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Rajasthan High Court · body

2014 DIGILAW 2068 (RAJ)

Alpha Laboratories, Pigdamber v. State of Rajasthan

2014-12-10

SANDEEP MEHTA

body2014
JUDGMENT 1. - Heard learned counsel for the parties. 2. The instant misc. petition has been filed on behalf of the petitioners seeking quashing of the proceedings of the Complaint No.8/2011 (835/2007) pending in the Court of learned Chief Judicial Magistrate, Bikaner for the offence under Sections 18(a)(1) read with 16(1)(a) and 18A(vi), 18B and 22(1)(cca) of the Drugs and Cosmetics Act, 1940 (referred to herein after as 'the Act of 1940'). 3. Succinctly stated facts of the case are that the Drug Control Officer, Bikaner filed a complaint in the Court of learned Chief Judicial Magistrate, Bikaner on 14.12.2007 for the offences under the provisions of the Act of 1940. A chronological list of events relevant for the disposal of the instant misc. petition and as set out in the complaint is enumerated herein below:- 27.5.2004 The Drug Control Officer, Bikaner inspected a shop named M/s.Guru Krishna Medical Store, Chhatargarh in presence of its owner Mr.Ramswaroop. He collected three samples of drug named "Inflamol ZX' (analgesic, antiinflammatary and muscle relaxant tablet) manufactured by the petitioner no.1 M/s. Alpha Laboraties and forwarded one part for analysis to the Government analyst under Section 22 of the Act of 1940. 17.8.2005 The Government analyst, vide his report dated 17.8.2005 opined that the sample of the drug was below standard as it did not conform to the claim with regard to disintegration of the drug. 9.9.2005 A corrigendum was issued by the Government analyst on 9.9.2005 that the date of manufacture of the drug analysed at the laboratory was October, 2002 and date of its expiry was September, 2005. 29.8.2005 After receiving the analysis report, the accused no.1 i.e. vendor, was sent a communication dated 29.8.2005 to provide the purchase details of the drug in question. The accused no.1 i.e. vendor informed that the drugs were purchased from the accused no.4 M/s. Man Medicos, Bikaner. 26.9.2005 M/s. Man Medicos, Bikaner, accused no.4, was sent a communication dated 26.9.2005 along with the test report and one part of the sealed sample. The dealer was also instructed to supply details of its procurement of the drugs. The dealer informed that it had procured the drug from M/s. Singhi Medicos, Jodhpur (accused no.8). 20.10.2005 The accused no.8, M/s. Singhi Medicos, was forwarded a copy of the analysis report vide letter dated 20.10.2005 and was also instructed to supply details of its procurement of the drug. The dealer informed that it had procured the drug from M/s. Singhi Medicos, Jodhpur (accused no.8). 20.10.2005 The accused no.8, M/s. Singhi Medicos, was forwarded a copy of the analysis report vide letter dated 20.10.2005 and was also instructed to supply details of its procurement of the drug. 4.11.2005 The accused no.8 in turn informed that the drug in question was procured from M/s. Panjon Pharma Ltd., Jodhpur (accused no.11). 23.11.2005 The accused no.11, M/s. Panjon Pharma Ltd., Jodhpur, was forwarded a copy of the test report vide letter dated 23.11.2005 and was also instructed to supply details of its procurement of the drug. The said letter returned back with a note that the premises were locked. 9.1.2006 Ultimately, another letter was sent to the accused no.11 to which it replied that the drug had been purchased from M/s. Panjon Pharma Ltd., Indore (accused no.13). 24.1.2006 The accused no.13, M/s. Panjon Pharma Ltd., Indore was forwarded a copy of the test report vide letter dated 24.1.2006 and was also instructed to supply details of its procurement of the drugs. 5.5.2006 The accused no.13 vide its letter dated 5.4.2006 informed that the drugs in question had been procured from M/s.Alpha Laboratories, Pigdambar, the petitioner no.1 herein, (accused no.16). 12.5.2006 The accused no.16, the petitioner no.1 herein, was forwarded a copy of the test report vide letter dated 12.5.2006 and was asked to submit its explanation regarding the drug manufactured by it being found sub-standard upon analysis. 25.5.2006 The petitioner no.1 being the manufacturer, replied to the letter of the Drug Control Officer vide its letter dated 25.5.2006 and sought one part of the sample so as to ascertain whether or not the drugs in question had been manufactured by it. 14.6.2006 The Drug Control Officer vide its letter dated 14.6.2006 replied that the drug sample could not be sent to the manufacturer. 15.6.2006 The petitioner no.1 by its letter dated 15.6.2006 communicated to Drug Control Officer that when it received the information about the drug in question being found substandard on analysis, by that time, the expiry date of drug had lapsed by 9 months and thus, the right to get the second sample analysed from the Central Drugs Laboratory had been infringed. 14.12.2007 Nonetheless, the communications continued to be exchanged between the Drug Control Officer and the accused and ultimately, the Drug Control Officer filed the complaint in question against the vendor, dealer, distributor and the manufacturer of the drug on 14.12.2007 in the Court of Chief Judicial Magistrate, Bikaner for the offences under the provisions of the Act of 1940. 4. The petitioners have now approached this Court by way of the instant miscellaneous petition seeking quashing of proceedings of the complaint on the ground of violation of their right to have the second sample of the drug analysed through the Central Drugs Laboratory as per Section 25 of the Act of 1940. 