General of Drugs control.
Pws 1 and 2 are filed Initial appointment of Gazette notification for the entire State of Andhra Pradesh and they have filed subsequent postings as Kamareddy Drugs Inspector by way of G.Os and proceedings of the
Director General of Drugs Control.
Relying upon the decision rendered by Hon’ble Apex Court in
Bharat Damodhar Kale and another V/s. State of Andhra Pradesh a narrow interruption cannot be taken so as to comply the requirement of the
Central Act, 1954, this Court finds that in larger interest, the notification issued by the government is applicable to the entire State and Ex.P-1, Ex.P- 3, Ex.P-19 and Ex.P-20 and Ex.P-21 shows that PW-1 and PW-2 authorised to act as Kamareddy area Drug Inspector. Therefore, this point is answered in favour of the prosecution against the accused persons.
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10. Point No. 2: Whether Government analyst (who
analyzed the sample of the subject drugs)” and issued form No.
13 i.e., Ex.P-6 analytical report are validly appointed
Government analyst in pursuance of the provisions of section 20
of the Drugs and Cosmetics Act, 1940?
It is submitted by the prosecution that Gazette notification of
Government analyst is a Public document and defence counsel can obtain the same from the Government by various means. The prosecution has enclosed attested copy of the Gazette notification of the Government analyst.
It was submitted by learned defence counsel that as per provisions of the section 20 of the Drugs and Cosmetics act, it is mandatory that the state Government must publish in official Gazette the appointment of Government analyst specifying therein the products with which the
Government analyst can analyse and the same notification should also specifying the area in which the said analyst is required to excise his power and also specify the drug or classes of the drug in respect of which the said analyst is entitle to test or analyze.
In support of the contention the learned counsel relied upon M/s
Gaba Pharmaceuticals, Hyderabad, V/s. State of Andhra Pradesh 2007(2)
Crimes 358 A.P. High Court, State of Maharastra V/S R. A Chandrawarkar and others 1999 Crl. Law Journal 4449. And Sri K. Rama Rao V/s. State of
Andhra Pradesh Criminal Appeal No. 285 of 2010 A.P. High Court.
On perusal of the entire record the prosecution has filed xerox copies of G.O. of appointment of Government Drug Analyst Smt. N. R.
Sangeetha which was attested by PW-1 it shows that G.O. Rt No. 001, Dtd.
25-06-2012 and on keen observation it also shows that Smt. N. R.
Sangeetha Senior Scientific officer appointed as Government Analyst for the entire State of Andhra Pradesh and authorized to issue reports for the samples of all the categories of the drugs and cosmetics lifted under the provisions of the act.
As rightly pointed out by the learned counsel for the defense that the prosecution has failed to file any Gazette notification for the appointment of Government analyst Smt. N. R. Sangeetha. It is to be noted that G.O is different from the Official Gazette notification. As per the section 20 of the act the appointment of Government analyst is must be by way of official Gazette notification. Mere filing G.O copies of Government
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analyst would not sufficient to prove that the Government analyst validity appointed as contemplated u/sec. 20 of the Drugs and Cosmetics Act.
Therefore, this Court is of the opinion that the prosecution has filed to prove the appointment of Government analyst thereby the prosecution violated section 20 of the Drugs and cosmetics Act.
11. Point No. 3: Whether report of Government analyst
Ex.P-6 has been proved legally and whether Ex.P-6 has legal
sanctity and same can be acted upon and can be read in
evidence especially when the author of Ex.P-6 i.e., Government
analyst is not examined at the trial?
Since the prosecution failed to meet the mandatory requirements of the said ingredients of section 20 of the Drugs and
Cosmetics Act in such situation it cannot be said that Ex.P-6 is issued by a validly appointed Gazetted notified authorized analyst.
Further, a care perusal of Ex.P-6/Form No. 13 it discloses that date of issuing of analytical report is mentioned as 30-07-2018.
Whereas in the column No. 4 of the Ex.P-6 it is mentioned that date of receipt is 20-10-2017. The prosecution failed to explain the reasons for the delay of 280 days for analysing the sample. The prosecution has not tender the public analyst to cross examine at the trial to elicit about the said delay(9 months 10 days = 280 days) and under what storage condition the said drug stored for about 9 months 10 days = 280 days.
Hence, a serious prejudice caused to be accused as they lost their valuable time to cross examine the analyst to elicit the above said facts from the analyst. Therefore, Ex.P-6 cannot be taken into consideration and cannot be relied upon.
Further, as per the Rule 46 of Drugs and Cosmetics Rules
Government analyst who analyzed the sample is bound to submit the protocols of the tests analyzed the sample seperately and monographs of the test, in support of the contention the learned counsel for accused relied upon following citations:
a. K.T. Rakotwala V/s. The State of Maharashtra, 1976
U.C.R(Bombay) 474 the Judgment of division bench of Bombay
High Court in Criminal Appeals No. 1008 to 1011 of 1967 decided on 25th April, 2969, b. State of Maharashtra V/s. J.S. Ujawane “(a) Drugs and
Cosmetics Act(23 of 1940). Ss. 12 and 18(a)(i)- Drugs and
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Cosmetics Rules(1945), Rs. 57(1) and 46 – Report of the
Analyst - Furnishing ‘protocols of test applied’ mandatory”, c. Rajkishan V/s. State (AIR 1960) Alhabad 460
In the instant case on hand the appointment of Government analyst is not proved and the Government analyst failed to furnish protocols of the test seperately and moreover non examination of
Government analyst will leads to serious prejudice to the accused.
