Chapter - 13 THE DRUGS AND COSMETICS ACT, 1940
The Drugs and Cosmetics Act, 1940 (hereinafter referred as the "Act") is mainly concerned with maintaining the quality of drugs and cosmetics and provides for the establishment of a board of technical experts to advise the central and the state governments on technical matters. It gives specific guidelines about the c o n t r o l of the i m p o r t , manufacture, sale and distribution of drugs and cosmetics. The provisions about the regulation of ayurueda, siddha and unani drugs have been incorporated in the Act separately.
The standards for manufacture, sale, distribution and import of drugs and cosmetics have been mentioned in two separate schedules appended to the Act. Guidelines have also been provided about the stocking, exhibition for sale and distribution of cosmetics. The Act is an attempt to ensure that no substandard drugs or cosmetics are sold in the market and no one would sell even a genuine drug without a licence.1
Under the Act, any person or a registered consumer association is entitled to submit for test or analysis to the government analyst any drug or cosmetic and to receive a report of the same.2 Consumer organizations can make use of this provision for the protection of consumers, particularly the)' can use it to prevent flow of spurious and adulterated drugs sold to government departments or used in hospitals maintained by the state.
Involvement of consumer agencies in the enforcement of standards has, therefore, been rightly provided for under the Act as it is absolutely necessary for the successful implementation of the provisions of the Act.
I. Drugs and Cosmetics Covered under the Act
For the purposes of the Act, the term "drug" has been defined to include:3
(i) all medicines for internal or external use of human beings or animals and all substances intended t o be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in
1. The provisions of the Act are in addition to, and not in derogation of, the Dangerous Drugs Act, 1930. The Act of 1930 empowers the central government to regulate operations about dangerous drugs and prescribes penalties in that respect. Its section 4 prohibits cultivation and gathering of coca plants and manufacture, possession, import and export, transit and sale of opium. See, Indian Chemical and Pharmaceutical
Works v. State ofAndhra Pradesh, AIR 1966 SC 713.
2. See below in this chapter, "Reports of government analysts".
3. The Drugs and Cosmetics Act, 1940, sec. 3(b).
human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; and (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;
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals;
Manufacturing means any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking-up or otherwise treating or adopting any drug or cosmetic with a view to sell or distribute it.
But, it does not include the compounding or dispensing of any drugs, or the packing of any drug or cosmetic in the ordinary course of retail business.4
The term "cosmetic" denotes any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.5
"Ayurvedic, Siddha or Unani drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or p r e v e n t i o n of disease or disorder in h u m a n beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of ayurvedic, siddha and unani tibb system of medicine.
These books have been specified in the first schedule of the Act.6
"Patent or proprietary medicine" means, in relation to ayurvedic, siddha or unani tibb systems of medicine, all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of ayurveda, siddha or unani tibb systems of medicine and specified in the first schedule of the Act. It does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in the said schedule. In relation to other systems of medicine, the "patent or proprietary medicine" includes a drug which is a remedy or prescription presented in a form ready for internal or external administration to h u m a n beings or animals and which is not included in the Indian Pharmacopoeia for the time being or any other pharmacopoeia authorised in
4. Id, sec. 3(f).
5. Id., sec. 3 (aaa).
6. Id., sec. 3(a), see Appendix-VII.
this behalf by the central government after consultation with the Drugs Technical Advisory Board.7
The definition of the term "drug" in the Act is comprehensive enough to cover not only medicines but also substances intended to be used for treatment of diseases of human beings or animals. This definition introduces a distinction between medicines and substances which are not medicines s t r i c t l y so called. T h e expression "substances", therefore, must be something other than medicines but which are used for treatment. For example, the bandages and gauze are the substances falling within the meaning of the said expression because these things are used for or in treatment. The definition has been, thus, extended to cover the substances, which are necessary aids for treating surgical or other cases.8 The definition of drugs also include the substances, which can be used for the preparation of medicine.9
The Gujarat High Court, in Subodh S. Shah v. Director, Food and Drugs, Ahmedabad,10 held that the given definition of "drug" includes "blood" also,
as it is undoubtedly a substance which can be used for or in the diagnosis, t r e a t m e n t , p r e v e n t i o n of any disease or disorder in h u m a n being.
Transfusion of h u m a n blood of the same group is now a well k n o w n treatment adopted by the medical profession for treatment, medication or prevention of any disease or disorder in human beings. Therefore, there is no scope for doubt that the blood is "drug" within the meaning of section 3(b) of the said Act. The expression "drug" includes medicine for external o r i n t e r n a l use and t h e expression "substance" includes a l i q u i d . Accordingly, the water used for dissolving other medicines for injection into human body is a "drug".11
The given definition of drug does not include medicines and substances exclusively used or prepared for use in accordance with the ayurvedic or unani systems of medicine. For example, arjuna as a medicine has been exclusively used in accordance with ayurvedic system since time immemorial, while its skill is u n k n o w n to the allopathic system of t r e a t m e n t . A n y of its preparations, whether for oral or parenteral use, cannot, therefore, come within the ordinary definition of drug.12
The intention of the legislature has been to exclude from the definition of drug all medicines and substances which are either used exclusively or prepared for use exclusively in accordance with the ayurvedic or unani systems of medicine, for which separate regulatory mechanism is prescribed under
