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Rajasthan High Court · body

2009 DIGILAW 1976 (RAJ)

Krishna Ballabh v. State of Rajasthan

2009-09-10

M.N.BHANDARI

body2009
JUDGMENT 1. - (Oral) - A challenge to the order dated 8th December, 1995 framing charges so also the order dated 8th September, 1999 rejecting the revision has been made in this petition filed under Section 482 Cr.RC. 2. It is contended that on 22nd December, 1988 the Drug Inspector purchased 12 bottles of Tr. OPII (hereinafter referred to as `the drug'). After purchase, it was divided in three samples each containing six bottles. The firm was given two samples and one sample was sent to the Government Analyst, Jaipur by the Drug Inspector. The Government Analyst, Jaipur sent the sample without marking analysis. The sample so received back was thereafter sent to Government Analyst, Central Indian Pharmacopaeia, Gaziabad on 22nd January, 1990. A report thereupon was received from Gaziabad on 15th June, 1990 and accordingly, an adverse report was sent to the petitioner firm on 28th July, 1990 (Ex.P/22). On receipt of the Government Analyst Report from Gaziabad, the petitioner firm made a notice under Section 25(3) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as `the Act'). The aforesaid notice dated 14th August, 1990 (Ex.P.32) under Section 25(3) of the Act was given within a period of 28 days from the date of receipt of the report from the Government Analyst, Gaziabad. Pursuant to the notice, the sample was sent to the Central Drug Laboratory, Calcutta. The laboratory test report dated 19th January, 1994 was given beyond the period of five years of drug life thus, could not have been relied upon by the trial court for framing charges against the petitioners. A reference to Rule 96(1) (vii) of The Drugs and Cosmetics Rules, 1945 (hereinafter referred to as 'the Rules') has been made to show that if any of the drugs is not mentioned in Schedule-P then its expiry date would not exceed the period of 60 months from the date of manufacture. It is thus, prayed that based on the report of the Central Drug Laboratory, Calcutta, the charges could not have been framed against the petitioners. Thus, the order framing charges so as the order passed on the revision may be quashed and set aside. 3. Learned Public Prosecutor supported the order framing charges and order passed on revision. 4. I have considered the rival submissions of the parties and perused the report. 5. Thus, the order framing charges so as the order passed on the revision may be quashed and set aside. 3. Learned Public Prosecutor supported the order framing charges and order passed on revision. 4. I have considered the rival submissions of the parties and perused the report. 5. It is a case where the drug was purchased and divided in three samples in the month of December, 1988 having manufacturing date of September, 1988. Initially the drug was sent to the Government Analyst, Jaipur and when it was returned back without marking, it was sent to Government Analyst, Gaziabad in the month of January, 1990. The report thereafter was received by the prosecution on 15th June, 1990 and accordingly it was informed to the petitioner firm on 28th July, 1990 (Ex.R22). As per the provisions of Section 25(3) of the Act, the petitioner firm issued notice showing its intention to adduce evidence in contra version of the report. Pursuant to the aforesaid, the sample was sent to the Central Drug Laboratory, Calcutta under the orders of the Chief Judicial Magistrate, Jaipur dated 27th July, 1993. The Central Drug Laboratory, Calcutta sent the report dated 19th January, 1994. The only contention raised by the learned counsel for the petitioners is that once Section 25(3) of the Act was invoked by the petitioners then in absence of the analysis report by the Central Drug Laboratory, the sample was required to be sent to Central Drug Laboratory as per Section 25(4) of the Act. In the present matter, the provision of Section 25(3) of the Act was invoked by the petitioner within a period of 28 days and the earlier report was not from the Central Drug Laboratory, the learned Chief Judicial Magistrate sent the third sample to the Central Drug Laboratory, Calcutta vide its order dated 27th July, 1993. Since the report from the Central Drug Laboratory is dated 19th January, 1994 the question raised is as to whether such report can be relied upon having been given after the expiry the date of the drug in reference. For that purpose my attention was drawn towards Rule 96(1)(vii) of the Rules wherein it has been provided that other than the drugs mentioned in Schedule-P all other drugs will have expiry date within a period of 60 months from the date of manufacture. For that purpose my attention was drawn towards Rule 96(1)(vii) of the Rules wherein it has been provided that other than the drugs mentioned in Schedule-P all other drugs will have expiry date within a period of 60 months from the date of manufacture. In the present matter, the date of manufacture is shown in September, 1988 and the drug in question is not scheduled in Schedule-R the maximum life of the drug as provided under Rule 96(1 )(vii) would be 60 months (five years). Thus, as per the Rules, expiry date of the drug comes to September, 1993 and in view of that the report submitted by the Central Drug Laboratory, Calcutta in the month of January, 1994 cannot be relied upon. For ready reference Section 25(3) and Section 25(4) of the Act along with Rule 96(1 )(vii) are being reproduced hereunder "25. Reports of Government Analysts- (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. (4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) 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 report in writing signed by or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein." "96. Manner of Labelling- (vii) Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of manufacture and the date of expiry of potency, and the period between the date of manufacture and the date of expiry shall not exceed that laid down in the said Schedule under the conditions of storages specified therein. Drugs and their preparations not included in Schedule R shall bear on their lables the date of their manufacture and also the date of their expiry which shall not exceed sixty months from the date of manufacture; Provided that this period may be extended by the licensing authority specified in clause (b) of Rule 21 in respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension." 6. Perusal of these provisions shows that rights of the petitioners so exist under Section 25(3) and 25(4) of the Act are frustrated if the report is not obtained from the Central Drug Laboratory within a period of five years in view of the provisions of Rule 96(1) (vii) of the Rules as the expiry period of the drug in this case comes to be of September, 1993. The charges against the petitioners have been framed without taking note of the aforesaid aspect and when this aspect was specifically raised before the revisional court it has not been properly dealt with rather the court tried to rely on the report of the Government Analyst, Gaziabad. In fact the report of the Government Analyst, Gaziabad could not have been taken into consideration once the petitioners have invoked the provisions of Section 25(3) of the Act by serving a notice within 28 days. The service of notice within the specified period is borne out from the fact that ultimately, the Magistrate had sent the third sample to Central Drug Laboratory, Calcutta and by the time the drug was analysed by the Central Drug Laboratory, the life of the drug expired. In such a situation, no charge could have been framed. The aforesaid position came up for consideration before the Hon'ble Apex Court in the case of Medicamen Biotech Limited and Another v. Rubina Bose, Drug Inspector, 2008(2) WLC (SC) Cri. 112 : (2008) 7 SCC 196 . In such a situation, no charge could have been framed. The aforesaid position came up for consideration before the Hon'ble Apex Court in the case of Medicamen Biotech Limited and Another v. Rubina Bose, Drug Inspector, 2008(2) WLC (SC) Cri. 112 : (2008) 7 SCC 196 . Dealing with the same facts, their Lordships came to the conclusion that when the shelf life of the sample drug was to be expired in the month of August, 2002, the Magistrate could not get the sample tested as per the provisions of Section 25(4) and looking to the delay in filing of the complaint, the appeal filed by the firm was allowed. 7. In view of the judgment aforesaid and also the provisions of the Act and Rules referred to above, the order framing charges against the petitioners and the order rejecting the revision cannot be allowed to sustain and accordingly, this misc. petition of the petitioners is allowed. The order dated 8th December, 1995 framing charges and also the order dated 8th September, 1999 dismissing the revision filed by the petitioners are quashed and set aside and they are discharged of the charges framed against them. *******