Page No.# 1/17 GAHC040008522023 2025:GAU-AP:529 THE GAUHATI HIGH COURT (HIGH COURT OF ASSAM, NAGALAND, MIZORAM AND ARUNACHAL PRADESH) Case No. : Crl.Petn./115/2023 Pratyay Majee and 2 Ors. (Production Officer), C/o Dr. Madhu Sudan Majee, Village Barabagan, PO Arrah District Purulia 723121, West Bengal, Responsible person of manufacturing of the drugs produced by M/s Caplet India Pvt. Ltd. 284/1, Bangur Avenue, Block B, Kolkata 700055, Work Rekjuani, Kolkata 7000135. Phone 8348974232 2: Saikat Bhunia Age: Occupation : (Analyst) C/o Joyanta Bhunia Rabindranagar P.O Pachim Midnapre 721101 West Bengal responsible person for testing of the drugs produced by M/s Caplet India Pvt. Ltd. 284/1 Bangur Avenue Block B Kolkata 700 055. Work Rekjuani Kolkata 7000135 3: Tapan Dutta Age: Occupation : (Office I/C Control) a Resident of Kajia PO Putia Ashok Nagar District 24 Parganas (North) for testing of the drugs produced M/s Caplet India Pvt. Ltd. 284/1 Bangur Avenue Block B Kolkata 700055 Work Rekjuani Kolkata 700013 Page No.# 2/17 VERSUS the Union of India Through the Ministry of Health and Family Welfare Represented by the Drug Inspector, Central Drugs Standard Organization, Govt. of India, having office at Central Drugs Standard Control Organization, East Zone, 234/4 AJC Bose Road, Nizam Palace, 1st MSO Building, Eastern Side, Bhawanipore, Kolkata 700020 Advocate for the Petitioner : D Das, Sr. Advocate, K Das,Binter Picha,Jumgam Jini,Tao Tarin Advocate for the Respondent : Marto Kato, DSGI Linked Case : Crl.Petn./114/2023 M/s Caplet India Pvt. Ltd. and 4 Ors. Age: 0 Occupation : Address:Represented by the Director Shri Subesh Kumar Pal S/o Late Sudhir Kumar Pal of 284/1 Bangur Avenue Block B Kolkata 700055 Presently registered office at 937 Lake Town Block A Kolkata 700089 West Bengal 2: Sunit Kumar Pal Age: 67 Occupation : Address:S/o Late Sudhir Kumar Pal Director (Shareholder) of M/s Caplet India Pvt. Ltd. 284/1 Bangur Avenue Block B Kolkata 700055 presently registered office at 937 Lake Town Block A Kolkata 700089 West Bengal 3: Supriya Kumar Pal Age: 65 Occupation : Address:S/o Late Sudhir Kumar Pal Page No.# 3/17 Director (Shareholder) of M/s Caplet India Pvt. Ltd. 284/1 Bangur Avenue Block B Kolkata 700055 presently registered office at 937 Lake Town Block A Kolkata 700089 West Bengal 4: Sujit Kumar Pal Age: 65 Occupation : Address:S/o Late Sudhir Kumar Pal Director (Shareholder) of M/s Caplet India Pvt. Ltd. 284/1 Bangur Avenue Block B Kolkata 700055 presently registered office at 937 Lake Town Block A Kolkata 700089 West Bengal 5: Sujit Kumar Pal Age: 68 Occupation : Address:S/o Late Sudhir Kumar Pal Director (Shareholder) of M/s Caplet India Pvt. Ltd. 284/1 Bangur Avenue Block B Kolkata 700055 presently registered office at 937 Lake Town Block A Kolkata 700089 West Bengal VERSUS THE UNION OF INDIA Age: 0 Occupation : Address:Through the Ministry of Health and Family Welfare Represented by Shri Neeraj Katiyar Drugs Inspector Central Drugs Standard Control Organization Govt. of India Page No.# 4/17 Having office at Central Drugs Standard Control Organization East Zone 234/4 AJC Bose Road Nizam Palace 1st MSO Building Eastern Side Bhawanipore Kolkata 700020 ------------ Advocate for : D Das Sr. Advocate Advocate for : Marto Kato appearing for THE UNION OF INDIA: Advocate appearing for respectively. BEFORE HONOURABLE MR. JUSTICE N. UNNI KRISHNAN NAIR Date of hearing : 19.12.2024 Date of Judgment & Order: 29.04.2025 JUDGMENT & ORDER (CAV) Heard Mr. Ushananda Jana, and Mr. Binter Picha, learned counsels, appearing on behalf of the petitioners. Also heard Mr. Marto Kato, learned Dy. SGI, appearing on behalf of the sole respondent. 2. These 2(two) criminal petitions have been instituted by the petitioners, herein, presenting a challenge to a criminal proceeding instituted against them being Criminal Complaint Case No. 77/2019, pending before the Court of learned Chief Judicial Magistrate, Capital Complex, Yupia, Arunachal Pradesh, along with the further orders passed therein. 3. The Criminal Petition No. 114(AP)2023 has been instituted by the Page No.# 5/17 accused Nos. 1, 2, 3, 4 and 5, who are the Directors of M/s Caplet India Pvt. Ltd.