M/S. Medicamen Biotech Ltd. & Anr vs Rubina Bose, Drug Inspector

3. The accused appellant No.1 is a manufacturer of Enalapril Maleate tablets, a drug which is being manufactured under licence in its factory premises. The drug was released for sale only after it quality had been certified by an independent laboratory. One such batch bearing No. NT 6000 was sold on 29th September 1999 with its shelf life upto August 2002 and in addition to other organizations some of the drug from the batch was supplied to the Government Medical Stores Depot, Kolkata. The Drugs Inspector, Central Drugs Standard Control Organisation, Kolkata visited the Government Medical Stores Depot at Belvedere, Kolkata on 14th June 2000 and collected samples of the drug and after dividing the sample into four equal parts, sent one portion to the Central Drugs Laboratory, Kolkata under Clause (i) sub- section(4) of Section 23 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the 'Act') for test/analysis. The sample portion of the drug was received in the laboratory at Kolkata on 23rd June 2000. The Drugs Inspector received the test report from the Drugs Laboratory on 6th July 2001 declaring the drug as not conforming to the prescribed standards. A show cause notice was issued to the appellants on 14th August 2001 on which the appellant once again carried out an in-house test and also obtained an analysis report from another approved laboratory. Both the reports opined that the sample satisfied the prescribed norms. The appellant also received a show-cause notice dated 14th August 2001/17th August 2001 from the Ministry of Health and Welfare from the Government Medical Stores Depot, Kolkata informing the appellant that the drug in question had been declared sub-standard. On 28th August 2001 the appellant sent a detailed reply to the show-cause notice to the Medical Stores Department with copies to the Drugs Inspector disputing the report of the Government Analyst and requesting for a re-testing of the drug. On 31st August 2001 the appellant received a letter dated 22nd August 2001 from the Drugs Inspector once again pointing out that the sample seized was not of the prescribed standard and also called for the comments of appellant No.1 within 10 days. The appellant received yet another letter dated 7th September 2001 from the Drugs Inspector seeking certain information to which the appellant gave a reply on 13th September 2001 giving the necessary information and also disputing the test report of the Central Drugs Laboratory, Kolkata and requesting for re- analysis. On 26th September 2001 the appellant No.1 received a communication from the Drugs Inspector that the test report submitted by the Central Drugs Laboratory was conclusive evidence of the facts stated therein under section 25 of the Act and declined to consider any other report and on the contrary, a complaint was filed before the concerned Magistrate under section 27 of the Act on 2nd July 2002. The Magistrate summoned the appellant and certain others for appearance on several dates but the summons were finally served on the appellant on 9th May 2005. The proceedings initiated on account of the complaint were challenged before the Calcutta High Court and a prayer for quashing was made under Section 482 of the Criminal Procedure Code. This petition has been dismissed by the impugned order dated 19th May 2006. The learned Judge held that it would be premature to look into the matter and to take a decision on the basis of affidavits and documents filed in Court as they were not evidence strictu sensu. The Court also opined that from the facts of the case, it appeared that the allegations made in the petition did indicate the commission of an offence as they did not suffer from any "inherent absurdity so as to raise controversy in regard to its maintainability". It also held that one portion of the sample had been given to the accused and the necessary formalities had been complied with. It is in this situation the matter is before us in appeal.

11. The appeal is allowed accordingly and the proceedings against the appellants are quashed.