Maneesh Pharmaceuticals Ltd vs The State Of Telangana
2025 Latest Caselaw 4284 Tel

Telangana High Court

Maneesh Pharmaceuticals Ltd vs The State Of Telangana on 26 June, 2025

     THE HONOURABLE SRI JUSTICE E.V.VENUGOPAL
         CRIMINAL PETITION No.5126 of 2025


ORDER:

The present criminal petition is filed under Section 528 of

BNSS, seeking to quash the proceedings in C.C.No.4 of 2023 on

the file of the learned I Additional District and Sessions Judge at

Khammam (for short, 'the trial Court').

2. The petitioners herein are the accused Nos.1 and 3 and the

respondent herein is the complainant before the trial Court. For

the sake of convenience hereinafter parties are referred to as

accused Nos.1 and 3 and the complainant.

3. The brief facts of the case are that on 25.09.2013, LW.1

visited the shop of LW.2 by name M/s. Sharada Medicals, upon

verification LW.1 identified Doxyla-B6 tablets, B.No.DBM-1206

manufactured by M/s. Maneesh Healthcare, are not of standard

quality, hence, LW.1 picked up said batch tablets for the purpose

of analysis. On the same day, he sent it to the Government

Analyst, Drugs Control Laboratory, Vengalrao Nagar, Hyderabad

along with Memorandum in Form-18, as per the provision and

procedure laid under Drugs and Cosmetics Act, 1940. On

11.10.2013, LW.1 received the report. The Government Analyst

declared Doxyla-B6 tablets B.No.DBM-1206 are of not standard

quality. Immediately, LW.1 served copy of the report to M/s.

Sharada Medicals, with instruction to disclose the source of

supply and produce the registers and records of said drug. M/s.

Sharada Medicals replied to the report stating that they have

pruchased the said drug from M/s. Lakshmi Sai Balaji Medicals,

Vijayawada LW.1 served notice to M/s. Lakshmi Sai Balaji

Medicals. M/s. Lakshmi Sai Balaji Medicals replied that they

have purchased the said drug from M/s. Mamatha Medicalas

Agencies, Vijayawada. LW.1 served notice to M/s. Mamatha

Medicals to disclose the supply of the said drug. On 18.10.2013

LW.1 received reply from M/s. Mamatha Medical stating that the

said drug was purchased from M/s. Vasu Pharma Distributors,

Gandhi Nagar, Hyderabad. LW.1 issued notice to M/s. Vasu

Pharma Distributors to disclose the source of supply of the said

drug and further instructed not to sell the said drug since it is

declared as "Not of Standard Quality". M/s. Vasu Pharma

Distributors sent a reply to LW.1 stating that the said drug was

purchased from M/s. Maneesh Pharmaceuticals, Mumbai. LW.1

sent notice to M/s. Maneesh Pharmaceuticals to disclose the

source of supply of the said drug. M/s. Maneesh Pharmaceuticals

replied to the notice sent by LW.1 stating that the said drug was

manufactured by their plant at Himachal Pradesh. LW.1 served

notice to M/s. Maneesh Pharmaceuticals, Himachal Pradesh with

an instruction to confirm the manufacture of the said drug and

produce information regarding the manufacturing records and

distribution particulars, and also instructed to produce the

attested copies of Drug Licenses, name and address of the

responsible person of the firm. But no reply has been received.

Thereafter, LW.1 addressed a letter to the Public Information

Officer-cum-State Drugs Controller, Baddi-173205, Solan District,

Himachal Pradesh with additional required fee through IPO and

requested to provide information. On 02.04.2014, LW.1 received

reply from Public Information Officer-cum-State Drugs Controller

provided attested copies of Drugs manufacturing licenses of M/s.

Maneesh Pharmaceuticals and memorandum and articles of

association. M/s. Maneesh Pharmaceuticals are manufactuing

drugs of not standard quality and also not replied to the notice

issued to it. Hence the complaint.

4. Basing on the above contents, case has been registered

against the M/s. Maneesh Pharmaceuticals/accused No.1 and its

directors, under Sections 18(a)(i), r/w Section 16 and 18-B,

22(1)(cca) Drugs and Cosmetics Act, 1940 punishable under

Section 27(d), 28(a) and 22(3) of Drugs and Cosmetics Act, 1940.

5. Heard learned counsel appearing for the

petitioners/accused Nos.1 and 3 and learned Assistant Public

Prosecutor appearing for the respondent-State. Perused the

record.

6. Learned counsel appearing for the petitioners would submit

that the drug - Doxyla B6 tablet is popular drug and of a standard

quality, the respondent collected the drug; and before sending it

for test, decided that it is not of standard quality. G.O.Ms.No.98,

dated 06.09.2011 is for constitution of Special Court for trial of

offences related to adulterated drugs or spurious drugs. The said

drug is not an adulterated drug or spurious drug, and is not liable

for the punishment under the Act. He further submitted that the

testing lab issued a vague test report without proper reason as to

why the drug is not of standard quality as the Drugs and

Cosmetics Act, 1940 without any mention of the standard

parameter.

7. Learned counsel further submitted that accused No.2 who

is the father of petitioner No.2 herein was managing the affairs of

the company, during the pendency of the case, accused No.2 died,

and the same was informed to the trial Court, and the case

against him was abated.

