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IN THE HIGH COURT OF JUDICATURE AT MADRAS
THE HONOURABLE DR. JUSTICE G. JAYACHANDRAN, J.
M/s.Medybiz Pharma Pvt. Ltd. & Ors. - Petitioners
Versus
The State of Tamil Nadu, Represented by the Drug Inspector, Teynampet, Chennai - Respondent
Crl.O.P.No.8095 of 2024 & Crl.M.P.No.5897 of 2024
Decided On : 30-04-2024
CRIMINAL LAW - DRUGS AND COSMETICS ACT VIOLATION - Section 18(c), Section 27(d), Rule 65(9)(b) - The court discussed the provisions of the Drugs and Cosmetics Act, 1940, particularly Section 18(c) which prohibits the sale of drugs without a proper license and Rule 65(9)(b) which mandates that Schedule H drugs be supplied only against a signed order. The court interpreted these provisions in light of the prosecution's failure to provide adequate notice regarding the signed order requirement, ultimately influencing the decision to quash the complaint against the petitioners.
Fact of the Case:
The Drug Inspector filed a complaint against M/s.Medybiz Pharma Pvt Ltd and its directors for selling Schedule H drugs without obtaining signed orders from registered medical practitioners, violating the Drugs and Cosmetics Act, 1940. The complaint arose from an inspection on 15.03.2018, revealing sales without proper documentation.
Finding of the Court:
The court found that the prosecution was barred by the law of limitation as the complaint was filed beyond the three-year period stipulated under Section 468 of the Cr.P.C. Additionally, the court noted that the show cause notice did not adequately inform the petitioners of the requirement to produce signed orders, rendering the prosecution invalid.
Issues: 1. Whether the complaint was filed within the limitation period. 2. Whether the petitioners were given adequate notice regarding the requirement for signed orders. 3. Whether the Director could be held vicariously liable for the company's actions.
Ratio Decidendi: The court held that the prosecution was time-barred due to the delay in filing the complaint beyond the statutory limit. Furthermore, the lack of a specific show cause notice regarding the signed order requirement meant that the petitioners were not given a fair opportunity to defend themselves, leading to the conclusion that the prosecution was illegal.
Final Decision: The petition to quash the complaint in C.C.No.1047 of 2022 was allowed, and the prosecution against M/s.Medybiz Pharma Pvt Ltd and its directors was quashed.
ORDER :
G. Jayachandran, J.
[PRAYER:- Criminal Original Petition has been filed under Section 482 of Cr.P.C., to call for the records in C.C.No.1047 of 2022 pending for trial on the file of the Learned IV Metropolitan Magistrate, Saidapet, Chennai and quash the same as against the petitioners.]
The Drug Inspector, T.Nagar Range has filed a complaint under Section 18 (c) r/w Rule 65 (9) (b) of the Drugs and Cosmetic Act 1940 against the petitioners herein and others for selling schedule H-Drugs to registered medical practitioners without obtaining the signed order in writing and for not mentioning the address of the licensee to whom the Drugs were sold and the license number of the purchaser which is an offence punishable under Section 27(d) of the Drugs and Cosmetic Act, 1940.
2. As per the complaint on 15.03.2018, the Drug Inspector inspected the premises of M/s.Medybiz Pharma Pvt Ltd at T.Nagar, Chennai. During the course of inspection, Mr. V. Balaji (A3) was present and he is the competent person appointed by M/s.Medybiz Pharma Pvt Ltd. During the inspection the following drugs which were already sold by M/s.Medybiz Pharma Pvt Ltd were not purchased with purchase invoices and sold without the license number of the buyer as follows.
