THEON PHARMACEUTICALS LIMITED Vs. STATE OF MAHARASHTRA

JUDGEMENT

(1.) This petition seeks quashment of RCC No. 4/2022 which is a complaint fled before the Judicial Magistrate First Class on 19/7/2022 by the Drug Inspector for controversion of provisions of Sec. 18-A(i) punishable under Sec. 27 of Drugs and Cosmetics Act, 1940 (for short "the Act").

(2.) Petitioner No. 1 is a public limited company incorporated under the Companies Act (for short 'company') and is engaged in the business of manufacturing and sale of several drugs and cosmetics. It is also licence holder for manufacture of drug named "SG Flames Tablets" (Aceclofenac Paracetamol and serratiopeptidase Tablets). It is a non-pharmacopeial drug wherein the method of analysis is not prescribed but it is with the manufacturer. It is further contended that the Drug Inspector visited the premises of M/s Pharma Seva Pharmaceuticals Distributors at Aurangabad and had drawn sample of the abovementioned drug for the purpose of its analysis by issuing Form No. 17 as provided by the Act and Rules. Drug Inspector sent one sealed part of the sample to the Government Analyst, Maharashtra State Drugs Control Laboratory, Mumbai and in report dtd. 12/11/2021 of Government Analyst it was opined that the sample is "not of standard quality". Respondent claimed to have sent the report to company on 1/12/2021 by registered post and since no response was received a reminder came to be issued on 27/12/2021. The said reminder was replied by the petitioner by letter dtd. 10/1/2022 wherein it is stated that petitioner No. 2 is the Incharge of the day to day affairs of company and is responsible for the analysis and manufacturing of the drugs of the company. It is also stated that they have analysed their control sample and have found the same to be in perfectly prescribed formulation and the test results were satisfactory. Petitioner No. 1 requested respondent to send one of the sealed sample as per Sec. 23 of the Act so that the same can be determined whether the same is authentic or substitute in the name of the company. Durg Inspector however, fled complaint before the Magistrate Corporation Court, Aurangabad which came to be registered as RCC No. 4/2022. It is contended that the shelf life of the said drug had expired in February 2022 and by ignoring the said fact, the learned Magistrate has issued summons mechanically against the accused.

(3.) Learned counsel for petitioners states that there is noncompliance of mandatory provision of the Act which has resulted into denial of the opportunity of defence to the petitioners/accused. It is submitted that it is a non-pharmacopeial drug and hence there is no prescribed method of analysis and as a result of which, the report of the Government Analyst cannot be treated as conclusive evidence. It is further submitted that the Drugs Inspector has failed to comply with the mandatory provisions of Sec. 23(4) of the Act and in any case, there is no sample provided to the manufacturer i.e. petitioner No. 1 herein in order to give an opportunity to challenge the said report of the Government Analyst. It is also submitted that since admittedly the sample has expired in February, 2022, it was not open for the learned Magistrate to take cognizance of the complaint and issue summons as petitioner No. 1 is denied an opportunity to refer the sample kept with the Court to the Central Drugs Laboratory. It is contended that it is indispensable right of the accused and since there is non-compliance of this mandatory provision, prosecution cannot proceed further and it deserves to be quashed. It is further canvassed that the Act has come into effect in the year 1940 and at that time it was not mandatory for the manufacturer to display his name and address on the carton of the drug however, since later it is made mandatory and therefore, it was incumbent on the part of the Drugs Inspector to forward one sample to the manufacturer in compliance of Sec. 23(4) of the Act. On these amongst other submissions, quashment of complaint is sought. To support contentions, she relied on following judgments :-