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Bakola Pharmaceutical Company Vs. the Union of Government of India, Represented by the Secretary, Ministry of Health and Family Planning and U.D., Government of India and anr. - Court Judgment

LegalCrystal Citation
SubjectCivil
CourtChennai High Court
Decided On
Reported in(1979)1MLJ285
AppellantBakola Pharmaceutical Company
RespondentThe Union of Government of India, Represented by the Secretary, Ministry of Health and Family Planni
Excerpt:
- .....by the appellant was recognised by the well-known homeopathic pharmacopoeias recognised in the united states of america, the united kingdom and germany. further it was contended that even if it was not recognised by the homeopathic pharmacopoeia of united states of america or the united kingdom or germany, still the government will have to consider whether this particular medicine can be recognised subject to such conditions as the government may prescribe as envisaged by the second clause of item 4-a of the second schedule to the drugs and cosmetics act, in column 2. we shall extract item 4______________________________________________________________________class of drug. standard to be complied with.______________________________________________________________________4-a.....
Judgment:

P. Govindan Nair, C.J.

1. This appeal is taken from the judgment of Ismail, J., dismissing Writ Petition No. 3171 of 1973 which sought the quashing of an order passed by the second respondent herein which is at page 9 of the typed set of papers. Briefly stated this order cancelled a licence held by the appellant in form No. 28 in so far as it related to Homeopathic medicines which are administered by parenteral route. The reasons given in the order s far as we are able to discern are (1) that Clause 2 of Part IX of Schedule F of the Drugs and Cosmetics Rules, 1945 has not been complied with by the licenses, (2) that Homeopathic medicines which are administered by parenteral route do not fall within drugs and medicines under the aforesaid rules and (3) that the administration of Homeopathic drugs by parenteral route has not been recognised in any of the Homeopathic Pharmacopoeial.

2. Ismail, J., felt that Homeopathic medicines administered by parenteral route will not fall within the purview of the Act, that Rule 2(dd) of the Rules referred to is not ultra vires the Act and that further there is no violation of Articles 14 and 19 of the Constitution of India as contended by the writ petitioner and on that basis dismissed the writ petition.

3. Before us it is contended that the order is defective in that the mind had not been applied to the various questions that arises in this case. This submission was made on the basis that the appellant had contended before the authority that passed the order, the second respondent, that the particular medicine manufactured by the appellant was recognised by the well-known Homeopathic Pharmacopoeias recognised in the United States of America, the United Kingdom and Germany. Further it was contended that even if it was not recognised by the Homeopathic Pharmacopoeia of United States of America or the United Kingdom or Germany, still the Government will have to consider whether this particular medicine can be recognised subject to such conditions as the Government may prescribe as envisaged by the second Clause of item 4-A of the Second Schedule to the Drugs and Cosmetics Act, in Column 2. We shall extract item 4

______________________________________________________________________Class of drug. Standard to be complied with.______________________________________________________________________4-A Homeopathic medicines. (1) The standards specified from time totime in the Homoeopathic Pharmacopoeiasof the United States of America or theUnited Kingdom or Germany for the medicinesincluded therein.(2) For the Homeopathic medicines notincluded in the Homoeopathic Pharmacopoeiasof the United States of America or theUnited Kingdom or Germany, the standardsapproved by the Central Government anddisplayed in the prescribed manner on thelabel of the container._______________________________________________________________________

4. Before we deal with this aspect, it is necessary to understand the purpose and intent of the Act.

'Drug' has been defined under the Act in Section 3(b). We shall extract that sub-section : 'drug' includes-

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of disease in human beings or animals;

(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

Though it is an inclusive definition even the inclusive part is wide enough to take within its ambit Homeopathic medicinal preparations which are administered by parenteral route. In other words, nothing in the definition would exclude Homeopathic medicines which are to be administered by parenteral route from the definition in the inclusive part of Section 3(b). In the inclusive definition what is mentioned as inclusive is not exhaustive of what is meant by a drug. A drug will have to be given its natural general meaning and in that respect, a particular medicine will fall under the term 'drug'.

5. Now if we turn to Section 18(c) of the Act, it is clear that no one can manufacture or sell a preparation similar to the one manufactured and sold by the appellant without a licence being applied for and issued in the prescribed manner. The purpose of the Act is to control by insisting on a license. Normally any person is entitled under our Constitution to engage himself in any business or trade and carry on any activity for profit and unless there are restrictions imposed by valid law this right to carry on any business or trade is fairly unlimited. But in the interest of the general public it is not only necessary that such activities are regulated but are even restricted. This is particularly so in the matter of medicines which are meant for human consumption or which are meant to be administered to human beings. It is very necessary from the point of view of hygiene and health and certainly, therefore, vital in public interest. This is the purpose of the act, namely that the public health must be safeguarded and people must not be allowed to manufacture and sell all sorts of preparations under various captions and perhaps misleading the unwitting public to swallow them or get them administered to them in any other manner which may be injurious to health if not injurious to life itself, This object of the statute must be borne in mind in determining the question that is posed before us. It is not, therefore, sufficient to say that a particular medicine is not recognised by a Homeopathic Pharmacopoeia of the United States of America, United Kingdom or Germany, particularly because of the terms of item 4-A of the Second Schedule which we have read.