7. Id., sec. 3(h).
8. Chaman Laljagjivan Das Seth v. State of Maharashtra, AIR 1963 SC 665.
9. Bahoolbhi Patel and Company v. Collector of Customs, Bombay, 1985 (19) ELT 287.
10. AIR 1997 Guj 83.
11. R.C. Sundarkav. StateofWest Bengal, 1971 Cr. LJ 1369.
12. State of Uttar Pradesh v. S.C. Sen Gupta, AIR 1966 All 520.
the Act. But whether a medicine or substance is used exclusively or prepared for use exclusively in accordance with the ayurvedic or unani systems of medicine is a question of fact and its decision would hing on expert evidence.13
II. Regulation of Drugs and Cosmetics other than Ayurvedic, Siddha and Unani Drugs
Regulating bodies
The Drugs Technical Advisory Board
Section 5 of the Act empowers the central government to constitute the Drugs Technical Advisory Board to advise it and the state governments on technical matters arising out of the administration of the present Act and to carry out the functions assigned to t h e m thereunder.1 4 T h e Board is comprised of the following members:
(1) the Director General of Health Services (ex-qfficio Chairman);
(2) the Drugs Controller, India; the Director of the Central Drugs Laboratory, Calcutta; the Director of the Central Research Institute, Kasauli; the Director of the Indian Veterinary Research Institute, Izatnagar; the President of the Medical Council of India; the President of the Pharmacy Council of India; and the Director of the Central Drugs Research Institute, Lucknow (ex-officio members).
(3) Two members nominated by the central government from among the persons who are in charge of drugs control in the states.
(4) Six members each elected from: (i) the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmocognosy on the staff of an Indian university or a college affiliated thereto; (ii) the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto; (iii) the pharmaceutical industry nominated by the central government; (iv) the governing body of the Indian Council of Medical Research (a pharmacologist); (v) the Central Council of the Indian Medical Association; (vi) the Council of the Indian Pharmaceutical Association.
' (5) T w o members from government analysts appointed under this Act, nominated by the central government.15
13. hhwar Singh Bindra v. State of Uttar Pradesh, AIR 1966 All 168.
14. Supra note 3, sec. 5(1).
15. Id., sec. 5(2).
The nominated and elected members of the Board hold office for three years, but are eligible for re-nomination and re-election. The person nominated or elected because of his appointment in a certain position can hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the Board.16 The Board can with the previous approval of the central government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.17 The Board may constitute sub-committees based on persons who are not members of the Board and they may be appointed for such periods, not exceeding three years, or temporarily for the consideration of a particular matter.1 8 The functions of the Board may be exercised notwithstanding any vacancy therein.1 9 The secretary of the Board is appointed by the central government and it is supposed to provide the Board with necessary clerical and other staff.20
As explained above, the Board is to consist of 18 members, of whom 8 are ex-officio members, 5 nominated members and 5 elected members. The Director-General of Health Services is the ex-officio chairman of the Board.
The nominated and elected members hold office for three years but they are eligible for re-nomination or re-election, as the case may be. The central government appoints a secretary to the Board and provides other necessary staff. The functions of the Board may be carried out in spite of there being a vacancy on the Board.
The Central Drugs Laboratory
The central government is also empowered to establish a Central Drugs Laboratory under the control of a director to carry out the functions entrusted to it by or under the Act. The central government may require the functions of the Central Drugs Laboratory, in respect of any drugs or cosmetics, be carried out by the Central Research Institute, Kasauli, or by any other prescribed laboratory. In such a case the functions of the director of the Central Drugs Laboratory in respect of such drug or class of drugs or such cosmetic or class of cosmetics can be exercised by the director of that institution or of that other laboratory. The central government is authorized, after consultation with the Advisory Board, to make rules prescribing the functions of the Central Drugs Laboratory and the procedure for the submission to the said laboratory samples of drugs or cosmetics for analysis or test. The rules are to be also made regarding the form of the reports on
16.
17.
18.
19.
20.
21.
Id, Id., Id.
Id.
Id.
Id.
sec.
sec sec sec sec sec
5(3).
5(4) 5(5) 5(6) 5(7) 6(1)
samples and the fees payable in respect of such reports.2 1 It can further make rules regarding other matters as may be necessary or expedient to enable the said laboratory to carry out its functions and the other matters related to carrying out the functions of the Central Drugs Laboratory by the Central Research Institute, Kasauli, or any other prescribed laboratory.22
Drugs Consultative Committee
T h e central government is authorised to c o n s t i t u t e an advisory committee, namely the Drugs Consultative Committee to advise it and the state governments and the Drugs Technical Advisory Board on matters tending to secure nationwide uniformity in the administration of the Act.
The committee comprises t w o representative nominees of the central government and one representative nominee of each state government. The committee meets whenever required by the central government to do so and has power to regulate its own procedure.23 The Board and the committee have no concern with the ayurvedic, siddha or unani drugs.24
Regulations about import of drugs and cosmetics Standards of quality
The expression "standard quality" in relation to drugs and cosmetics, for the purposes of import, implies that these should comply with the standards set out in the second schedule t o the Act and such o t h e r standards as may be prescribed.2 5 The central government can, after consultation with the Board, amend the second schedule for that purpose within three m o n t h s .2 6 Section 12 and 13 of the Act vest the central government with power to make rules prescribing the methods of tests or analysis to be employed for determining standard quality of any drug.27
For the purposes of import of drugs and cosmetics, some other terms have also been explained in the Act. Section 9 provides that a drug would be deemed to be a misbranded drug: (a) if it is so coloured, coated, powdered or polished that damage is concealed or it is made to appear of better or greater therapeutic value than it really is; or (b) it is not labeled in the prescribed manner; or (c) its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. Section 9A describes a drug, to be an adulterated drug, if it consists, in whole or in part, of
22. Id, sec. 6(2).
23. Id., sec. 7.
24. Id, sec. 7A.
25. For second schedule of the Act, see appendix VII.
26. Id., sec. 8.
27. Dickins v. Randerson (1900) 1 KB 437.
any filthy, putrid or decomposed substance; or has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or it bears or contains, a colour other than one which is prescribed; or it contains any harmful or toxic substance which may render it injurious to health; or any substance has been mixed with it which has reduced its quality or strength.
