Madras High Court
M/S.Carenow Medical Pvt. Ltd vs State Represented By Its on 11 September, 2023
Author: N.Anand Venkatesh
Bench: N.Anand Venkatesh
Crl.O.P.No.25479 of 2022
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED : 11.09.2023
CORAM :
THE HON'BLE MR.JUSTICE N.ANAND VENKATESH
Crl.O.P.No.25479 of 2022
and Crl.M.P.No.15819 of 2022
1. M/s.Carenow Medical Pvt. Ltd.,
No.3/272-5, Neelambur Road,
Muthugoundenpudur, Coimbatore,
TN-641406,
Represented by its
Director cum person responsible,
Rajkumar Thangaraj
2. Rajkumar Thangaraj
3. R.Kathiresan
4. V.Rajesh .. Petitioners
Versus
State Represented by its
The Drugs Inspector,
Suramangalam Range,
O/o. The Assistant Director of Drugs Control,
Salem West Zone, No-130/9 & 130/10,
Pannagadu, Meyanoor Main Road,
Salem - 04. .. Respondent
Prayer : Criminal Original Petition filed under Section 482 of the Code of
Criminal Procedure, to call for the records relating to the C.C.No.561 of
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Crl.O.P.No.25479 of 2022
2021 on the file of the learned Judicial Magistrate No.II, Salem, quash the
same by allowing this Criminal Original Petition.
For Petitioners : Mr.M.Guruprasad
For Respondent : Mr.A.Gopinath,
Government Advocate (Crl. Side)
ORDER
This petition has been filed to quash the proceedings pending in C.C.No.561 of 2021 on the file of the learned Judicial Magistrate No.II, Salem.
2. Heard Mr.M.Guruprasad, learned Counsel for the petitioners and Mr.A.Gopinath, learned Government Advocate (Crl. Side) for the respondent.
3. The respondent has filed a complaint against the petitioner for contravention under Section 18(a)(i) read with Section 17(b) and Section 18(c) of the Drugs and Cosmetics Act, 1940 read along with Rule 74 read with condition No.3 of Form 25 of the Drugs and Cosmetic Rules, 1945 punishable under Section 27D of the Act.
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4. The case of the prosecution is that a drug sample was lifted from the premises under Form 17 on 03.06.2020 and it was sent for analysis on the same day. The report of the sample, dated 04.08.2020 was received and it was reported that it is a standard quality, but, has been misbranded since the label should have stated the active ingredient in the drug and the same is missing.
5. In view of the above, show-cause notice came to be issued by the respondent. The petitioner had also given a reply and the petitioner had provided the necessary details also. Based the same, an interim report was submitted by the Drug Inspector, dated 13.10.2020. Thereafter, yet another show-cause notice, dated 28.10.2020 along with Form 13 was sent to the M/s.Rainbow Healthcare System. A reply was also received from the said Company and it was disclosed that the drug was purchased by them from the first petitioner who is the manufacturer of the drug. Once again, a show-
cause notice, dated 18.11.2020 along with Form 13 was issued to the petitioners and the petitioners gave a reply, dated 09.12.2020 along with all the relevant documents.
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6. Pursuant to the above, the complaint came to be filed before the Court below against the petitioners. The main allegations that have been made against the petitioners is that they had misbranded the product and they failed to properly provide the active ingredient in the sample. Thereby, it is alleged that the petitioners have committed the offence punishable under the Drugs and Cosmetics Act.
7. There is no dispute with regard to the fact that the first petitioner is the manufacturer of the drug. They also possess a license for manufacturing the drug. The report of the Government Analyst shows that the sample that was lifted was of standard quality and the only issue that was put against the petitioners was that it was misbranded and the content of the active ingredient is not expressed either in terms of percentage by weight or volume or in terms of unit per gram or millimeter.
8. A similar complaint came to be filed against the petitioners even on an earlier occasion on the very same grounds and the same became a subject matter of challenge before this Court in Crl.O.P.Nos.11696 and 13627 of https://www.mhc.tn.gov.in/judis 4/10 Crl.O.P.No.25479 of 2022 2022. This Court considered the very same issue in detail and it was held as follows:-
" 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.
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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. https://www.mhc.tn.gov.in/judis 6/10 Crl.O.P.No.25479 of 2022 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 Drug Central Organizations should have internal mechanism of checks and balances to ensure that law abiding https://www.mhc.tn.gov.in/judis 7/10 Crl.O.P.No.25479 of 2022 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."
9. The above findings rendered by this Court squarely apply to the facts of the present case also. It is brought to the notice of this Court that the above order has become final and no appeal has been filed. Therefore, the reasons that have been given in the above order will equally apply to this case also and it will enure in favour of the petitioners.
10. In the light of the above discussion, the proceedings in C.C.No.561 of 2021 on the file of the learned Judicial Magistrate No.II, Salem is hereby quashed. This Criminal Original Petition stands allowed.
Consequently, connected miscellaneous petition is closed.
https://www.mhc.tn.gov.in/judis 8/10 Crl.O.P.No.25479 of 2022 1109.2023 Index : yes/no Speaking order/Non-speaking order Neutral Citation : yes/no grs To
1. The Judicial Magistrate No.II, Salem.
2. The Drugs Inspector, Suramangalam Range, O/o. The Assistant Director of Drugs Control, Salem West Zone, No-130/9 & 130/10, Pannagadu, Meyanoor Main Road, Salem - 04.
3. The Public Prosecutor, High Court of Madras.
https://www.mhc.tn.gov.in/judis 9/10 Crl.O.P.No.25479 of 2022 N.ANAND VENKATESH, J.
grs Crl.O.P.No.25479 of 2022 and Crl.M.P.No.15819 of 2022 11.09.2023 https://www.mhc.tn.gov.in/judis 10/10