IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA.
CWPIL No. 16 of 2014 .
Judgment reserved on: 24.2.201 . 6 P Date of Decision : 15.3.2016. Court on its own motion. … PHetitioner. Versus f
State of H.P. and others. …Respondents. _______________________________ t __ __o_____________________ Coram The Hon'ble Mr. Justice M u anso r or Ahmad Mir, Chief Justice. The Hon'ble Mr. Justice Tarlok Singh Chauhan, Judge . Whether approved fo o r reporting? Yes.
For the petitio ne C r: Mr. Satyen Vaidya, Senior Advocate, as Amicus Curiae with Mr. Vivek h
Sharma, Advocate. For the respondents: Mr. Shrawan Dogra, Advocate g
General, with Mr. Anup Rattan, i
Mr.Romesh Verma, Additional Advocate Generals and Mr. J. K. H
Verma, Deputy Advocate General, for respondents No. 1 to 5, 8 and 9. Mr.Ashok Sharma, Assistant Solicitor General of India with Mr.Ajay Chauhan, Advocate, for respondents No. 7 and 8.
Tarlok Singh Chauhan, Judge
"As long as greed is stronger than compassion, there will always be suffering". Rusty Eric. This is precisely what is revealed in the instant case. On 24.11.2014, this Court took notice of a news item published in daily Hindi vernacular Amar Ujjala in its 9thNovember, 2014
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edition, wherein the illegal use of lethal vaccine 'Oxytocin' in fruits, vegetables and on milching animals was highlighted. .
2. What is Oxytocin has been lucidly explaine . d P in the affidavit of respondent No. 1, wherein it is stated th H at Oxytocin was originally extracted from animal posterior pi f tuitaries and is now chemically synthesized. Its only use is o in obstetrics, where it is employed to stimulate uterine r con t traction to induce or reinforce labour or to promote ejection of breast milk. Oxytocin causes milk ejection by contracting o the m u yoepithelial cells around the mammary alveoli. Although toxicities are uncommon when the drug is used
properly; hyp ert C ensive crises, uterine rupture, water retention, and fetal de h ath have been reported. Oxytocin is contraindicated in abn g ormal fetal presentation, fetal distress and premature births. O i xytocin for human use is available in injections as also by way of
H nasal solution. 3. Mr. Satyan Vaidya, learned Senior Advocate and Amicus Curiae is at pains to point out that there is rampant and extensive misuse of Oxytocin, not only in the dairy sector, but also
in the agriculture and horticulture sector and the State Authorities,
as also the Central Authorities entrusted with the task of preventing
the misuse of Oxytocin have completely failed to check and curb
this menace.
4. In order to buttress his submission, learned Amicus Curiae has relied upon the statistics reflected in the affidavits filed
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by the official respondents themselves as the basis of his arguments. Apparently, in the last three years, only eleve.n samples of fruits, four samples of vegetables, eleven sa . m P ples of non-vegetarian food items and ninety one sam ple H s of milk were lifted in the entire State of Himachal Pradesh. f Meaning thereby that over the last three years, in all only 117 o samples of food articles
were lifted, out of which only 65 s r am t ple s had been analyzed, which means that only one sample per ten days was lifted in the entire State. u
5. It is furthe o r pointed out by the learned Amicus Curiae that the sole C Government Common Testing Laboratory (CTL) Kandagh h at, District Solan does not even have the facility for det g ection of Oxytocin in food samples, as has been admitted by r i espondent No. 5 in his affidavit and if that be so, then there is no
H purpose of sending the food articles to CTL Kandaghat and the action of the respondents in doing so is merely an eye wash. 6. It is also pointed out that respondents in their replies have been conspicuously silent about the possibility of the drug
Oxytocin being illegally imported in the State of Himachal Pradesh
from other parts of the country or even overseas and their
assertion that strict vigil and check is being maintained falls flat on
the ground as during the last three years, there was only one
seizure, wherein 254 injections of Oxytocin (for veterinary use)
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were seized. This inaction clearly reflects the casual approach of the authorities to such a serious issue. .
7. The learned Amicus Curiae has painstakingly . pla P ced on record additional material, wherein it is pointed out H that the misuse of drug Oxytocin is rampant and wide sp f re ad and is being indiscriminately used in most parts of o the country on milching animals, vegetables, fruits and non t -ve getarian consumable items by unscrupulous people wit u h the r motive to earn more profits at the cost of serious consequences on the animals as well as human health. A few of the o dangers and hazards, beside many others
have been su mm C arized as follows:- h "(a) Its usage predisposes the new born baby to jaundice and reduces the supply of blood to its brain.