It was submitted by learned defence counsel that PW-1 has not send the form No. 18 with a memorandum of specimen impression of seal used to seal the pocket to the Government analyst seperately then in such a case how the Government analysis compare the seals on the pocket received by him with another form No. 18 specimen impression of seal. It was admitted by PW-1 that she has not filed any acknowledgment or receipt to show that she has sent above send form
No. 18 to Government analyst seperately in support of the contention the learned defence counsel relied upon the following citations.
The State of Delhi V/s. Hukam Chand in 2008 Crl. Law
Journal(NOC) 503, The State of Madras High Court V/s. M/s. Scotch
Pharmaceutical works Madras in 1986 Drugs cases 150, The State of
Maharashtra V/s. J.S. Ujawane 1979 CRI.L.J. 530 Bombay High Court
On the other hand the prosecution submitted that they have submitted form No. 18 with specimen impression seperately and in support of their contention they have marked Ex.P-5/(two pages out of which one is postal receipt bearing No. CA 616 667 504 IN, Dtd. 18-10- 2017 and another one is form No. 18). But on perusal of postal receipt it shows that it was addressed to Drug Central Office, Drug Controlling authority, Hyderbad, but not Drug Controlling Laboratory, Hyderabad.
Further date of issuing form No. 18 is 13-10-2017 whereas postal receipt date shows it was sent on 18-10-2017.
The prosecution not clearly established that on what date they have sent form No. 18 along with specimen seperately to Government
Analyst. Further, date of issuing form No. 18 is 13-10-2017 whereas date of sending is 18-10-2017 i.e., 6 days delay in sending the form No.
18 is not explained by the prosecution. Furthermore, in Ex.P-6/form No.
13 it is simply mentioned that selas intact and identical with specimen seal but it was not mentioned that whether form No. 18 along with specimen seal received sepearately or not. Whether if received what is the postal consignment number is not clearly mentioned in form No. 13.
Therefore, it is doubtful whether form No. 18 sent by PW-1 or not.
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8. Point No. 4 : Whether there is breach of mandatory rule 45 of the Drugs and Cosmetics Rules, 1940?
As per rule 45 of the Drugs and Cosmetics Rules the
Government Analyses shall furnish report within 60 days from the date of the receipt of the sample. Further, if it is not possible Government
Analyst shall seek extension of the time from the Government giving specific reasons for delay for analysis.
On perusal of Ex.P-6/Form No. 13 it shows that date of inspection is 30-10-2017 and whereas date of issuing form No. 13 is 30- 07-2018. There is 9 months 10 days delay in issuing form No.
13/analytical report. Further, it is doubtful that whether the Government analyst obtained permission from the Government to analyse the sample after expiry of 60 days or not.
It is submitted by the prosecution that the sample is analysed well before the date of of Expiry of the sample drug and delay is because of the work load. In other words the samples will be analysed on a first come first serve basis according to the serial of recipt of the sample.
However, it is remained unanswered that on what storage condition the sample subject drug was stored during this 9 months 10 days period, how much samples used for analysis and what is the method which was followed by the analyst, period of analysis and date of analysis. To sum up the prosecution utterly failed to prove that the
Government analyst validly appointed u/sec. 20 of the Act, non- examination of Governmenat analyst, non-furnishing of the protocols of the tests and methods followed for the test, period of test, how much sample used for test will leads to doubt over prosecution case. It is to be noted that when the appointment of Government analyst is itself not proved, hence, in these circumstances it can be held that form No.
13/Ex.P-6 is of no legal sanctity and cannot be relied upon. Accordingly, this point is answered in favour of the defence counsel and against the prosecution.
9. Point No. 5: Whether PW-1/Drug Inspector, who lifted
the sample and investigated the case has complied with the
mandatory provisions of section 25(2) of the Drugs and
Cosmetics Act, by delivered the signed copy of analytical
report/Ex.P-6 to the accused No.1/Manufacture?
It is submitted by the prosecution that, the Drugs Inspector/Pw- 1 has followed the procedure laid down 25(2) of the Drugs and
Cosmetics Act, 1940, and the Inspector on receipt thereof, shall deliver
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one copy of the report to the person whom the sample was taken and another copy to the person if any whose name, address and other particulars of they have been disclosed u/sec. 18(a) of the Drugs and
Cosmetics Act, 1940 and shall retain the 3rd copy of their use in any prosecution in respect of sample. The PW-1 had delivered one copy to
PW-3, another copy to M/s. Aditya Ram Medical Agencies, Kamareddy.