Accordingly, section 9B provides that a drug would be a spurious drug, if it has been imported under a name which belongs to another drug; or it is an imitation or a substitute for another drug or resembles another drug in a manner likely to deceive or bears upon it or its label or container the name of another drug and is not plainly and conspicuously marked to reveal its true character and its lack of identity with such other drug. If the label or container of a drug bears the name of an individual or company, purporting t o be the manufacturer of the drug, and that individual or company is fictitious or does not exist, or it has been substituted wholly or in p a n by another drug or substance, such a drug would also be termed as spurious.
Under section 9C, a cosmetic can be deemed to be misbranded if it contains a colour which is not prescribed or it is not labeled in the prescribed manner;
or its label or container or anything accompanying it bears any misleading or false statement. A cosmetic, as explained by section 9D, can be deemed to be a spurious cosmetics if it is imported under the name of another cosmetic; or it is an imitation or substitute for another cosmetic; or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, and not plainly and conspicuously marked to reveal its true character and make it distinct from such other cosmetic. A cosmetic would also be spurious if its label or container bears the name of a fictitious individual or company p u r p o r t i n g to be its manufacturer; or it p u r p o r t s to be the product of a particular manu
facturer.28
Section 10 empowers the central government to restrict import of any drugs or cosmetics which are not of standard quality or which are misbranded, spurious or adulterated. Any drug or cosmetic, for the import of which a licence is prescribed, cannot be imported without such licence. Any patent or proprietary medicine can also not be imported unless it displays its true formula or list of its active ingredients, with quantity, on its label or container. Import of certain drugs or cosmetics may be prohibited because of any statement, design or device accompanying it or because of any effects, as may be prescribed, or because of any ingredient which may render it unsafe or harmful for use. The government should specify the date from which the import of a drug or cosmetic is restricted. These restrictions
28. Id.,stc. 9D.
do not apply to the import of small quantities of any drug for the purpose of examination, test or analysis or for personal use. The central government may also, after consultation with the Board, permit the import of any drug or class of drugs not being of standard quality on specified conditions.
Under section 10A, the central government may prohibit the import of any drug or cosmetic in public interest, if it is satisfied that the use of any such drug or cosmetic is likely to involve any risk to human beings or animals or that it does not have the therapeutic value claimed for it or contains ingredients in such quantity for which there is n o therapeutic justification.
Application of law relating to sea customs
The prohibition on the import of goods under the Sea Customs Act, 1878, is applicable in respect of drugs and cosmetics also and the officers of customs have the same powers in respect of such drugs and cosmetics as they have in respect of other prohibited goods. Such application of the Sea Customs Act does not affect the provisions of the Drug and Cosmetics Act, 1940 relating to offences and punishments.29 The customs collector or any authorized officer may detain any imported package which he suspects to contain any drug or cosmetic the import of which is prohibited and forthwith report such detention to the Drugs Controller, India, and if necessary, forward such package or sample of any suspected drug or cosmetic to the Central Drugs Laboratory.30
Rule making about import of drugs and cosmetics
The rules for the purpose of import of drugs and cosmetics can be made by the central government after consultation with or on the recommendation of the Board and after previous notification in the official gazette. The c o n s u l t a t i o n w i t h the Board may be dispensed w i t h if the central government is of the opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board is to be consulted within six months of the making of the rules and such rules may be accordingly amended if any suggestion is made by the Board to that effect.31 Such rules may specify the drug or classes of drugs or cosmetics or classes of cosmetics for the import of which a licence is required and prescribe the form and conditions about issuance, suspension or cancellation of licences, the authority empowered for the same and the fees payable thereto.32 Such rules may also:33