[accused No. 1 company], whereas, the Criminal Petition No. 115(AP)2023, has been instituted against the same very proceedings by the accused Nos. 6, 7 & 8, who are/were the employees of M/s Caplet India Pvt. Ltd.. 4. The brief facts requisite for adjudication of the issue arising in the present proceedings, is noticed as under: The complainant i.e. G. Narendra Kumar, Drugs Inspector, CDSCO, Kolkata, had received directives to conduct a joint surprise check for drawing drug samples in the State of Arunachal Pradesh, from the competent authority. Thereafter, the Drugs Inspector on 22.03.2017, took possession of a drug sample, namely, “T-LET-80(Telmisartan Tablets I.P. 80mg), bearing Batch No. SET601, manufactured by the M/s Caplet India Pvt. Ltd.. The said sample was so drawn from M/s Indian Pharmaceuticals, Banderdewa. On drawing the said sample, the complainant had packed and sealed the samples in 4 separate portions. The 2nd portion of the said sample was forwarded to the Government Analyst, Central Drugs Laboratory, Kolkata, for analysis. The 2nd portion of the said sample was retained to be produced before the Court, in the event, the proceedings are so required to be instituted therein. The Government Analyst, Central Drugs Laboratory, Kolkata, thereafter, on analysis of the said samples, proceeded to submit a report of the test/analysis, vide certificate, dated 06.07.2017. In the said certificate, it was held that the samples so forwarded, was not of “standard quality” and the sample does not conform to IP with regard to “dissolution test”. Page No.# 6/17 It is projected that the complainant, thereafter, in terms of the provisions of Section 18(A) of the Drugs & Cosmetics Act, 1940, proceeded to require the authorities of M/s Indian Pharmaceuticals, Banderdewa, from whom the samples was drawn, to disclose the source of procurement of the drugs, in question, vide communication, dated 28.07.2019. On receipt of the response from the authorities of the M/s Indian Pharmaceuticals, Banderdewa, vide their reply, dated 10.08.2017, wherein, they had contended that the drugs, in question, was procured from M/s Umachal Agency Pharmaceuticals & Distributors, Guwahati, Assam, vide purchase invoice No. CP-612, dated 21.11.2016, and purchase invoice No. CP-912, dated 28.03.2017; the complainant, thereafter, proceeded to require the authorities of M/s Umachal Agency Pharmaceuticals & Distributors, Guwahati, Assam, to disclose the name, address and other particulars of the person from whom the drugs, in question, was procured vide communication, dated 30.08.2017. The authorities of M/s Umachal Agency Pharmaceuticals & Distributors, Guwahati, Assam, vide communication, dated 09.09.2017, responded to the query made with them by the complainant vide communication, dated 30.08.2017, and reported that the same was procured from M/s Caplet India Pvt. Ltd.. In terms of the disclosure made under the provisions of Section 18(A) of the Drugs & Cosmetics Act, 1940, the complainant, thereafter, issued communication, dated 13.10.2017, to M/s Caplet India Pvt. Ltd.(accused No. 1), along with a test report, in original, of said drug sample drawn and one sealed portion of the sample. It is contended that the M/s Caplet India Page No.# 7/17 Pvt. Ltd. was given an opportunity to adduce evidence in contravention of the report, in accordance with Section 23(4)(iii) and 25(3) of the Drugs & Cosmetics Act, 1940. In response to the said communication, dated 13.10.2017, M/s Caplet India Pvt. Ltd. had contended in the matter that it had received a memorandum from the Directorate of Drugs Control, Government of West Bengal, and they were preparing to respond to the same and a copy of such response so made, would also be furnished to the complainant. The Directorate of Drugs Control, Government of West Bengal, in pursuance of receiving a reply to the Show Cause Notice issued to M/s Caplet India Pvt. Ltd., had, vide order, dated 09.01.2018, closed the matter by issuing a warning to M/s Caplet India Pvt. Ltd., that further occurrence of such violation, would be seriously dealt with. The complainant, thereafter, approached the competent authority, praying for according of sanction to prosecute the accused persons involved. The competent authority, thereafter, vide communication, dated 25.09.2018, accorded requisite sanction for prosecution of the accused persons involved in the matter. Thereafter, after collecting the requisite particulars of M/s Caplet India Pvt. Ltd.; the complainant had instituted the Criminal Complaint Case No. 77/2019, before the Court of learned Chief Judicial Magistrate, Capital Complex, Yupia. The learned trial Court issued notices to the accused persons and accordingly, the accused persons appeared before the learned trial Court. Page No.