Akums Drugs and Pharmaceuticals Ltd v. State of Andhra Pradesh
2025-04-24
HARINATH.N
body2025
DigiLaw.ai
ORDER : HARINATH.N, J. 1. The petition is filed praying to quash CC 969 of 2023 on the file of Judicial First Class Magistrate, Jangareddygudem, West Godavari District. 2. As per the allegations in the complaint, it is stated that LW1 visited the stores at the Government Area Hospital, Jangareddygudem and picked up Ranitidine tablets IP 150 with batch number OCCQ 31 with the manufacturing date as 11/2020 and an expiry date of 10/2022. 3. It is stated in the complaint that when the drug was sent for analysis to the Government Analyst, Drugs Control Laboratory, Vijayawada as per the procedure for analysis of the drug. A report bearing number 219/APDCL/2022 dated 22.01.2022 was submitted reporting that the drug was declared as not of standard quality for the reason that the sample failed in general requirements. 4. It is also stated in the complaint that the notice was issued to the pharmacist at the main stores of the Government Area Hospital on 07.02.2022 and that the pharmacist has replied on 08.02.2022 informing that the subject drug was supplied by APMSIDC West Godavari District. On 08.02.2022 LW1 addressed a notice to APMSIDC, Central Medical Stores, Eluru by enclosing a copy of the analysis report. On 21.03.2022 LW1 received a reply from APMSIDC, Central Medical Stores informing that the subject drug was supplied by the first petitioner and invoice dated 18.11.2020. 5. It is stated in the complaint that, the first petitioner has addressed replies to the notices received from the LW1. However, the1 st petitioner did not furnish the relevant information as desired by the LW1. As such the complaint was filed against the company and its Directors. 6. Sri T.Pradyumna Kumar Reddy, the Learned Senior Counsel submits that the complaint filed by the Drugs Inspector has violated the provisions of the Drugs and Cosmetics Act. It is submitted that Complaint was filed after the subject tablets shelf life had expired. The expiry date on the drug is October 2022 the sample was lifted on 10/12/2021 and the complaint was filed on 16.08.2023. 7. The Learning Senior Counsel submits that the petitioners are manufacturers of life saving drugs and the factory is based at Haridwar. The petitioners 2 and 3 are residents of New Delhi. There are no specific averments in the complaint to fasten the vicarious liability of the company on all its Directors blanketly. 8.
7. The Learning Senior Counsel submits that the petitioners are manufacturers of life saving drugs and the factory is based at Haridwar. The petitioners 2 and 3 are residents of New Delhi. There are no specific averments in the complaint to fasten the vicarious liability of the company on all its Directors blanketly. 8. It is submitted that there was no opportunity for the petitioner company to request the court to send the sample for testing to the Central Drug Laboratories at Calcutta. It is also submitted that as per Section 25(4) of the Drugs and Cosmetics Act, the sample that has been deposited in the court can be sent to the central lab by the accused or the drug inspector. In the present case the petitioners have been denied the opportunity of requesting the sample to be sent for central lab at Calcutta for reanalysis as the complaint filed after the drug expired its shelf life. 9. It is also submitted that the tablets ought to have been stored appropriately and duly following the storage conditions as prescribed on the packaging. The petitioners have no control over the manner in which the drugs are stored at the hospitals or at the medical stores as such non-compliance with the storage conditions by the hospitals or the medical shops cannot make the petitioners responsible or liable for the penal consequences under the Drugs and Cosmetics Act. 10. The learned senior counsel places reliance on Section 20(4) and Section 34 of the Drugs and Cosmetics Act. It is submitted that as per section 34 of the Drugs and Cosmetics Act unless and until the offense alleged to have been committed by the responsible officer of the company who is responsible for conduct of the business of the company would be deemed to be guilty of the offence and can be prosecuted and punished accordingly. In the present case the entire complaint is silent as to in what manner the petitioners 2 and 3 are responsible for conduct of business of the company. 11. It is submitted that petitioners 2 and 3 are residents of New Delhi while the company and its manufacturing facility is at Haridwar. Thus, the petitioners 2 and 3 cannot be held as officers who are responsible for conduct of the business of the first petitioner company on a day to day basis. 12.
