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2022 DIGILAW 170 (JK)

K. K. Patel (Dr. ) v. Union of India

2022-04-19

JAVED IQBAL WANI

body2022
JUDGMENT : (Javed Iqbal Wani, J.) : 1. Inherent jurisdiction of this Court under section 561-A (now 482 Cr.P.C.) is being invoked by the petitioners seeking quashment of proceedings in criminal complaint (for short impugned complaint) filed under sections 18(a)(i) read with section 27(d) of the Drugs and Cosmetics Act, 1940 (for short the Act) titled as "Union of India v. Dr. K.K. Patel & Ors." as also order dated 16.09.2016 (for short the impugned order) pending before the court of Chief Judicial Magistrate, Jammu (for short the trial court). 2. According to the petitioners the impugned complaint came to be filed by the respondent No. 1 herein before the trial court against the petitioners herein and on the basis of which, the trial court is stated to have taken cognizance and issued process against the petitioners herein in terms of the impugned order after observing that prima-facie offences under section 18(i)(a) read with Section 27(d) of the Act are committed by the petitioners herein. 3. It is alleged in the impugned complaint that the complainant/petitioners herein being Drug Inspector appointed under the Act and in exercise of his power therein conducted a routine inspection on 25.04.2013 at District Anantnag, while visiting the premises of M.M.A.B.M District Hospital, Anantnag and after disclosing her identity found huge stock of Drugs namely Midanir-1000 (Ceftriaxone Injection IP) Batch No. 1012043A, Mfg. date 06-2014, Exp. date 05-2014 lying there for sale and distribution and lifted samples of drugs for testing/analysis while expressing her intention to do so. The drug is stated to have been divided and sealed into 4 portions and whereafter sent one sealed sample portion of the drug in question to Government Analyst C.D.L. Kolkata. A certificate of Test dated 18.07.2013 is stated to have been received from the Government Analyst C.D.L. Kolkata under section 25(1) of the Act of 1940 declaring the drug not of 'standard quality' and not conforming to B.P with respect to assay of Midazolam and PH only. 4. It is stated in the complaint that after receipt of the aforesaid test report, the complainant vide letter dated 30.07.2013 directed Medical Superintendent M.M.A.B.M District Hospital Anantnag to submit the details of the dealer from whom the drug in question has been purchased. A copy of the test report is stated to have been furnished to Medical Superintendent along with the said letter. A copy of the test report is stated to have been furnished to Medical Superintendent along with the said letter. The Medical Superintendent in response to the aforesaid letter is stated to have submitted the record of purchase with regard to the drug in question to the complainant, revealing that the drug in question has been supplied and distributed to the Superintendent by Provincial Medical Store Baramulla, whereafter Notice dated 17.10.2013, is stated to have been issued by the complainant/respondent herein to the said Medical Store for disclosing the name of the person/dealer from whom the drug has been purchased and in response thereto the said Medical Store vide Reply dated 19.11.2013 is stated to have disclosed that the drug in question has been supplied by Caulson and Co. Trikuta Nagar, Jammu and whereafter a notice Dated 27.11.2013 is stated to have been issued to the said Caulson and Co., by the complainant asking for disclosing the name of the dealer from whom drug in question had been purchased and in response whereof it is stated to have been disclosed vide Reply dated 02.12.2013 that the same had been purchased from M/s Anshul Medicos, Amritsar and whereafter again notice dated 03.12.2013 is stated to have been issued to said M/s Anshul Medicos by the complainant for disclosing the name of the dealer/manufacturer from whom the drug in question had been purchased, in response whereof it is stated to have been disclosed vide Reply dated 11.12.2013 that the drug in question had been purchased from the accused company. 5. It is further stated in the complaint that the complainant after receiving the aforesaid information issued a notice vide Letter dated 16.12.2013 and sent through registered post, informing the accused persons/petitioners herein about the report of the Government Analyst and directed the accused persons to submit manufacturing, stock, purchase and sale record of the drug. A copy of the said report is stated to have been furnished by the complainant to the accused persons/petitioners herein. 6. It is next stated in the complaint that accused company replied to the complainant vide letter dated 15.01.2014 while submitting desired documents made a request for re-examination of drug in question, even though the drug had been tested from C.D.L Kolkata. 7. 6. It is next stated in the complaint that accused company replied to the complainant vide letter dated 15.01.2014 while submitting desired documents made a request for re-examination of drug in question, even though the drug had been tested from C.D.L Kolkata. 