Conviction under drug regulation provisions requires proving non-compliance, highlighting the importance of disclosing the manufacturer's details for legal protection.

JUDGMENT :

Deepak Gupta, J.

1. The three criminal revisions titled above have arisen out of the same case in the following facts and circumstances.

2. Complaint was filed by State of Haryana through District Drug In-spector under Section 18(a)(i) read with Section 17A, 17B and 18B of The Drugs and Cosmetics Act, 1940 [hereinafter referred as 'the Act'] and Rules made thereunder, against as many as ten accused as named below:

Manufacturer:

1) M/s Burnent Pharma 974 MIE, Bahadurgarh

2) Sh. Surender Kumar Seth son of Inder Sain

3) Sh. H.S. Rathi son of Sh. Sahu Ram

4) Sh. Jai Gopal son of Sh. Luxami Chand

5) Sh. Darshan Arora son of Sh. Des Raj

Dealer/Distributor:

6) M/s Kavita Medico Agencies, Rohtak

7) Sh. Ved Parkash son of Sh. Gian Dev

Retailer:

8) M/s Super Medicos, Charkhi Dadri

9) Sh. Bhupinder Singh son of Sh. Dalip Singh

10) Attar Singh Phogat son of Sh. Bhola Ram Phogat

3.1 As per complaint, on 24.07.2003, Drug Inspector, Bhiwani visited the premises of M/s Super Medicos i.e. accused No.8 along with Medical Officer, General Hospital, Charkhi Dadri, where accused Nos.9 and 10 i.e. proprietor and pharmacist of the said retailer were present. Vials of Diclofenac Sodium Injection 12 x 30m bearing on its label B>No.DF-04, Date of Manufacture 8/2002, Expiry Date 07/2004, manufactured by M/s Burnet Pharma 9074 MIE Bahadurgarh 124507 were found, along with other allopathic drugs stocked for sale. Samples of the aforesaid drugs were taken as per prescribed rules.

3.2 On analysis through the Government Analyst, Haryana of one of the drug sample, the same was found to be not of standard quantity, as it contained small white particles as suspended matter; and assay of Diclofenac Sodium was less that IP (Indian Pharmacopoeia). As per standards in IP limits, drug was required to be free from particulate matter, hence, the injection was not fit for consumption for human beings and was injurious to health. The drug Diclofenac Sodium (DS in short) claimed per ML on the label as 25mg, whereas the Government analyst found it to be 2.6mg/ml and thus, drug falls within the definition of being spurious, the manufacture and sale of which is prohibited under Section 18(a)(i) of the Act.

3.3 Notice under Section 18-A of the Act was issued to accused Nos.8 and 9 on 05.11.2003 by the Drug Inspector, Bhiwani requiring them to disclose the name, address and other particular of the person, from whom they had acquired the drug. The said accused disclosed the name and address of M/s Kavita Medico Agencies Rohtak i.e. accused No.6, from whom they had acquired the drug. Purchase bill number 4218 dated 22.07.2003 was also produced by them.

3.4 At this, the Drug Inspector, Bhiwani issued notice to accused Nos.6 and 7 i.e. M/s Kavita Medicos and its proprietor Ved Parkash under Section 18-A of the Act requiring them to disclose the name and particulars of the persons, from whom they had acquired the drugs. As per the reply received from them, the name of the manufacturer was M/s Burnet Pharma i.e. accused No.1, from whom they had acquired the drug. As per the label found on the drug while sampling, the manufacture of the drug was accused No.1. Accused Nos.6 and 7 also enclosed copy of the purchase bill No.1395 dated 28.11.2002 issued by accused No.1.

3.5 Upon the aforesaid information being supplied, Drug Inspector, Bhiwani issued notice on 12.01.2004 under Section 18-B to accused No.1 i.e. manufacturing firm through its partner- accused No.2 along with copy of the test report of the drug in question and a sealed portion of the sample. Accused No.2 Surender Kumar Seth, disclosed that accused No.4 Jai Gopal was the manufacturing chemist and person responsible to man