8. To support his case, learned counsel relied upon the

judgment of High Court of Maharasthra, in the case of State of

Maharashtra vs. Jawaharlal Shamlal Ujawane 1. The relevant

portion of the judgment reads as under:

"5. Rule 46 provides, in so far as is material for this judgment, that on receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall forthwith supply to the Inspector a report of the result of the test or analysis, together with full protocols of the tests or analysis applied. It was the grievance of Mr. Manohar that the provisions of Rules 57 and 46 have been breached in this case, with the result that the order of conviction and sentence passed by the learned Magistrate should be set aside and the respondent should be acquitted.

7. Coming to the requirements of Rule 46, on 26th May 1971, the Government Analyst gave his certificate, stating that the sample was not of standard quality as defined in the Act, that the sample was not "Santonine", and that the sample gave I.P. Qualitative tests for the presence of magnesium and sulphate. The report of the Government Analyst reads as under:-

"Details of the results of Test or Analysis with Protocols of Tests applied.

                     Proper Name                          Santonine

                Observation of labelling                       -



    (1970) Mh.L.J





           Outer label              Santonine India (Hand written)

         container label                    Santonine, India

           Description                 White Crystalline powder

          Identification             The sample does not comply
                                    with I.P. identificational tests for
                                                Santonine.

The sample gives qualitative tests for Magnesium and Sulphate.

"Now, it is not in dispute that it is not known what the "protocols of tests applied" were. The report is silent on this point, and so is the record. In view of the provisions of rule 46 which are mandatory, the Government Analyst was bound to furnish to the Inspector the full protocols of the tests applied. Admittedly, this has not been done. This lacuna, in our opinion was a fatal hurdle in the path of the prosecution.

8. The Analyst has not given evidence, nor is there anything on record to indicate what test was applied to reveal the alleged presence of Magnesium and Sulphate. If the prosecution had led the evidence of the Analyst, he could have been cross-examined and the prosecution case could have been tested on this point also. This was a lacuna which must militate against the prosecution.

9. Rules 57(1) and (2) and 46, with which we are concerned, are mandatory. It is, therefore, imperative that they must be strictly observed. It must also be manifest from the record that they have been so observed to the letter and not only in substance or spirit. These rules are framed as a measure of security and safeguard not only to an accused but also to the officers of the department. Their observance must not, in the interest of justice, be left to conjecture or inference. A strict observance of these rules can also enable the prosecution to prove its case, which in this case, on the aspect of the drug not being of standard quality, it has failed to do beyond reasonable doubt, the benefit whereof must go to the respondent.

10. In the result, we uphold Mr. Manohar's first contention and held that the conviction of the respondent-accused under section 18 (a) (i), namely stocking of a drug which is not of standard quality, cannot be sustained.

9. High Court of Andhra Pradesh in Chekka Venkata Chenna

Kesava Sudheer Vs. Drugs Inspector (Ayurveda), Andhra

Region, Indian Medicines and Homeopathy Department,

Secunderabad and another 2, wherein it was held that in the

absence of any averment in the complaint to the effect that the

accused person was in charge of and responsible for the conduct

of business of company, the proceedings initiated against him are

liable to be quashed. He further relied upon the decisions passed

by the Apex Court in Sunita Palita & Others Vs. M/s Panchami

Stone Quarry 3, Dayle De' Souza Vs. Government of India

through Deputy Chief Labour Commissioner (C) and another 4,

Siby Thomas Vs. M/s. Somany Ceramics Limited 5 and Ashok

Shewakramani and Others Vs. State of Andhra Pradesh and

another 6 and sought to allow the criminal petition.

2008 (1) ALD (Crl.) 27 (AP)

Arising out of SLP (Crl.) No.10396 of 2019

Arising out of Special Leave Petition (Crl.) No.3913 of 2020

@Special Leave Petition (Crl.) No.12 of 2020

(2023) 8 Supreme Court Cases 473

10. Per contra, the learned Assistant Public Prosecutor

vehemently contended that petitioner No.2 being the director of

petitioner No.1-Company, is equally responsible for the business

of the company. All the grounds as have been raised by the

petitioners in this petition can very well be raised by them before

the trial Court itself but they have approached this Court in

exercise of power under 528 of BNSS. The allegations against the

petitioner No.1-Company and petitioner No.2-Director of

preparing sub standard medicines are serious in nature and it is

dangerous for human consumption, hence they cannot be

absolved of their criminal liability under the provision of the

Drugs and Cosmetics Act, 1940. It is hence submitted that the

petition deserves to be dismissed.

11. In view of the aforesaid submissions, and on careful perusal

of the judgments placed on record, there are no specific

allegations as against the petitioners, except stating that petitoner

No.1 is the company and petitioner No.2 is the Director of the

company. The averments as alleged in the complaint do not

disclose that the report has not been sent to the manufacturer,

but to M/s. Sharada Medicals, where the sample has been

collected. The said M/s. Sharada Medicals has been arrayed as

one of the witnesses to speak against the petitioners. It is

impermissible, that itself is sufficient to infer that the prosecution

failed to trial the offences under Sections 18(a)(i), r/w Section 16

and 18-B, 22(1)(cca) Drugs and Cosmetics Act, 1940 punishable

under Section 27(d), 28(a) and 22(3) of Drugs and Cosmetics Act,

1940. Except being the company and the director, no other

cogent or corroborative evidence is available on record to show

that the petitioners have involved in the manufacture of sub-

standard quality of alleged drug. Therefore, this Court is inclined

to quash the proceedings against the petitioners in C.C.No.4 of

2023.

12. Accordingly, the Criminal Petition is allowed.

Pending miscellaneous applications, if any, shall stand

closed.

____________________________ JUSTICE E.V.VENUGOPAL Dated: 26.06.2025 vsu