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(b) Diary owners use the Oxytocin injection twice a day injecting it into the cow-buffaloes to make the milk flow faster by H
causing the animal's uterus to start contracting putting the animal in enormous pain. (c) The drug makes the animal barren within three years and also lowers its life span. The cow-buffalo is inseminated within 24 hours of calving by the dairy owners and then the animal, without any respite, has to undergo the agony and pain of
maltreatment with the drug of Oxytocin.
(d) The Oxytocin not only effects the cow/buffalo, it filters into the milk and consequently, has been held responsible for breast and uterine cancers, male impotence, excessive hair on woman and balding for men, early or erratic periods, early development of breasts (in both sexes). Its use is also considered harmful eyes, especially in children. The hormone affects the reproductive ability of woman. Its most common symptoms are exhaustion and loss of energy. Consumption of Oxytocin infected milk by pregnant woman increases risk of hemorrhage.
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It is also responsible for high spike in tuberculosis cases . in humans.
(e) Beef all over India has been found to be extremely toxic with large amount of this drug. P
(f) The direct infusion of this drug in vegetables., fruits and other consumables for humans is also wide sp H read making such food items highly infected with Oxytocin."
8. At this stage we may notice t o hat u
fnder Section 5 of the Drugs and Cosmetics Act, 1940 (f t or short the "Act"), the Central Government is required to const r itute the Drugs Technical Advisory Board (for short DTAB), u whose duty is to advice the Central
Government and Sta o te Government on technical matters arising
out of the ad m C inistration of the Act and to carry out the other functions h assigned to it by the Act. 9. g
Similarly, under Section 7 of the Act, the Central G i overnment may constitute an advisory committee to be called
H Drugs Consultative Committee (for short DCC) and its duties is to advise the Central Government, State Government and DTAB on any matter tending to secure uniformity throughout India in the administration of the Act.
10. The respondents in their response have not disputed the misuse of Oxytocin. Rather in the affidavit filed by respondent No. 2, it is clearly pointed out that in the 44thmeeting of DCC, held on 20.7.2012, the issue of misuse of Oxytocin injection by dairy owners to extract milk from milch animals and its harmful effects were discussed and the following recommendations were made:-
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"The members felt that the misuse of oxytocin is rampant in many of the States and reports of its clandestine manufactu . re and sale appear now and then in the press. The Drug is available as unlabelled or wrongly labelled packs. Man P y of the States like UP, Delhi have taken action in seizures o.f stocks on the basis of intelligence gathered. As the manufacture and sale of these products is through clandestin f e c haHnnels, it becomes difficult to stop their misuse o except through continuous surveillance. After deliberation s it was opined that as the bulk drug (oxytocin) is being ma t nufactured in a few States only, the diversion of the bulk r drug to the illegal channels could be curtailed to a large u extent if it is ensured that the bulk drug is sold to the licensed manufacturer only."
11. The matte o r was again considered in the 46thDCC meeting held on 12-13 November, 2013 and the following recomm h endat ion
Cs were made:
"The members felt that the illicit manufacture of Oxytocin
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injection for the use of extracting milk from milch animals by the diary owners is a clandestine activity. The manufacture of the H
drug for diary owners etc. takes places in the regions where drug control administration is lax and then the drug is transported to other States clandestinely. It is available in unlabelled or wrongly labelled packs. Even though many of the States have taken action on the basis of intelligence gathered through surveillance. However, strong measures are required to restrict
the supply of oxytocin injection for veterinary use and also
ensured that diversion of the bulk drug to illegal channels is
curtailed."
12. In the 65thmeeting of DTAB, a statutory body under the Drugs and Cosmetics Act, 1940 (for short the Act of 1940), the issue of continued misuse of Oxytocin injections by the dairy owners for extracting milk from milch animals and its harmful effects on the health of cows and buffaloes as well as on the
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consumers was again discussed and the silent features of the discussion emerged as under:- .
"The drug Oxytocin has medical use for inducti P on and augmentation of labour, to control post par H tum ble.eding and uterine hypo tonicity. The alleged abundan t availability and use of the drug in a clandestine way, howe f ver, is a matter of great concern for public health. The s o ale of the Oxytocin injection is regulated under Schedule H of the Rules, which requires the drug to be dispensed on the t pre scription of a Registered Medical Practitioner only. Fu r rther, to avoid its bulk sale, Oxytocin injection is required to be packed in single unit blister pack only."
