Allowed

Atra Pharmaceuticals Pvt.Ltd. v. State of Kerala

Kerala HC10 Jul 2014Crl.MC/2146/2010

Case brief

AI extract

What is this about?

In a criminal miscellaneous petition filed under Section 482 Cr.P.C., the High Court of Kerala quashed a complaint alleging the manufacture of spurious drugs under the Drugs and Cosmetics Act. The petitioners were accused of selling two products: one allopathic and one Ayurvedic. The Court held the prosecution to be an abuse of process. It noted that the alleged imitation charge was misplaced beca

What did the court decide?

The criminal complaint C.C No.52/2010 is quashed.

Atra Pharmaceuticals Pvt.Ltd. Vs State of Kerala — Corruption | Kerala HC (2014)

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IN THE HIGH COURT OF KERALA AT ERNAKULAM

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PRESENT:

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THE HONOURABLE MR. JUSTICE A.HARIPRASAD

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THURSDAY, THE 10TH DAY OF JULY 2014/19TH ASHADHA, 1936

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Crl.MC.No. 2146 of 2010 ( )

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AGAINST THE ORDER/JUDGMENT IN CC 52/2010 of CHIEF JUDL.MAGISTRATE, ERNAKULAM.

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PETITIONER(S)/ACCUSED 1 to 4:

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1. ATRA PHARMACEUITICALS PVT.LTD,A COMPANY INCORPORATED UNDER THE COMPANIES ACT, 1956 HAVING ITS REGISTERED OFFICE AT H-19, MIDC, WALUJ, AURANGABAD-431 133.

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2. CDR ANIL SAVE,ATRA PHARMACEUTICALS PVT. LTD, H-19, MIDC, WALUJ, AURANGABAD-431 133.

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3. NOVARTIS INDIA LTD, A CO;INNCORPORATED UNDER THE COMPANIEST ACT, 1913, HAVING ITS REGISTERED OFFICE AT SANDOZ HOUSE, SHIVSAGAR ESTATE, DR.ANNIE BESANT ROAD, WORLI, MUMBAI-400018;HAVING LOCAL OFFICE AT 40/2202, K.N.MATHEW BLDNG, MARKET ROAD, KOCHI-11, REPRESENTED BY ITS AREA BUSINESS MANAGER MR.BABU GEORGE EMMANUEL.

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4. MR.RANJIT SHAHANI(R.SHAHANI),NOVARTIS INDIA LTD, SANDOZ HOUSE, SHIVSAGAR ESATE, DR.ANNIE, BASANT ROAD, WORLI, MUMBAI-400018.

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BY ADVS.SRI.E.K.NANDAKUMAR

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SRI.A.K.JAYASANKAR NAMBIAR SRI.K.JOHN MATHAI SRI.P.BENNY THOMAS SRI.P.GOPINATH SRI.P.VIJAYA BHANU (SR.).

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RESPONDENT(S)/COMPLAINANT:

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STATE OF KERALA REPRESENTED BY THE DRUGS INSPECTOR (INTELLIGENCE BRANCH), OFFICE OF THE ASST. DRUGS CONTROLLER, ERNAKULAM DISTRICT, THROUGH THE PUBLIC PROSECUTOR, HIGH COURT OF KERALA, ERNAKULAM.

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2. DRUGS INSPECTOR (INTELLIGENCE BRANCH), OFFICE OF THE ASSISTANT DRUGS CONTROLLER, ERNAKULAM

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ADDITIONAL SECOND RESPONDENT IS IMPLEADED AS PER ORDER DATED 12-08-2010 IN CRL.M.A NO.3623/2010 IN CRL.M.C NO.2146/2010.

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BY PUBLIC PROSECUTOR SMT.BINDU GOPINATH.

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THIS CRIMINAL MISC. CASE HAVING BEEN FINALLY HEARD ON 10-07-2014, THE COURT ON THE SAME DAY PASSED THE FOLLOWING:

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Crl.MC.No. 2146 of 2010 ( )

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APPENDIX

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PETITIONER'S ANNEXURES :

