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2022 Supreme(Mad) 3016

IN THE HIGH COURT OF JUDICATURE AT MADRAS
N. SATHISH KUMAR, J.
M/s. Carenow Medical Pvt.Ltd., Coimbatore Represented by its Managing Director Anand Venkatachalam & Another - Appellant
Versus
State rep by: The Drug Inspector, Ranipet Range, O/o The Assistant Director of Drugs Control, Vellore - Respondent
Crl.O.P.Nos. 11696 & 13627 of 2022 & Crl.M.P.Nos. 6642, 6644,7288 & 7289 of 2022
Decided On : 25-07-2022

Advocates appeared:
For the Petitioners:V. Lakshminarayanan, Advocate. For the Respondent:Leonard Arul Joseph Selvam, Government Advocate (Crl. Side).

Headnote:

Misbranding - Drugs and Cosmetics Act, 1940 - Section 18(a)(i) r/w Section 17 and Section 18(c) - Rule 74 r/w condition No.3 of Form 25 of the Drugs and Cosmetics Rules 1945

Fact of the Case:

The petitions were filed to quash complaints for offences under Section 18(a)(i) r/w Section 17 and Section 18(c) of the Drugs and Cosmetics Act, 1940 along with Rule 74 r/w condition No.3 of Form 25 of the Drugs and Cosmetics Rules 1945. The prosecution alleged misbranding of a drug named Theruptor Hand Rub and the sale of the drug without a valid license.

Finding of the Court:

The court found that the prosecution could not sustain the charges of manufacturing without a valid license as the petitioner had obtained a valid license before the manufacturing of the drugs. Additionally, the court determined that the alleged misbranding was not substantiated as the composition of the drug was in line with the license conditions and the minor labeling violation did not amount to misbranding.

Issues: The issues revolved around the validity of the license obtained by the petitioner, the alleged misbranding of the drug, and the interpretation of the relevant provisions of the Drugs and Cosmetics Act, 1940.

Ratio Decidendi: The court held that the prosecution failed to prove misbranding as the composition of the drug was in accordance with the license conditions and the minor labeling violation did not constitute misbranding. The court also emphasized the need for comprehensive implementation of the provisions of the Act and the consideration of minor variations in quality by licensed manufacturers through administrative measures.

Final Decision: The court quashed the prosecutions against the petitioner in both cases.

JUDGMENT

(Prayer in Crl.O.P.No.11696 of 2022: Petition filed under Section 482 of Cr.P.C. to call for the records relating to the STC No.01 of 2022 on the file of the learned Judicial Magistrate No.II, Walajah and quash the same.

Prayer in Crl.O.P.No.13627 of 2022: Petition filed under Section 482 of Cr.P.C. to call for the records relating to the STC No.20 of 2022 on the file of the learned Judicial Magistrate No.I, Vellore and quash the same.)

Common Order:

These Criminal Original Petitions have been filed to quash the complaints filed by the Drug Inspectors of Ranipet Range and Vellore II Range, taken on file as STC.No.1 of 2022 by the learned Judicial Magistrate No.11 Walajah and in STC No.20 of 2022 by the learned Judicial Magistrate No.I, Vellore for the offences under Section 18(a)(i) r/w Section 17 and Section 18(c) of the Drugs and Costmetics Act, 1940 along with Rule 74 r/w condition No.3 of Form 25 of the Drugs and Cosmetics Rules 1945 .

2. Brief facts of the prosecution is that sample of drug Theruptor Hand Rub was drawn from the premises of M/s. Rajan Medical Shop, Walajah on 23.05.2020 by the Drug Inspector of Ranipet Range sent for analysis to Government Analyst, Chennai. Another drug sample of Therupter Hand Rub was taken from same shop by the Drug Inspector of Vellore II Range on the same day and the same was also sent for analysis to Chennai. After the Reports were received, show cause notices were issue on 16.09.2020 and 10.09.2020 respectively and filed cases against the Petitioner.

3. It is the case of the Prosecution that the samples were lifted from the premises at Walajah, after sent for Government Analysis, they were reported as standard quality however, there is a “Misbranding”. It is the contention of the prosecution that Label Claim Composition is Each 100g of solution contains: Chlorhexidine Gluconate Solution IP 2.5%v/v equivalent to Chlorexidine Gluconate 0.5%v/v, Denatured Ethyl Alcohol 70%v/v. Thereafter show cause notice issued and finally found that the Petitioner is the manufacturer and they issued show cause notice and found that they have not obtained any license to produce the above drug, besides there is a misbranding. Hence the prosecution has been launched for the above offences.

4. Learned counsel appearing for the Petitioner Mr.V. Lakshminarayanan submitted that the very prosecution is proceeded as if there was no licence obtained by the manufacturer. It is proceeded as if license was only obtained on 17.06.2020 after the manufacturing of the drugs. According to him it is absolutely false on the records of Respondent. The Petitioner has in fact, obtained valid license on 23.04.2020. Therefore, the charges that the drugs were sold without any valid license has no leg to stand. It is his further contention that the alleged misbranding is also not correct. The licence clearly show the composition of the drug. The Analysis Report itself indicate that there was no change in composition and the report also indicated that it was standard quality. The ingredient in the given sample is expressed neither in terms of percentage by weight or volume nor in terms of unitage per gram or millilitre and it is the conclusion of the Analyst that the volume and weight have been mentioned as per licence. Therefore, it caanot be said that there is a misbranding. The Report itself clearly indicates that there is no difference in composition and volume and weight are also properly mentioned. Therefore, submitted that the entire prosecution is nothing but abuse of process of law.

5. Learned Additional Public Prosecutor fairly admitted that the license was obtained on 23.04.2020, however, submitted that the prosecution is still lying for the misbranding. It is his contention that in the label instead of “CHG-EA”, Theruptor Hand Rub has shown. It is his contention that as per the old label of the Petitioner it is stated that each 100 gram of the solution contains Chlorhexidine gluconate solution IP 2.5% v/v equivalent

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