JUDGMENT : 1. Heard. 2. RULE. Rule is made returnable forthwith. Heard finally by consent of the parties. 3. The applicant No.1 is the Managing Director and applicant No.2, is a Director of M/s Care Formulator Private Limited, applicant No.3, have approached this Court by way of this application under Section 482 of the Code of Criminal Procedure, 1973 (hereinafter referred to as “ Cr.P.C .”) by making following prayers : “(A) Quash and set aside the criminal complaint being Regular Criminal Case No.20/2002 dated 14.01.2002 pending on the file of Chief Judicial Magistrate, Yavatmal; (B) Quash and set aside the impugned order of issuance of process dated 14.01.2002 passed by the learned Chief Judicial Magistrate, Yavatmal in Regular Criminal Case No. 20/2002; (C) Quash and set aside the impugned order dated 06.07.2022 passed by the learned Sessions Judge, Yavatmal, in Criminal Revision Application No. 50/2018 (Annexure “H”); (D) Quash and set aside the impugned order dated 05.09.2018 passed by the learned Chief Judicial Magistrate, Yavatmal in Regular Criminal Case No. 20/2002, rejecting the application for discharge preferred by the applicants; (E) During the pendency and final disposal of the application, stay all further proceedings in Regular Criminal Case No.20/2002 pending before the learned Chief Judicial Magistrate, Yavatmal (Annexure-C);” The brief facts of the present case are as under :- 4. The respondent filed a complaint namely Regular Criminal Case No.20 of 2002, for the offences punishable under Section 27 (d) and 28-A read with Section 34 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as “the Act of 1940”) before the Chief Judicial Magistrate, Yavatmal. 5. It is the case of the complainant that, he visited the premises of M/s Anup Pharmaceuticals situated at shop No.25, Dawa Bazar, Dutta Chowk, Yavatmal, and drew a sample of Careclox 500 mg. Capsules, manufactured by the applicant No.3, for the purpose of test and analysis as per the procedure laid down under Section 23 of the said Act. 6. It is stated that, on 01.02.2001, a Memorandum in Form-18 dated 01.02.2001 was prepared in triplicate and original copy of the Form-18 along with one sealed counter portion of the said sample was sent to the Government Analyst, Drugs Control Laboratory, Bandra East, Mumbai. 7. On 16.10.2001, the complainant received the analytical report in Form-13 dated 08.10.2001, and it was reported that “Not of Standard Quality”. 7. On 16.10.2001, the complainant received the analytical report in Form-13 dated 08.10.2001, and it was reported that “Not of Standard Quality”. It further states that, “Content of Cloxacillin in the sample is less (14.63%) than the labelled amount”. Accordingly, the complaint came to be filed. 8. Shri Naik, learned Senior Advocate argues that, the learned Chief Judicial Magistrate committed an error in issuing process, ignoring the non-compliance of provisions of the Act of 1940 and the Drugs Rules, 1945 (hereinafter referred to as “Rules of 1945”). 9. He further submits that, despite the objection to the analyst report dated 08.10.2001, and a request made by the authorized Competent Technical Person (Manufacturing) to adduce the evidence against the said analytical report, the same was not considered and such a right was denied. 10. Shri Naik, learned Senior Advocate has taken this Court through various provisions, namely Sections 23 and 25 of the Act of 1940 and Rule 45 of the Rules of 1945, to point out the right of the applicants to lead evidence against the analytical report and further the timeline fixed for providing such analytical report to show non- compliance of the said provisions. It is argued that such non-compliance vitiates the proceeding and to buttress this submission has placed reliance on the judgment of the Hon’ble Supreme Court of India in the case of Medicamen Biotech Limited and another vs. Rubina Bose, Drug Inspector, (2008) 7 SCC 196 . 11. As regards the right to adduce evidence to counter the analytical report, he has placed reliance on a judgment of the Coordinate Bench of this Court in the case of P.R. Naik and another vs. State of Maharashtra, 2024 SCC OnLine Bom 3856 . 12. He further placed reliance on a judgment of the Hon’ble Supreme Court of India in the case Managing Director, Castrol India Limited vs. State of Karnataka and another, (2018) 17 SCC 275 and the judgment of the Hon’ble Supreme Court of India in the case of GHCL Employees Stock Option Trust vs. India Infoline Limited, (2013) 4 SCC 505 to submit that in absence of any pleadings, disclosing any specific act of the applicant Nos.1 and 2 in commission of alleged offence the complaint cannot be maintained against the applicant Nos.1 and 2. 13. 13. It is argued that, it is a bounden duty of the Court to ensure such compliances and to verify whether a case is made out for taking cognizance before issuing process. In support, he has placed reliance on the judgment of the Hon’ble Supreme Court of India in the case of Lalankumar Singh and others vs. State of Maharashtra, 2022 SCC OnLine SC 1383 . 14. On the other hand, learned A.P.P. argued that necessary compliances under the Act of 1940 and the Rules of 1945 have been made and the learned Magistrate after satisfying that prima facie case is made out, issued process. It is argued that there is no illegality committed by the learned Magistrate in issuing the process. He further submits that, the Revisional Court has rightly confirmed the order of the Magistrate. 