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CRR-328-2018 (O&M) and CRR-355-2018 (O&M)

Decided On: 08.03.2018

Appellants: Rajan Bhardwaj and Ors. Vs. Respondent: State of Haryana

Hon'ble Judges/Coram:
Sudhir Mittal


Sudhir Mittal, J.

1. This order shall dispose of abovementioned two revision petitions as they have arisen out of the same impugned judgment and common question of law is involved therein.

2. On 22.12.2014, the premises of M/s. Amit Medicine Centre, Bus Stand Road, Near Norang Ice Factory, Uklana Mandi, District Hisar, was inspected by the competent authority under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act'). Four types of drugs were taken for test and analysis out of which one sample was of Bonorwin Injection (Buprenorphine Injection), which was manufactured by Willmark Pharmaceutical Pvt. Ltd., Amritsar (accused No. 3). This sample shall be referred to as the 'sample in question' hereinafter. After completion of formalities, the 'sample in question' alongwith other samples was sent to the Government Analyst Haryana, Chandigarh for analysis under a covering letter dated 23.12.2004. A test report of the 'sample in question' was received on 22.02.2005, according to which, the sample was declared as 'not of standard quality' on account of following reasons:-

a) Sample contains suspended matter compromising of white particles and fibre.

b) Ext. Vol./ampoule is less than claim/I.P limit.

c) Assay of Buprenorphine/ml is found to be less than I.P. limit.

d) Address of the 'Mfgd. by' not labeled completely on ampoule No. label on outer pack of 10 ampoules.

3. Notice dated 23.02.2005 was issued to accused No. 2 and served upon it on the same date. Accused No. 1 was present at the time of service, but he could not disclose from whom he acquired the drug in question. On 26.02.2005, a report was sent to the State Drugs Controller, Haryana and request was made for permission to investigate the matter at the level of manufacturer. Pursuant to grant of permission, the complainant visited Amritsar on 21.03.2005 and a copy of the test report dated 14.02.2005 with a sealed sample portion was handed over to the Managing Director of accused No. 3. Certain documents were collected from the premises of accused No. 3. Reply was also obtained and after perusal of the same the following observations were made by the complainant:-

1. "As per label drug in question contains Buprenorphine Hydrochloride IP equivalent to 0.3 mg of Buprenorphine while the test report of the manufacturer itself dated 03.07.2004 shows that 'Each ml. contains Buprenorphine Hydrochloride 0.29 mg.' At the same the revised test report of manufacturer dated 22.03.2005 shows each ml contains Buprenorphine HC1 eq. Buprenorphine 0.288 mg. Thus the reports of the manufacturer are self contradictory and the product manufactured by the firm is not as per IP. Indian Pharmacopoeia states that Buprenorphine injection IP is a sterile solution of Buprenorphine Hydrochloride contains not less than 90.0 per cent and not more than 110.0 per cent of states amount of Buprenorphine Hydrochloride.

2. The firm has not supplied the records of the labels deliberately and their version in reply regarding past of the label on the paper tray of the ampoules laps on the part of the manufacturer. Moreover, no differences were noticed in the label of control sample and ampoules of the sealed sample portion opened by accused No. 4 at the time of investigation. As per record submitted to the investigation team on 21.03.2005 by the accused Firm (through accused No. 4) was bearing labels pasted on the Analytical Report of finished goods and manufacturing record. There was no difference in the labels on these reports and the sampled drugs, the sample portion was opened by the accused firm during investigation and compared with labels of the control sample not difference was noticed. As per the record supplied, the manufacturing of the drug was completed on 08.07.2004 while finished goods were tested on 03.07.2004 well before the complet........