By: Parveen

The Supreme Court of India has taken stern view against the order of J&K High Court refusing to quash the Criminal Complaint filed by Drug Inspector, at Jammu against M/s Brawn Laboratories Ltd. As per judgment, Government Analyst, Patoli, Jammu vide its report dated 31.07.2009 declared the drug Not of Standard Quality. The company however vide letter 27.02.2010 conveyed to the Drug Inspector, that the method adopted for testing is not correct and also attached the report of testing which company got it from private lab. The company averted in its reply that “the result obtained after investigation of the finished product was found to be around97.35% and same was attached for your reference along with all the calculation sheet and chromatogram.”
The company further stated that “During the investigation we also noticed that the analytical method followed by Govt. analyst at CFDL was potentionmetric which was adopted only for pure raw material testing and this method is not suitable for finished product. By using potentionmetric method for finished product the interference by the excipients will not be properly considered and hence the finished product result will not meet expectation”
Mr. N. Shoeb Alam, Advocate for State of Jammu and Kashmir, argued the case and stated that no clear challenge was made by the appellant as per the requirement of section 25(4). As per him the word “adduce evidence” and “controversion” of the report is a necessary words that must follow in the letter.
Mr. Sushant Mahapatra, Advocate, for M/s Brawan Laboratories Ltd, argued that the submission of test report of private lab is sufficient to show the intention to controvert the report of Government Analyst. He tressed upon the letter dated 27.02.2010 as sufficient compliance. The Supreme Court took the view that “We do not see how in the aforesaid facts the High Court could have left the matter to be decided in the trial. Compliance with the requirement under Section 25(4) of the 1940 Act had been made by the appellant by addressing the letter dated 27th February, 2010. From the order of the learned Chief Judicial Magistrate, Jammu dated 7th May, 2011 it is clear and evident that the sample had not been received by the Central Drugs Laboratory, Calcutta. In these circumstances one can reasonably understand that the valuable right of reanalysis vested in the appellant under Section 25(4) of the 1940 Act has been denied to him and the prosecution on the materials available was bound to be a lame prosecution. The High Court, therefore, ought to have quashed the proceedings. The same not having been done, we are of the view that the present is a fit case where we ought to interfere and quash the criminal proceedings against the appellant. We order accordingly”
Thus, the law is set right by the Hon’ble Supreme Court that it is not necessary to use the word challenge or controversion. The accused company has to show their intention to “adduce evidence” and said challenge can be made in different way. What is necessary is that the accused has to communicate to the Drug Inspector all such evidence on which it wish to rely and if such evidence is brought to the notice of the Drug Inspector, he is bound to take note of these evidence. It is not necessary that the accused must have to challenge in the specific words that they wish to adduce evidence in controversion to the report of Government Analysis. However, it must be noted that such challenge must be made within 28 days from the receipt of the copy of Form-13. There is dispute as to the photocopy of Form-13 if received whether challenge can be made. The prosecution always relies upon the earliest information like photocopy of Form-13 as cutoff date and the defense always rely upon the original copy of Form-13 as per Section 25(2). The law as stood today supports the theory of original copy (Second Copy) of Form-13 yet some other High Courts considered the earliest date of information of NSQ as relevant date. By strict interpretation of Drug & Cosmetics Act, 1940, the second copy original is necessary concomitant for challenging the sample. The Drug Inspector is bound to supply original copy of Form-13 said Mr. Mahapatra.


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