15. In the above referred backdrop and having gone through the record it is evident that in a complaint, except the avernments that the accused Nos.1 to 4 are the Directors of the company, there are no pleadings to show the role of the applicant Nos.1 and 2 to make them liable as Managing Director or Director of the company. There are no averments whatsoever that applicant Nos. 1 and 2 were responsible or in- charge of the conduct of the business of the company, or connected with or responsible for the commission of any act. 16. The Hon’ble Supreme Court of India in the case of Managing Director (Supra), has held thus :- “6. Section 74 of the Standards of Weights and Measures Act, 1976, which is in the following terms engrafts the principle of vicarious liability for offences committed by a Company. “74. Offences by companies and power of court to publish name, place of business, etc. of companies convicted. Section 74 of the Standards of Weights and Measures Act, 1976, which is in the following terms engrafts the principle of vicarious liability for offences committed by a Company. “74. Offences by companies and power of court to publish name, place of business, etc. of companies convicted. - (1) If an offence under this Act is 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 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 punishment if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence.” 7. In the present complaint petition, there is no averment or statement whatsoever that the appellant as the Managing Director of the Company was responsible or incharge of the conduct of the business of the Company in respect of which the offence in question has been alleged to have been committed. Neither there is any averment to the effect that the appellant is otherwise connected or responsible for commission of any of the acts on the basis of which the offence(s) is alleged to have been committed. 8. It will not be necessary to burden this order by a detailed reference to numerous pronouncements of this Court interpreting similar provisions of other statutes holding that a clear and categorical statement to the above effect is required to be made in the complaint petition to proceed against an officer of the Company so as to determine his vicarious liability for the offence committed by the company. In the present case the Company is not even arrayed as an accused.” 17. In the matter at hand, it is evident that there is no avernment or statement whatsoever, that the applicant Nos.1 and 2 as Managing Director or the Director of the Company were responsible or in-charge of the conduct of the business of the company in respect of which the offence in question alleged to have been committed, so as to determine their vicarious liability for the offence committed by the Company. Moreover, there is no satisfaction recorded by the learned Magistrate about the prima-facie case against the applicant Nos. 1 and 2 and the role played by them in the capacity of the Managing Director and the Director, respectively, of the applicant No.3-Company, which is sine qua non for initiating criminal action against them. 18. Thus, I have no hesitation to hold that the learned Magistrate has committed error in issuing process against the applicant Nos. 1 and 2. 19. Moving further to examine and to evaluate the merits in the submissions made on behalf of the applicants as regards the non- compliance of the provisions of the Act of 1940 and the Rules of 1945, it would be better to find out the scheme of the Act relating to such matters. 20. Chapter IV of the Act of 1940 deals with manufacture, sale and distribution of the drugs and cosmetics. 21. Section 16 defines “standards of quality” which means in relation to a drug, that the drug complies with the standard set out in the Second Schedule. 22. Section 18 of the Act of 1940 deals with prohibition of manufacture and sale of certain drugs and cosmetics. For the purpose of present matter, Section 18 (a)(i) is relevant, which says that 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, or is misbranded, adulterated or spurious. Section 18-A mandates every person not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic. 23. Section 20 empowers the State Government and the Central Government to appoint Government Analyst in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notification issued for such appointment. 24. Section 22 deals with powers of the Inspector. Whereas, Section 23 prescribes procedure of Inspectors. 25. 23. Section 20 empowers the State Government and the Central Government to appoint Government Analyst in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notification issued for such appointment. 24. Section 22 deals with powers of the Inspector. Whereas, Section 23 prescribes procedure of Inspectors. 