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IN THE HIGH COURT OF JUDICATURE OF BOMBAY BENCH AT AURANGABAD
SURENDRA P. TAVADE, J.
Ravindra S/o. Deoram Sonawane - Applicant
Versus
The State of Maharashtra & Ors. - Respondents
Criminal Application No. 809 of 2021
Decided On : 06-10-2021
Drugs and Cosmetics Act, 1940 and Rules - Sections 18-A, 18-B, 19 (3) and 25 (3) - Government Analyst - Business of stock for sale and distribution of drugs - Whether applicant is entitled to benefit of the provisions of Section 19 (3) of Act, 1940 - Applicant is a Medical Whole-seller having shop he is doing business of stock for sale and distribution of drugs.. Complainant (respondent No. 2) visited premises of the applicant for purpose of drawing sample Accordingly, he has drawn sample of Rabeprazole and Domperidone Capsules complainant (respondent No. 2) received the test report of subject drug from Government Analyst (“G.A.”). It was declared that subject drug was not of standard quality.
Finding of the Court: A drug purchased by the applicant from the licensed distributor for selling the same under a written warranty found to be sub-standard by the Government Analyst - applicant proved that he purchased the drug from a licensed distributor, that he did not know and could not with reasonable diligence know that the drug in question in any way contravened the provisions of Act and that he had properly stored those capsules - he is entitled to the benefit of Section 19 (3) of the Act - Applicant had produced on record the invoices and certificate of the analyst, which show that the applicant had relied on the warranty given in the certificate of analyst. He did not know and could not know with reasonable diligence that the drug in question in any way contravened the provisions of the Act, 1940.
Result: Application is allowed.
JUDGMENT :
1. Rule. Rule made returnable forthwith. By consent of learned counsel for both the parties, heard finally at the admission stage.
2. This Criminal Revision Application is directed against the order of ‘issue of process’ passed by the Additional Chief Judicial Magistrate, (Corporation Court), Aurangabad in RCC No. 41 of 2018.
3. The applicant is a Medical Whole-seller having shop in the name and style as “M/s. NTMED Pharmaceutical, Shop No. G-7-B and 8-B, Kasliwal Market-B, Mukundwadi, N-2, CIDCO, Aurangabad. He is doing the business of stock for sale and distribution of drugs. On 30.09.2016, the complainant (respondent No. 2) visited the premises of the applicant for the purpose of drawing the sample. Accordingly, he has drawn the sample of Rabeprazole and Domperidone Capsules “NTDOM-DR” B. No. AC1601287, D/mfg. 01/2016, D/Exp. 12/2017, manufactured by Accura Health Care Pharmaceuticals Pvt. Ltd, village Moginand, Nahan Road Kala Amb. Dist. Sirmour (Haryana), 173030, vide Invoice No. 0077 dated 19.01.2016 and invoice No. 00118 dated 10.02.2016, through TCI, Transport in the name of original accused No. 8. As per the procedure laid down in the Drugs and Cosmetics Act, 1940 and Rules there under (for short the “Act 1940”). The said sample was sent to the Government Analyst, Drug Control Laboratory, Mumbai along with Form No. 18 dated 30.09.2016. On 07.06.2017 the complainant (respondent No. 2) received the test report of the subject drug from the Government Analyst, Mumbai (for short “G.A.”). It was declared that the subject drug was not of standard quality for the following reasons :
4. After receiving the report from G.A., a copy of the same was given to the applicant as per the provisions of Section 25 (3) of the Act, 1940 and called upon him to disclose the name of the supplier of the drug by a letter. The complainant (Respondent No. 2) issued notice under Section 18-B of the Act, 1940 dated 28.08.2017, to the original accused No. 2 and asked to submit the details from whom he had acquired the subject drug. He also received a letter along with documents from accused No. 2 and they disclosed that they acquired the subject drug from accused No. 8.
5. The applicant has disclosed to the complainant that original accused No. 2 has supplied him the subject drug vide their invoice No. 0077 dated 29.01.2016 and invoice No. 00118 dated 10.02.2016 respectively. Accordingly, one copy of test report was furnished to original accused No.8 by letter dated 07.06.2017. Original accused No.8, the Manufacturer challenged the said report and demanded one part of sample for sending it to the Central Drugs Laboratory, Kolkata for re-analysis. Accordingly a demand draft was sent by original accused No.8 to the complainant (Respondent No.2). The complainant deposited the sample part of the subject drug along with demand draft received from original accused No. 8, in the Court and sent the subject sample portion to the Central Drugs Laboratory, Kolkata on 03.07.2017.
6. The Central Drugs Laboratory, Kolkata sent the test report in Form No. 2 to complainant (respondent No. 2) wherein, it was opined that “The Subject Sample Drug Was Not Of Standard Quality” for the reasons stated thereunder as “the sample does not confirm to Manufacturer’s specification with respect to Assay/Content of ‘Rabeprazole Sodium’ i.e. 73.15%”. It is alleged that the contents of Rabeprazole Sodium in the sample was found to be 74.09% as per G.A. Maharashtra and 73.15% as per the Director of Central Drugs Laboratory, Kolkata. From both the reports, it is clear that the sample was of not of standard quality with respect to the Rabeprazole Sodium. The complainant (respondent No. 2) sought permission to prosecute the applicant and others. Accordingly the complainant (respondent No. 2) received the prosecution order on 29.05.2018, from the Joint Commissioner (D
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