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ANNEXURE 1 :	TRUE COPYOF THE MANUFACTURING LICENSE DATED 20-02-2010 ISSUED by the STATE OF HIMACHAL PRADESH.
ANNEXURE 2 :	TRUE COPY OF THE MANUFACTURING LICENSE DATED 18-03-2010 ISSUED BY THE STATE OF MAHARASHTRA TO THE 1ST PETITIONER.
ANNEXURE 3 :	TRUE COPY OF THE RECEIPT ISSUED AS PER FORM 16 REGARDING SEIZURE OF STOCK.
ANNEXURE 4 :	TRUE COPY OF THE ENGLISH TRANSLATION OF THE SPOT REPORT (MAHAZAR)
ANNEXURE 5 :	TRUE COPY OF THE PACK SHOTS OF CALCIUM SANDOZ WOMEN & CALCIUM SANDOZ (KHATIKA CURNA).
ANNEXURE 6 :	TRUE COPY OF THE LABELS AFFIXED ON CALCIUM SANDOZ WOMEN & CALCIUM SANDOZ (KHATIKA CURNA).
ANNEXURE 7 :	TRUE COPY OF THE NOTICE ISSUED BY THE DRUGS INSPECTOR (INTELLIGENCE BRANCH) TO THE 3RD PETITIONER DATED 16-03-2010.
ANNEXURE 8 :	TRUE COPY OF THE 3RD PETITIONER'S REPRESENTATION DATED 24-3-2010.
ANNEXURE 9 :	TRUE COPY OF THE JUDGMENT DATED 29-3-2010 IN W.P.(C) NO.10672/2010.
ANNEXURE 10:	CERTIFIED COPY OF the COMPLAINT DATED 29-3-2010 WHICH IS NUMBERED AS C.C N.52/2010 ON THE FILE OF THE CHIEF JUDICIAL MAGISTRATE COURT, ERNAKULAM.
ANNEXURE 11:	TRUE COPY OF THE ORDER/PROCEEDINGS DATED 6-4-2010 (AS ENDORSED ON THE ANNEXURE 10 COMPLAINT).
ANNEXURE 12:	TRUE COPY OF THE ARGUMENT NOTE, FILED BY THE 3RD PETITIONER BEFORE THE RESPONDENET DATED 5-8-2010.
ANNEXURE 13:	TRUE COPY OF the REPLY TO THE RTI QUERY OF the PETITIONER BY THE JOINT COMMISSIONER.
ANNEXURE 14:	TRUE COPY OF THE ENGLISH TRANSLATION OF ANNEXURE 13 (SL. NO.2 ABOVE).

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RESPONDENT'S ANNEXURES : NIL.

//TRUE COPY//

P.A TO JUDGE

amk

A.HARIPRASAD, J.

Crl.M.C No.2146 of 2010

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Dated this the 10^th day of July, 2014.

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O R D E R

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Petition filed under Section 482 Cr.P.C. Petitioners

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are accused in a complaint filed by the Drugs Inspector alleging offences punishable under Sections 18(a)(vi) r/w Section 17B(b) and Section 27 of the Drugs and Cosmetics Act, 1940 (in short 'the Act').

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Conspectus of allegations in the complaint are as

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follows :

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Complainant is a Drug Inspector, appointed under Section 21 of the Act and he is competent to file the complaint. Accused No.1 is a company, under whose license and for whom the drug Calcuim Sandoz was manufactured both as Allopathic and Ayurvedic Proprietary Medicines, simultaneously, which the prosecution alleges to be imitations to one another. It is alleged

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that both of them were sold simultaneously by the first accused. The alleged offence was detected on 21-01-2008 when the

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Crl.M.C No.2146 of 2010 2

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Drugs Inspector inspected the premises of the third accused in the presence of witnesses. Accused No.2 is said to be the person responsible for conduct of the business of accused No.1 at the time of commission of the offence. Accused No.3 is the company which manufactured the Ayurvedic drug by name 'Khatika Curna Calcium Sandoz'. In the complaint it is alleged that the second one is an imitation of Calcium Sandoz Women manufactured by the first accused. Fourth accused is the Managing Director of the third accused company. All the above medicines carried the name “Calcuim Sandoz” clearly written on the package. But Calcium Sandoz Women is being marketed as Allopathic drug while Khatika Curna Calcium Sandoz is marketed as Ayurvedic Proprietary Medicine. It is also averred in the complaint that Calcium Sandoz Women is manufactured under the agreement since April 2005, while the Ayurvedic version of the same was started only from June 2008. Therefore,

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Crl.M.C No.2146 of 2010 3

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the complainant deduced that the Ayurvedic drug is a spurious one as defined under Section 17B(b) of the Act. Hence, with these averments, the prosecution was launched.

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Heard Sri.P.Vijaya Bhanu, learned Senior counsel for

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the petitioners and Smt.Bindu Gopinath, learned Public Prosecutor.