11. It is submitted that petitioners 2 and 3 are residents of New Delhi while the company and its manufacturing facility is at Haridwar. Thus, the petitioners 2 and 3 cannot be held as officers who are responsible for conduct of the business of the first petitioner company on a day to day basis. 12. The learned Senior Counsel places reliance on the judgement of the Bombay High Court in the matter of State of Goa V/s Carly Pharma, [2015 SCC online Bombay 6361] , while dismissing the appeal filed by the state the Hon’ble High Court of Bombay held that the drugs which are to be stored at the optimum temperature would be the responsibility of the stockist or the pharmacist at the place where it is distributed/sold for use of the patients. Storing of the drugs at the desired temperature as mandated under the packaging cannot be the look out of the manufacture of the drug after they are sold to the stockist/pharmacist/Medical Shops. 13. In the matter of State of Haryana V/s Brij Lal Mittal and Others , [1998(5) SCC page 343] , the Hon`ble Supreme Court acquitted the Directors of a Pharma Company against whom the complaint alleging violation of the provisions of the Drugs and Cosmetic Act was made. It was held that vicarious liability of a Director for prosecution of offence committed under the act would arise only if it is established that the said Director was incharge and responsible for conduct of the business of the company during the relevant point of time. 14. In the case of Lalankumar Singh and Others V/s State of Maharashtra , [2022 SCC Online SC 1383] . The Hon`ble Supreme Court held that a person simply because is a director of the company, it does not necessarily mean that he fulfills the twin requirements of Section 34(1) of the said Act so as to make him liable. It has been held that a person cannot be made liable unless, at the material time, he was in charge of and was also responsible to the company for the conduct of its business. 15. Heard the learned Senior Counsel for the petitioner and the learned Assistant Public Prosecutor for the state. Perused the record. 16.
It has been held that a person cannot be made liable unless, at the material time, he was in charge of and was also responsible to the company for the conduct of its business. 15. Heard the learned Senior Counsel for the petitioner and the learned Assistant Public Prosecutor for the state. Perused the record. 16. The drug inspector after sending the tablets for analysis and after receipt of the report from the laboratory corresponded with the pharmacist and also with APMSIDC, Mangalagiri. Thereafter, addressed a communication to the first petitioner calling for furnishing of the information relating to the tablets which formed subject of the Drug Analysis. 17. The 1 st petitioner exchanged correspondence with the drug inspector as and when the drug inspector sought clarifications. However, the drug inspector claims that the relevant information was not furnished. It is not stated in the correspondence of the drug inspector as to what further details are not furnished by the 1 st petitioner. Admittedly, the drug inspector has not addressed any correspondence to the petitioners 2 and 3. However, the petitioners 2 and 3 have been arraigned as accused alleging commission of the alleged offences. 18. It is also a matter of record that the complaint was filed after the expiry of the shelf life of the tablets on 16.08.2023. The petitioners have been denied an opportunity of seeking a second opinion from the Central Drugs Laboratory Kolkata. Had the complaint been filed well within the shelf life of the tablets which form subject of the complaint, the petitioners could have had an opportunity of referring the sample of the drug to the Central Laboratory for reanalysis. This opportunity was denied to the petitioners as the complaint was filed by the drug inspector much after the date of expiry of the said drugs. 19. That apart the entire complaint is silent as to in what manner the petitioners 2 and 3 are responsible for the day to day affairs of the company. Even as per the cause title of the complaint, the address of the petitioners 2 and 3 is mentioned as that of New Delhi. The first petitioner company is operating from Haridwar. As such the omnibus allegations against petitioners 2 and 3 by extending the vicarious liability to the petitioners 2 and 3 for the alleged offences committed by the first petitioner cannot sustain.
The first petitioner company is operating from Haridwar. As such the omnibus allegations against petitioners 2 and 3 by extending the vicarious liability to the petitioners 2 and 3 for the alleged offences committed by the first petitioner cannot sustain. Law on this is clear and well settled without establishing the role and responsibility of petitioners 2 and 3 the complaint cannot sustain against the petitioners 2 and 3. On account of denial of an opportunity of referring the sample of the drug to the Central Laboratory a fair opportunity which is provided under Section 25(4) of the Drugs and Cosmetics Act was denied to the first petitioner. On these grounds this court is of the considered opinion that the complaint deserves to be quashed against the petitioners. 20. Accordingly the criminal petition is allowed quashing CC 969 of 2023 on the file of Judicial First Class Magistrate Jangareddygudem, West Godavari District. As a sequel, miscellaneous petitions pending, if any, shall stand closed.