5. Mr.Sanjay Mathur, learned counsel for the petitioner vehemently contended that as per the admitted case set out in the complaint, the drug in question was manufactured in October, 2002 and the expiry date thereof was September, 2005. The sample was purchased by the Drug Control Officer from the vendor i.e. accused no.1 in May, 2004. The Government analyst analysed the sample and forwarded its report on 17.8.2005 i.e. after nearly 1 year and four months from the sample being drawn. Thereafter, a corrigendum was issued on 9.9.2005 by which time, the expiry date of the drug had already arrived. He submitted that all the communications sent to the petitioners regarding the drugs in question being sub-standard were forwarded after the expiry date of the drug and thus, the petitioners have been deprived of their statutory right to have the second sample of the drug analyzed through the Central Drugs Laboratory as provided under Section 25(4) of the Act of 1940. Right to have the second drug sample retested from the Central Drugs Laboratory is a mandatory right available to every person against whom a prosecution under the provisions of the Act of 1940 is proposed and the infringement thereof leads to the proceedings being vitiated. He thus prayed that the proceedings of the complaint are liable to be quashed. 6. Per contra, learned Public Prosecutor vehemently opposed the submissions advanced on behalf of the petitioners and submitted that there was no delay on the part of the Drug Control Officer in initiating the prosecution. It was submitted that the manufacturer is not entitled to challenge the report of the State Government analyst by invoking the provisions of Section 25(4) of the Act of 1940. It was submitted that the manufacturer is not entitled to challenge the report of the State Government analyst by invoking the provisions of Section 25(4) of the Act of 1940. The said right is only available to the vendor and dealer. They did not make any prayer to challenge the report of the Government analyst. He, therefore, submitted that no interference is called for in the matter for quashing the proceedings by exercising the inherent powers of this Court. 7. Heard and considered the arguments advanced at the bar and perused the material available on the record.The Hon'ble Apex Court in the case of M/s. Medicamen Biotech Ltd. & Anr. v. Rubina Bose, Drug Inspector, AIR 2008 SC 1939 dealing with the provisions of the Drugs and Cosmetics Act, 1940 held that delay in intimating the accused about the report of the Government Analyst, which results in the expiry date of the drug being lapsed, tantamounted to denial of exercise of right by the accused to challenge the report of the Government Analyst under Section 25 of the Act, and vitiates the proceedings. The Hon'ble Apex Court in the above cited judgment held as below: "We find that the aforesaid interpretation supports the case of the appellants inasmuch they had been deprived of the right to have the fourth sample tested from the Central Drugs Laboratory. It is also clear that the complaint had been filed on the 2nd July 2002 which is about a month short of the expiry date of the drug and as such had the accused-appellant appeared before the Magistrate even on 2nd July 2002 it would have been well nigh impossible to get the sample tested before its expiry. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9th May 2005. This is begging the question. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9th May 2005. This is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf-life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the; notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for re-testing of the drug had been made by the appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for re-testing well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellants have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them." This Court examined the issue in detail in the case of Cadila Healthcare Ltd. & anr. v. State of Rajasthan & anr. (S.B. Crl. Misc. Petition No.205/2009) decided on 23.5.2012 and held that failure to intimate the accused about the report of the State analyst within a reasonable time of the expiry date has the effect of deprivation of the right available to all the accused who desire to challenge the report of the State analyst by having the second sample retested through the Central Drugs Laboratory. This Court held that the manufacturer too has the right to be intimated about the report of the State Analyst and to challenge its report under Section 25(3) of the Act.In the case at hand, the facts are graver. Herein, the first intimation, to the petitioner being the manufacturer, regarding the drugs in question being sub-standard, was sent nine months after the expiry date of the drug had lapsed. Herein, the first intimation, to the petitioner being the manufacturer, regarding the drugs in question being sub-standard, was sent nine months after the expiry date of the drug had lapsed. The petitioner immediately informed the Drug Control Officer of its intention to challenge the report of State analyst by having the second sample analysed from the Central Drugs Laboratory but by that time, the expiry date of drug had already lapsed. Thus, it is obvious that the delay which has been occasioned by the prosecution in communicating the report of the Government Analyst to the petitioners resulted into them being deprived of the statutory right to challenge the report of the Government Analyst as provided under Sections 25(3) and 25(4) of the Act and thus, the prosecution of the petitioners in this case is vitiated.As a consequence of the above discussion, this Court has no hesitation in holding that the petitioners' prosecution in this case for the offences under the Act of 1940 is not permissible and is liable to be quashed.Resultantly, the misc. petition deserves to be and is hereby allowed. The proceedings of the complaint no.8/2011 (835/2007) pending in the Court of Chief Judicial Magistrate, Bikaner are illegal and amount to abuse of process of court and thus are hereby quashed qua the petitioners only. The proceedings shall however continue against the other accused. It is made clear that none of the observations made herein above shall prejudice the case of either the prosecution or the remaining accused at the trial.Stay petition also stands disposed of.Petition Allowed. *******