29. Id., sec. 11(1).
30. W., sec. 11(2).
31. Id., sec. 12(1).
32. Id., sec. 12(2)(a).
33. Id., sec. 12(2)(b) to (o).
(1) prescribe the methods of test or analysis to find out the standard quality of drugs and cosmetics;
(2) prescribe, in respect of biological and organometallic compounds, the units or methods of standardization;
(3) prescribe the colour or colours which a drug may bear or contain for purposes of colouring;
(4) specify the disease or ailments which an imported drug may not purport or claim to prevent, cure or mitigate and such other effects which such drug may not purport or claim to have;
(5) prescribe the conditions subject to which small quantities of drugs, the import of which is otherwise prohibited, may be imported for the purpose of examination, test or analysis or for personal use;
(6) prescribe the places at which drugs or cosmetics may be imported, and prohibit their import at any other place;
(7) require the date of manufacture and the date of expiry to be clearly and truly stated on the label or container of any specified imported drug or class of such drugs and prohibit the import of the said drug or class of drugs after the expiry of a specified period from the date of manufacture;
(8) regulate the submission by importer, and the securing of samples of drugs or cosmetics for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis;
(9) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs or cosmetics sought to be imported, the procedure of officers of customs in dealing with such evidence and the manner of storage at places of import of drugs or cosmetics detained pending admission;
(10) provide for the exemption, conditionally or otherwise, from all or any of the prohibitions or regulations of drugs or cosmetics imported for transportation through, and export from India;
(11) prescribe the conditions to be observed in the packing in bottles, packages or o t h e r containers of i m p o r t e d drugs or cosmetics, including the use of packing material, which comes into direct contact with the drug;
(12) regulate the mode of labeling drugs or cosmetics imported for sale in packages, and prescribe the matters which are to be or are not to be included in such labels;
(13) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import of any drug in which proportion is exceeded, and specify substances which shall be deemed to be poisonous;
(14) require that the accepted scientific name of any specified drug be displayed on the label or w r a p p e r of any i m p o r t e d p a t e n t or proprietary medicine containing such drug;
(15) provide for the-exemption, conditionally or otherwise, from all or any of the aforesaid prohibitions any drugs or cosmetics.
Penalties for importing prohibited drugs or cosmetics
Importing any adulterated or spurious drug or cosmetic is punishable with imprisonment for a term which may extend to three years and fine which may extend to five thousand rupees. Same punishment is prescribed for importing any drug or cosmetic containing harmful ingredients. Importing any other prohibited drug or cosmetic is punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both. Importing of any drug or cosmetic, the import of which has been prohibited by the central government in public interest is punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.34 Subsequent conviction for offences regarding import of adulterated and spurious drugs or cosmetics or those prohibited in public interest are punishable with imprisonment for a term which may extend to five years, or w i t h fine which may extend to ten t h o u s a n d rupees, or with b o t h . Subsequent conviction for the offences regarding any other prohibited drugs or cosmetics are punishable with imprisonment for a term which may extend t o one thousand rupees, or with both.3 5 The punishments so provided are in addition to any penalty to which the offender may be liable under the Sea Customs Act.36
The consignment of any drug or cosmetic, in respect of which the offence has been committed, is liable to confiscation.37 The Calcutta High Court, in Sherwal Jain v. Collector of Central Excise?* held that even if the person who has smuggled the goods is not traceable, they can be confiscated without proceeding against any person. These offences are not triable by any court inferior to that of a metropolitan magistrate or of a judicial magistrate of the first class.39
Restrictions about manufacture, sale and distribution of drugs and cosmetics
Section 18 of the Act restricts manufacture, sale and distribution of certain 34. Id, sec. 13(1).
35. Id., sec. 13(2).
36. Id., sec. 13(3).
37. Id., sec. 14.
38. AIR 1956 Cal 621.
39. Id., sec. 15.
drugs and cosmetics which are not of a standard quality or are misbranded, adulterated or spurious. The restriction extends to any patent or proprietary medicine, on the label or container of which the true formula or list of its active ingredients, with the quantities thereof, have not been displayed. Such prohibition may also be extended because of any statement, design or device accompanying a drug or cosmetic or because of its peculiar effect or containing harmful ingredients.4 0 For the purposes of prohibition on manufacture, sale and distribution of drugs and cosmetics, the terms
"standard quality", "misbranded", "adulterated", and "spurious drugs" have the same meaning as they have with regard to their import.
Furthermore, the manufacture for sale or distribution or sale of any drug or cosmetic should take place only in accordance with the conditions of licence issued for the purpose. These restrictions do not apply to the manufacture of small quantities of any drug or cosmetic for the purpose of examination, test or analysis. The central government may, however, after consultations with the Board permit the manufacture, sale, distribution, stocking or offering for sale or distribution of any drugs or cosmetics, not being of standard quality on specified conditions.41
Wherever, it may become necessary, every person, not being the manufacturer of a drug or cosmetic, or his agent would be bound to disclose to the inspector the name, address and other particulars of the person from whom he has acquired the drug or cosmetic.42 O n the availability of the name and address of the concerned person, he should be provided with a portion of the sample of such drug and cosmetic.43 For any action against an accused should be in accordance with the principles of fairness and justice. In Core Healthcare Limited, Ahmedabad v. The State of Bihar and others44, the p e t i t i o n e r s challenged a m e m o by which some of the drugs manufactured by the petitioner company had been declared to be banned and the petitioner company had been black listed. It was mentioned in the memo that drugs allegedly manufactured by the petitioner company had been declared sub-standard by the government analyst after examination and the drugs were supplied by the petitioner company to different hospitals of the state at different rates. During the pendency of the writ petition another resolution was brought on record which was also challenged. The court found that the authorities had not sought any explanation from the p e t i t i o n e r s c o m p a n y before black-listing and it had still offered an explanation in answer to the charge of black-listing. In view of that, it was held by the court that there was no need to go into the correctness of the
40. Id., sec. 18(a) and (b).
41. Id., sec. 18(c).
42. Id, sec. 18A.
43. In re: R Dayalan, 1978 Cr LJ 1852.
44. 2000 CriLJ 3150.
explanation as black-listing a company/organization without calling for an explanation from it is something which offends the fundamentals of fair play in action. The court strongly condemned the casual manner in which the order of black-listing was passed and allowed the petition.