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At the outset, the learned Senior counsel for the petitioners submitted that the prosecution is totally misconceived. At the time of hearing, the disputed preparations in two bottles were produced. Calcium Santoz Women is in a larger packet with face of a woman depicted on the container. Khatika Curna Calcium Santoz is in a smaller packet with a different colour scheme and it is having face of a puppy. My attention is drawn to the fact that the ingredients in both the preparations are different, according to the pharmacopoeia. Learned Senior counsel for the petitioners submitted that none

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Crl.M.C No.2146 of 2010 4

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of the offences alleged is attracted and the criminal prosecution is an abuse of process of the court. My attention is drawn to Annexure 7 notice issued by the complainant/Drug Inspector dated 16-03-2010. The documents mentioned in Annexure 7 were directed to be produced within five days from the receipt of the notice. Annexure 8 is the reply sent by the third accused. Thereafter, the third accused approached this Court with Writ Petition No.10672/2010. The writ petition was disposed on 29-03-2010 with a direction to take appropriate action on Annexure 8 (which was exhibited as Ext.P10 in the writ petition) within a period of one month. Learned Senior counsel submitted that on the very same day of disposal of the writ petition, Annexure 10 complaint was filed without complying with the directions in the writ petition.

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Section 17B of the Act defines 'Spurious drugs', it

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reads as follows :

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Crl.M.C No.2146 of 2010 5

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“17B. Spurious drugs .- For the purposes of this Chapter, a drug shall be deemed to be spurious,-

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(a) if it is manufactured under a name which belongs to another drug; or

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(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

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(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

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(d) if it has been substituted wholly or in part by another drug or substance; or

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(e) if it purports to be the product of a manufacturer of whom it is not truly a

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Crl.M.C No.2146 of 2010 6

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product.”

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Section 18(a)(vi) of the Act says that no person shall

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himself or by any other person on his behalf from such date as may be prescribed by the State Government by notification in the Official Gazette, manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic in contravention of any of the provisions of Chapter IV or any rule made thereunder. According to the complainant the accused persons have manufactured for sale and distribution and stocked spurious drugs in violation of the said provisions.

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Section 27 is the penal provision. The relevant provisions of section reads as follows :

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“ 27. Penalty for manufacture, sale, etc., of

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drugs in contravention of this Chapter .Whoever, himself or by any other person on his behalf, manufactures for sale or distribution, or sells, or stocks or exhibits or offers for sale or distributes,-

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Crl.M.C No.2146 of 2010 7

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(a) x x x x x

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(b) x x x x x

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(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than five thousand rupees :

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Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year;

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(d) x x x x x ”

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Learned Senior counsel for the petitioners submitted

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that the whole prosecution is baseless. The definite case of the complainant is that the Ayurvedic drug is the spurious one defined in Section 17B(b) of the Act. Chapter IV takes in Section 16 to 33A. The heading of the Chapter is “Manufacture,

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Crl.M.C No.2146 of 2010 8

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Sale and Distribution of Drugs and Cosmetics”. Section 33A of

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the Act reads as follows :

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“ 33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs .- Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to Ayurvedic, Siddha or Unani drugs.”

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It can be seen that Chapter IVA deals with provisions relating to Ayurvedic, Siddha and Unani drugs. As the prosecution has a definite case that the offence committed is traceable to Section 17B(b) of the Act r/w Section 18(a)(vi) of the Act and also that the Ayurvedic preparation is the imitation of the Allopathic one, I am unable to accept the contention of the prosecutor that if falls within Section 17B of the Act. With respect to Ayurvedic preparations there is a special provision in Chapter IVA, i.e., Section 33EEA of the Act. Although the provisions are almost similar, the charge in this case is not under

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Crl.M.C No.2146 of 2010 9

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the said provision, but under the provision relating to Allopathic preparations. Learned Senior counsel for the petitioners therefore submitted that the prosecution is bad for this reason alone.

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Regarding the sustainability of allegation under

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Section 17B of the Act, it was contended that the two preparations are totally distinct and different. One is intended to be used by women, whereas the other is not confined to that category. It is submitted that it cannot be stated that one product is the imitation of the other or a substitute for the other. Both drugs are differently packed with clear inscriptions conspicuously made on the package to reveal their true character. There is no question of obscure identity in showing the chemical components.

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Learned Public Prosecutor submitted that there is no

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mention that the Ayurvedic product contains 'calcium'. Hence it

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Crl.M.C No.2146 of 2010 10

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is a spurious drug. It is true that the word 'calcium' is not mentioned in the package. However, I am unable to accept this contention of the prosecution because no such plea is seen made in the complaint. Further, the prosecution could have taken recourse to the provisions in Chapter IVA relating to Ayurvedic drugs, if it had such a case. Considering the facts and circumstances of the case, I find that the prosecution is an abuse of process of the court.

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In the result, Crl.M.C is allowed. The complaint now pending in C.C No.52/2010 on the file of the Chief Judicial Magistrate Court, Ernakulam is hereby quashed.

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All pending interlocutory applications will stand dismissed.

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Sd/-

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A.HARIPRASAD, JUDGE.

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amk

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//True Copy//

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P.A to Judge

Atra Pharmaceuticals Pvt.Ltd. v. State of Kerala

Case brief

What is this about?

What did the court decide?

Atra Pharmaceuticals Pvt.Ltd. v. State of Kerala

Case brief

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