# 8/17 The accused persons, in response to the notices, had instituted an interlocutory application being IA(c)26/2022, requiring the learned trial Court to dismiss the said complaint case as not being maintainable. From the materials brought on record, it is seen that when the said interlocutory application being IA(c)26/2022 was taken-up for consideration on 21.12.2022, the learned counsel for the complainant had prayed for an adjournment in the matter so as to enable him to file a withdrawal application on the next date. However, on the next date, the learned counsel for the complainant had submitted that the complainant was no longer interested in withdrawing the complaint case being Criminal Complaint Case No. 77/2019. The learned trial Court, accordingly, fixed 23.08.2023, for hearing of the interlocutory application being IA(c)26/2022 as well as the Criminal Complaint Case No. 77/2019. Being aggrieved, the accused persons, as petitioners, herein, have assailed the institution of the said Criminal Complaint Case No. 77/2019, by way of instituting the above-noted criminal petitions, before this Court. 5. Mr. Jana, learned counsel for the petitioners, has, at the outset, submitted that basing on the same materials, proceeding having already been instituted by the Directorate of Drugs Control, Government of West Bengal, and the said proceeding after considering the response submitted in the matter along with the test reports of the said batch of drugs involved in the complaint case, in question; was closed by recording a warning to Page No.# 9/17 M/s Caplet India Pvt. Ltd., that further occurrence of such violation, would be seriously dealt with by the Directorate of Drugs Control, Government of West Bengal, vide order, dated 09.01.2018. It is submitted by the learned counsel that out of the same batch No. SET-601, drugs were drawn by one Shri Sushen Mazumder, Inspector of Drugs, Cachar, Assam, and the same was so forwarded to the Regional Drug Testing Laboratory, Guwahati. The said drug was analysed and the Government Analyst, Regional Drug Testing Laboratory, Guwahati, vide report, dated 04.10.2017, had found the samples so forwarded involved to meet the standard quality as defined under the provisions of the Drugs & Cosmetics Act, 1940. The learned counsel has further submitted that M/s Caplet India Pvt. Ltd. had also analysed samples of the drug involved out of the batch involved and had found the same to conform to the quality mandated. 6. Mr. Jana, learned counsel, has submitted that the samples, in question, was drawn by the complainant on 22.03.2017, and thereafter, had forwarded the sample involved to the Government Analyst, Central Drugs Laboratory, Kolkata. The said sample was received by the Central Drugs Laboratory, Kolkata, on 28.03.2017. However, after analysis, the report, thereof, was submitted on 06.07.2017. The learned counsel has further submitted that in terms of the provisions of Rule 45 of the Drugs Rules, 1945, the Government Analyst is mandatorily required to submit the test report within a period of 60 days. The learned counsel has also submitted that in the event, the Government Analyst is not in a position to submit his report within a period of 60 days of receipt of the sample, it is mandatorily required that the Government Analyst shall seek extension of time from the Government giving specific reasons for delay in such testing or analysis. Page No.# 10/17 7. Mr. Jana, learned counsel, has further submitted that the from the materials brought on record in the complaint case, in question; it is not revealed that the Government Analyst involved had sought for extension of time for submission of the test report in accordance with the provisions of Rule 45 of the Drugs Rules, 1945. Accordingly, the learned counsel has submitted that the test report not having been so submitted in accordance with the provisions of Rule 45 of the Drugs Rules, 1945, such test report cannot form the basis of initiating proceeding against the accused persons. 