1. The legal sustainability of a prosecution launched by a Drug Inspector whose name has not been notified in the official gazette to exercise his powers over the specified area from where he had booked a case for the commission of offence under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940, (for short, ‘Act’), is the main challenge in all these cases. Another serious ground raised against the maintainability of these prosecutions is that the appointment of the Government Analyst, who conducted the laboratory analysis of the drug involved, was also not notified in the official gazette specifying the areas coming under the jurisdiction of that Government Analyst. Thus the scope and ambit of Section 20 and 21 of the Act, are to be subjected to scrutiny for the effective resolution of the matter in issues in these cases.

2. In Crl.R.P.No.984/2016, the petitioner/accused challenges the order dated 13.06.2016 in C.M.P.No.4434/2012, passed by the Chief Judicial Magistrate Court, Ernakulam, in C.C.No.48/2008, dismissing the above discharge petition filed under Section 245(2) of the Code of Criminal Procedure, 1973.

3. In Crl.M.C.No.2408/2022, the accused in C.C.No.364/2014 on the files of the Chief Judicial Magistrate Court, Thrissur, seek to quash the proceedings in the said case.

4. In Crl.M.C.No.2985/2018, the accused Nos.1 & 2 in S.T.No.1223/2014 on the files of the Judicial First Class Magistrate Court-III, Kottayam, seek to quash the proceedings in the said case.

5. In Crl.M.C.No.2335/2020, the accused Nos.1 & 2 in C.C.No.1641/2018 on the files of the Judicial First Class Magistrate Court-III, Thiruvananthapuram, seek to quash the proceedings in the said case.

6. In Crl.M.C.No.5375/2017, the accused Nos.1 to 4 in S.T.No.830/2021 on the files of the Judicial First Class Magistrate Court, Kalpetta (formerly pending before the Chief Judicial Magistrate Court, Kalpetta as S.T.No.521/2016), seek to quash the proceedings in the said case.

7. In Crl.M.C.No.2019/2025, the accused Nos.1 to 3 in C.C.No.122/2022 on the files of the Judicial First Class Magistrate Court–I, Chenganur, seek to quash the proceedings in the said case.

8. In Crl.M.C.No.1312/2020, the second accused in C.C.No.396/2019 on the files of the Chief Judicial Magistrate Court, Manjeri (formerly numbered as C.C.No.267/2018 before the same court), seeks to quash the proceedings in the said case.

9. In Crl.M.C.Nos.4435 & 4436/2013, the accused Nos.1 & 2 in C.C.Nos.282/2007 on the files of the Chief Judicial Magistrate Court, Manjeri, seek to quash the proceedings in the said case.

10. In Crl.M.C.No.2707/2017, the accused Nos.1 & 2 in C.C.No.1461/2016 on the files of the Judicial First Class Magistrate Court, Koothuparamba, seek to quash the proceedings in the said case.

11. In Crl.M.C.No.6859/2014, the accused in C.C.No.1533/2013 on the files of the Judicial First Class Magistrate Court-I, Hosdurg, seek to quash the proceedings in the said case.

12. In Crl.M.C.No.6843/2014, the accused Nos.1 & 2 in C.C.No.582/2011 on the files of the Judicial First Class Magistrate Court, Karunagappally, seek to quash the proceedings in the said case.

13. In Crl.M.C.No.7499/2018, the accused Nos.1 & 2 in C.C.No.1126/2016 on the files of the Judicial First Class Magistrate Court-III, Thiruvananthapuram, seek to quash the proceedings in the said case.

14. In Crl.M.C.No.6445/2017, the accused in C.C.No.70/2013 on the files of the Chief Judicial Magistrate Court, Thrissur, seek to quash the proceedings in the said case.

15. In Crl.M.C.No.7084/2024, the accused Nos.1 to 3 in C.C.No.261/2018 on the files of the Judicial First Class Magistrate Court, Kunnamangalam, seek to quash the proceedings in the said case.

