Madras High Court
M/S.Cipla Ltd vs State Represented By on 26 October, 2018
Author: P.Rajamanickam
Bench: P.Rajamanickam
1
IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED: 26.10.2018
CORAM
THE HON'BLE MR.JUSTICE P.RAJAMANICKAM
CRL.O.P.No.19364 of 2015
and
M.P.Nos.1 and 2 of 2015
1.M/s.Cipla Ltd,
Plot No.L-134, Phase-III B,
Verna Industrial Estate,
Verna Salcette, Goa-403 722,
Represented by R.Gopalakrishnan,
Authorized Signatory of Cipla Ltd,
Verna Indl. Estate, Goa-403 722.
2.R.Gopalakrishnan,
Authorized Signatory of Cipla Ltd,
Verna Industrial Estate,
Verna Salcette, Goa-403 722. ... Petitioners
Vs.
State Represented by
Drugs Inspector,
Georgetown – I Range
Park town – I Range i/c,
O/o Asst. Director of Drugs Control,
Zone -I, Chennai – 600 006. ... Respondent
PRAYER: This Criminal Original Petition filed under Section 482 of Cr.P.C.,
praying to call for the records in C.C.No.447 of 2015 pending on the file of
the learned XV Metropolitan Magistrate, George Town, Chennai and quash
the same in entirety with costs.
For Petitioners : Mr.J.Sivanandaraaj
For Respondent : Mr.T.Shunmugarajeswaran,
Government Advocate (Crl.Side)
http://www.judis.nic.in
2
ORDER
This petition has been filed by the accused Nos.1 and 2 to quash the proceedings against them in C.C.No.447 of 2015 on the file of the learned XV Metropolitan Magistrate, George Town, Chennai.
2.The petitioners herein are manufacturers of the drug “E.K. Pill”, Levonorgestrel 1.5 mg tablets. On 10.11.2009, the Drugs Inspector of Park Town-I range, Chennai, inspected the sales premises of M/s.Khazana Life Remedies situated at 1st Floor, No.123, Nyniappa Naicken Street, Chennai- 600 003. During inspection, it was found that the drug “E.K. Pill”, Levonorgestrel tablets B.P.B.No.TX-8501 M/d.8/08, E/D7/10 manufactured by M/s.Meditab Specialties Pvt. Ltd., Verna Industrial Estate, Goa - 403722, for sale. On verification of the label of the product, it was found that it bears the following claim:
“E K Pill is an Emergency Contraceptive Pill. It can prevent an unplanned pregnancy that may occur due to unprotected sex or failure of a contraceptive (birth control) method.” This is objectionable as per Section 3(a) of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 (herein after referred to as the Act).
3.The Drugs Inspector, after issuing show cause notice and getting reply and not satisfied with the said reply, filed a private complaint against the manufacturers of the said drug (petitioners herein) and also the http://www.judis.nic.in 3 distributors of the said drug to punish them under Section 7 of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.
4.The petitioners herein who are the Accused Nos.1 and 2 after receipt of the summons from the concerned Magistrate Court have filed the present petition under Section 482 of Cr.P.C. to quash the proceedings against them in C.C.No.447 of 2015.
5. The respondent has filed a counter stating that exemption is given for the formulation contains two ingredients viz., Levonorgestrel - 0.15 mg, Ethinyl Estradiol - 0.03 mg. Further as per the permission granted by the Drugs Controller General, dated 09.03.2007 the advertisement should contain the particulars as to ''when to take, how to take of EC pills and side effects of the EC pills and side effects of the EC pills'', but the aforesaid facts not advertised by the petitioners. Further the permission granted under the letter dated 09.03.2007, has been withdrawn by the letter dated 11.01.2010 and therefore the respondent prayed to dismiss the above petition.
6.The learned counsel for the petitioners has submitted that in exercise of the powers conferred by Section 15 of the Act, the Central Government had issued a Notification on 24.01.1961, giving exemption for the advertisement in respect of ''Prevention of Conception in Women''. He further submitted that in pursuance of the said G.O., the Drugs Controller General http://www.judis.nic.in has granted permission to the first petitioner/company by the order 4 dated 09.03.2007, to advertise Emergency Contraceptive Pills Levonorgestrel tablets 0.75 mg and 1.50 mg and therefore the petitioners cannot be prosecuted as they have violated the provisions of Section 3(a) of the aforesaid Act.
7.The learned Government Advocate who is appearing for the respondent has submitted that the the Central Government had issued a notification dated 30.04.1992, wherein it is specifically stated that the advertisements can be permitted in respect of the Drugs viz., Levonorgestrel 0.15 mg, but the petitioners have advertised for drugs containing 1.50 mg. He further submitted that the Drugs Controller General by the letter dated 11.01.2010 has withdrawn the permission which was given to the petitioners under the letter dated 09.03.2007 and therefore the petitioners cannot rely upon the aforesaid permission letter dated 09.03.2007.
