(1.) THE petitioner, Rameshwar Puri, in the partnership with one N.K. Gadi, manufactured Gramyeaetin Chloramphenicol Palmitate Oral Suspension drug in their laboratory Messrs Gram Laboratories, Mohali. The drug was manufactured and packed in 50 grams glass bottles cap sealed. A lot thereof as is the case of the petitioner, was sold to Messrs Gian Enterprises, Moga. Cash Memo, however, as claimed by the petitioner, was interpolated to read as if the lot had been sold to R.K. Medical Agencies, Jalandhar, the proprietor whereof is one Rajinder Kumar. Allegedly, Rajinder Kumar sold the lot or a part thereof to Messrs Gupta Medical Stores, Jalandhar Cantt. The Drugs Inspector when visiting Messrs Gupta Medical Stores, Jalandhar Cantt on 30th September, 1981, purchased eight bottles allegedly each containing 50 mgs. of the drug for analysis. He divided these eight bottles into lots of two each. One lot was sent for analysis to the Public Analyst. The Public Analyst opined that the sample sent was not of standard quality as defined under the Drugs and Cosmetics Act, 1940 (for short, the Act). This led to the prosecution of Kamal Kumar, retail-dealer, Rajinder Kumar the wholesale dealer and the petitioner and his partner as the manufacturers of the drug. This petition is to challenge the proceedings terming them to be an abuse of the process of the Court and leading to injustice to the petitioner.
(2.) FILE has been summoned and the learned Counsel have been heard.
(3.) THE first afore-referred to charge pertains to the drug being not of standard quality. Section 27(b) in the year 1981, when all such activity took place, provided that whosoever himself or by any other person on his behalf manufactures for sale, sells, stocks or exhibits for sale or distributes any drug other than a drug referred to in clause (a) in the contravention of any of the provisions of Chapter IV of the Act or any rules made thereunder, shall be punishable with imprisonment for a term which may extend to three years or with fine or with both. And Section 18(a)(i) provides for Prohibition for a person for himself or by any other person on his behalf to manufacturer for sale, or sell, or stock or exhibit for sale, or distribute any drug which is not of standard quality. Section 16 describes what are standards of quality and in relation to a drug mens that the drug should comply with standards set out in the second schedule. Second Schedule sets out standards of drugs to be manufactured for sale, sold, stocked or exhibited for sale or distributed. Item 5 thereof covers the drug in question under the head 'other drugs' and refers to standards set out in Pharmacopoeia of India. The requirement is that standards of identity, purity and strength be such as specified in the edition of Pharmacopoeia of India for the time being in force and such other standards as may be prescribed. Care is taken as well to provide for drugs whose standards are not specified in the Indian Pharmacopoeia, but we are not concerned in the instant case with that situation. In Pharmacopoeia of India, applicable to the times, Chloramphenicol Palmitate Oral Suspension has been described as below :- Chloramphenicol Palmitate Oral Suspensson contains Chloramphenicol Palmitate suspended in a suitable vehicle. It may contain dispersing flavouring, colouring and buffering agents. It contains not less than 950 per cent and not more than 115.0 per cent of the stated amount of chloramphenicol." Its usual strength prescribed is 125 mg. of chloramphenicol in 5 ml.