16. In all the cases mentioned above, the gazette notifications of the appointment of the Drug Inspectors concerned were made only at the time when they were inducted to the service. The cases were booked by those Drug Inspectors after their transfer and posting by the Drugs Controller to the places concerned. In other words, there was no gazette notification made, stating that the areas, including the place from where the samples were collected, were assigned to them for the exercise of their duties. However, the proceedings and orders passed by the Drugs Controller, transferring and posting the Drug Inspectors concerned to the respective places from where the cases have been booked, are produced before the Trial Courts in almost all cases.

17. Likewise, the gazette notifications appointing Government Analyst for such areas, including the place from where the Drug Inspector took the samples, were not produced, obviously for the reason that no such gazette notifications were effected.

18. According to the petitioners, the aforesaid drawbacks in publishing the appointments of the Drug Inspectors and Government Analysts as required under Sections 21 & 20 respectively of the Act, would vitiate the prosecutions launched against them. For the above reasons inter alia, the petitioners seek to terminate the criminal prosecutions pending against them in the various courts mentioned in paragraph Nos. 2 to 15 hereinabove.

19. Heard the learned counsel representing the petitioners in all these cases, the learned Additional Director General of Prosecution and the learned Public Prosecutor representing the State of Kerala.

20. Section 32 of the Act deals with the persons and authorities under whose complaint the court concerned could take cognizance of the offences coming under Chapter IV of the Act. For the sake of convenience and easy reference, the aforesaid Section is extracted hereunder:

                  “Cognizance of offences- (1) No prosecution under this Chapter shall be instituted except by

                  (a) an Inspector; or

                  (b) any gazetted officer of the Central Government or a State Government authorised in writing in this behalf by the Central Government or a State Government or by a general or special order made in this behalf by that Government; or

                  (c) the person aggrieved; or

                  (d) a recognised consumer association whether such person is a member of that association or not.

                  (2) xxx xxx xxx

                  (3) xxx xxx xxx”

21. It is clear from the above Section of the Act that the Inspector concerned is the authority in first priority to institute the criminal prosecution in respect of an offence punishable under Chapter IV of the said Act. Going by the definition clause under Section 3(e)(ii) of the Act, an Inspector shall be appointed by the Central Government or State Government under Section 21 of the Act.

22. Section 21 of the Act, which is of prime importance in the adjudication of the issues involved in these cases, is extracted hereunder:

                  “21. Inspectors.—(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.

                  (2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or [classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.

                  (3) No person who has any financial interest [in the import, manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector under this section.

                  (4) Every Inspector shall be deemed to be a public servant within the meaning of Section 21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such authority [having the prescribed qualifications,] as the Government appointing him may specify in this behalf.]”

23. A reading of Sub-Section (1) of Section 21 of the Act will make it clear that the appointment of Inspectors shall be made by notification in the official gazette specifying the areas assigned to them for the exercise of their duties as Inspectors. Admittedly, in none of the cases mentioned above in paragraph Nos. 2 to 15, the appointment of the Drug Inspectors concerned who lodged the complaint, were made in the official gazette specifying the areas in which the above Drug Inspectors were to exercise their powers and discharge their duties. True that the initial appointment of those Drug Inspectors at the time when they were recruited to the State service, were made in the official gazette. However, those officers were later on transferred to various places under the orders of the Drugs Controller, and the aforesaid cases were booked by them after their postings to such places, which were admittedly not notified in the official gazette.

