Case: Glaxosmithkline Pharmacet. Ltd.  Vs. State Of M.P

A. The Drug Inspector under the Act 1940 had taken a sample of Betnesol tablets (Batch No. NC 160 Mfg. October 1996, expiry March 1998), manufactured by the appellant-company from the shop of one Mahesh Agarwal at Chattarpur on 9.12.1996. The statutory authority sent the medicine for chemical analysis to the laboratory i.e. Government Analyst, Madhya Pradesh (Bhopal) on 10.12.1996.B. The said Government Analyst vide certificate dated 27.8.1997 declared that the sample was not of "standard quality" as defined under the Act 1940. The sample led to "analytical difficulties" for the purpose of determining compliance with the official standards as stated under uniformity of content.C. In view thereof, a show cause notice was issued to the appellant-company by the statutory authority on 29.9.1997 as to why proceedings should not be initiated against the appellants and others. The appellant submitted its reply on 3.11.1997, submitting that sample of the aforesaid medicine ought to have been examined/analysed under Indian Pharmacopoeia (hereinafter called `I.P.) 1996 and it had wrongly been analysed under I.P. 1985. Subsequent thereto, the department filed a complaint against the appellants on 3.7.2001 impleading the company as well as its Managing Director and Officers under the provisions of the Act 1940. A prayer was made that the appellants and other accused be punished under Section 35 of the Act 1940 and information of the said punishment be published in the newspapers at the cost of the accused.D. The Chief Judicial Magistrate, Chattarpur, took cognizance and issued summons to all accused persons including the appellants. The appellants filed an application under Section 25(3) of the Act 1940 before the Chief Judicial Magistrate, Chattarpur, with a prayer that sample of Betnesol tablets be sent for chemical analysis to the Director, Central Drugs Laboratory for being tested as per I.P.1996 on 1.10.2007. The said application stood rejected vide order dated 5.5.2008. The appellants approached the High Court by filing Misc. Criminal Case No. 6315 of 2008 for quashing the proceedings in Criminal Case No. 982 of 2001 (State of Madhya Pradesh v. M/s Aggarwal Medical Stores and Ors.). The said application stood rejected by the impugned judgment and order dated 14.9.2010. Hence, this appeal.

Reasoning: 8. In view of the fact that the appellants did not express an intention to adduce evidence to controvert the analyst report within the statutory limitation period of 28 days, further delay in filing the complaint becomes immaterial. Even otherwise, expiry date of the medicine was March 1998 i.e. only after 4 months of submission of the reply by the appellants, and they did not fulfill their burden of expressing intention to adduce evidence in contravention of the report. Therefore, they cannot raise the grievance that the complaint had been lodged at a much belated stage. So far as the application of I.P. 1985 or I.P. 1996 is concerned, such an issue can be agitated at the time ofis pertinent to mention herein that present appellants had earlier also been informed by the Drug Inspector of various cities on many occasions that the aforesaid medicine was i.e. Betnesol Tablet, was not of standard quality and the authorities had been making an attempt to initiate proceedings against them. As is evident from the pleadings taken by the appellants themselves and the letter dated 1.7.1996 (Annexure P-9) wherein the appellant-company wrote a letter to The Controller, Food and Drug Administration, Madhyarelevant part thereof reads asthe past one month we have received requests from Drug Inspectors of Dhar, Rewa, Seoni and Ambikapur all under your kind control, to provide Memorandum of Articles of Association, constitution etc. of our company to initiate action for manufacturing Betnesol Tablets B.No. NA 660, Mfd. Dec. 92, Exp. May 94, NB 290, Mfd. Nov. 94, Exp. Apr. 96, NB 538, Mfd. May 95, Exp. Dec. 96 and NB 656, Mfd. Sep. 95, Exp. Feb. 97, which were earlier declared as not of standard quality by Government Analyst, Bhopal for facing analytical difficulties during the determination of uniformity of content by the IP 1985 method." (Emphasisthat letter also the appellant company does not make its intention clear to adduce any evidence to controvert the Government Analysts report rather made the followingthese circumstances, we respectfully reiterate that our product Betnesol Tablets referred above are of standard quality and request you to kindly treat all the matter as closed.As explained hereinabove, the appellants and other co-accused did not give any option to adduce evidence in contravention of the analysts report within statutory limitation period. Even if there was inordinate delay in launching the criminal prosecution or filing the complaint, it is thereby of no consequence.