8.It is an admitted fact that the petitioners herein are manufacturers of the ''E.K.Pill'' (Emergency Contraceptive Pill) containing Levonorgestrel of 1.50 mg. According to the petitioners, the Central Government by exercising the power which was conferred under Section 15 of the said Act had issued notification on 24.01.1961 giving exemption in respect of in relation to any advertisement in respect of contraceptives. The said notification reads thus:
“MINISTRY OF HEALTH New Delhi, the 24th January 1961 http://www.judis.nic.in 5 S.O. 282. - In exercise of the powers conferred by section 15 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (21 of 1954), the Central Government hereby directs that the provisions of clause (a) of Section 3 in so far as they relate to “prevention of conception in women” and those of Section 6 of the said Act shall not apply to or in relation to any advertisement in respect of contraceptives, provided that the advertisement shall relate only to such contraceptives as have been approved by the Government.”
9. From the aforesaid notification it is clear that the Central Government in exercise of the powers conferred by Section 15 of the Act, gave exemption in respect of the applicability of Section 3(a) insofar as they relate to ''Prevention of Conception in Women'' and these of Section 6 of the Act in relation to any advertisement in respect of contraceptives, provided that the advertisement shall relate only to such contraceptives as have been approved by the Government.
10. It is seen from the typed set of papers filed by the petitioners that on 07.02.2007, the petitioners were permitted to manufacture Levonorgestrel 1.50 mg tablets for Emergency Contraceptive. It is seen from the letter dated 09.03.2007 that the Drugs Controller General has granted permission to the petitioners herein for making advertisement in respect of Levonorgestrel Tablets. The relevant portion of the said letter is extracted here under:
“The Expert Group has considered your request in its meeting held on 23.02.2007 and decided to give permission to advertise Emergency Contraceptive Pills- Levonorgestrel tablets 0.75 mg and 1.50 mg. It is further stated that your advertisement should http://www.judis.nic.in be free from any obscenity, should follow Code of 6 Ethics and it should give information with respect to the following:
1. When to take EC pills;
2. How to take EC pills; and
3. Side effects of the EC pills.”
11. From the aforesaid letter, it is clear that the petitioners were permitted to advertise Emergency Contraceptive Pills - Levonorgestrel tablets 0.75 mg and 1.50 mg. The learned Government Advocate (Crl.Side) relying upon the additional instructions issued in the said letter, has argued that the petitioners should have mentioned in the said advertisement as to when to take EC pills and how to take EC pills and side effects of the EC pills. It is not the case of the respondent that they have not mentioned those additional particulars in the said advertisement. The case of the respondent is that the petitioners are not at all entitled to make any advertisement in respect of the aforesaid drug. So, now the learned Government Advocate cannot take a different stand deviating from the allegations made in the complaint.
11. In the notification dated 30.09.1992, the Central Government had stated that for public interest, the advertisement of chemical contraceptive for oral use can be permitted and as per the said decision, it had issued notification in exercise of the powers conferred by the Section 15 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
http://www.judis.nic.in 7 In the said notification it is stated as follows:-
''Advertisement related to chemical contraceptive for oral use having been following composition for tablet viz., DL-Norgestrel 0.30 mg, Ethinyl Estradiol 0.03 mg or Levo-norgestrel 0.15 mg, Ethinyl Estradiol – 0.30 mg or Centchroman – 30mg.
Class of advertisement Conditions Advertisement of chemical 1 Advertisement relates to chemical contraceptives for oral use. contraceptives for oral use having the following composition per tablet:
(a) DL-Norgestrel – 0.30 mg.
Ethinyl Estradiol – 0.03 mg.
or
(b) Levo-norgestrel – 0.15 mg.
Ethinyl Estradiol – 0.30 mg or
(c) Centchroman – 30mg.
2 It shall be the respobsibility of the advertiser to prove any claim made in the advertisement in respect of the drug is not false, exaggerated or misleading.
12.But as already pointed out that the Director General of Drugs Controller by the letter dated 09.03.2007 had permitted the petitioners herein to make advertisement in respect of contraceptive pills viz., Levonorgestrel tablets 0.75 mg and 1.50 mg. So, as per the aforesaid permission, the petitioners are entitled to make advertisements.
13.It is seen from the letter dated 11.01.2010, issued by the http://www.judis.nic.in 8 Drugs Controller General, the earlier permission which was granted through the letter dated 09.03.2007 has been withdrawn with effect from 11.01.2010, but the alleged offence said to have been committed on 10.11.2009. So, at that time, the permission which was granted to the petitioners under letter dated 09.03.2007 was in force.
14. For the aforesaid reasons, this Court is of the view that even if the allegations made in the complaint are taken as true, the petitioners cannot be convicted. Therefore, the proceedings against them have to be quashed.
15.In the result, this petition is allowed. The proceedings against the petitioners herein in C.C.No.447 of 2015 on the file of the the XV Metropolitan Magistrate, George Town, Chennai, alone is quashed.
Consequently, connected miscellaneous petitions are closed.
26.10.2018 stm/gsi Index:Yes/No Internet:Yes/No Speaking order/Non-speaking order Note: Issue order copy on 19.12.2018 http://www.judis.nic.in 9 To
1.The Drugs Inspector, Georgetown – I Range, Parktown – I Range i/c, O/o Asst. Director of Drugs Control, Zone -I, Chennai – 600 006.
2.The XV Metropolitan Magistrate, George Town, Chennai.
3. DMS Compound, Teynampet, Chennai.
4.The Public Prosecutor, High Court, Madras.
http://www.judis.nic.in 10 P.RAJAMANICKAM., J.
stm/gsi CRL.O.P.No.19364 of 2015 and M.P.Nos.1 & 2 of 2015 26.10.2018 http://www.judis.nic.in