8. Mr. Jana, learned counsel for the petitioners, by referring to the guidelines formulated by the competent respondent authorities under the provisions of Section 33(p) of the Drugs & Cosmetics Act, 1940, has submitted that the prosecution in the matter is permissible to be so instituted only in the event the drug sample falls below the limit prescribed for the dissolution test as well as the active content therein, more particularly, when the drug is thermo labile. The learned counsel has submitted that until the sample of the drug, in question, fails the twin test of dissolution as well as active content, no criminal proceeding is mandated to be instituted against the manufacturer and its employees in the matter. By referring to the test report, dated 06.07.2017, the learned counsel has submitted that while the dissolution test of the said drug was found to be falling below prescribed limit of 75%; the active content of the drug was found to be 101.33% and accordingly, has submitted that on this count also, the criminal proceeding so instituted against the petitioners, is not maintainable. 9. Mr. Jana, learned counsel, has also assailed the institution of the Page No.# 11/17 criminal proceeding and issuance of notices, therein, by alleging that the learned trial Court had not complied with the provisions of Section 202 of the Code of Criminal Procedure, 1973. 10. Accordingly, in the above premises, Mr. Jana, learned counsel, has submitted that Criminal Complaint Case No. 77/2019, pending before the Court of Chief Judicial Magistrate, Capital Complex, Yupia, would call for an interference from this Court. 11. Per contra, Mr. Kato, learned Dy. SGI, has submitted that although there was a delay of submission of test report by the Government Analyst, Central Drugs Laboratory, Kolkata, in the matter, however, the test of the drugs sample was so done within the period mandated under the provisions of Rule 45 of the Drugs Rules, 1945. The learned Dy. SGI, has, accordingly, submitted that the delay so occasioning in the matter in submission of the test report by the Government Analyst, Central Drugs Laboratory, Kolkata, would not be fatal. 12. Mr. Kato, learned Dy. SGI, has further submitted that the test report being received, the complainant had complied with the provisions of Sections 18 and 24 of the Drugs & Cosmetics Act, 1940, and had, thereafter, instituted the complaint case, in question, before the learned trial Court. Accordingly, the learned Dy. SGI has submitted that there was no delay in the institution of the criminal proceedings against the accused persons. The learned Dy. SGI, by referring to Section 25(3) of the Drugs & Cosmetics Act, 1940, has submitted that although the drug sample along with the original was forwarded by the complainant to M/s Caplet India Pvt. Page No.# 12/17 Ltd., the same was not disputed by M/s Caplet India Pvt. Ltd. within 28 days of receipt of a copy of the said report. The learned Dy. SGI has, therefore, submitted that the accused persons had lost the opportunity to assail the test report involved and the same must be held to be conclusive for the purpose of institution of criminal proceeding against the petitioners in the present proceedings. 13. In the above premises, Mr. Kato, learned Dy. SGI, has submitted that this Court while entertaining an application for quashing of criminal proceedings under its inherent jurisdiction in terms of the provisions of Section 482 of the Code of Criminal Procedure, 1973, has to exercise such jurisdiction sparingly and carefully. The learned Dy. SGI has submitted that the accused persons, herein, had an opportunity to approach the learned trial Court under Section 245 of the Code, for discharge from the complaint case which they had admittedly not availed and accordingly, the criminal petitions would mandate an interference by this Court. 14. We have heard the learned counsels appearing for the parties and also perused the materials available on record. 