13. The issue o of p u rohibiting the drug also came up for consideration, but after detailed deliberations the members of DTAB agreed t C hat as the drug has a definite use for therapeutic purpose h s, it need not to be prohibited. However, the DTAB agreed w i ith g the suggestion that the manufacturers of bulk drug should supply active pharmaceutical drug only to the manufacturers
H licensed for manufacture of formulations and the formulations meant for veterinary use are sold to the veterinary hospitals only. The DTAB further recommended that the State Drug Controllers may be asked to curb the misuse of the drug through increased
surveillance and raids conducted on the possible hideouts of
clandestine manufacture and sale of this drug and take strict action
against the offenders.
14. It was on the basis of the aforesaid recommendations of the DTAB that the Ministry of Health and Family Welfare issued
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G.S.R. 29(E) dated 17.1.2014, restricting the manufacture and sale of Oxytocin as under: .
"The manufacturers of bulk Oxytocin drug shall su P pply the active pharmaceutical drug only to the manu H facture.rs licensed under the Drugs and Cosmetics Rules, 194 5 for manufacture of formulations of the said drug. The formulations meant for veteri f nary use shall be sold to
the veterinary hospitals only."
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15. It was also came in the t a ffidavit of respondent No. 2 that at one time concerns u were r raised and the Government was requested to have co o mplete ban on circulation/marketing of this drug except in r C egistered hospitals and for this a special meeting of DTAB was convened on 1 st April, 2014. The DTAB again delibera h ted the matter in depth and the members were of the view t i ha g t the drug is already a prescription drug and can be sold only under the prescription of a Registered Medical Practitioner (RMP).
H The drug as such had a definite role in the medical field both for humans and animals and the legitimate manufacture and sale of the drugs would not, therefore, be stopped. Moreover, keeping in view the medical emergency in rural or remote areas, the drug
could only be obtained from the sale outlets and its sale could not,
therefore, be restricted to the registered hospitals.
16. However, even in this meeting, it was acknowledged that there was rampant and wide spread misuse of the drug for the milking purposes and was required to be stopped. The suggestions then mooted and put forth for preventing the misuse of
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Oxytocin was by way of enhanced surveillance by the regulatory authorities, strict action against the violators, sensitizing th.e general public by launching campaigns through print a . nd P audio visual media and the local police could also boo H k the offenders under Prevention of Cruelty to Animals Act, f 19 60 and the Drugs and Cosmetics Act, 1940, which do no t p o ermit the sale of the drug except under proper prescription. t
17. It was further u recom r mended that a new clause be added to the already o issued notification stating that the supply of the Oxytocin shall be recorded by the retail chemist at the time of supply giving th C e name and address of the prescriber, name of the
patient h and the quantity supplied. Such records would be ma g intained for three years and shall be open for inspection. This w i ould help in not only maintaining the legitimate supply of the drug
H but also to curb misuse of the drug through legitimate sale channels. 18. It was pursuant to the aforesaid recommendations that notification G.S.R. 29(E) dated 17.1.2014, restricting the
manufacture and sale of Oxytocin was issued and reads thus:-
"The manufacturers of bulk Oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug."
The formulations meant for veterinary use shall be sold to the veterinary hospitals only.
The supply of the Oxytocin formulations for human use by the retail chemist shall be recorded at the time of supply giving
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the name and address of the presciber, name of the patient and the quantity supplied. Such records shall be maintained for thre . e years and be open for inspection."
19. Further, in order to curb the misuse of . OxPytocin, especially by the dairy owners, a notification was H issued by the Central Government on 22.10.2014. The rele f va nt portion whereof reads thus: o
"Strict regulatory cont r rol t ove r the manufacture, sale and distribution of Oxytocin and measures required to be taken to curb the misuse o u f Oxytocin by dairy owners for milking milch animals. In o order to take stringent measures on all cases of misuse of Oxytocin by the State Drug Control Authority in their State C s/UT and a constant vigil needs to be kept on the illegal mo vement of the Oxytocin. Investigate the source of the illegal supply of the Oxytocin sold to dairy owners. The help from the h NGOs in the States/UT could be taken to locate the areas where g
such illegal sale is being done. In this connection, the State i
Drugs Controllers are requested to provide the details of the manufacturers of bulk and formulations of Oxytocin in their State
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along with the statistical information on the seizures conducted, quantity seized along with its value persons arrested, prosecutions filed, samples taken, reports of sub-standard quality received during the last three years to the office DCG (I) within 30 days of receipt of this letter."
