Judgment :

Dr. B.S. CHAUHAN, J.

1. Leave granted.

2. This appeal has been preferred against the judgment and order dated 14.9.2010 passed by the High Court of Madhya Pradesh at Jabalpur in Misc. Criminal Case No. 6315 of 2008 which rejected the application of the appellants for quashing the complaint under the provisions of The Drugs and Cosmetics Act, 1940 (hereinafter called `the Act 1940').

3. Facts and circumstances giving rise to this appeal are that:

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.

4. Shri R. Ramachandran, learned senior counsel appearing for the appellants, submitted that the Drugs Inspector issued show cause notice dated 29.9.1997 which was duly replied by the appellants on 3.11.1997. Therefore, there was no occasion for the respondent- authorities to file a complaint, that is too after the expiry of more than 3 years and 9 months of the expiry date of the medicine itself. The appellants could not avail their remedy under Section 25(3) of the Act 1940 which can be exercised within 28 days from the date of service of show cause notice. The chemical analyst's report was not clear at all. The certificate declared that the medicine "was not of the standard quality". The analyst had analytical difficulties in determining the compliance with the official standards as stated "Under uniformity of Contents". The purpose of exercising his right under Section 25(3) of Act 1940 is to ask the statutory authority to send the medicine to some other laboratory for chemical analysis in case the report was not acceptable to the accused. In the instant case, it was the technical problem as the fault had been found in view of analytical defects, and thus, there was no violation of substan