The accused has not lost statutory right u/sec. 25(3) of the Act. In support of the prosecution contentions relied upon Ameri
Pharmaceuticals and another V/s. State of Rajasthan.
Whereas the learned counsel for the accused relied upon V.
Venkata Raju V/s. State of Andhra Pradesh, 1993(1) Crimes 739, Ms Vivid
Laboratories V/s Stated of Rajasthan 2015(2) Drugs cases(DC) 98 , Dr.
Kewal Krishnan V/s. State of H.P 2018(1) DRUGS CASES(DC) 367.
As seen from the record A-1 is the company, A-2 and A-3 are the representatives of the company have been charged by the prosecution for manufacturing of drug. The A-1 being a manufacture of the drug it was incumbent duty of PW-1 to serve copy of analytical report to the accused No.1. Relying upon Hon’ble High Court of
Telangana Judgment in The Drug Inspector represented by Public
Prosecutor, High Court for the State of Telangana V/s. S. Nagireddy
and M/S Cortex Laboratories Pvt Limited in Crl Appeal No. 94 of
2020. This Court is of the view that since the manufacture only charged by the prosecution as such, non-serving copy of analytical report will cause a serious prejudice to the accused. Hence, the prosecution failed to establish that they have complied Rule 25(2) of the Drugs and
Cosmetics Act, 1940.
10. Point No. 6: Whether the complaint has filed belatedly after
life time/self-life of the drug expired will leads to the serious
prejudice to the accused or not?
As seen from the record the manufacturing date of sample drug is 04/2017 expiry date of sample 03/2019, complaint filed on 30- 03-2019 i.e., one day prior to the expiry date of subject drug. A careful perusal of various letters addressed by PW-1/Drug Inspector to different persons connected with the present case shows that Drug Inspectors wasted their time for making correspondence. Though the Pw-1 as per her admission she has knowledge of Aagya Biotechs/A-1 company at the time of the lifting the sample I.e,. firsthand information about the manufacturing details of the subject drug and shell life of the subject
CC. No. 658/2019 Page 20 of 34 Dtd. 25-04-2023
drug is going to be expired very soon it is the minimum duty of the Drug
Inspectors to skip up making correspondence with the medical shop owner and medical distributors etc and straight away soon after receipt of Ex.P-6/Analyst report she shall issue a letter to A-1 company with a request to furnish the details as required under the Act but admittedly
PW-2 has filed present complaint before this Court one day prior to the expiry of the subject drug. And there is no dispute in this regard from the prosecution thereby A-1 to A-3 has lost their valuable right to apt for reanalysis of the subject drug by Central Drugs Laboratory with a sample produced before the Court. The learned counsel for the accused cited several citation as in this aspect i.e.,
1) The Parenteral Drugs (India) Ltd., Indore and Others V/s.
State of A.P, 2020(1) ALD(Crl.) 475,
2) Vijaya Lakshmi Jhawar V/s. State of Telangana 2018(2)
Drugs cases(DC) 2929,
3) Seelam Koti Reddy V/s. State of A.P/and another 2013 ALD (Crl.) 105,
4) Laborate Pharmaceuticals India Ltd., & others V/s. State of
Tamil Nadu, AIR 2017 the Hon’ble Supreme Court 2423,
5) M/s. Medicamen Biotech Ltd., & Another V/s. Rubina Bose,
Drugs Inspector 2008 Drugs cases 163,
6) M/s. Embiotech Laboratories(P) Ltd., and another V/s. The
State of Tamil Nadu 2016(1) Drugs cases (DC) 499,
7) Northern Minerals Ltd., V/s. Union of India and another 2010(2) ALD (Crl.) 944 SC)
The accused has made his appearance for the first time and receiving summons of the court is on 15-03-2021.
There is no contrary view of the views expressed by Hon’ble
Court in the aforesaid decisions that It is indefeasible right of the accused party to exercise his right to prefer for reanalysis of the subject drug by forwarding the sample drug produced before the court to
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Central Laboratory but due to belated filing of complaint they have lost such valuable right which ultimately would shake the validity of prosecution’s case launched against them. Therefore, this point is answered in favour of the defence and against the prosecution.
11. Point No. 7:Whether the prosecution established that the
accused No.2 and 3 were incharge of and responsible for the day
to day business affairs of the accused No.1 firm as on the date
of commission of alleged offence?
As per the prosecution on 20-03-2019 PW2 addressed a letter dated 19-03-2022 to the accused No.1 firm by enclosing copy of list of directors of accused No.1 which was downloaded from website with a request to confirm the persons for day to day activities of the accused No.1 firm. As the accused
No.1 firm could not furnish constitutional particulars of it, so as per available information of accused No.1 firm, accused No.2 and 3 found to be directors of the above said firm and are deemed to be guilty for the contravention of the provisions of the Act. Accused No.1 firm represented by A2 and A3, is found with manufucture, sale of nucet cold NF Tablets B.No.T-1704198 Mfg. Date 04- 2017 expiry dt. 03-2019 whose sample was declared as not of standard quality with respect to Assay Content of Paracetamol thereby A1 to A3 violated section 18 (a)(i) r/w Sec.16 of Drugs and Cosmetics Act punishable under section 27 (d) of the Act. In support of the prosecution contentions the learned APPO relied upon Hon’ble Madras High Court in Judgment in Vikas Rambal and 3 others Vs.