24. The learned Additional Director General of Prosecution has placed before me for perusal a gazette notification dated 06.03.2026, in which G.O.(P)No.30/2026/H&FWD dated 05.03.2026 (SRO No.314/2026) has been published in respect of the appointment of 57 Drug Inspectors in various offices across the State of Kerala. In the above gazette notification, the local area of jurisdiction of all those Drug Inspectors is shown as the whole State of Kerala. Thus, it is argued that Drug Inspectors are now appointed by notification in the official gazette, specifying the area assigned to them as the ‘whole State of Kerala’. For the above reason the prosecution would argue that, once the appointments of Drug Inspectors are made notifying their area of jurisdiction in the gazette concerned as the ‘whole State of Kerala’, there is no need to effect gazette notifications each and every time when they are transferred and posted to various places. The aforesaid argument is of no help for the prosecution as far as the present cases are concerned. The gazette notification effected on 05.03.2026 in respect of the appointments of certain Drug Inspectors assigning their area of jurisdiction as the ‘whole State of Kerala’, cannot be said to be having retrospective effect to cover up the omission in effecting the gazette notifications showing the appointment and area of jurisdiction of the Drug Inspectors concerned who had lodged these complaints on yester years. Therefore, the argument advanced by the learned Additional Director General of Prosecution, upon the strength of the aforesaid gazette notification, is totally untenable.

25. The legal aspect as to the necessity for publication of a matter in official gazette, when a statute requires such publication to be effected, has been dealt with by the Hon’ble Supreme Court in B.K.Sreenivasan and Another v. State of Karnataka and Others [(1987) 1 SCC 658]. The relevant paragraph in the aforesaid judgment of the Hon’ble Supreme Court is extracted hereunder:

                  “15. There can be no doubt about the proposition that where a law, whether Parliamentary or Subordinate, demands compliance, those that are governed must be notified directly and reliably of the law and all changes and additions made to it by various processes. Whether law is viewed from the standpoint of the 'conscientious good man' seeking to abide by the law or from the' standpoint, of Justice Holmes's 'Unconscientious bad man' seeking to avoid the law, law must be known, that is to say, it must be so made that it can be known. We know that delegated or subordinate legislation is all pervasive and that there is hardly any field of activity where governance by delegated or subordinate legislative powers is not as important if not. more important, than governance by Parliamentary legislation. But unlike Parliamentary legislation which is publicly made, delegated or subordinate legislation is often made unobtrusively in the chambers of a Minister, a Secretary to the Government or other official dignitary. It is, therefore, necessary that subordinate legislation, in order to take effect, must be published or promulgated in some suitable manner, whether such publication or promulgation is prescribed by the parent statute are not. It will then take effect from the date of such publication or promulgation. Where the parent statute prescribes the mode of publication or promulgation that mode must be followed. Where the parent statute is silent, but the subordinate legislation itself prescribes the manner of publication, such a mode of publication may be sufficient, if reasonable. If the subordinate legislation does not prescribe the mode of publication or if the subordinate legislation prescribes a plainly unreasonable mode of publication, it will take effect only when it is published through the customarily recognised official channel. namely, the Official Gazette or some other reasonable mode of publication. There may be subordinate legislation which is concerned with a few individuals or is confined to small local areas. In such cases publication or promulgation by other means may be sufficient. See Narayana Reddy v. State of Andhra Pradesh, 1969 (1) Andh WR 77.”

                  In the aforesaid decision, the Hon’ble Supreme Court has emphasised the mandatory nature of the requirement to effect publication of a matter in official gazette when the legislation concerned requires it to be so done.

26. The proposition of law in the above regard has been followed by the Hon’ble Supreme Court in ITC Bhadrachalam Paper Boards and Another v. Mandal Revenue Officer, A.P and Others [(1996) 6 SCC 634].

27. As regards the requirement to effect publication in the mode prescribed by the statute it has been held by the Hon’ble Supreme Court in Gulf Goans Hotels Co. Ltd. and Another v. Union of India and Others [(2014) 10 SCC 673] that if the legislation prescribes any mode of publication it has to be scrupulously followed. The relevant paragraph in the aforesaid decision of the Hon’ble Apex Court is extracted hereunder:

                  “20. It will not be necessary to notice the long line of decisions reiterating the aforesaid view. So far as the mode of publication is concerned, it has been consistently held by this Court that such mode must be as prescribed by the Statute. In the event the Statute does not contain any prescription and even under the subordinate legislation there is silence in the matter, the legislation will take effect only when it is published through the customarily recognized official channel, namely, the Official Gazette B.K. Srivastava v. State of Karnataka 1987 (1) SCC 658 . Admittedly, the 'guidelines' were not gazetted.”