7. It is further stated in the complaint that during the pendency of the matter, a joint investigation was undertaken by the Department and a detailed report submitted to the office of Assistant Drug Controller Sub Zone Jammu, whereafter completing the said investigation, the complainant found that the Accused No. 7 is that manufacturing company of the drug in question and Accused No. 1 and 2 as Chairman and Managing Director of the said company and Accused No. 3 the Plant Head of the Company manufacturing process, whereas Accused Nos. 4 to 6 as company assurance in charge of the accused company and that the drug in question had been manufactured and distributed under the direct supervision of the accused persons. 8. The petitioners have maintained the instant petition on multiple grounds, yet the counsel for the petitioners while making his submissions in tune and line with the case setup in the petition would confine his arguments to a sole fundamental ground that after receiving information from the complainant/respondent herein by the petitioners on 26.12.2013 about the alleged sub-standard quality of the drug in question, the petitioners-company vide Letter dated 15.01.2014 addressed to the complainant/respondent herein expressed its desire to exercise right of re-examination of sample of the drug in question under section 25(3) of the Act with an intention of adducing evidence in contravention of Government Analyst report and that the complainant/ respondent herein did not give opportunity to the petitioners- company to exercise the said legal right and instead proceeded to institute the impugned complaint. 9. According to the learned counsel under Section 25(1) of the Act a report of the Government Analyst is not a conclusive evidence. 10. According to the learned counsel for the petitioners the non-compliance of provisions of Section 25(3) of the Act renders the whole case setup by the respondent nullity and liable to dismissal in the light of law laid down by the Apex court in case titled as "Medicamen Biotech Ltd. & Anr. v. Rubina Bose, Drug Inspector reported in AIR 2008 SC 1939 ". 11. v. Rubina Bose, Drug Inspector reported in AIR 2008 SC 1939 ". 11. According to the learned counsel for the petitioners, under section 25(4) of the Act, the report of a sample drug issued under the authority of Director Central C.D.L. Kolkata, can alone be treated as a conclusive evidence of the facts stated therein and not the report of Government Analyst under an in terms of the Section 25(1) of the Act, more so when the said report is sought to be contravened by adducing evidence by the persons concerned in terms of Section 25(3) of the Act. 12. Per contra, counsel for the respondents would resist and controvert the submissions made by learned counsel for the petitioners and would insist that the impugned complaint has been validly filed and legally dealt with by the trial court. Heard learned counsel for the parties and perused the record. 13. Before proceeding further in the matter a reference to Section 25(3) of the Act becomes imperative and is, as such, extracted and reproduced hereunder: “25. Reports of Government Analysts:- (1) .................................................... (2) ................................................... (3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence 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 18A] 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 proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report." 14. Indisputably the sample of the drug has been lifted on 25.04.2013 by the complainant respondent herein. Record of the compliant reveals that drug in question reflected in Form-17 prepared by the complainant bears Batch No. 5H-10365 with Manufacturing dated August 2011 and Expiry date July 2013 with drug name Midazolam injection B.P. 15. Perusal of the record further reveals that same drug had been divided into 4 portions by the complainant in Form-17-A and then sent to C.D.L Kolkata, under Form 18 on 27.04.2013 and stands tested by it on 18.07.2013 and intimation thereafter sent to the petitioner company through registered post vide letter dated 16.12.2013. 16. Perusal of the record further reveals that same drug had been divided into 4 portions by the complainant in Form-17-A and then sent to C.D.L Kolkata, under Form 18 on 27.04.2013 and stands tested by it on 18.07.2013 and intimation thereafter sent to the petitioner company through registered post vide letter dated 16.12.2013. 16. All the forms be it, Form 17, Form 17-A or Form 18 reflected the Mfg date of the drug as August 2011 and Exp date as July 2013 so much so the test certificates received from the C.D.L. Kolkata dated 18.07.2013 also reflects the same date of manufacturing and expiry of the drug. Ironically complaint in Para 2 while referring to the drug in question has mentioned the drug with a different batch No i.e. 1012043A with Mfg. date as 06-2012 and Exp. date as 05-2014 as against the actual batch No. i.e. 5H-10365 with Mfg date August-2019 and Exp date July 2013. 