The state represented by Drug Inspector in Crl.O.P.No.11184/2019 &
Crl.M.P.No.5726/2019 the relevant paras of the above said judgment are
reproduced hereunder :
“ 23.In the said context, section 34 of the Act to be read
and understood. Section 34 reads as below :-
34. Offences by companies :- (1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company shall be
CC. No. 658/2019 Page 22 of 34 Dtd. 25-04-2023
deemed to be guilty of the offence and shall be liable to be
proceeded against and punished accordingly ;
Provided that nothing contained in this Sub-section shall render any such person liable to any punishment providec in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or it attributable to any neglect on the part of any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punishable accordingly.
Explanation : For the purposes of this section -
(a) “Company’ means a body corporate, and includes a firm or other association of individuals; and
(b) “ director’ in relation to a firm means a partner in the firm.”
24. The offences and the offenders in the case of this nature is manufacturing and distribution of sub-standard drugs by a company which is managed by its Board of Directors. The decision to manufacture the drugs is the collective decision of the Board of Directors. Therefore, the Directors cannot claim that they are not directly involved in the product of the drugs, when the decision to produce the drugs itself is the outcome of their decision. Therefore, the case of Directors signing the cheque on behalf the company and the case of Directors participating in the decision to produce sub-standard drugs are not one and the same to hold that these petitioners are
not involved in day to day affairs of the company.
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It is submitted by learned defence counsel that the PW1 has filed the complaint against A1 to A3 attributing the offence against them. In the compliant he did not made and plead manner of connection of offence with A1.
A1 firm is the company incorporated under companies Act, Vicarious liabililty of a person for being prosecuted for offence committed by company arises if at material time he was incharge of and was also responsible to company for conduct of its day to day business affairs. Because a person is managing director of a company it does not merely mean that he fulfills both above requirements so as to make in liable. In the present case complainant did not make an averment in the complaint not he deposed in his evidence before this
Hon’ble Court that A2 and A3 were at the material time were incharge of and
was also responsible to the company for the conduct of its day to day business affairs except a bare statement that A2 and A3 were the Directors of the manufacturer there is no other allegation to indicate even prime-facie that they were incharge of company and responsible for day to day affairs. The PW2 who is the complaint during the course of cross examination admitted that as the
A1 firm could not furnish constitutional particulars of it along with details of
Directors or Managing Directors responsible under this Act for the day to day affairs of the company and as per available information on A1 firm A2 and A3 are found to be Directors in this firm and are deemed to be guilty for the contravention of the provision of the Act. Further it was elicited that he have not stated in the complaint that A2 and A3 are the persons responsible for day to day activities of the firm. Learned defence counsel relied upon on following citations :
a) Hon’ble High Court of the Telangana Judgment in Akums Drugs and Pharmaceuticals Ltd and others Vs. State of Andhra Pradesh and another 2022 (2) ALD (crl) 621 (TS).
b) Hon’ble High Court of the Telangana Judgment in P.Vaikuntam
Vs. State of Telangana 2018 (2) Drugs cases (DC) 310 (TS).
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c) Hon’ble High Court of the Andhra Pradesh Judgment in N.
Dandapani & Another Vs. State of Andhra Pradesh 2005 (1) ALD (crl) 956 (AP).
d) Hon’ble High Court of the Andhra Pradesh Judgment in Tumu
Venkateshwarad Reddy & others Vs. State of Andhra Pradesh 2010 (1) ALD (Crl) 195 (AP).
e) Hon’ble Supreme Court of India judgment in the State of
Haryana Vs. Brij Lal Mittal and others 1998 (2) ALT (Crl) 92.
f) Hon’ble High Court of the Andhra Pradesh Judgment in M/s.
Hippo Labs Pvt. Ltd. Sec’bad and others Vs. State of Andhra
Pradesh 2005 (2) ALT (Crl) 13.
g) Hon’ble Bombay High Court judgment in State of Maharashtra
Vs. Chandawarkar and others 1999 Crl. L.J. 4449.
i) Hon’ble High Court of the Andhra Pradesh Judgment in M/s.
Biddle Sawyer Ltd. Mumbai and others Vs. State of Andhra Pradesh 2000 (2) ALD (Crl) 522.
J) Hon’ble Bombay High Court Judgment in State of Goa Vs. M/s.
Caryl Pharma & others Crl. Appl.No.14 of 2014.
The above citations of the Hon’ble Courts clearly shows that there shall be allegations on the complaint or shall be any material on record to show that the A2 and A3 are incharge of A1 firm and were responsible for conducting business on firm, such specific overtact is necessary to fasten the criminal liability. In the case the complainant not made any averment in the complaint not he deposed in his evidence that A2 and A3 in the material time were in charge of and responsible for day to day business affairs. Since there is no allegation in the complaint and there is no material on record to show that A-2 and A-3 are in charge of A-1 firm as such, with due respect I am of the view that the citation relied by the prosecution is not applicable to the case on hand.