                  The same position of law has been reiterated by the Hon’ble Supreme Court in Union of India and Others v. M/s. G.S. Chatha Rice Mills and Another [(2021) 2 SCC 209].

28. Following the law laid down by the Hon’ble Supreme Court in Babu Varghese v. Bar Council of Kerala [(1999) 3 SCC 422] that if the manner of doing a particular act is prescribed under any statute, that act must be done in that manner, or not at all, it has been held by the Apex Court in Nabha Power Limited v. Punjab State Power Corporation Ltd. [(2025) 5 SCC 353] that the publication of an exemption under the Customs Act in official gazette, as required by the statute, is imperative to give effect to that exemption. The relevant portion of the judgment of the Hon’ble Supreme Court is extracted hereunder:

                  “56. It will be very clear that for an exemption under the Customs Act to operate thereon there has to be a notification issued in the manner provided by the Customs Act and duly published in the Official Gazette. It is so well-settled that if a certain thing has to be done in a certain manner, it shall be done in that manner or not at all. (See Babu Verghese v. Bar Council of Kerala [Babu Verghese v. Bar Council of Kerala, (1999) 3 SCC 422] , relying on Taylor v. Taylor [Taylor v. Taylor, (1875) LR 1 Ch D 426] and Nazir Ahmad v. King Emperor [Nazir Ahmad v. King Emperor, 1936 SCC OnLine PC 41 : AIR 1936 PC 253 (2) : (1935-36) 63 IA 372] .)”

29. In the light of the settled proposition of law in the above regard about the indispensable nature of the requirement to have gazette notification to give effect to a legislation, if it is so prescribed, the prosecution cannot be heard to say that the requirement under Section 21 of the Act to effect gazette notification of the appointment of Inspectors specifying the areas assigned to them, is not of mandatory nature.

30. The learned Additional Director General of Prosecution and the learned Senior Public Prosecutor representing the State of Kerala pointed out that the the proceedings initiated by the Drug Inspectors concerned will not be rendered nugatory for the sole reason that the appointments of those Drug Inspectors in the respective areas assigned to them, were not published in the official gazette, since the above Drug Inspectors were competent and qualified in all other respects to initiate the proceedings and to launch the criminal prosecution against the petitioners herein. It is thus argued that the principles embodied under the ‘defacto doctrine’ would afford adequate protection to the acts of the Drug Inspectors initiating proceedings against the petitioners herein for the manufacture of Drugs which were not of standard quality. The law laid down by the Hon’ble Supreme Court in Gokaraju Rangaraju v. State of AP [(1981) 3 SCC 132] has been relied on by the prosecution in support of the aforesaid argument.

31. The contingency in which the ‘defacto doctrine’ comes into play could be explained in simple terms as follows:

                  a) The law prescribes a particular formality or requirement to be fulfilled as a pre-requisite for the performance of an act, exercise of authority, initiation of proceedings etc., by an authority or officer.

                  b) The authority or officer, legally competent in all other respects except for the fulfillment of such legal formality or requirement prescribed by law, proceeds with the performance of such act, initiation of proceedings, exercise of powers etc.

                  c) The above performance of act, initiation of proceedings, exercise of powers etc., by the authority or the officer results in consequences directly related to the subject matter of litigations and issues between parties other than the authority or officer who performed the act, initiated the proceedings, or exercised the powers.

                  In such a situation, the non-fulfillment of the formality or requirement which the law had prescribed for the authority or the officers to function in their respective capacities, need not be taken as a legal infirmity which would vitiate the merits of the decisions taken, issues resolved or litigations decided in between third parties. The purpose sought to be achieved by this principle is to avoid gross and irreparable hardships, sufferings and chaos which might be caused due to overturning the status quo on technicalities.

