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M/s. Carenow Medical Pvt.Ltd., Coimbatore Represented by its Managing Director Anand Venkatachalam & Another v/s State rep by: The Drug Inspector, Ranipet Range, O/o The Assistant Director of Drugs Control, Vellore

    Crl.O.P.Nos. 11696 & 13627 of 2022 & Crl.M.P.Nos. 6642, 6644,7288 & 7289 of 2022
    Decided On, 25 July 2022
    At, High Court of Judicature at Madras
    For the Petitioners: V. Lakshminarayanan, Advocate. For the Respondent: Leonard Arul Joseph Selvam, Government Advocate (Crl. Side).

Judgment Text
(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 to Chlorhexidine gluconate 0.5%w/v Ethanol Denatured eq.to Ethanol 70%v/v. According to the learned Additional Public Prosecutor that each 100 gram should not have been in the label.

6. From the perusal of the above submissions and materials on record, the fact that there was a license issued to manufacture of the drug Theruptor Hand Rub is not disputed. In such a view of the matter, the very prosecution for the offence under Section 18(c) of Drugs and Cosmetic Act 1940 r/w Rule 74 of Drug and Cosmetic Rules 1945 r/w Condition No.3 of conditions of licence stated in Form 25 for having manufactured without a valid licence cannot sustain in the eye of law.

7. Now, the only ground which has to be seen whether the prosecution has proved the alleged misbranding. The licence was issued to manufacture for sale of Theruptor Hand Rub. In the composition the petitioner has added Each 100g of solution contains Chlorhexidine Gluconate Solution I.P 2.5% v/v equivalent to Chlohexidine 0.5% w/v, Denatured Ethyl Alcohol 70% v/v, Glycerine, skin emollients and excipients. Mentioning 100 gram said to be the violation. As per the lab report, there is no difference in composition. The composition in fact, in tune with the licence conditions. That was the Analyst has given report stating that drug was a standard quality. There was neither adulteration nor any extra composition found out. The only difference in the label wast the word “each 100 gram” appeared in the label. According to the prosecution, it is “Misbranded”.

8. Sub-Clause (c) of Section 17 of the Drugs and Cosmetics Act, 1940, reads as follows:

17. Misbranded drugs: a drug shall be deemed to be misbranded,—

(a). ... ... ... ... ... ...

(b) ... ... ... ... ... ...

(c) if its label or container or anything accompanying the drug bears

any statement, design or device which makes any false claim for

the drug or which is false or misleading in any particular.

9. To hold it is misbranded the statement must have been false or misleading any particular. Admittedly, with regard to the composition there is no dispute. The licence has also give only to manufacture of Hand Rub and the weight and volume in the samples also in the same quality which has not been disputed. It is also found in the Analyst Report. It is not the case of the prosecution that the weight and volume noted by the Analyst is not in terms of the gram. Even in the counter, it is admitted that after the show cause notice the word “100g” was also removed. When the composition is not against even the 100 gram as mentioned by the petitioner in the old label, it cannot be presumed that statement was false and misleading any particular to attract misbranding. It is only a minor violation which has not been considered by the prosecution.

10. It is also to be noted that in the guidelines for taking action and samples of Drugs declared spurious or not of standard quality, the guidelines framed u/s.33 (P) of the Act category (C) of the guidelines narrates the following:

Category (C) (Minor defects):

Drugs manufactured by the licenced manufacturers found not of standard quality because of defects arising out of minor variations in quality. Such defects may arise because of inadequate pre-formulation development studies, lack of in process controls exercised by the manufacturer or unsuitable conditions under which drugs are stored or transported. Examples of some such the defects are as under:

(i) Broken or chipped tablets

(ii) Presence of spot / discolouration / uneven coating.

(iii) Cracking of emulsions.

(iv) Clear liquid preparations showing sedimentation.

(v) Change in colour of the formulation.

(vi) Slight variation in net content.

(vii)Formulations failing in weight variation.

(viii)Formulations failing to respond to the colour test.

(ix) Isolated cases of presences of foreign matter.

(x) Labelling error including nomenclature mistake, Rx,

Nrx, Red Line, Schedule H. Caution, Colour etc.

11. On a perusal of the above guidelines further, it makes it very clear that the State Drug Control Organisation for uniform implementation of the provision of the Drugs and Cosmetics Act and Rules made thereunder. While implementing new provisions, the State Regulatory Authorities should ensure that the law is implemented in a comprehensive way. In order to effectively use the said instrument of law, it is necessary to have Standard Operative Procedures set in each State to examine and process various violations of the provisions of the Act. The State Dru

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g Central Organizations should have internal mechanism of checks and balances to ensure that law abiding manufacturers and sellers of drugs are not harassed or put to a disadvantageous position. Care should be taken that while violations with criminal intent or gross negligence leading to serious defects are dealt with heavy hand, the violations involving minor variations in quality by licenced manufacturers are resolved through administrative measures. At any event this Court after seeing the very small variation in the label is of the view that it would not amount to misbranding. Accordingly, the prosecution against the petitioner in STC No.01 of 2022 on the file of the Judicial Magistrate No.II, Walajah and STC No.20 of 2022 on the file of the Judicial Magistrate No.1, Vellore, stand quashed. 12. In view of the same, both the Criminal Original Petitions in Crl.O.P.Nos.11696 and 13627 of 2022 are Ordered. Consequently connected Crl.M.Ps are closed.