This point is answered in favour of the accused and against the prosecution.
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12. Point No. 8: Whether the sample drug was stored within
permissible temperature i.e., as per direction of the manufacturer as
mentioned on the label of the drug and whether there is any violation
of mandatory provisions of Rule 65 (17) of Drugs and Cosmetic Rules?
During the course of cross examination of the PW1 has admitted that the label of the Drug containing direction that store in cool, dry and dark place.
There is no evidence on record suggesting that either PW1, PW2 or PW3 maintained at the label direction of the store. The PW1 has admitted that if the drug are not stored or maintained in proper condition the quality of the drug deteriorated and the same will be reflected in the analysis report. There is no record anywhere that subjected drug was stored in cool and proper storage condition in the shop of PW3 or at the shop Aditya Ram Medical
Agencies or at Vignesh Enterprises or Intas Pharmaceuticals Ltd., when the subject drug was in possession and control. Further it was elicited that Aditya
Ram Medical Agencies or Vigneshwara Enterprises or Intas Pharmaceuticals have not mentioned in their replies that they have stored the subject drug in the said storage conditions. PW1 did not made any observation at the time of lifting sample from PW3 that the shop of PW3 i.e., Krishna Medical and General
Store has practicing good storage practicing or at the shop of Aditya Ram
Medical Agencies or Vignesh Enterprises or Intas Pharmaceuticals Ltd., have stored good storage particles. Further PW1 and PW2 failed to investigate to prove that at what stage the drug was deteriorated. There is no positive evidence adduced by the prosecution that the drug was in deteriorated condition at the time of its supply. Since the storage conditions are not maintained by PW3 and Aditya Ram Medical Agencies, Vignesh Enterprises,
Intas Pharmaceuticals Ltd., there is strong belief that the drug might have been deteriorated due to improper storage condition and benefit of doubt be given to the accused.
Further it was specifically contended that the subject drug was stored On what storage condition the sample subject drug was stored during this 9 months 10 days period by the analyst in laboratory. The Government
Analyst failed to mention in Ex.P-6/Form No. 13 that on what storage condition
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the sample subject drug was stored during this 9 months 10 days period and date of analysis.
In support of his contention the learned counsel for the accused relied upon the following citations :
a) Hon’ble Bombay High Court judgment in State of Goa Vs. M/s.
Caryl Pharma and others Crl.Appl. No.14 of 2014.
b) Hon’ble High Court of Andhra Pradesh Judgment in K. Rama Rao & others Vs. State of A.P. Criminal Appeal No.285 of 2010.
c) Hon’ble Bombay High Court judgment in State of Maharastra Vs.
R.A. Chandrawarkar & others 1999 Crl. Law Journal 4449.
As rightly pointed out by the learned counsel for the defence, the prosecution did not filed any positive evidence that the subjected drug was stored as per label direction in the shop of PW3 or other connected distributors/agencies or in Government laboratory (during 9 months 10 days) as mentioned above. This leads to a doubt that the subject drug was stored as per label direction or not. If the subject drug was not stored as per label direction in such circumstances accused cannot be held responsible for such deterioration and accused entitled for benefit of doubt as per above Hon’ble
Courts rulings. Therefore this point is answered in favour of accused and against the prosecution.
13. Point No. 9: Whether there is any violation of valuable
statutory right of the accused given U/s. 25 (3) of the Drugs and
Cosmetic Act?
It is submitted by the learned defence counsel that PW-1 has intimated the accused about the result of the analysis through her letter/Ex.P- 8, Dtd. 18-08-2018. Though the said letter was originally addressed to PW-3 but the copy of the said letter was marked to the accused. On 10-09-2018 the accused firm received the said letter and inturn the A-1 firm have intimated the PW-1 through letter/Ex.P-16, Dtd. 11-09-2018. They were not in receipt of report of Government analyst. So they were unable to know facts stated in the said report.
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Further, on 25-09-2018 A-1 firm again sent another reply letter through Ex.D-1, Dtd. 25-09-2018 in continuation of their previous reply i.e.,
Ex.P-16 stating and intimating to PW-1 that they did not agree with the analytical report of the government analyst and they intending to adduce the evidence in contravention to the findings of the Government analyst. The said intimation letter /Ex.D-1 was sent to PW-1 through registered post vide consignment No. RV 720 500 469 IN, Dtd. 25-09-2018 and the said letter was received by PW-1 on 29-09-2018.
