Madras High Court
M/S.Win Healthcare vs The State Of Tamilnadu on 11 December, 2019
Author: M.Dhandapani
Bench: M.Dhandapani
Crl.O.P.Nos.21917, 21918 & 29743 of 2008
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED :11.12.2019
CORAM
THE HON'BLE MR.JUSTICE M.DHANDAPANI
Crl.O.P.Nos.21917 & 21918 & 29743 of 2008
1.M/s.Win Healthcare
A Division of Win Medicare Pvt. Ltd.,
No.1400, Modi Tower, 98, Nehru place,
Rep by Thiru J N Khurana
Vice President (o)
2.J.N.Khurana
Vice President (o)
M/s.Win Healthcare
A Division of Win Medicare Pvt. Ltd.
No.1400, Modi Tower, 98, Nehru Place,
New Delhi -110019
..Petitioners in Crl.O.P.No.21917
of 2008
1.M/S Cipla Ltd
A.33 & A37/2//2 MIDC
Tatalganga 410 220
Raiged District
Rep. by Thiru Anjanikumar,
Authorized Signatory &
Chief Chemist In-charge
2.Thiru Anjanikumar,
Authorized Signatory &
Chief Chemist in-charge
M/s Cipla Limited
A.33 & A37/2//2 MIDC
Tatalganga 410 220
Raiged District
Maharashtra
..Petitioners in Crl.O.P.No.21918 of 2008
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Crl.O.P.Nos.21917, 21918 & 29743 of 2008
1.M/s Cipla Limited
106A Ground & First Floor,
Alapakkam Main Road
Alapakkam, chennai 600 116
Represented by
Thiru Narayanan Narasimhan Iyyanar
P A Holder of the said firm
2.Narayanan Narasimhan Iyyangar,
Personal incharge of
& P Aholder of M/s Cipla Limited
106A Ground & First Floor,
Alapakkam Main Road,
Alapakka, Chennai 600 116
3.S.S.Jetty,
Person incharge of
M/s.Cipla Ltd
Plot No.L139/2144 Verna Industrial Estate
Verna, Goa
..Petitioners in Crl.O.P.No.29743 of 2008
vs
The State of Tamilnadu
Represented by R.Kannan
Drugs Inspector
Thiruvallur Range,
Office of Asst. Director of Drugs Control,
Thiruvallur Zone,
201, J.N.Road, Thiruvallur -602 001
.. Respondent in Crl.O.P.No.21917,21918
& 29743 of 2008
Common Prayer: Criminal Original Petition is filed under under
Section 482 of Criminal Procedure Code to call for the records in
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Crl.O.P.Nos.21917, 21918 & 29743 of 2008
C.C.No.96 of 2008 & C.C.No.127 of 2008 now on the file of the Chief
Judicial Magistrate, Thiruvallur and quash the same.
For Petitioners in both Crl.Ops : Mr.V.Karthic
Senior Counsel
For Respondent in both Crl.O.Ps : Mr.C.Iyyapparaj
Addl.Public Prosecutor
COMMON ORDER
These Criminal Original Petitions have been filed seeking to quash the C.C.No.96 of 2008 & C.C.No.127 of 2008 on the file of the learned Chief Judicial Magistrate, Thiruvallur.
2.The petitioners in Crl. O.P.Nos.21917, 21918 & 29743 of 2008 are arraigned as A1, A2, A3, A4 & A5 for the alleged offence under Section 18(a)(1) r/w Section 17(b), Section 27(d) of the Drugs and Cosmetics Act and Rule 97(1)(b) of the Drugs and Cosmetics Act, 1940, in C.C.No.96 of 2008 and C.C.No.127 of 2008.