Every person holding a licence regarding manufacture, sale, distribution, stocking or exhibition of drugs or cosmetics has to keep and maintain relevant records, registers and other d o c u m e n t s and furnish t o the concerned officer or authority the required information whenever asked for.45 On prosecution, the accused cannot plead ignorance about the nature, substance or quality of the drug or cosmetic in respect of which the offence has been committed or of the circumstances of its manufacture or import.
The accused cannot contend that the purchaser had bought the substances only for the purpose of test or analysis and had not been prejudiced by the sale.46
For the purposes of extension of prohibitions under section 18 of the Act, a drug or cosmetic cannot be deemed misbranded, adulterated, spurious or to be of below standard quality only by reason of the fact that some innocuous substance or ingredient has been added to that or because the same is required for the manufacture or preparation of the drug or cosmetic as an article of commerce in a state fit for carriage or consumption, and not to increase the bulk, weight or measure of the drug or cosmetic or to conceal its inferior quality or defects. Also a drug or cosmetic cannot be deemed to be m i s b r a n d e d or so, if in the process of m a n u f a c t u r e , preparation or conveyance some extraneous substance has unavoidably become inter-mixed with it. This provision does not apply in relation to any sale or distribution of the drug or cosmetic occurring after the vendor or distributor became aware of such inter-mixture.47
In Mrs. Meenaz Moloobhay v. State of Maharashtra,48 the drug inspector filed complaint against seven accused partners of a firm for contravention of the provisions about licence. He noticed that the accused had sold some tablets without holding requisite licence. The magistrate took cognizance and framed charges against all the accused. One of the accused pleaded guilty for himself on behalf of all the partners of the company. The learned magistrate proceeded to convict all the accused for the aforesaid offences and sentenced them even though he had not recorded evidence in the presence of the accused. The applicant challenged the order of conviction.
The court held that the magistrate had committed certain irregularities and, therefore, order of conviction was illegal. The court, accordingly, set aside the order passed by the magistrate, acquitting all the applicants.
45. Supra note 3, sec. 18B.
46. Id., sec. 19(1).
47. Id., sec. 19(2).
48. 2000 Cri LJ 3998 (Bom).
In Pratap Pharma (Pvt.) Ltd. v. Union of India,49 the Supreme Court has held that if a drug is found to be not in conformity with the prescribed standards and is likely to cause injury to health or to endanger the life of a patient, by necessary consequence, the prohibition on such a drug is implicit and, therefore, there is no need for an express prohibition under the Act.
Under the Act, certain defences are available to the accused on genuine grounds. Accordingly, a person other than the manufacturer of a drug or cosmetic or his agent cannot be held liable for the contravention if he proves that he acquired the drug or cosmetic from a duly licenced manufacturer, distributor or dealer and he did not know and could not, with reasonable diligence, have ascertained the defects in the drug or cosmetic.
Also he w o u l d have to show that the drug or cosmetic, while in his possession, was properly stored and remained in the same state in which he acquired it. This defence is available to an accused under section 19(3) of the Act. In Public Prosecutor v. Hatambhai,50 it has been held that to establish the guilt, the p r o s e c u t i o n has to just prove that the accused had sold or exhibited for sale the drug which was not of standard quality or which was a misbranded drug. To escape liability, it was for the accused to establish the said defence.
A private hospital which caters to the prescriptions of several doctors storing huge quantity of drugs, cannot be equated with a registered medical practitioner who administers and supplies drugs for emergency purposes to his own patients only by storing limited quantity of 'physician's sample' for distribution. However, even a registered medical practitioner if indulges in sale of drugs is certainly required to acquire a license under the Act and will not be saved by any exemption incorporated in the schedule of the Act.5 1
The defence is mainly available to a person who is not a manufacturer of a drug or who is not the agent of such a manufacturer for distribution.
T h u s , a stockiest or seller of a drug is not entitled to the defence. As mentioned above, mere ignorance on the part of the accused person that he was unaware of the nature of the substance or the quality of the drug is not a defence. All that the prosecution is required to prove, in order to establish contravention, is that the accused has sold the exhibited drug which was not of standard quality or which was a misbranded drug. It is not necessary for the prosecution to establish that the accused has done so knowingly, willfully or with a guilty mind. If the accused wants to get rid of the prosecution evidence, then it is for him to proceed under section 19(3)(a) to establish that he did not know that the drug, in any way contravened the prohibition under section 18 of the Act and he could not with reasonable
49. AIR 1997 SC 2648.
50. AIR 1969 AP 99.
51. Thomas v. Union of India, AIR 2000 Ker, 325; see Appendix VII.
diligence ascertain that the drug was in contravention with the requirements under the Act. Furthermore, he has to show that the drug, whilst in his possession, remained in the same state in which it was when he acquired it.
All these defences are cumulative and all of them must be established to substantiate the innocence of the accused. It is not enough for a person to show that he had purchased the drug from a recognized dealer or in the open market. He must establish that fact too. In addition to this, while making the purchase, it is the duty of the seller or a stockiest to inspect reasonably the drug, including the outward wrappings in which the drug is contained, so that spurious articles do not come to be placed in the market and he does not become, even unconsciously, an agent for passing off spurious drugs to the consumers.52
In Sanjay Medical Stores, Allahabad v. State ofU.P.,^ the accused had purchased the disputed capsules from a licensed distributor. On the invoice of purchase, there was a warranty that these capsules contained standard quality of colloidal calcium. The applicant had no reason to doubt the correctness of this warranty. All the proved circumstances definitely showed that the applicant did not know and would not with reasonable diligence, know that the drug in question in any way contravened the provisions of the Act. Thus, the applicant was clearly entitled to the benefit of section 19(3) of the Act.