15. It is not disputed that the samples, in question, was drawn by the complainant on 22.03.2017 and accordingly, the same was forwarded to the Government Analyst, Central Drugs Laboratory, Kolkata, for analysis. On perusal of the test report, dated 06.07.2017, it is revealed that the sample was received by the Government Analyst, Central Drugs Laboratory, Kolkata, on 28.03.2017. The analysis of the said sample was carried-out on 18.04.2017 to 20.04.2017. However, the report was so submitted on Page No.# 13/17 06.07.2017. 16. The provisions of Rule 45 of the Drugs Rules, 1945, being relevant, in the present proceedings, is extracted hereinbelow: “45. Duties of Government Analysts. - (1) The Government Analyst shall cause to be analysed or tested such samples of drugs as may be sent to him by Inspectors or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these rules ²[within a period of sixty days of the receipt of the sample: Provided that where it is not possible to test or analyse the sample within the specified period, the Government Analyst shall seek extension of time from the Government giving specific reasons for delay in such testing or analysis.] (2) A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government.” 17. A perusal of Rule 45 of the Drugs Rules, 1945, reveals that a Government Analyst shall cause to analyse or test such samples of drugs as may be sent to him by Inspectors or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with the Rules within a period of sixty days of the receipt of the sample. The proviso to sub-Rule 1 of Rule 45, further provides that where it is not possible to test or analyse the sample within the specified period, the Government Analyst shall seek extension of time from the Government giving specific reasons for delay in such testing or analysis. 18. The fact that the provisions of Rule 45 of the Drugs Rules, 1945, mandates a period of 60 days for submission of the result of the test or the analysis is with a purpose that the accused involved, is not deprived of an opportunity to dispute such report within the validity period of the drug involved, more particularly, when the drug is thermo labile like the drug Page No.# 14/17 involved in the present proceeding. Accordingly, it was mandatorily required that the Government Analyst, Central Drugs Laboratory, Kolkata, complied with the provisions of Rule 45 of the Drugs Rules, 1945. 19. It is, therefore, obvious that it is the clear legislative intent that the process of taking a sample of the drug, getting it tested by a notified Analyst and sending a copy of the report to the persons responsible, are to be undertaken with a sense of urgency so that the cloud of suspicion hanging on the drug is resolved promptly. 20. If the intention of the Legislature was to allow the Government Analysts to take their own sweet time to conduct the test/analysis and also enable the person affected by the test to react to the report of the test leisurely, the fixation of time-frames under Sections 23 and 25 of the Drugs & Cosmetics Act, 1940, as well as Rule 45 of the Drugs Rules, 1945, would be rendered redundant. 21. It is quite possible that the persons responsible for the drug can adduce evidence to the Inspector on the veracity of the report, and the Inspector may accept it and choose not to launch prosecution. However, if he does decide to launch prosecution, or, if he has already launched prosecution, the manner of challenge to the report is indicated under Section 25(4) of the Drugs & Cosmetics Act, 1940. 22. Section 25(4) of the Drugs & Cosmetics Act, 1940, deals with the situation following the reaction to the test report by the persons responsible for the drug and question it as provided in Section 25(3). It Page No.# 15/17 states that the Court may, in its discretion or at the request of either the complainant or the accused, cause the sample to be tested by the CDL which has been established under Section 6 of the Drugs & Cosmetics Act, 1940. 23. However, the rigours of the provisions of Section 25 of the Drugs & Cosmetics Act, 1940, would not call for an examination in the present matters, in-as-much as, there is an apparent violation of the provisions of Rule 45 of the Drugs Rules, 1945. Accordingly, on the ground of violation of the provisions of Rule 45 of the said Rules of 1945; the criminal proceeding instituted against the accused persons i.e. the petitioners, herein, in the above-noted criminal petitions, would not be maintainable. 