3. The petitioners are leading manufacturers of quality drugs in India, having factories in various areas, where drugs are being manufactured. Some of the factories of the petitioners are situated in 3/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 Verna Industrial Estate, Goa and Patalganga in Maharashtra state. The petitioners are leading Drug Manufacturing Company and the said companies are incorporated the Indian Companies Act,1956 having its registered office at 1400, Modi Tower, 98 Nehru Place, New Delhi. The drugs manufactured by it are marketed through various agencies throughout the country. The main objects of the company is manufacturing and marketing of drugs, medicines, etc. Subsequently, M/s.Win Health Care was also incorporated as a division of the aforesaid company through which division, the company was doing exclusive business of marketing various drugs and medicines throughout the length and breadth of the country. It would be pertinent to mention here that right from the date of its incorporation, the company has been diligently involved in a bona-fide business of marketing various drugs and medicines including contraceptives throughout the country and at no point of time has the company been involved in any illegal activities.
4.The 1st petitioner's company executed an agreement with the French Company, namely M/s. HRA Pharma and as per the said agreement the petitioner agreed to manufacture the drug under the 4/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 name & style of ‘Norlevo’, which is an oral contraceptive and contains a drug called ‘Levonorgestrol’ which is a well known drug falling under the category of ‘Androgenic Anabolic’, Oestrogenic & Progestational substances, commonly used as an emergency contraceptive pill to prevent pregnancy. As per the terms of this agreement the drug ‘Nerlevo’ was to be manufactured and supplied by M/s.Cipla Ltd. ( a Company incorporated under the relevant provision of Indian Companies Act, 1956).
5.On 18.08.2005 M/s.Cipla Ltd., which is the manufacturer of the aforesaid drug Norlevo was conferred a permission by the Directorate of General Health Services, Drugs Controller General of India, Nirman Bhawan, New Delhi, with a condition that the drug which is to be sold on the prescription of a Registered Medical Practitioner, was waived/deleted by the order dated 18.08.2005. By virtue of the said order, it was therefore, no longer necessary for the manufacturer i.e. M/s. Cipla to have the necessary warning for the Schedule-H drug i.e., ''to be sold under the prescription of a Registered Medical Practitioner only''. The Government order was issued in favour of M/s.Cipla on account of the fact that the drug was an oral contraceptive and it was imperative in view of the objects and reasons 5/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 of the family health program and policy of Government of India, to have easy access to contraceptives, which were fundamental for better health care and family welfare throughout.
6.While so, on 21.09.2006, the respondent inspected the premises of accused M/s.Mahavir Agencies, having its office at Ratna Complex, Ambal Nagar, Ramapuram, Chennai and found that M/s.Mahavir Agencies had stocked for sale the ‘Norlevo’ tablets under batch No.K-50699, M.D.8/2005:E/D 7/8 manufactured by M/s.Cipla Ltd. The drugs were seized allegedly in the presence of two independent witnesses as the respondent deemed the said drugs to be misbranded, as they did not bear the statutory warning under Rule 97(b) of the Drugs and Cosmetics Rules, 1945. The seized drugs were brought before the Court of learned Chief Judicial Magistrate,Thiruvallur, on 21.09.2006.
7. On 04.10.2006 a show cause notice was issued by respondent No.3 upon M/S.Mahavir Agencies alleging that there had been a violation of Section 18(a) (1) read with Section 17(b) of the Drugs & Cosmetics Act,1940 along with Rule97(b) of the Drugs and Cosmetics Rules 1945. M/s.Mahavir Agencies in turn informed the offices of 6/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 respondent that they were having a valid drug licence in Form 20 (b) & 21(b). After issuance of show cause notice, since the reply submitted by the petitioner was not convincing, the respondent filed a criminal complaint in C.C.No.96 of 2008 and C.C.No.127 of 2008 before the learned Chief Judicial Magistrate, Thiruvallur, against the petitioners. The learned Chief Judicial Magistrate, Thiruvallur having taken cognizance in C.C.No.96 of 2008 and C.C.No.127 of 2008, and aggrieved by the same, the present Criminal Original Petitions are filed.