25. Section 24 bounds every person in charge of any premises whereon any drug or cosmetic is being manufactured or is kept for sale or distribution shall, of being required by any Inspector so to do, to disclose to the Inspector the place where the drug or cosmetic is being empowered or is kept, as the case may be. 26. Section 25(1) relates to reports of Government Analyst which mandates the Government Analyst to deliver report of test or analysis in triplicate in the prescribed form. Section 25(2) mandates the Inspector to deliver one copy of the report to the person from whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed under Section 18-A, and shall retain the third copy for use in any prosecution in respect of the sample. Section 25(3) provides that such report shall be the evidence of the facts stated therein, and shall be conclusive unless the person from whom the sample was taken or the person whose name, address and other particulars have been disclosed under Section 18-A has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceeding in respect of the sample are pending that he intends to adduce evidence in controversion of the report. Section 25(4) says that unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has notified his intention of adducing evidence in controversion of a Government Analyst’s report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug or cosmetic produced before the Magistrate under sub-section (4) of Section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and such report shall be conclusive evidence of the facts stated therein. 27. 27. Similarly, Rule 45 is relevant for the purpose of the present matter which says that the Government Analyst shall cause to be analysed or tested such sample of drug as may be sent to him by Inspectors or any other person under the provisions of Chapter IV of the Act and shall furnish reports of the result of test or analysis in accordance with these Rules within the 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. 28. In light of the above referred provisions, it is important to note certain dates in the present matter. The Government Analyst received the drug sample on 05/02/2001, of which manufacturing date was 01/02/2000. Whereas, the expiry date was 31/01/2002. The analyst’s report is dated 08/10/2001 and the prosecution was initiated on 14/01/2002. 29. To seek the compliance of Rule 45 of the Rules of 1945, if the date of receipt of the sample and the date of the report are considered, it is evident that the report was furnished beyond the stipulated period of 60 days. The 60 days period in this case would expire on 05/04/2001. However, the report was furnished on 08/10/2001. 30. The Coordinate Bench of this Court, while dealing with the importance of the time frame given under the Act of 1940 and the Rules of 1945 for analysis in the case of P.R. Naik (Supra), has observed that the fastest course of action is expected as it relates to drugs which are consumed by the consumer and public at large. It relates to the life of the consumer who consumed these drugs across the counter as they are prescription drugs. Therefore any action taken by the Drugs Inspector in accordance with the provisions of the Act of 1940 and more specifically the provisions delineated herein above have to be in strict compliance of the said Act and timelines have to be scrupulously followed for taking and initiating any action. Therefore any action taken by the Drugs Inspector in accordance with the provisions of the Act of 1940 and more specifically the provisions delineated herein above have to be in strict compliance of the said Act and timelines have to be scrupulously followed for taking and initiating any action. This is so, because once the stocks are released to the stockiest and distributed to the market, if no timely action and if its later found that the stocks are required to be withdrawn there should not be delay in taking such action. 31. It is to be noted that in the matter at hand it took about eight months to furnish the report against the timeline of sixty days fixed for such report. 32. Thus, considering the date of expiry of the drug i.e. 31/01/2002, it can be said that the delay in furnishing analytical report is prejudicial to the rights of the accused. It is so because 28 days time is provided under Section 25(3) of the Act of 1940 from the date of receipt of the copy of the report to notify intention to adduce evidence in controversion of the report. 33. The chronology of events shows that after receipt of the report dated 08/10/2001, the report was supplied to M/s. Anup Pharmacuticals from whom the sample was taken, on 16/10/2001. 34. On 17/10/2001 Proprietor of M/s. Anup Pharmaceuticals disclosed that the said drug was purchased from M/s. Shree Care Distributors, Nagpur. 35. On 28/10/2001 a copy of the Government Analyst Report dated 08/10/2001 was sent to M/s. Shree Care Distributors, Nagpur, but the said letter was received back undelivered. 36. On 24/10/2001 the Drugs Inspector visited the premises of M/s. Shree Care Distributors, Nagpur and handed over the letter dated 24/11/2001 along with copy of the Government Analyst Report dated 08/10/2001. 37. On 24/11/2001 M/s. Shree Care Distributors, Nagpur disclosed that the said drug was purchased from M/s.Shree Care Distributors, Nandurbar. 38. On 05/12/2001 the complainant along with the Drug Inspector, Dhulia visited the premises of M/s. Shree Care Distributors, Nandurbar and handed over letter dated 05/12/2001 along with report dated 08/10/2001. 39. On 05/12/2001 M/s.Shree Care Distributors, Nandurbar disclosed that the said drug was purchased from M/s. Care Formulators Private Limited-applicant No.3 company herein. 40. On 05/12/2001 M/s.Shree Care Distributors, Nandurbar further informed that the factory at Mahad is closed from last three months. 41. 39. On 05/12/2001 M/s.Shree Care Distributors, Nandurbar disclosed that the said drug was purchased from M/s. Care Formulators Private Limited-applicant No.3 company herein. 