32. The ‘defacto doctrine’ is based on public policy, good sense and practical experience to prevent public and private mischief, and the protection of public and private interest. It is intended to avoid confusion and needless chaos which might be caused by mechanical and technical application of formalities which otherwise would not have any impact on the results caused. For instance, the acts of the officers defacto performed by them within the scope of their assumed official authority, in the interests of the public or third persons and not for their own benefit, are generally valid and binding, as if they were the acts of officers de jure. An illegal appointment may be set aside and proper appointment may be made, but the acts of those who held office are not so easily undone since it might lead to everlasting repercussions and confusing sequels if attempted to be undone. It is the above principle of law contained in ‘defacto doctrine’ which the Hon’ble Supreme Court has applied in Gokaraju Rangaraju (supra), which was a case in which the validity of the judgments rendered by certain Sessions Judges were challenged stating the reason that the appointments of those Sessions Judges were later on set aside for non-compliance of Article 233 of the Constitution of India. In the aforesaid decision, the Hon’ble Supreme Court held that the judgments and orders passed by those Sessions Judges would continue to be valid as the judgments and orders of the Court of Sessions, notwithstanding that their appointments were declared invalid.

33. The ‘defacto doctrine’ which was applied in Gokaraju Rangaraju (supra) has been followed in various decisions of the Apex Court and High Courts. In Veerendra Kumar Gautham and Others v. Karuna Nidhan Upadhyay and Others [(2016) 14 SCC 18], where the Hon’ble Supreme Court dealt with the scope of the aforesaid doctrine while deciding the appointments made by the Uttar Pradesh Higher Education Service Commission to the posts of Principals and Teachers to various colleges, it has been held by the Hon'ble Apex Court as follows:

                  “26. It is no doubt well settled that the acts of the officers de facto performed by them within the scope of their assumed authority in the interest of the public or the third persons and not for their own benefits are generally held valid and binding as if they were the acts of the officers de jure. A reading of the said paragraph does not give an omnibus authority even while applying de facto doctrine to hold that every illegal acts or acts performed which smacks of very many illegalities and incongruities should be merely ignored and validated. It has to be kept in mind that even while applying the de facto doctrine whether such acts performed were aimed at the prevention of public and private mischief and for the protection of public and private interest. The doctrine is intended to prevent invalidation of Acts, such as appointments, on the sole ground that they were performed without de jure authority. Therefore, keeping the well thought out principles set down in the said judgment in mind when we examine the approach of the Division Bench we find that the Division Bench having noted that the respondents 4 to 9 in the writ petition ceased to hold office had to necessarily not deal with the challenge made to their appointment for issuance of quo warranto. It also rightly applied the de facto doctrine but the approach of the Division Bench in stating that even while applying the de facto doctrine, the selection made required deeper scrutiny cannot be held to be improper. It must be stated that the allegations as against the appointment of respondents 4 to 9 as members of the Commission were not without any basis. The Division Bench also noted the fact that the details of respondents 4 to 9 disclosed that except respondent No.9, the other respondents viz., 4 to 8 were working as Readers in different post graduate and degree colleges in the State of U.P. The scale of pay drawn by them was far less than the scale of pay of Principal, for which post, the selection process was initiated. It was also noted that one of the members viz., one Shri Ramveer Yadav was working as Reader in Narayan College, Firozabad, was also an applicant for the post of Principal pursuant to the Advertisement No.36 of 2003. The Division Bench has also noted that all the above members came to be appointed on the basis that they satisfied the qualification viz., "an eminent person having made valuable contribution in the field of education". The Division Bench though did not want to proceed with the writ of quo warranto yet found that when such challenge is made with reference to the appointment of respondents 4 to 9 as members of the Commission, had substantial basis in making the challenge. Therefore, though, it had to apply the de facto doctrine, thought it fit to make a strict scrutiny of the entirety of the selection procedure.”