8.The Learned Senior counsel appearing for the petitioners submit that though the office of the Drugs Controller General, Nirman Bhawan, New Delhi, issued permission for manufacture of the new drug formation ‘Norlevo’ being ‘Levenorgestrol’ tablets composition of each tablet in packs of 2 tablets contains ’Levenorgestrol’ 0.75 gms for emergency contraception in women on 24.12.2002 with a condition that the tablet of the immediate container of the drug as well as the packing in container enclosed, should contain a ‘’WARNING' to be sold by retail ''on the prescription of the Registered Medical Practitioner.'' However, condition No.4 of the said permission that the drug is to be sold on the prescription of a R.M.P.,only was deleted while all other 7/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 conditions of the permission remained intact. Vide order dated 18.08.2005. Subsequent to the said order launching prosecution is unsustainable even as per the Act, as once the said condition is deleted, there is no mens rea relating to said violation of the said condition, and accordingly prays for allowing the Criminal Original Petitions.
9.Per contra, it is the submission of the learned Addl. Public Prosecutor that the mere letter issued by the Director General of Health Services would not suffice to state that the petitioners have not violated Condition No.4 of the licence dated 24.12.02 in the absence of any notification issued by the Government. Therefore, there is blatant violation of Sections 18 (1) (i) r/w Section 17 (b) of the Drugs and Cosmetics Act and Rule 97 (b) of Drugs and Cosmetics Rules. It is the submission of the learned Addl. Public Prosecutor that the Central Government has not given any permission to cause advertisement of any specified drug or class of drugs and in the absence of specific permission for any class of drugs, advertising the same on the strength of a 8/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 letter given by individual persons holding the capacity of Drugs Controller General of India would not in any way absolve of the petitioners from the offence. Therefore, the registration of the case and filing of the charge sheet against the petitioners does not require any interference.
10.This Court heard the learned senior counsel appearing for the petitioners and the learned Addl. Public Prosecutor appearing for the respondents and perused the materials available on record as also the provision of law to which this Court’s attention was drawn.
11.The petitioners have predicated their contention on the following premise :-
‘’6. The petitioners are stated that they have obtained the permission from the Drugs Controller General of India under its letter DY No.1031/02 dated 05.12.2002 for manufacture of new drug formation Levanorgestrol Tablets (NORLEVO) and 9/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 also proceedings dated 18.08.2005 in ref.No.1248/98 DC Part 2 from Director General of Health Services for relaxing condition 4 whereby the warning regarding the sale by the Drugs Controller General (I) has granted a valid & legal permission under form 46 of Schedule ‘A’ of the Drugs and Cosmetics Rules to manufacture the tablet NORLEVO with condition 4 SPECIFYING CLEARLY the warning:
to be sold by the retail on the prescription of a R.M.P only. But the petitioners submitted a letter dated 18.08.2005 in ref. No.1248/98DC part 2 from Director General of Health Services for relaxing condition 4. Further stated that a condition under statutory form 46 cannot be deleted merely by a letter of Directorate General of Health Services.
7. It is submitted a condition under Statutory form 46 cannot be deleted merely by a letter of Director General of Health Services. Hence, the petitioners product is a Misbranded drug as per Section 18(a)(i) r/w Section 17(b) of the Drugs & Cosmetics Act 1940 and Rule 97(1) (b) of Drugs & 10/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 Cosmetics Rules 1945.This is not an Official Notification as received by the petitioners/Accused.
It is a letter given by the individual persons holding the capacity of Drugs Controller General (India) to any individual company and it is not the discretion given to the Central Government to publish in the official gazette regarding the advertisement.’’
12.Before adverting to the issue on hand, it would be relevant to refer to the provisions of the Act to which this Court’s attention was drawn :-
17-C. Misbranded cosmetics.-- For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded,--
(a) if it contains a colour which is not prescribed; or
(b) if it is not labelled in the prescribed manner; or ( c) if the label or container or anything accompanying the cosmetic bears any statement 11/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 which is false or misleading in any particular.