It was vehemently submitted that, though the PW-1 denied about receiving of the said letter/Ex.D-1 by her but the records of the case shows that the PW-1 received the said letter Ex.D-1, Dtd. 25–09-2018. Since the PW- 3 who have filed complaint before this Court has filed a postal cover along with material paper annexed with the complaint and the said cover has been marked as Ex.P-17. A bare perusal of Ex.P-17 postal cover shows that the said postal cover contains postal consignment No. RB 720 500 469 IN which is same with the postal receipt Ex.D-2 and it was send by the Accused/A-1 firm and it was addressed to PW-1. The PW-1 cannot say that she did not receive letter/Ex.D-1 since the postal cover Ex.P-17 and postal receipts Ex.D-2 contains the same consignment No. RB 720 500 469 IN, therefore, is served on PW-1 on 29-09-2018. Evenafter receiving the reply letter adduced by the accused
Ex.D-1, the PW-1 did not take any steps to send the samples of subject drug to
CDL for re analysis. Hence, the accused suffered serious prejudice.
The learned APPO submitted in his written arguments that the PW-1 only received Ex.P-16 on 29-09-2018 vide reference No. AB/18/09/01, Dtd. 11- 09-2018 which contain the postal receipt number RV 720 500 469 IN, Dtd. 25- 09-2018 in that A-1 firm not mentioned that not satisfied with the analysis of the Government analyst and A-1 firm intending to challenge the said report.
The firm was not submitted a letter vide reference number AB/18/09/02, Dtd.
25-09-2018. And it is a fabricated document.
On careful scrutiny of the record, it shows that the Ex.D-2 consignment number i.e., RV 720 500 469 IN is matched with the postal cover
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of Ex.P-17. Further on perusal of the Exhibits it clearly shows PW-1 has received three letters from Aagya Biotechs Limited vide consignment numbers
EV 782 973 353 IN, EV 752 459 198 IN, RV 720 500 469 IN and the three postal covers filed before this Court by the prosecution. However, the prosecution failed to show the particulars letters received from the above postal consignment i.e., which letter received from each postal consignment number and also not filed inward register copies of their office.
Relying upon section 114(f) of Indian Evidence Act this Court presumes that a letter from Aagya Boitechs was received by PW-1 but question
before this Court which letter was received. Since the prosecution failed to
establish which letter was received from which consignment number this court is of the view that the prosecution might have received the letter of Ex.D-1.
Hence, the point is answered in favour of the defence and against the prosecution. Therefore, analytical report of the government analyst lost its conclusive character.
14. Point No. 10: Whether the evidence available on record is
sufficient to record conviction for the offences punishable U/s.
27 (d) of Drugs and Cosmetics Act, 1940 against A1 to A3
beyond all reasonable doubt?
It is the bounden duty of the prosecution to prove the guilt of the accused beyond all reasonable doubt. It is a cardinal rule of criminal law jurisprudence is that penal statutes should be construed strictly. If any reasonable doubt arises then benefit shall be given to the accused.
In the instance case on hand the prosecution fails on following aspects
a)The prosecution failed to establish that the Government
Analyst validly appointed as contemplated u/sec. 20 of the act.
And there was 9 months 10 days delay in analyzing the sample, further on what storage conditions subject drug was kept by the Government analyst during this 9 months 10 days are not established, non furnishing the protocals of the test,
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method of test, monographs of test, period of test, how much samples used for test, more particularly none examination of
Government analyst shaken the entire case of the prosecution.
The entire story of the prosecution is on basis of report of
Government analyst/Ex.P-6/Form No. 13 in the given case on hand the appointment of Government analyst itself is not proved there are several reasonable doubts arising that out of
Ex.P-6/Form No. 13. Prosecution failed to examine the
Government analyst to strengthen their case. It is to be noted that a sole report of Government Analyst cannot be leads to conviction unless the author of the report is examined before this Court.
b)Furthermore, the prosecution failed on following aspects that the PW-1 failed to furnish copy of analytical report/Form
No. 13/Ex.P-6 to A-1.
c)The complaint was filed belatedly i.e., a day before expiry of subject drug as such, accused lost his valuable right to prefer for reanalysis of the subject drug by forwarding a subject drug produced before this Court to central laboratory.
d)The prosecution failed to adduce positive evidence that the subject drug stored as per label direction in the shop of PW- 2 or other connected distributors/Agencies or in Government laboratory during (9 months 10 days). This leads to a doubt that whether subject drug was stored as per label direction or not if the subject drug is not stored as per label direction due to moisture or changes in temperature which leads to change of analytical report.
The prosecution has filed three covering letters of Aagya
Biotechs which were received by Drug Inspectors and their
CC. No. 658/2019 Page 30 of 34 Dtd. 25-04-2023
consignment numbers as follows: EB 782 973 353 IN, 2) EB 752 459 198 IN 3) RV 720 500 469 IN
The Ex.D-2 consignment No. i.e., RV 720 500 469 IN is tallied with the postal cover Ex.P-17. Since the prosecution failed to established that which letter received from which consignment and nonfiling of inward register copy, this Court holds that D.I might have received the letter of Ex.D-1. When the Ex.D-1 is matched with the Ex.P-17 then burden lies on the prosecution to show that they have not received Ex.D-1. In the instant case on hand prosecution failed to show the same.
e)The prosecution failed to establish that A-2 and A-3 are the incharge and responsible for A-1 firm as on date of commission of alleged offence.
f)The prosecution failed to prove the guilt of the accused beyond all reasonable doubt, hence, the accused Nos 1 to 3 are entitled for acquittal.