40. On 05/12/2001 M/s.Shree Care Distributors, Nandurbar further informed that the factory at Mahad is closed from last three months. 41. It is to be noted that under Section 18-A of the Act of 1940 the information about manufacturer could have been obtained by the complainant on the date of collection of sample drug. However, he took 12 months to know who is the manufacturer. 42. It is of a common knowledge that strip in which the drug is packed, discloses the necessary details about Brand Name, Generic Name, Active Ingredients, Doses Instructions, Storage Conditions, Expiry Date, Lot Number, Warning and Precautions, Allergy Warnings etc. and also the Manufacture and Distributor Information along with their addresses. 43. Despite this, the complainant took 12 months to know the name of the manufacturer and it is the case of the complainant that on receiving such information from the person whom the sample drug was collected, he got the knowledge of manufacturer. 44. The above referred delay of about 12 months to find out the name of the manufacturer cannot be ignored and discarded while considering the timeline framed under the Act of 1940 and the Rules of 1945 and also the right of the applicants to lead evidence in such matter in controversion of the Government Analysis report. 45. Let us see the further dates of events which are also important and relevant for the decision in the present matter : 46. On 27/11/2001 the complainant received directions from the Joint Commissioner, Food and Drug Administration to institute prosecution in the Court of law against applicant-M/s. Care Formulators Pvt. Ltd. 47. On 07/12/2001 the complainant sent a letter dated 07/12/2001 to the Director of M/s. Care Formulators Pvt. Ltd. and asked for certain information, including the drug manufacturing licences, list of directors at the time of manufacturing and distribution of the said drugs etc. 48. On 24/12/2001 the Drugs Inspector, Pen visited the premises of the applicant No.3 and noted the inspection in Form No.35 dated 24/12/2001. During the visit Shri R.B. Sutar, Competent Technical Person (Manufacturing) of applicant No.3 company was present and he produced the copy of manufacturing licences and other information. 49. 48. On 24/12/2001 the Drugs Inspector, Pen visited the premises of the applicant No.3 and noted the inspection in Form No.35 dated 24/12/2001. During the visit Shri R.B. Sutar, Competent Technical Person (Manufacturing) of applicant No.3 company was present and he produced the copy of manufacturing licences and other information. 49. On 31/12/2001 the complainant received letter dated 28/12/2001 from Shri Ravindra B. Sutar, Competent Technical Person (Manufacturing) of the applicant No.3-Company, inter alia mentioning that they do not agree with the Government Analyst Report dated 08/10/2001 and intended to adduce evidence against the said analytical report. However, his request was not considered on the ground that he had neither mentioned that it is made on behalf of the Director nor he has attached any authorization on behalf of the company. 50. It is to be noted that the complainant himself in para 19 of the complaint stated that during the visit of the Drug Inspector, Pen, Shri R.B. Sutar, Technical Person (Manufacturing) was present and he produced the documents demanded by the Drugs Inspector. 51. Thus, on one hand, Shri R.B. Sutar was treated as Technical Person (Manufacturing) of the applicant No.3 to receive the necessary record as demanded by the complainant. But, Shri Sutar’s request to adduce evidence against the analytical report was not considered saying that authorization on behalf of the company was not filed. 52. In the entire complaint, there are no averments made to the effect that a copy of Government Analyst Report was supplied to the applicant No.3 company. 53. The supply of such report is significant for the purpose, as stated herein above to notify the intention to lead evidence in controversion of the report, if receiver of the report so desires. 54. Paragraph 20 of the complaint states that M/s. Anup Pharmaceuticals, Yavatmal from whom the sample was taken and M/s.Shree Care Distributors, Nagpur and Nandurbar have not notified in writing that they intend to adduce evidence in controversion of the report. 55. In paragraph No.19 of the complaint it is stated that on 24/12/2001 the Drug Inspector, Pen visited the premises of the company and thereupon Shri Sutar, Technical Person (Manufacturing) supplied all the documents demanded by the complainant. However, there is no mention of supply of copy of the Government Analyst Report dated 08/10/2001 to the applicant No.3-company. 56. 55. In paragraph No.19 of the complaint it is stated that on 24/12/2001 the Drug Inspector, Pen visited the premises of the company and thereupon Shri Sutar, Technical Person (Manufacturing) supplied all the documents demanded by the complainant. However, there is no mention of supply of copy of the Government Analyst Report dated 08/10/2001 to the applicant No.3-company. 56. It has also come on record that on 31/12/2001 i.e. immediately within seven days after the visit of the Drug Inspector to the premises of the applicant No.3-Company, the Competent Technical Person (Manufacturing) of the company expressed an intention to adduce the evidence against the analytical report. 57. Thus, in this case the company exercised its right to adduce evidence against the analytical report within a period of 28 days as stipulated under Section 25(3) of the Act of 1940. 