18. Prohibition of manufacture and sale of certain drugs and cosmetics—From such date as may be fixed by the State Government by notification in the Official Gazatte in this behalf, no person shall himself or by any other person on his behalf--
(a) (Manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, ) or distribute--
97. Labelling of medicines--(1) The container of a medicine for internal use shall--
(b) if it contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:-
''Schedule H drug-- Warning: To be sold by retail on the prescription of Registered 12/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 Medical Practitioner only'';
13.Section 17-C of the Act deals with drugs/cosmetics, which are misbranded, while Section 18 of the Act relates to prohibition of manufacture and sale of certain drugs and cosmetics and Section 97 of the Act deals with Labelling of Medicines. From the above provisions of law, it is clear that on the failure to comply with the provisions as mandated under the specific provision of law, the drugs would be deemed to have violated the said provision of law. There is no quarrel with regard to the said provision of law or adherence to the same.
14.In the present case, it is an admitted fact that the petitioner had obtained permission from the Drugs Controller General of India for manufacture and sale of a certain formulation on 24.2.02 and subsequent to the said permission for formulation of the medicine, “Levanorgestrol Tablets” composition of 0.75 mg., for the purpose of emergency contraception in women, the same was manufactured and marketed by the petitioner, viz., 13/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 Cipla. Subsequent to the said permission, based on the request of the manufacturer, vide order dated 18.8.05, permission was granted deleting condition No.4, viz., “to be sold on the prescription of a R.M.P.”, while all the other conditions remained the same.
15.The petitioner having been permitted to manufacture and market the product above, had no mens rea in approaching the Drugs Controller for deletion of condition No.4, and the Drugs Controller, on proper application of mind had acceded to the said request made by the petitioner. The Drugs Controller, being the authority under the Act to decide as to the potency of the drugs and its use on humans, has applied its mind and had deleted condition No.4. The Act nowhere prohibits the Drugs Controller from granting such permission and exercising his right, the Drugs Controller has granted the permission for deletion of condition No.4.
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16.The respondents are not able to point out any provision of law or Governmental instruction barring the Drugs Controller from granting permission. In the absence of any explicit bar on the Drugs Controller from granting permission, as above, the act of the Drugs Controller cannot be said to be illegal or void. Once this Court has come to the conclusion that the act of the Drugs Controller is in accordance with law, the subsequent act of the petitioner in not showing the particular mark on the drugs manufactured by it and further advertising the said commodity in the print/visual media, could in no way be termed to be misbranding of cosmetics, as provided u/s 17-C of the Act. Once the Drugs Controller has granted permission to the petitioner, it is open to the petitioner to advertise the commodity and in the absence of any bar for advertising, the act of the petitioner cannot be said to be illegal, whilst the act of the respondents in confiscating the drugs and initiating criminal prosecution, unmindful of the legal provisions, which definitely is illegal and is liable to be interfered with.
15/14 http://www.judis.nic.in Crl.O.P.Nos.21917, 21918 & 29743 of 2008 M.DHANDAPANI,J.
vsn
17.For the reasons aforesaid, this criminal original petition deserves to be allowed and, accordingly, the same is allowed. Consequent upon the allowing of this petition, C.C. No.96 of 2008 and 127 of 2008 on the file of the Chief Judicial Magistrate, Thiruvallur are quashed.
11.12.2019
Index : Yes/No
vsn
To
1.The Chief Judicial Magistrate, Thiruvallur
2.The Drugs Inspector Thiruvallur Range, Office of Asst. Director of Drugs Control, Thiruvallur Zone, 201, J.N.Road, Thiruvallur -602 001 Crl.O.P.Nos.21917, 21918 & 29743 of 2008 16/14 http://www.judis.nic.in