- (1.)THIS is criminal misc. petition under Section 482 Cr.P.C. against the order dated 7.10.2011 passed by Additional Sessions Judge, Churu in Criminal Revision Petition No.9/2009 (48/2005), vide which, the revisional court dismissed the revision petition of the petitioners and maintained the order dated 8.6.2005 passed by Chief Judicial Magistrate, Churu framing charge under Section 27 (c) of Drugs & Cosmetics Act against the petitioners. The petitioners No.1 & 2 are partners of petitioner No.3 Firm and are engaged in manufacturing of drugs. In the year 1992, a drug-cum-cosmetic cream by name "Gentamycin Sulphat Cream (USP)" was manufactured and sold by the firm. On 6.4.1993, a Drug Inspector carried out an inspection of M/s Dhoot Medical Hall, Churu and collected the samples of Gentamycin cream having date of manufacturing as May, 92 and date of expiry as April, 1994, in terms of Section 23 of Drugs & Cosmetics Act, 1940 (hereinafter referred to as "the Act of 1940")
(2.)THE sample was sent for testing to C.I.P.L. Raj Nagar, Gaziabad (U.P.) on 8.4.1993 and the report dated 18.2.1994 was received by the Drug Inspector on 15.3.1994. The laboratory declared the sample as unauthentic and mentioned that "the sample is spurious, in that it given negative test for identification of gentamycin." The copy of the report was sent to the petitioners on 29.3.1994 i.e. just a few days before date of expiry of the drug. The said report stated to have been received by the petitioners around 7.4.1994. Admittedly, the date of expiry of this sample was 30th April, 1994. The complaint was accordingly filed by the Drug Inspector against 12 accused including the petitioners on 22.11.1994. However, the trial court proceeded only against the present petitioners for offence under Section 27(c) of the Act of 1940. While praying for setting aside the order dated 8.6.2005, passed by the trial court as well as the order of the revisional court, the learned counsel for the petitioners submitted that delay by the Drug Inspector to inform the petitioners about failing of the sample in test has prejudiced the entire case of the petitioners. It was argued that the date of expiry of the sample was 30th April, 1994, whereas the petitioners were informed in April, 1994 itself about failing of the sample and therefore, the statutory right as enshrined in Section 25(3) of the Act of 1940 has been infringed.
Learned Public Prosecutor, however, while opposing the same relied upon the judgment of the Hon'ble Apex Court rendered in the case of Amery Pharmaceuticals & Anr. Vs. State of Rajasthan, reported in 2001 Drugs Cases 168 to contend that to adopt the course of acquitting such offending manufacturers only on the legislative lacuna would be dangerous to the public health and the lives in of the patients and the courts need not feel helpless in administering criminal justice. It was further argued by learned Public Prosecutor that the petitioners had sufficient days to exercise the option. It is admitted by him that the information was received by the petitioners in the second week of April, 1994 and the date of expiry was 30th April. Thus, the petitioners could have easily exercised their right before the expiry of 30th April.

Heard . Section 25(3) of the Act of 1940 of the Act reproduced as Under:-

"25(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."
A perusal of the above Section shows that the law allows a drug manufacturer to controvert the report by allowing him 28 days to get the second sample re-analyzed. The said remedy under Section 25(3) can be exercised within 28 days from the date of service of notice.
There is no doubt that Section 25(4) also makes it clear that the sample tested by the Central Government Laboratory accrues to a person, accused in the case, only if he has notified his intention as per sub-section (3) to controvert the report of the government analyst. Meaning thereby that the right to get the drugs tested by Central Drugs Laboratory does not rise unless the requirement of sub-section (3) is complied with. Thus, there is no dispute with the provisions of the Act and the law laid down that the petitioner has statutory right under Section 25(3) of the Act of 1940 and in case, the petitioners are deprived of the said right i.e. to get the second sample re- analyzed, criminal proceedings cannot be allowed to proceed against them. Thus, the only issue that requires to be decided in the facts of the present case is as to whether the petitioners had sufficient time to exercise their option or not? It is not disputed that expiry date of the drug was 30th April, 1994, whereas the copy of the report was sent to the petitioner- firm on 29.3.1994.