Inspection of drugs and cosmetics Appointment and position of inspectors
For the purposes of inspection of drugs and cosmetics, the central and the state governments are empowered to appoint inspectors, having the prescribed qualifications, in different areas with such powers and duties as may be prescribed. However, any person who has any financial interest in the import, manufacture or sale of drugs or cosmetics cannot be appointed as an inspector. In order to exercise his/her powers validly the inspector should be duly appointed fulfilling all the prescribed requirements. In State ofMaharastra v. Ghanshyam K. Zaveri and another5*, the respondents were tried for the offence that a laboratory was manufacturing tablets at their factory premises without permission for sale or licence as required under the Act.
The inspector visited the premises and made enquiry regarding the sale and purchase of tablets and prohibited the sale of the drug. The respondent applied for discharge and they were discharged by the m e t r o p o l i t a n magistrate holding that drug inspector was not duly appointed and,
52. State v. Han Lai, AIR 1963 Guj 36.
53. (1978) 1 FAG All 237.
54. 2001 Cri LJ 1629.
therefore, not authorised to exercise power under the provisions of the Act.
The drug which was seized was not meant for sale in India but only for export to another country, and, therefore, there was no violation of the Act.
The court confirmed the order of the discharge of the respondent by the learned magistrate. In this case reference was also made to the judgment of the Supreme Court in Drug Action Forum v. Union of India,** where the question involved was the export of a drug to a foreign country where it was not banned. The court, in that case, had allowed export of the existing stock of the concerned drugs restricting their consumption in India.
Every Inspector is deemed to be a public servant within the meaning of section 21IPC and is officially subordinate to the authority, specified by the a p p o i n t i n g g o v e r n m e n t .5 6 There is no bar on prescribing different qualifications for inspectors for different purposes. The central government has full freedom to prescribe the qualifications for inspectors and can prescribe one set of qualifications for an inspector for one purpose and another set of qualifications for another purpose.57
Powers of Inspectors
The inspectors are having multifarious powers including power to inspect, conduct search, examine samples, call records etc. They can, therefore, inspect any premises wherein any drug or cosmetic is being manufactured, sold, stocked or exhibited or offered for sale or distribution or where any other related action is being taken with respect to them. The inspectors can take samples of any drug or cosmetic which is being manufactured, sold, stocked, etc. Such samples can be taken from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee.58
Further, an inspector can, on reasonable belief, search any person who may have secreted any drug or cosmetic or enter and search any place on a similar belief. H e can stop and search any vehicle, vessel or o t h e r conveyance, which is being used for carrying any drug or cosmetic in contravention with the provisions of the Act. The inspector can direct the person in possession of the drug or cosmetic not to dispose of any stock of such drug or cosmetic for any period upto twenty days. If the alleged offence with respect to a drug or cosmetic is such a defect which can be removed by the possessor, the inspector should seize the stock of such drug or cosmetic, along with any other substance or article used in the offence.59
55. (1997) 9 SCC 609.
56. Supra note 3, sec. 21.
57. Raj Kishan v. State, AIR 1960 All 460.
58. Supra note 3, sec. 22(a) and (b).
59. Id, sec. 22(c).
An Inspector can examine and seize any record, register, or any other material object or any place, vehicle, etc. and seize the same if it can furnish any evidence about the commission of an offence. For like reasons, he can require any person to produce any record, register, or other document relating to the manufacture or distribution of any drug or cosmetic and exercise other necessary powers.60 The provisions of Cr PC apply to any such search or seizure as they apply to any search or seizure made under the authority of a warrant issued under section 94 of the Code.61
Every record, register or other document seized from or produced by a person should be returned to him within a period of twenty days from the date of such seizure or production, after receiving their certified copies or extracts.62
The offence of willfully obstructing an inspector in the exercise of his p o w e r s or refusal to produce any d o c u m e n t s , when so required, is punishable with imprisonment up to three years, or with fine, or with both.63
A drug inspector can take the signature of any witness or an accused on any statement made by him. The question had been raised in Raj Kisban v.
Stated where the signatures of the accused were taken by the inspector merely to acknowledge the receipt of copies of the search ists and the notices issued to the accused. There was held to be nothing objectionable in the conduct of the drugs inspector in taking the signatures of the accused on these documents. Since search or seizure by an inspector is equivalent to the search and seizure made under the authority of a warrant issued under the relevant provision of the Cr PC, it is necessary to record the reasons for such search or seizure. A police officer should give reasons in writing in case he is compelled to conduct search without the warrant of a magistrate.65 Procedure of inspection
An inspector should take sample of any drug or cosmetic on the payment of its price with proper acknowledgement.6 6 Where the price tendered is refused or the inspector seizes the stock of any drug or cosmetic, he should tender a receipt for that in the prescribed form.67 O n taking sample of a drug or cosmetic for the purpose of test or analysis, the inspector should
60. Id., sec. 22(1).
61. Id., sec. 22(2); sec. 94 Cr PC deals with search of places suspected to contain stolen property, forged documents etc.; see Appendix-X.
62. Id., sec. 22(2A).
63. Id., sec. 22(3).
64. (1960) All LJ 43.