20. It would be noticed that inspite of various provisions of the Drugs and Cosmetics Act and other statutes in place, this Court cannot be oblivious to the fact that there is large scale manufacture and sale of drugs carried out in clandestine manner and that there is grave misuse of Oxytocin by farmers and dairy owners, which is the matter of great concern. This clandestine activity of manufacture and sale of the drug to the farmers or dairy owners
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requires constant surveillance and interstate coordination and the violators are required to be dealt with heavy hand. It is not only th.e health of the animals, especially milch animals, which is . m P atter of concern, but a greater concern lies in the fact that it H is this very milk and vegetables which have been injected with f Ox ytocin to increase its size, that is being consumed by all of u o s.
21. The above narration o t f facts do indicate that the respondents have though u initia r ted steps to check and curb the misuse of Oxytocin, o but yet the same cannot be termed to be sufficient and therefore, taking into consideration the entirety of the facts and ci rcu C mstances, we proceed to pass the following direction h s:- g (i) The respondents shall bring about an efficient Drug i
Regulatory System both at the Centre and the State for H
better co-ordination and handling of the entire problem so as to regulate the manufacture, import and distribution, especially, those drugs like Oxytocin. For efficient administration, these authorities are directed to work with effective co-ordination among themselves, so
that there is uniformity of approach amongst different
stakeholders.
(ii) The Union of India will establish within three months an Academy for training all drug regulatory officers both from Enforcement and Laboratory set up as decided, in principle, in the 49thmeeting of DCC held on 16th October, 2015.
(iii) The State Government shall make available adequate testing facilities of Oxytocin at its Kandaghat Laboratory
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within a period of three months and the respondent- State shall further ensure that all vacancies and pos . ts in the said Laboratory are made functional by appointing duly qualified personnel(s) w . ithPin the aforesaid period.
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(iv) The State Government will hencef orth examine the licences of all the existing manu f factures of drugs to ensure that the same t ha ve o been issued strictly in accordance with the r Drugs and Cosmetics Act and Rules.
(v) The State Go u vernment through its Drug Controller (under the o Drugs and Cosmetics Act) shall place on its web C site by 10 th of each month the details of the lic ences issued to the various manufacturers alongwith h monthly statement of production and sales with g
complete particulars and details made by the i
manufacturers. The manufacturers of the drugs shall in turn submit these details in advance so as to reach the
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Office of the Drug Controller by 7 th day of every month.
(vi) The respondent-State shall within three months constitute a Special Task Force in each district, whose duty shall be to ensure that no drug which is either
prohibited or regulated is readily available in the open
market, save and except, in the manner prescribed.
(vii) The wholesalers and retailers of all prohibited scheduled drugs shall maintain records as required under the law and the same shall be produced for inspection after every quarter before the Officer specially appointed for this purpose by the Drug Controller.
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(viii) The State Government will ensure the deployment of sufficient police personnel (atleast four) at all its Inte . r- State Borders so as to ensure that no pro . hibited or contraband drugs enter into the State and fPor this purpose it shall be incumbent upon these officials to
check all vehicles viz. taxis, private vHehicles, official
vehicles, public transport vehicles e f tc.
(ix) Respondent No. 1 is further o directed to consider the feasibility of restrict r ing t th e manufacture of Oxytocin only in public se u ctor companies and also restricting and limiting the manufacture of Oxytocin by companies to whom licen o ses have already been granted. (x) The C competent authorities under the Food Safety and St andards Act, 2006 are directed to ensure random h sampling of milk and vegetables and carryout g
prosecutions where such products tests positive for i
Oxytocin. H
(xi) The police authorities are directed to book all the offenders under the Prevention of Cruelty to Animals Act, 1960 who are found using Oxytocin, more particularly in milching animals.
(xii) Respondents No. 1 and 2 are directed to sensitize the general public about the misuse and abuse of drugs and its ill effects by launching campaigns through print, audio, video modes etc.
22. With these observations, the petition is disposed of, so also the pending application(s), if any.
Before parting, we place on record our appreciation and gratitude for the valuable assistance rendered by Mr.Satyen
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Vaidya, Senior Advocate as Amicus Curiae, Mr. Sharwan Dogra, learned Advocate General and Mr.Ashok Sharma, P learne.d Assistant Solicitor General of India to this Court.
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(Mansoor A H hmad Mir) C f hie f Justice. (Ta o rlok Singh Chauhan), 15th March, 2016 Judge.
(KRS)
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