| Sl. No. | Name of the Drug | Batch No. | Sale Bill No. and dated | Qty sold | To whom drug sold |
| 1. | Remicade 100 mg Inj | HBM94014A | 1700284001349 dated 01.03.2018 | 7 | Get fast pharmaceuticals Private Limited, Nungambakkam, Chennai. |
| 2. | Remicade 100 mg Inj | HCM05015 | 1700284001349 dated 01.03.2018 | 8 | Get fast pharmaceuticals Private Limited, Nungambakkam, Chennai. |
| 3. | Imbruvica Caps 90's pack | 481276 | 1700284001283 dated 08.02.2018 | 1 | Get fast pharmaceuticals Private Limited, Nungambakkam, Chennai. |
| 4. | Imbruvica Caps 90's pack | 481402 | 1700284001283 dated 08.02.2018 | 4 | Get fast pharmaceuticals Private Limited, Nungambakkam, Chennai. |
| 5. | Imbruvica Caps 90's pack | 481276 | 1700284001188 dated 28.12.2017 | 1 | Medybiz Pharma Pvt Ltd. |
| 6. | Juvederm voluma with lidocaine | VB20A70515 | 17002830069 dated 22.01.2018 | 2 | Dr. Gayathri, Chennai – 42. |
| 7. | Juvederm voluma with lidocaine | VB20A70515 | 17002830071 dated 27.01.2018 | 2 | Dr. Gayathri, Chennai – 42. |
| 8. | Juvederm voluma with lidocaine | VB20A70603 | 17002830088 dated 23.02.2018 | 1 | Dr. Gayathri, Chennai – 42. |
| 9. | Juvederm Voluma with lidocaine | V17LA70472 | 17002830088 dated 23.02.2018 | 2 | Dr. Gayathri, Chennai – 42. |
Thus, there is a contravention of Section 18 (c) read with Rule 65 (5)(1)(3) of the Drugs and Cosmetic Act, 1940.
3. The show cause notice was issued calling for particulars from M/s.Medybiz Pharma Pvt Ltd. Based on the information furnished by M/s.Medybiz Pharma Pvt Ltd, M/s.Jhohnson & Jhohnson Pvt Ltd which has supplied those drugs to M/s.Medybiz Pharma Pvt Ltd was called for explanation. Being satisfied that M/s.Medybiz Pharma Pvt Ltd and its Directors through competent person had violated Section 18 (c) r/w Rule 65 (9) (b) of Drugs and Cosmetic Act by selling the following H-schedule Drug to registered Medical practitioners without obtaining the signed order of the purchaser, hence liable to be prosecuted.
| Sl. No. | Name of the Drug | Batch No. | Sale Bill No. and dated | Qty sold | To whom drug sold |
| 1. | Juvederm voluma with lidocaine | VB20A70515 | 17002830069 dated 22.01.2018 | 2 | Dr. Gayathri, Chennai - 42. |
| 2. | Juvederm voluma with lidocaine | VB20A70515 | 17002830071 dated 27.01.2018 | 2 | Dr. Gayathri, Chennai – 42. |
| 3. | Juvederm voluma with lidocaine | VB20A70603 | 17002830088 dated 23.02.2018 | 1 | Dr. Gayathri, Chennai – 42. |
| 4. | Juvederm Voluma with lidocaine | V17LA70472 |
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The prosecution for violations under the Drugs and Cosmetics Act must adhere to statutory limitations and provide adequate notice of charges; failure to do so renders the prosecution invalid.
The central legal point established in the judgment is the importance of adhering to the prescribed limitation period for filing a complaint under the Drugs and Cosmetics Act, 1940, and the consequen....
Unexplained inordinate delay can be fatal to a prosecution case, and individuals involved in the day-to-day affairs of a company can be held liable for contraventions under the Drugs and Cosmetics Ac....
The petitioner contravened Section 18(c) of the Drugs and Cosmetics Act by stocking and selling drugs without a license. The petitioner is liable under Section 27(b)(ii) of the Act.
Non-compliance with inspection procedures under the Drugs and Cosmetics Act, 1940 is not fatal for prosecution in cases involving allegations of spurious drugs.
Sildenafil Citrate is an allopathic drug and it cannot be used by anybody else unless a person who holds licence for it.
Directors of a company not involved in drug manufacturing cannot be held liable under the Drugs and Cosmetics Act absent specific evidence of their responsibility for the conduct of business.
The main legal point established in the judgment is the need for specific allegations to establish vicarious liability and the importance of following mandatory provisions before launching prosecutio....
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