65. Public Prosecutor (AP) v. Mahaveer Prasad, 1972 Cr LJ 1546.
66. Supra note 3, sec. 23(1).
67. Id., sec. 23(2).
intimate the purpose to the person, from whom it is taken in writing, even if he willfully absents himself. He should divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of them.68
Where the sample is taken from manufacturing premises, it should be divided into three portions only. And if the drug or cosmetic is made up in containers of small volume or the drug or cosmetic is such that it is likely to deteriorate or be otherwise damaged by exposure, the inspector may take three or four of the said containers after suitably marking and sealing them.69
The inspector should restore one portion of a sample or one container to the person from whom he takes it and handover the second portion to the government analyst for test or analysis. The third portion is to be produced before the court in which proceedings, if any, have been initiated and the fourth is t o be send to the person identified by the accused as manufacturer or so.70
Where an Inspector conducts search on person, place or a vehicle regarding any secreted drugs or cosmetics, he should use all dispatch in ascertaining whether or not any of the prohibition under section 18 about manufacture, sale etc. of drugs or cosmetics has been contravened. If it is ascertained that there is no such contravention, he should revoke any order passed about that and take such action as may be necessary for the return of the stock seized.71 When he seizes any stock of the drug or cosmetic he should, as soon as may be, inform the judicial magistrate concerned and take his orders about the custody thereof.72 If the order to seize has been passed because of any defect in the drug or cosmetic which can be remedied by the possessor, the inspector should, on the removal of such defects, forthwith revoke the said order of seizure.7 3 The revocation of the order will, however, not be prejudicial to the institution of any prosecution.74 As in case of seizure of any drug or cosmetic, the orders of the magistrate are to be taken, same is the requirement in case of seizure of any record, register or any other documents.75
T o facilitate action on the part of inspectors, section 24 of the Act requires every person in charge of any premises, where any drug or cosmetic is being manufactured or kept for sale or distribution, to disclose the place
68. Id., sec. 23(3).
69. Id., proviso to sec. 23(3).
70. Id., sec. 23(4) and sec. 18A.
71. Id., sec. 23(5)(a).
72. Id., sec. 23(5)(b).
73. Id., sec.*23(5)(c).
74. Ibid.
75. Supra note 3, sec. 23(6).
where any drug or cosmetic is being manufactured or kept, whenever asked to do so.
Reports of government analysts
Section 25 requires the government analyst to whom a sample of any drug or cosmetic has been submitted for test or analysis under section 23(4) to deliver a signed report of his findings in triplicate to the inspector.76 The inspector has to deliver one copy of the report to the person from whom the sample was taken and another to the manufacturer or seller as identified by such person. The third copy is to be retained by the inspector for use in any prosecution in respect of the sample.7 7 The report signed by the government analyst is treated as a conclusive evidence unless some other evidence is adduced in contravention.7 8 The evidence contravening the report of the government analyst should be adduced within twenty-eight days of the receipt of a copy of the report of the inspector or the court before which any proceedings in respect of the sample are pending. The evidence so adduced should be given a prompt consideration.79 In M/S Zim Laboratories, Bombay and Others v. State of Maharasthra,80 it has been emphasized that because of the failure to take prompt appropriate steps in this regard, the petitioner can loose his valuable statutory right.
A sample can be sent for test or analysis t o the C e n t r a l D r u g s Laboratory, where it has not been tested or analysed earlier. Such an action can be taken where a person has notified his intention of adducing evidence in contravention of the government analyst's report, or by the court, suo- motu or in its discretion, at the request by the complainant or the accused.
The report signed by or under the authority of the Director of the Central Drugs Laboratory would be the conclusive evidence of the facts stated t h e r e i n .8 1 The cost of the test or analysis shall be payable by the complainant or accused, as the court may direct. 82
In Mohan Lai v. State of Rajasthan,83 it has been held that if the petitioner has been deprived of his right to retesting of the sample, despite his request, the proceedings against the petitioner would obviously amount to abuse of the process of the court.
In Shiv Narain Bansal v. State ofHaryana,84 the petitioner was running a medical store having a retail drug licence. The drug inspector took sample of
76. Id., sec. 25(1).
77. Id, sec. 25(2).
78. Id., sec. 25(3); State v. MA Uni Drug, 1983 MLJ (Cr) 256.
79. Ibid.
80. 1999 Cri LJ 2903.
81. Supra note 3, sec. 25(4).
82. Id., sec. 25(5).
83. 1998 Cri LJ 2592 (P&H).
84. 1996 Cri LJ 338.
a capsule and sent it to a government analyst for analysis. The sample was declared to be not of standard quality and the petitioner was charged. The p e t i t i o n e r filed a petition under section 482 Cr P C for quashing the complaint and the proceedings. The court found that the petitioner had informed the drug inspector for sending their sample to get it tested from the Central Drug Laboratory, but for the fault of the inspector, the sample could not be sent to the said laboratory in time and it was sent only after the expiry date. The petitioners had, therefore, been deprived of their right of contravention given to them under section 25(3) of the Act. The court allowed the petition and quashed the complaint as well as other proceedings taken in pursuance thereof including the charge against the petitioners.
In Jaginder Pal Vohra v. State ofHaryana,8* it was held that at the time of framing of the charge, the magistrate should consider the report of the Central Drugs Laboratory before taking any decision about the violation, if any, committed by the petitioner. Once the report of the Central Drugs Laboratory is on the record, it would supersede the report of the state drug laboratory irrespective of the findings contained therein.