15. IN THE RESULT , the accused Nos 1 to 3 are found not guilty for the offences U/s. 18(a)(i) r/w 16 of Drugs and Cosmetics Act, 1940 punishable U/s. 27 (d) of the Drugs and Cosmetics Act, 1940.
Accordingly, the accused is acquitted under section 255(1) of Cr.P.C. The
Bail bonds of accused if any shall stand canceled after the expiry of appeal time. MO-1 shall be destroyed after expiry of appeal time.
(Typed to my dictation corrected and pronounced by me in the open court on this 24th day of April, 2023.)
FAC Prl. Junior Civil Judge cum Judl. Magistrate of First Class, Kamareddy
CC. No. 658/2019 Page 31 of 34 Dtd. 25-04-2023
APPENDIX OF EVIDENCE
WITNESS EXAMINED
Witness examined for Prosecution :
Pw-1:- Smt R. Srilatha
Pw-2:- Sri B. Praveen
Pw-3:- Sri Krishna
Witness examined for accused :
Dw-1:- Archit Arora/Director of A-1 firm.
EXHIBITS MARKED
Exhibits marked for Prosecution :
Ex.P-1:-Attested copy of the official Gazette notification vide GORT
No. 747( Health Medical & Family Welfare) Dtd. 11-10-2016.
Ex.P-2:-Attested copy of the Gazette notification, Dtd. 30-05-2013.
Ex.P-3:-Attested copy of the appointment proceedings, Dtd. 09-04- 2013.
Ex.P-4:-Inspection report, Dtd. 13-10-2017 at Krishna Medical and
General Store, Pitlam, along with enclosures of form 17 and form 17 A.
Ex.P-5:-Memorandum to Govt. Analyst vide from No. 18 vide No.
72/Oct/sample/D.I/KMR/2017, Dt. 13-10-2017 along with postal receipt, Dtd. 18-10-2017.
Ex.P-6:-Form 13 report No. 297/NRS/DCL/2018, Dt. 30-07-2018 along with a covering letter vide laboratory No. 172703/Oct/Act.,
Dt. 30-07-2018 along with envelope of registered post.
Ex.P-7:-Deposition of the property along with form No. 13 vide CPR
No. 365/2018.
Ex.P-8:-Letter vide RC No. 318/NSQ/DI/KMR/2018, Dt. 18-08-2018, addressed to Krishna Medical and General stores.
Ex.P-9:-Reply letter Dtd. 18-08-2017, received from Krishna medical and General Stores along with self attested documents.
Ex.P-10:-Letter vide RC No. 318/NSQ/DI/KMR, 2018, Dtd. 28-08-2018, addressed to Aditya Ram Medical Agencies along with form 13.
Ex.P-11:-Reply letter Dtd. 28-08-2017, received from Aditya Ram
Medical Agencies along with self attested documents.
Ex.P-12:-Letter vide RC. No. 318/NSQ/DI/KMR/2018, Dtd. 29-08-2018, addressed to Vigneshwara Enterprises, Narayanguda,
Hyderabad along with postal receipt and attested coy of form
CC. No. 658/2019 Page 32 of 34 Dtd. 25-04-2023
13.
Ex.P-13:-Letter vide RC No. 318/NSQ/DI/KMR/2018, Dt. 18-08-2018, addressed to A-1 firm, along with postal receipt and form 13.
Ex.P-14:-Reply letter Dt. 06-09-2018, received from Vigneshwara
Enterprises, Narayanguda, Hyderabad, along with postal receipt along with self attested documents and envelope.
Ex.P-15:-Letter vide RC No. 318/NSQ/DI/KMR/2018, Dtd. 22-09-2018, addressed to Intas Pharmaceuticals, Shameerpet, along with postal envelope and form 13.
Ex.P-16:-Reply letter Dtd. 11-09-2018, received from A-1 firm along with corresponding enclosures and envelope.
Ex.P-17:-Reply letter Dtd. 10-09-2018, received from A-1 addressed to
Intas Pharmaceuticals Ltd., along with postal envelope.
Ex.P-18:-Attested copy of the official Gazette notification vide GOMS
No. 335( Health Medical & Family Welfare) L-2 Dept., Dtd. 24- 11-2011.
Ex.P-19:-Attested copy of the official Gazette notification vide GOMS
No. 23(Health Medical & Family welfare) C-2 Dept., Dt: 29-04- 2016.
Ex.P-20:-Attested copy of the proceedings vide R.C. No.
1063/E/TS/2018-s, Dtd. 12-06-2018 of Director, DCA,
Hyderabad.
Ex.P-21:-Attested copy of the proceedings vide R.C. No. 6630/E1/2018,
Dtd. 25-09-2018 of Director, DCA, Hyderabad.
Ex.P-22:- Original Instructions of Director DCA, Hyderabad, vide Memo
No. 1495/Admn-STC/2018, Dtd. 09-04-2018.
