MEDREICH STERILAB LTD Vs. UNION OF INDIA

JUDGEMENT

(1.) PETITIONER is a company incorporated under the provisions of Companies Act, 1956 and is engaged in the manufacture of various Pharmaceuticals preparations

(2.) THE second respondent-Drug Controller licensing Authority, is the competent authority to issue licence under the provisions of Drugs and Cosmetics Act, 1940 ('the act 'for short) and the Rules framed thereunder. He has issued a licence to the petitioner company for manufacture of pharmaceutical preparations, apart from others, a drug formulation by trade name "augmentin duo Syrup" (Amoxicillian and Clavulanic acid) and the said licence is renewed from time to time. It is the claim of the petitioner company that the Augmentin range of preparations manufactured by the petitioner-company is sold all over the country.

(3.) THE cause of action pleaded in the petition for the petitioner-company to approach this Court is the show cause notice issued by the second respondent to the petitioner-company dated 7-12-2002 under rule 85 (2) of Drugs and Cosmetics Rules, ('rules' for short) inter alia directing it to show cause, why action as per law should not be taken against it, to cancel, suspend or revoke the licence granted, on the ground that "augmentin Duo Syrup" batch No. 1017 date of manufacture June, 2001 date of expiry May, 2003 has been declared as 'not of standard quality' by the Government analyst, Drug Testing Laboratory, New delhi, vide test report dated 24-10-2002 and along with the show cause notice the report of the Govt. Analyst was also enclosed. The petitioner-company was also directed to appear on 18-12-2002 and to produce the records of production, test and analysis in support of its defence and to adduce evidence, if any, controverting the report.