34. The principles embodied in ‘defacto doctrine’ cannot be applied in the cases on hand since the Drug Inspectors concerned, whose acts are sought to be protected under the aforesaid doctrine, are parties to the issues involved in those cases. It is very important to note that the privilege and protection of ‘defacto doctrine’ cannot be extended to such persons or authorities, who are parties to the issues and litigations which arose out of the acts and proceedings of those persons or authorities, performed in purported exercise of their powers. In other words, the Drug Inspectors concerned who lodged the complaints in the present cases cannot be termed as third parties not interested in the results of the litigations, to claim the benefit of ‘defacto doctrine’. Therefore, the argument advanced from the part of the prosecution that the failure to make gazette publication of the notification of appointment of the Drug Inspectors concerned deserves the protection of ‘defacto doctrine’, is devoid of merit.

35. As regards the challenge relating to the failure to effect gazette notification of the appointment of Government Analysts in compliance with Section 20 of the Act, the argument advanced from the part of the prosecution under the strength of the ‘defacto doctrine’, has to be accepted. This is because of the reason that the Government Analysts concerned were qualified in all other respects to carry on the laboratory analysis of the drugs sent to them as sample, and they stand on their footing as third parties in the litigations between the Drug Inspectors and the petitioners herein. The mere technicality in not effecting the gazette notification of the appointment of the Government Analysts, cannot be taken as a reason vitiating the entire prosecution proceedings, in view of the larger public interest and health safety of the citizens sought to be achieved by the proceedings. However, when it comes to the legal competence which the law prescribes for a complainant to institute proceedings against the accused, the requirement to have gazette notification of the appointment of the complainants to exercise their powers and perform their duties over the area specified thereunder, cannot be put under the carpet by extending the benefits of ‘defacto doctrine’ to them also. As a conclusion to the aforesaid discussions, I find that the criminal prosecutions launched against the petitioners herein cannot survive, since the complainants who launched those prosecutions lacked the authority which the law prescribed.

                  In the result, all these petitions stand allowed as follows:

                  (i) The accused are discharged from the criminal prosecution launched against them in C.C.No.48/2008 on the files of the Chief Judicial Magistrate Court, Ernakulam.

                  (ii) All proceedings pending against the accused in C.C.No.364/2014 of the Chief Judicial Magistrate Court, Thrissur, are hereby quashed.

                  (iii) All proceedings pending against the accused in S.T.No.1223/2014 of the Judicial First Class Magistrate Court-III, Kottayam, are hereby quashed.

                  (iv) All proceedings pending against the accused in C.C.No.1641/2018 of the Judicial First Class Magistrate Court-III, Thiruvananthapuram, are hereby quashed.

                  (v) All proceedings pending against the accused in S.T.No.830/2021 on the files of the Judicial First Class Magistrate Court, Kalpetta, are hereby quashed.

                  (vi) All proceedings pending against the accused in C.C.No.122/2022 of the Judicial First Class Magistrate Court-I, Chengannur, are hereby quashed.

                  (vii) All proceedings pending against the accused in C.C.No.396/2019 of the Chief Judicial Magistrate Court, Manjeri, are hereby quashed.

                  (viii) All proceedings pending against the accused in C.C.No.282/2007 of the Chief Judicial Magistrate Court, Manjeri, are hereby quashed.

                  (ix) All proceedings pending against the accused in C.C.No.1461/2016 of the Judicial First Class Magistrate Court, Koothuparamba, are hereby quashed.

                  (x) All proceedings pending against the accused in C.C.No.1533/2013 of the Judicial First Class Magistrate Court-I, Hosdurg, are hereby quashed.

                  (xi) All proceedings pending against the accused in C.C.No.582/2011 of the Judicial First Class Magistrate Court, Karunagappally, are hereby quashed.

                  (xii) All proceedings pending against the accused in C.C.No.1126/2016 of the Judicial First Class Magistrate Court-III, Thiruvananthapuram, are hereby quashed.

                  (xiii) All proceedings pending against the accused in C.C.No.70/2013 of the Chief Judicial Magistrate Court, Thrissur, are hereby quashed.

                  (xiv) All proceedings pending against the accused in C.C.No.261/2018 of the Judicial First Class Magistrate Court, Kunnamangalam, are hereby quashed.