17. Record reveals that as per the own showing, complainant has stated in the complaint that petitioners came to be informed about the sub standard quality of the drug on 16.12.2013 i.e. after the expiry date of the drug which is not denied to have been received by the petitioners herein on 26.12.2013 and consequently a response is stated to have been received from the accused petitioners herein by the complainant on 15.01.2014 requesting for re-examination of the drug in question. No explanation worth the name is expressed in the complaint as to why the complainant did not promptly and with due diligence instituted complaint following the mandatory requirement of the provisions of the Act after receipt of the report of the Government Analyst C.D.L. Kolkata on 18.07.2013. 18. Record further reveals that unexplained delay has been caused in conducting the proceedings and launching the prosecution. Even the complaint seemingly is filed in respect of a different drug with a different batch number as noticed in the preceding paras appearing in Para 2 of the complaint. The whole exercise undertaken by complainant respondent herein patently is misconceived and faulty. 19. Even the complaint seemingly is filed in respect of a different drug with a different batch number as noticed in the preceding paras appearing in Para 2 of the complaint. The whole exercise undertaken by complainant respondent herein patently is misconceived and faulty. 19. Be that as it may, fact remains that complainant respondent herein despite having received a request for re-testing of the drug in question by the petitioners herein in terms of Section 25(3) has declined the same and instead proceeded to file the complaint apparently in order to shun the responsibility while taking refuge under the orders passed by this Court in PIL No. 06/2013 which directed launching of prosecution against all concerned persons for violation under the Drug and Cosmetics Act, in terms of order dated 02.05.2014 which order per-se never meant to launch of prosecution in violation or in breach of the provisions of the Act. The delay having occasioned in the matter is not even attributed to the petitioners herein by the complainant/respondents herein. In the whole process the right of the petitioners herein envisaged under section 25(3) of the Act has been lost on account of callous, lackadaisical approach and conduct of the complainant/respondent herein. It was incumbent upon the complainant/ respondent herein to undertake appropriate proceedings upon receipt of the report from C.D.L. Kolkata diligently and without wasting any time and that the expiry date of the sample of the drug in question would have been relevant in order to safeguard the rights of the accused petitioners herein to communicate the accused petitioners about the test report well before the expiry date of the drug in question and to provide the accused persons the safeguard enshrined under section 25(3) of the Act. The callousness and negligence on the part of the complainant/respondent herein has rendered the whole case setup by the complainant mere academic, insignificant and inconsequent. The complainant has not only filed the misconceived complaint but has also defeated the right of the petitioner qua re-testing of the drug as envisaged under section 25(3) of the Act. The Apex court in case titled as "Medicamen Biotech Limited & Anr. The complainant has not only filed the misconceived complaint but has also defeated the right of the petitioner qua re-testing of the drug as envisaged under section 25(3) of the Act. The Apex court in case titled as "Medicamen Biotech Limited & Anr. v. Rubina Bose Drug Inspector reported in 2008 (7) SCC 196 " in relation to the Section 25(3) supra provided as follows: - "A reading of the aforesaid provisions would reveal that they lay certain obligations as well as provide safeguards for a person from whom a drug has been seized for analysis or testing as Section 25(3) specifies that unless such a person controverts the correctness of the report submitted by the Government Analyst within 28 days in writing that he intends to adduce evidence to controvert the report of the analyst, it would be deemed to be conclusive evidence of the quality of the drug whereas sub-section (4) of Section 25 obliges the Magistrate on the request of the complainant or the accused or on his own motion to send the fourth sample which has been disputed for fresh testing to the Director of the Central Drugs Laboratory." 20. For the foregoing reasons, the instant petition deserves to be allowed and is accordingly allowed, as a consequence whereof, the impugned complaint, proceedings initiated thereupon including the impugned of cognizance are set aside. 21. The judgements relied upon by counsel for the complainant/respondent herein, having regard to the aforesaid observations made by this court do not lend any support to the case of the complainant/respondent herein.