Case Note & Summary
In this criminal revision application before the High Court of Judicature at Bombay, Bench at Aurangabad, the applicant, a medical wholesaler trading as M/s NTMED Pharmaceutical, challenged the order of the Additional Chief Judicial Magistrate (Corporation Court), Aurangabad issuing process in RCC No. 41 of 2018. The prosecution arose under the Drugs and Cosmetics Act, 1940 after a sample of Rabeprazole and Domperidone Capsules 'NTDOM-DR' batch AC1601287 drawn from the applicant's shop on 30 September 2016 was found not of standard quality. The Government Analyst, Mumbai reported that the content of Rabeprazole Sodium was 74.09% of the labelled amount, below permissible limits. The manufacturer, Accura Health Care Pharmaceuticals Pvt. Ltd, exercised the right to challenge the report, and the sample was sent to the Central Drugs Laboratory, Kolkata, which also reported the drug as not of standard quality with Rabeprazole Sodium content of 73.15%. The Joint Commissioner (Drugs) cum Controlling Authority granted prosecution order on 29 May 2018, and the Drug Inspector filed a complaint; the Magistrate thereafter issued process against the applicant and others. The applicant's case was that he was only a wholesaler and not the manufacturer. He had purchased the subject drug from M/s Biotech Health Care Pvt. Ltd, the distributor and original accused No.2, which had supplied invoices dated 19.01.2016 and 10.02.2016. The manufacturer was Accura Health Care Pharmaceuticals Pvt. Ltd, original accused No.8. The applicant contended that he stored the drug properly, received a certificate of analysis from the manufacturer's quality control department dated 06.01.2016 indicating standard quality, and had no knowledge that the drug contravened the Act. After receiving notice under Section 18-A, he disclosed the name of the supplier and submitted the invoice and analyst's report. He claimed protection under Section 19(3) of the Drugs and Cosmetics Act, 1940, which exempts a person who is not a manufacturer or its agent from liability for contravention of Section 18 if he proves acquisition from a duly licensed manufacturer, distributor or dealer, lack of knowledge with reasonable diligence, and proper storage in the same state. The applicant argued that since the supplier and manufacturer were arrayed as accused, the retailer should not be made an accused and the Magistrate did not consider Section 19(3) properly. The court noted that it was undisputed that the applicant was a competent person to store and distribute the medicine, that the Drug Inspector collected the sample on 30 September 2016, that the applicant was not the manufacturer, and that he had purchased the drug from M/s Biotech Health Care Pvt. Ltd. The court quoted Section 19(3) and stated it would examine whether the applicant could be blamed and penalized for sub-standard quality. The extracted portion of the judgment ends before the court's final analysis and conclusion; therefore, the final decision, ratio decidendi and operative order are not available in the text provided.
Headnote
A) Criminal Law - Issue of Process - Challenge to Cognizance - Drugs and Cosmetics Act, 1940, Sections 18, 19(3), 25(3) - The criminal revision application challenged the order of the Additional Chief Judicial Magistrate issuing process against the applicant in RCC No. 41 of 2018 for alleged sale of sub-standard drug. The applicant contended that as a non-manufacturer who disclosed licensed supplier and manufacturer, no process should have issued against him. The court was examining whether the material before the Magistrate made out a prima facie case against the applicant (Paras 2, 7-10). B) Drugs and Cosmetics - Sub-standard Drug - Sample Analysis and Statutory Defence - Drugs and Cosmetics Act, 1940, Sections 18, 19(3), 25(3), 18-A, 18-B - Sample of Rabeprazole and Domperidone Capsules drawn from applicant's premises was declared not of standard quality by both Government Analyst (74.09% Rabeprazole Sodium) and Central Drugs Laboratory, Kolkata (73.15%). The applicant relied on the statutory defence under Section 19(3) that he acquired the drug from a duly licensed distributor, had no knowledge of contravention, and stored it properly; he had submitted invoices and manufacturer's certificate of analysis in response to notice (Paras 3-8, 10). C) Drugs and Cosmetics - Statutory Defence for Non-Manufacturer - Section 19(3) Defence - Drugs and Cosmetics Act, 1940, Section 19(3) - The provision exempts a person not being manufacturer or agent for distribution from liability for contravention of Section 18 if he proves acquisition from licensed manufacturer/distributor/dealer, lack of knowledge with reasonable diligence, and proper storage in same state. The court quoted the provision and noted the applicant's contentions regarding each condition, but the available text does not record the final finding on whether the defence was established at the stage of process issuance (Para 10).
Issue of Consideration
Whether the order of issue of process passed by the Additional Chief Judicial Magistrate against the applicant, a non-manufacturer wholesaler, is sustainable in view of the statutory protection under Section 19(3) of the Drugs and Cosmetics Act, 1940, when the applicant disclosed the licensed supplier and manufacturer and relied on lack of knowledge and proper storage.
Law Points
- A person not being manufacturer or his agent for distribution is not liable for contravention of Section 18 if he proves acquisition from duly licensed manufacturer/distributor/dealer
- lack of knowledge with reasonable diligence
- and proper storage in same state
- Copy of test report to be supplied under Section 25(3)
- Notice under Section 18-B to disclose source
- Statutory defence under Section 19(3) of Drugs and Cosmetics Act
- 1940