6. The Government have a duty if any application is made before it to consider whether Homeopathic medicines not included in the Homeopathic Pharmacopoeia of the United States of America, United Kingdom or Germany can be allowed to be manufactured according to standards approved by the Central Government and displayed in the prescribed manner on the label of the container. What happened in this case was hat from the year 1958 the appellant was holding a licence in form 28 and he was manufacturing this particular homeopathic preparation which was to be administered by parenteral route. Later on it was felt that there was no justification for the licence of the appellant being extended for this particular Homeopathic medicine as the view was taken that the medicine was not recognised by the Homeopathic Pharmacopoeia of the United States of America, United Kingdom or Germany. It was also submitted by counsel for the second respondent that the medicine was not within the purview of the Act as at that time and therefore no licence was granted and in that view the licence should be cancelled. We must point out that the purpose of the Act being what we have stated, namely safeguarding the public health and public interest, by merely saying that a particular medicine is not recognised by any particular. Pharmacopoeia, a licence cannot be refused, nor a licence already granted be cancelled. To take such a view would mean that any body can manufacture anything he likes as long as it is not recognised by well-known Pharmacopoeias and that it could be labelled under any description he likes and can be sold to the public. If such a view is to be taken, the very object of the Act will be defeated. So the question will also have to be considered whether a particular item of medicine manufactured or attempted to be manufactured is such in regard to which a licence can be refused. It is not as though the Act and the Rules did not make any provision in this regard, for, under Part VII-A of the Rules dealing with manufacture for sale of Homeopathic medicines, provision is made under Rule 85-G for application to manufacture 'new Homeopathic medicines'. New Homeopathic medicines in this rule will have the same meaning as in Rule 30-AA which states that for the purpose of that rule 'new Homeopathic medicine' means a Homeopathic medicine which is not specified in the Homeopathic Pharmacopoeias of the United States of America or the United Kingdom or which is not recognised in authoritative Homeopathic literature as efficacious under the conditions recommended. It is thus clear that the rules contemplate 'new Homeopathic medicines9 being taken into account for being considered as to whether it is good for being administered to human beings, orally or otherwise, including by parenteral route. But it appears to us prima facie that somehow the procedure has been stultified, if not completely eliminated, by the definition that has been incorporated in Rule 2(dd) which is in these terms:

Homeopathic medicines include any drug which is recorded in Homeopathic provings or therapeutic efficay of which has been established through long clinical experience as recorded in authoritative Homeopathic literature of India and abroad and which is prepared according to the techniques of Homeopathic pharmacy and covers combination of ingredients of such Homeopathic medicines but does not include a medicine which is administered by parenteral route.

We are not considering the validity of this rule in these proceedings because we think that relief can be granted to the appellant without considering the larger question of the rule being ultra vires of the Act and the action taken by the order of the second respondent to which we have referred to being violative of Article 14 or Article 19 of the Constitution of India in view of the provisions made in item 4-A of the Second Schedule to the Act which we have adverted to and in view of the specific provision for recognising 'new Homeopathic medicines' even if the particular medicine manufactured by the appellant is not recognised by the Homeopathic Pharmacopoeia of the United States of America or United Kingdom or Germany. We hasten to point out that the appellant's case is that it is a recognised one and that in any event the question will have to be considered in the light of the provisions of item 4-A of Schedule 2 of the Act. The order of the second respondent is not a speaking order which does not deal with this aspect and it has certainly caused serious injury to the appellant before us; we think, therefore, it necessary to direct a complete reconsideration of the whole question in the light of the provisions of the Act. The case of the appellant that this particular medicine has been recognised by the Homeopathic Pharmacopoeia will have to be examined carefully. The appellant will have ample opportunity to establish his case by adducing evidence and producing such documents as they may be able to produce. Further even if this medicine is not recognised by the Homeopathic Pharmacopoeia of the countries mentioned, the further question whether this medicine could not be recognised a as 'new Homeopathic medicine as envisaged in Rule 30AA of the rules will have to be considered and under what conditions if any the second respondent will be able to allow the manufacture and sale of this item will also have to be considered. In the case of the appellant, a blanket cancellation of the licence which has been held by the appellant for a number of years, without adverting to these aspects, cannot be accepted under our law. On this short ground we set aside the order of the second respondent at page 9 of the typed set of papers which we have already adverted to. We direct that the whole matter be reconsidered by the second respondent in the light of what we have discussed above.

7. We repeat that the appellant shall be afforded considerable opportunity to state and prove its case. In considering these aspects perhaps the second respondent and the Central Government may find it necessary to consider the question whether Rule 2(dd) does not stand in the way of such consideration and if so whether Rule 2(dd) is supportable under the provisions of the Act or whether it is ultra vires of the provisions of the Act. After consider lag all these aspects, the second respondent will pass fresh orders.

8. We are sure that if there is discrepancy between Rule 2(dd) and the Act, and that the rule-making authority has perhaps unwittingly limited the expression 'drug' by applying it only to some drugs, then the Central Government will certainly make such amendments to the rules which are necessary for giving the true scope of the Act in the rules.

9. We dispose of the writ appeal in the above terms and direct the parties to bear their respective costs.


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