ASSOCIATED BIOTECH Vs. STATE GOVERNMENT OF A P

JUDGEMENT

(1.) The petitioners 1 to 5/A-1 to A-5 are accused of offences punishable under Sections 27(d) of the Drugs and Cosmetics Act, 1940 (in short, the Act) for violation of Section 18(a)(i)/16 and schedule-II and punishable under Section 27(c) of the Act for violation of Section 18(a)(i)/17B(d) of the Act. A-1 is having approval to manufacture drug viz., Rabpraz from the Licensing Authority, Shimla and A-2 to A-5 are partners of A-1 firm. It is alleged that they are all responsible for the day-to-day activities of the firm. On 05.09.2008 Drugs Inspector, Mahaboobnagar District had drawn sample of Rabpraz tablets from G.M.

(2.) Medical and General Stores, Atmakur by allegedly following procedure prescribed by law and forwarded sealed portion of the sample drug to the Government Analyst, Drugs Control Laboratory, Hyderabad under registered parcel. On 06.07.2009, analysis report of the sample drug is received in Form-13 from the Government Analyst declaring the sample as not of standard quality for the reason that the sample does not comply the Assay for Rabprazole Sodium as per STP (claim 20mg/tablet, found 4.9 mg/tablet). On 03.12.2009, the incharge drugs inspector addressed notice to Proprietor of G.M. Medical and General Stores to disclose source of supply of the sample drug under Section 18(A) of the Act and to submit copy of purchase invoice. On the same day, reply was received from the said proprietor that subject batch drug was purchased from Thirumala Pharma, Mahabubnagar through invoice dated 14.06.2008, along with enclosure of attested copy of purchase invoice. On the same day, the incharge drugs inspector notice under Section 18(A) and 22(1)(cca) of the Act to Thirumala Pharma, Mahabubnagar requesting to disclose source of the sample drug and to submit copies of purchase invoice. The drugs inspector also handed over a sealed portion of the sample drug and copy of analysis report to Partner of Thirumala Pharma under Section 23(4)(ii) and 25(2) of the Act. On 04.12.2009, reply was received from Thirumala Pharma stating that the subject batch drug was purchased from Neosun Biotech India Pvt. Ltd, Hyderabad vide invoice dated 07.06.2008 and from Sadguru Pharmaceuticals, Hyderabad vide invoice dated 05.03.2008. Attested copies of purchase invoices were also furnished. On 29.12.2009, incharge drugs inspector addressed letter to Neosun Biotech India Pvt., Ltd., Hyderabad under Sections 18(A), 18(B) and 22(1)(cca) of the Act to disclose source of supply and to submit purchase invoices. On 07.01.2010 reply was received from Neosun Biotech India Pvt., Ltd., stating that the subject drug was purchased from A-1 through invoice dated 31.07.2007, along with attested copy of purchase invoice and sale bill. On 12.01.2010, incharge drugs inspector addressed notice to Sadguru Pharmaceuticals, Hyderabad under Sections 18(A), 18(B), 22(1)(cca) of the Act to disclose source of supply of the sample drug. The said notice sent by registered post was returned unserved as left. On 02.02.2010, incharge drugs inspector, Mahabubnagar personally visited Neosun Biotech India Pvt., Ltd., Hyderabad and on enquiry found that 1000 strips of Rabpraz tablets were sold to Sadguru Pharmaceuticals by them through sales invoice dated 08.11.2007. On 11.02.2010, incharge drugs inspector addressed notice to A-1 under Section 18(B) and 22(1)(cca) of the Act to confirm the manufacture and sale of the sample drug and to submit details of manufacturing licences manufacturing and analytical records. On 22.04.2010, reply was received from A-1 stating that the product is already expired and it is not available in the market and their control samples found quality based over expiry. Hence, Assistant Director who is incharge drugs inspector, Mahabubnagar District filed complaint in the lower Court against A-1 to A-5 for punishing them under the above provisions for the alleged violations. The complaint was filed before the Magistrate on 04.08.2010. The Magistrate took cognizance and issued summonses to A-1 to A-5 by order dated 14.11.2011.

(3.) It is contended by the petitioners' counsel that the analyst report in this case was received by Drugs Inspector on 06.07.2009 by which month the sample drug expired and the complaint was filed before the Magistrate thereafter on 04.08.2010 and the offences were taken cognizance by the Magistrate on 14.11.2011 and therefore, the petitioners/accused have lost their valuable right of sending second sample to the Central Drugs Laboratory for second analysis and for revised report, challenging report of the Government analyst, Hyderabad. The relevant provisions of the Act on this aspect are Sections 25(3) and 25(4) which read as under: