SC relief to Pharma Company in criminal trial for ‘substandard drug’

SC relief to Pharma Company in criminal trial for ‘substandard drug’

SRINAGAR: The Supreme Court of India has set aside J&K High Court’s order refusing to interdict criminal proceedings against a pharmaceutical company after its drug sample was found ‘substandard’ by a government analyst in 2009.
The government analyst—CFDL, Patoli Jammu— on 31 July 2009 had found a drug by M/S Brawn Laboratories Ltd as “not of standard quality.”
The report was forwarded to the pharmaceutical company on 4 February 2010 and in reply, it disputed the correctness of the report of the government analyst. In a letter to concerned drug inspector on 27 February 2010, the company stated that it had got the drug analysed on its own which attested it as standard.
In the letter, the company pointed out that: “During the investigation we also noticed that the analytical method followed by government 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”.
The company moved high court and had contended that the provisions of Section 25(4) of the Drugs and Cosmetic Act, 1940 have not been adhered to for re-analysing the drug by the Central Drugs Laboratory, Calcutta and that on account of the sample being lost/misplaced, no criminal liability can be attributed to it.
“We do not see how in the 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 (drug company) 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 apex court said and quashed the criminal proceedings against the company.

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