O R D E R

This is a Criminal M.C. filed under Section 482 of the Code of Criminal Procedure seeking to quash Annexure-A complaint and further proceedings in C.C. 1465 of 2015 on the file of the Judicial First Class Magistrate, Ottapalam. Petitioners are the accused in the said Calendar Case. The case was registered on Annexure-A complaint preferred by the Drugs Inspector, Palakkad. The facts of the case are thus: On 11.06.2012, the then Drugs Inspector visited the premises of the Employees State Insurance Dispensary, Kulappully, Shornur, Palakkad and drew statutory samples of medicine Adil-90 (Diltiazem Sustained Release Tablets) Batch No.T-IC22 with manufacturing date 12/2011, expiry date 11/2014 manufactured by the 1st accused firm. The samples were taken for analysis following the provisions under Section 23 of the Drugs and Cosmetics Act, 1940, hereinafter referred to as the Act, and the items were seized adopting the procedural formalities. The first sample was sent to the Government Analyst Drugs Testing Laboratory, Thiruvananthapuram as provided under Section 23(4)(i) of the Act by registered post. After testing, the Government Analyst declared that the drug does not conform to standard quality for the reason that it failed in the test for dissolution.

The test report was received and the matter was informed to the Superintendent, ESI Dispensary, Shornur. Thereafter the second sample was sent to the Central Drugs Laboratory, Calcutta. After testing, they also reported that the sample does not conform to IP with respect to 'test for dissolution'. Thereafter the details of the manufacturer of the drug were collected and it came out that the accused are the manufactures and thus the complaint was filed and that was how the case was taken on file and the accused persons were summoned. The 1st petitioner is the company which admittedly manufactured the medicine. Petitioners 2 and 3 are the Managing Director and Joint Managing Director respectively of the company. One of the directors, the 5th accused has passed away; others are the directors of the company. They have approached this Court under Section 482 of the Cr.P.C. for quashing the proceedings predominantly for two reasons, firstly, that there is absolutely no averment in the complaint that the petitioners, especially petitioners 4 to 8, have played any role in the management and day-to-day business of the company. According to them, there are no averments that all the petitioners are dealing with the day-to-day administration and management of the company and therefore Section 34 of the Act is not applicable and it is a clear abuse of the process of law that a complaint has been filed against the petitioners without making positive averments with regard to the roles played by them in the manufacture and business deals of the company. Secondly, it is stated that the said Adil-90 is not a drug as provided under Section 3(b)(i) of the Act. On the other hand, the standards for dissolution applied by the Central Drugs Laboratory as prescribed in Indian Pharmacopoeia (IP) are inapplicable to a drug in question; as it is not an Indian Pharmacopoeia drug, but a patent/proprietary drug as defined under Section 3(h)(ii) of the Act. So, according to the petitioner, the drug in question being a patent/proprietary drug has to achieve the standards prescribed for the patent/proprietary drug under Rule 124B and not the standards prescribed for Indian Pharmacopoeia drug under Rule 124(1) of the Drugs and Cosmetics Rules, 1945, hereinafter referred to as the Rules. In this connection, the petitioners have also relied on Annexure-C certificate dt. 07.04.2016 issued by the Commissioner, Food and Drugs Control Administration, Gandhinagar, Gujarat State.

2. I heard the learned counsel for the petitioners and also the learned Senior Public Prosecutor.

3. The learned counsel for the petitioners has reiterated the above two arguments. According to him, there is no positive averment that the pe