58. The Hon’ble Supreme Court of India in the case of State of Haryana vs. Unique Farmaid (P) Ltd., (1999) 8 SCC 190 had an occasion to consider the effect of non-compliance of the provisions of Sections 25(3) and 25(4) of the Act of 1940, wherein the Hon’ble Supreme Court of India in paragrpah 12 has held thus : "12. It cannot be gainsaid, therefore, that the respondents in these appeals have been deprived of their valuable right to have the sample tested from the Central Insecticides Laboratory under sub-section (4) of Section 24 of the Act. Under sub- section (3) of Section 24 report signed by the Insecticides Analyst shall be evidence of the facts stated therein and shall be conclusive evidence against the accused only if the accused do not, within 28 days of the receipt of the report, notify in writing to the Insecticide Inspector or the court before which proceedings are pending that they intend to adduce evidence to controvert the report. In the present cases the Insecticides Inspector was notified that the accused intended to adduce evidence to controvert the report. By the time the matter reached the Court, the shelf life of the sample had already expired and no purpose would have been served informing the Court of such an intention. The report of the Insecticide Analyst was, therefore, not conclusive. By the time the matter reached the Court, the shelf life of the sample had already expired and no purpose would have been served informing the Court of such an intention. The report of the Insecticide Analyst was, therefore, not conclusive. A valuable right had been conferred on the accused to have the sample tested from the Central Insecticides Laboratory and in the circumstances of the case the accused have been deprived of that right, thus, prejudicing them in their defence.” 59. In the teeth of the above referred observations and considering the above referred chronology of events and the facts it is evident that the applicant-company has been deprived of its valuable rights to have the sample tested from the Central Insecticides Laboratory under sub-section (4) of Section 25 of the Act of 1940. 60. From the language of sub-section (3) of Section 25 of the Act of 1940 it is evident that the Government Analyst report shall be the evidence of the facts stated therein and shall be conclusive evidence against the accused only if the accused do not, within 28 days of the receipt of the report, notify in writing that they intended to adduce evidence to controvert the report. 61. In the present case, the complainant did not consider the request of Shri Ravindra B. Sutar, Competent Person (Manufacturing) of the applicant No.3-Company to adduce evidence against the Government Analyst Report though such intention was expressed within 28 days from the date of visit of the Drug Inspector to the premises of the Company. 62. Furthermore, the prosecution was initiated on 14/01/2002, and therefore, time of twenty eight days was not available with the company to make such prayer before the Court to lead evidence in controversion of the Government Analyst Report as the expiry date of the sample drug was January-2002. In the circumstances, the Government Analyst Report dated 08/10/2001 cannot be considered as the conclusive proof of the facts stated therein. 63. Thus, I reiterate here that the delay in giving the report by the Government Analyst and further denying the right to the applicant No.3 company to lead evidence in controversion of the report is prejudicial to the applicants in their defence. Therefore, it would be an abuse of process if the prosecution is allowed to continue against the applicants. 64. Thus, I reiterate here that the delay in giving the report by the Government Analyst and further denying the right to the applicant No.3 company to lead evidence in controversion of the report is prejudicial to the applicants in their defence. Therefore, it would be an abuse of process if the prosecution is allowed to continue against the applicants. 64. It is a settled law that a wide discretion has been given as to grant or refusal of the process and it must be judicially exercised. A person ought not to be dragged into the Court merely because a complaint has been filed. If a prima-facie case has been made out, the Magistrate ought to issue process and it cannot be refused merely because he thinks that it is unlikely to result in a conviction. However, the words “sufficient ground for proceeding” appearing in Section 204 are of immense importance. It is these words which amply suggest that an opinion is to be formed only after due application of mind that there is sufficient basis for proceeding against the said accused and formation of such an opinion is to be stated in the order itself. [As held in the case of Lalankumar Singh (supra)] 65. In the circumstances, having held that it will be an abuse of process of the Court if the prosecution is allowed to continue against the applicant and despite the same in such matter since the process was issued by the Magistrate, it is apparent on the face of the record that the Magistrate has not applied his mind to satisfy himself whether a prima-facie case has been made out. 66. Furthermore, both the Courts below committed error in not allowing the applications of the applicants for discharge. In that view of the matter, I pass the following order :- i) The Criminal Application is allowed in terms of prayer clauses (A) to (E). Rule is made absolute accordingly.