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 2 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 3 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, 4 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 5 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 -
1
(1970) Mh.L.J
6
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.7
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. 2 2008 (1) ALD (Crl.) 27 (AP) 3 Arising out of SLP (Crl.) No.10396 of 2019 4 Arising out of Special Leave Petition (Crl.) No.3913 of 2020 5 @Special Leave Petition (Crl.) No.12 of 2020 6 (2023) 8 Supreme Court Cases 473 8
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 9 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