Ex.P-23:-Original reply letter, Dtd. 12-02-2019 received from Intas
Pharmaceuticals Ltd., Shameerpet, Rangareddy addressed to
PW-1 along with self attested documents as enclosures(10 pages).
Ex.P-24:-Original letter Vide RC. No. 318/NSQ/DI/KMR/2018, Dt. 21-02- 2018, addressed to Intas Pharmaceuticals, Ghziabad,(3 pages) along with a copy of reply of M/s. Intas
Pharmaceuticals Limited, Ranga Reddy District.
Ex.P-25:-Original letter vide RC. No. 318/NSQ/DI/KMR/2018, Dtd. 22- 02-2019, addressed to A-1 firm(3 pages) along with a copy of firm No. 13.
Ex.P-26:-Original reply letter Dtd. 05-03-2019 of A-1 firm(2 pages) along with correspondeing documents as enclosures(6
CC. No. 658/2019 Page 33 of 34 Dtd. 25-04-2023
pages).
Ex.P-27:-Original reply letter, Dtd. 14-03-2019 of M/s. Intas
Pharmaceuticals Ltd., along with self attested documents as enclosures(6 pages).
Ex.P-28:-Original letter vide RC No. 318/NSQ/DI/KMR/2018, Dt. 19-03- 2019, addressed to A-1 firm, (2 pages) along with attested copy of list of directors of A-1 firm downloaded from MCA website(1 page).
Ex.P-29:-Original reply letter, Dtd. 25-03-2019 of A-1 firm(1 page) along with corresponding self attested documents as enclosures(62 pages).
Exhibits marked for Defence :
Ex.D-1:Reply letter issued by A-1 company to PW-1, Dtd. 25-09- 2018.
Ex.D-2: Postal receipt, Dtd. 25-09-2018.
Ex.D-3: Track consignment letter.
::Material objects marked for prosecution::
MO.1: One sealed cover of 5 strips of medicine.
FAC Prl. Junior Civil Judge cum Judl. Magistrate of First Class, Kamareddy
CC. No. 658/2019 Page 34 of 34 Dtd. 25-04-2023
C A L E N D E R
IN THE COURT OF THE PRL. JUNIOR CIVIL JUDGE CUM
JUDL. MAGISTRATE OF FIRST CLASS,
AT KAMAREDDY
CC. No. 658 of 2019
Between:- The State of Telangana through Drugs Inspector, Kamareddy.
...Complainant
//And//
1.M/s. Aagya Biotech Private Limited, 1.5 Km, Manglour – Saharanpur Road, Manglour, Roorkee, Dist. Haridwar – 247656, Uttarakhan(India) Represented by A-2 & A-3.
2.Mr. Aditya Arora Director, office address: M/s. Aagya Biotech Private Limited 1.5. K.M, Maglour – Saharanpur Road, Manglour, Roorkee, Dist. Haridwar – 247656, Uttarakhand(India) R/o. H.No. 557, South Civil Lines, Muzaffarnagar – 251001, Uttar Pradesh.
3.Mr. Archit Arora Director, Office Address: M/s Aagya Boitech Private Limited, 1.5 Km, Manglour – Saharanpur Road, Manglour, Roorkee, Distt. Haridwar – 247656, Uttarakhand(India) R/o. H.No. 557, South Civil Lines, Muzaffarnagar – 251001, Uttar Pradesh. …Accused Nos 1 to 3 1Date of offence/Occurrence13-10-2017 2Date of report/complainant30-03-2019 3Name of complainantThe State of Telangana through Drugs Inspector, Kamareddy.
4Name and description of the accused:
1.M/s. Aagya Biotech Private Limited, 1.5 Km, Manglour – Saharanpur Road, Manglour, Roorkee, Dist. Haridwar – 247656, Uttarakhan(India) Represented by A-2 & A-3.
2.Mr. Aditya Arora Director, office address: M/s. Aagya Biotech Private Limited 1.5. K.M, Maglour – Saharanpur Road, Manglour, Roorkee, Dist. Haridwar – 247656, Uttarakhand(India) R/o. H.No. 557, South Civil Lines, Muzaffarnagar – 251001, Uttar Pradesh.
3.Mr. Archit Arora Director, Office Address: M/s Aagya Boitech Private Limited, 1.5 Km, Manglour – Saharanpur Road, Manglour, Roorkee, Distt. Haridwar – 247656, Uttarakhand(India) R/o. H.No. 557, South Civil Lines, Muzaffarnagar – 251001, Uttar Pradesh.
5Date of apprehension– /surrendered/summons 6Date of release-- 7Offences for the offences U/s. 18(a)(i) r/w 16 of Drugs and Cosmetics Act, 1940 punishable U/s. 27 (d) of the Drugs and Cosmetics Act, 1940 8Date of commencement of trial30-09-2021 9Date of closure of trial29-08-2022 10Finding of the Judge Not guilty 11Sentence or Order25-04-2023, Acquitted 12Explanation for delay---
FAC Prl. Junior Civil Judge - cum- Judl. Magistrate of First Class,
Kamareddy
To: the Hon’ble I Addl. District & Sessions Judge, Kamareddy