The petitioner has placed on record the certified copy of the letters of Drugs Controller & Director of Medical & Health Services (FW) Rajasthan, Jaipur dated 28.3.1994 & 18.6.94, statement of PW-1 Ramniwas, letter Exhibit-P/17 dated 16.8.1994. It is evident from the complaint that there were as many as 12 accused and the petitioners before this Court are accused Nos.8, 10 and 12. The copy of the report was sent only to petitioner No.3 i.e accused No.12, which is the firm concerned. The petitioners No.1 & 2 i.e. accused Nos.8 & 10 are the partners of the firm. The fact that the notice was only sent to petitioner No.3 M/s Nimph Laboratories is evident from the complaint itself. The fact is further evident from the letter dated 18.6.1994 sent by the Drug Controller and Director of Medical and Health Services (FW) Rajasthan, Jiapur to the Commissioner, Food & Drugs Administration, Bombay verifying that the firm stands closed due to the disputes between the partners. The same reads as under:-

"Copy of the test report was forwarded to you by regd. letter No.218 dated 28.3.94 for initiating suitable action against the manufacturer. Telegraphic request was also made for investigation in the matter on 4/4/94 in reply of which you have informed vide reference letter that the firm is closed since last two months due to the dispute between the partners."
Meaning thereby, that, even if the said report was sent to the petitioner No.3, i.e. accused No.12- the Firm, there was no one to receive the same. The non-petitioners have not mentioned any proof of the said report having been received by either firm or the other partners of the firm, i.e., petitioners No.1 & 2. The letter further shows that it was for the first time, the Commissioner, Food and Drug Administration, Bombay was requested to send the information/details qua the name of partners, proprietor and responsible person for the conduct of the business of the firm. PW-1 Ramniwas appeared as witness and stated that he had sent the letter to the firm. He further stated that he had sent the notice to all other partners of the firm vide Exhibit-P/17. The letter Exhibit-P/17 is dated 16.8.1994. It was on receiving the details of partners, that notices were issued to them as late as on 16.8.1994 i.e. after the expiry date of the drug. Thus, there is nothing on record to specify as to when the report was received by either the firm or its partners. It is apparent that the report was sent to the partners of the petitioner-firm only on 16.8.1994 after the date of expiry of the drug. Even if, for the sake or arguments, it is accepted that the alleged notice to the firm was received by the partners in or around 7th or 8th of April, it leaves only about 20 days and the said period cannot be sufficient to enable the petitioners not only to exercise the option but also to have it re- tested during this period.
(3.)THE Hon'ble Apex Court in somewhat similar circumstances in the case of M/s Medicamen Biotech Ltd. & Anr. Vs. Rubina Bose, Drug Inspector, reported in 2008 AIR SCW 2201, in para 10 of the judgment held as under:-
10. We find that this judgment helps the case of the appellant rather than that of the respondent because in spite of two communications from the appellant that it intended to adduce evidence to controvert the facts given in the report of the Government Analyst, the fourth sample with the Magistrate had not been sent for re-analysis. The observations in Amery Pharmaceuticals's case [(2001) 4 SCC 382.] are also to the same effect. 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. 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 retesting 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 retesting 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 Section 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them."

In the present case, the report was sent to the partners of the petitioner firm only on 16.8.1994 i.e. after the date of expiry of the drug; the report sent to the firm was not received in time; even if it is accepted that the same was received, there is nothing on record to show that who received the same as admittedly, the firm was lying closed. It is not understood as to why the said report was not sent to the petitioners prior in time i.e. when the same is stated to have been sent to the firm as well. The answer lies in their own letter dated 18.6.1994 referred above, vide which, the Commissioner, Food & Drugs Administration, Bombay was requested to sent the details and more particulars of the partners of the petitioner-firm, so that notices could be sent to them as the firm stood closed. It was in these circumstances that the notices were sent to the petitioners as late as on 16.8.1994 i.e. after the expiry date.

In view of the above and applying the law laid down by Hon'ble Apex Court in the case of M/s Medicamen Biotech Ltd. & Anr. Vs. Rubina Bose, Drug Inspector (supra), the present criminal misc. petition is allowed. The order dated 7.10.2011 passed by Additional Sessions Judge, Churu in Criminal Revision Petition No.9/2009 (48/2005) and order dated 8.6.2005 passed by Chief Judicial Magistrate, Churu framing charge under Section 27 (c) of the Drugs & Cosmetics Act against the petitioners are quashed.