24. Having drawn the above conclusions, it is also required to be noticed that from the same batch of the drug involved, a sample was drawn by one Shri Sushen Mazumder, Inspector of Drugs, Cachar, Silchar, and the same was forwarded to the Government Analyst, Regional Drugs Testing Laboratory, Guwahati, which was received on 06.09.2017, by the Government Analyst. A perusal of the report submitted by the Government Analyst in the matter on 04.10.2017, reveals that the drug involved, had met the required standard quality as defined in the provisions of Drugs & Cosmetics Act, 1940. This position is not disputed by the respondents, herein. 25. It is to be noted that the petitioners, herein, in the present proceedings, have averred that the drug, in question, being thermo labile, requires to be stored with care and caution. Accordingly, a benefit of doubt Page No.# 16/17 in the matter in view of the said materials brought on record is also called upon to be extended to the accused persons i.e. the petitioners, herein. 26. Further, the petitioners have also relied upon the guidelines formulated by the Government of India under the provisions of Section 33(p) of the Drugs & Cosmetics Act, 1940. The said guidelines lays down as to how grossly standard drugs are to be so identified. The defects so highlighted, relevant to the present proceedings, is provided in Clause (iii) under Category B of the said guidelines. The same being relevant, is extracted hereinbelow: “Category B (Grossly sub-standard drugs) Drugs manufactured by licensed manufacturers and reported to have defects of serious nature to affect the quality of the drug. Such defects may arise out of gross negligence or non-conformance to GMPs during manufacture. These defects may broadly be as under: (i) Active ingredient contents below 70% for thermo labile products and below 5% of the permitted limits for thermo stable products. (ii) Tablets/Capsules failing in disintegration tests wherever prescribed. (iii) Tablets/Capsules failing in dissolution test and active contents found less than 70% for thermo labile products and below 5% of the prescribed limits for thermo stable products. (iv) Liquid preparations showing presence of fungus. (v) Parental preparations failing in sterility, pyrogen/endotoxin test or undue toxicity. (vi) Vaccines falling in potency, sterility, toxicity or moisture content. (vii) Presence of any adulterant which renders the product injurious to health.” 27. Applying the provisions of Clause (iii) of Category B to the facts of the present case, it would be revealed that while the Government Analyst in the test report, dated 06.07.2017, had found the drug to have not complied with the dissolution test, however, it is seen that the active contents of the drug, involved, was found within the permissible limit. Page No.# 17/17 28. Accordingly, the twin tests laid down under the provisions of Clause(iii) of Category B of the Guidelines, in question, has clearly not been satisfied in the matter and the drugs, in question, could not have been held to be a grossly sub-standard one, mandating institution of the criminal proceeding against the petitioners, herein. 29. In view of the above discussions and on a close perusal of the materials brought on record, this Court is of the considered view that this is a fit case wherein the inherent power vested in this Court under the provisions of Section 482 of the Code of Criminal Procedure, 1973, is called to be applied and accordingly, the criminal proceedings pending against the petitioners, herein, in the above-noted criminal complaint case being criminal complaint case No. 77/2019, presently, pending before the Court of learned Chief Judicial Magistrate, Capital Complex, Yupia, would mandate an interference and accordingly, the said proceedings are hereby set aside and quashed. 30. With the above directions and observations, the instant criminal petitions being Criminal Petition No. 114(AP)2023 and Criminal Petition No. 115(AP)2023, are allowed and stand disposed of. JUDGE Comparing Assistant