Section 26 of the Act enables any person or any recognized consumer association, whether such person is a member of that association or not, on application, t o receive a report of such test or analysis signed by the government analyst in the prescribed manner and on payment of the prescribed fee. Accordingly, any person purchasing a drug or cosmetic can on payment of prescribed fee, submit the drug or cosmetic to government analyst for test or analysis. Particulars of application for test or analysis and fee t o be paid is given in form 14-A and Schedule B to the Drugs and Cosmetics Rules, 1945.86
Prohibition on manufacture of drugs in public interest
Section 26A of the Act empowers the central government to prohibit the manufacture, sale or distribution of any drug or cosmetic, the use of which is likely to involve any risk to human beings or animals or it does not have the therapeutic value as claimed or contains ingredients in a quantity without therapeutic justification. In Unichen Labs Ltd. v. Union oflndiaf7 regarding ban on anabolic steroids, the question involved was whether the total ban imposed on anabolic steroid with a combination of vitamins Bl, B6 and B12 was within the terms of section 26A. The court allowed the drug to be sold upon the prescription of a registered medical practitioner subject to his having the minimum qualification of graduation in medicine and surgery from a recognized university.88
85. 1998 Cr LJ 2592 (P&H).
86. See for these Appendix VII.
87. 1988 Drugs Cases 111 (Bom HC).
88. Ibid.
As regards following the principles of natural justice in matters under section 26A, the Calcutta High Court, in Drug Controller General of India v.
West Bengal Small Scale Manufacturers Association,^ has observed that this Act is a complete code in itself and an order issued under the said section by the central government is an exercise of its legislative power. And where the legislative power is exercised, the question of complying with the principles of natural justice would not arise. Furthermore, satisfaction of the central government as to whether a drug should be prohibited or not on the ground that the same is injurious to public health is essentially a matter dealing with a policy decision, and thus, compliance with the principles of natural justice must be held to be excluded in such a situation.
Penalties for contraventions in manufacture and sale of Drugs Under section 27 of the Act, the sale, stocking, exhibition or distribution of any adulterated, spurious and sub-standard drugs or any such drug, which if used by any person is likely to cause his death or harm his body amounting to grievous hurt, is punishable with imprisonment for a term of five years to a term of life and with fine of not less than ten thousand rupees.90 The manufacture, sale etc. of any adulterated drug without a valid license, which is unlikely to cause death, is punishable with imprisonment for a term, from one year to three years, and with fine of not less than five thousand rupees.
H o w e v e r , the court may, for any adequate and special reasons t o be mentioned in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five t h o u s a n d rupees.9 1
S u b s e q u e n t c o n v i c t i o n for any such offence is p u n i s h a b l e w i t h imprisonment for a term of two to six years and with fine upto ten thousand rupees. T h e court may, for any adequate and special reasons t o be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than ten thousand rupees.92
The offence regarding any spurious drug, not likely to cause death, is punishable with imprisonment for a term of three to five years and with fine of not less than five thousand rupees. However, 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.93 Subsequent conviction for any such offence is punishable with imprisonment for a term upto ten years and with fine which shall not be less than ten thousand rupees.94 Offences regarding any drug, which has
89. AIR 2000 Cal 133.
90. Supra note 3, sec. 27(a).
91. Id, sec. 27(b).
92. Id, sec. 30(l)(a).
93. Id., sec. 27(c).
94. Id., sec. 30(l)(b).
not been mentioned above, would be punishable with imprisonment for a term ranging from one year to two years and with fine. However, 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 one year.9' Subsequent conviction for such an offence is punishable with imprisonment for a term of two to four years or with fine which shall not be less than five thousand rupees, or with both.96
Penalties for c o n t r a v e n t i o n s regarding manufacture, sale etc. of cosmetics have been separately prescribed under section 27A. According to that, any manufacture, sale, stocking, or distribution of any spurious cosmetic is punishable with imprisonment for a term which may extend to three years and with fine. The manufacture of any other cosmetic, in contravention of the provisions of the Act, is punishable with imprisonment for a term which may extend to one year or with fine upto one thousand rupees or with both.9 7 Any such subsequent offence is punishable with imprisonment for a term which may extend to two years, or with fine which may extend to two thousand rupees or with both.98
If any person involved in an offence fails to disclose the name of the manufacturer or any other person, as may be required, he would be punishable with imprisonment for a term which may extend to one year or with fine upto one thousand rupees or with both.99 In State ofOnssa v.
Janmajay Dinda,100 it was held that the offence of such non-disclosure is punishable with either imprisonment up to one year or with fine which may extend to one thousand rupees or both, but the sentence of imprisonment is not compulsory.
The burden of proof for contraventions under the Act lies on the p r o s e c u t i o n . In Kailash Chandra Das v. State ofOrissa,10' as regards unauthorized stocking of drugs, it has been held that the burden lies on the prosecution to prove its case beyond doubt. In the case, it was declared to be the duty of the prosecution to prove that certain drugs could not be stocked by the licencee. The court pointed out that even assuming that the drugs had been seized from the shop of the petitioner, it could not be assumed, in the absence of any list, containing names of drugs not allowed to be stocked by the licence, that any conditions of the licence had been violated.
95. Id,, sec. 27(d).
96. Id., sec. 30(l)(c).
97. Supra note 3, sec. 27A.
98. Id., sec. 30(1A).
99. Id., sec. 28.
100. AIR 1998 SC 1606.
101. 1999 Cr LJ 1701.
It has been laid down in Mohd. Shabir v. Maharashtra,102 mere recovery of a box containing sub-standard drugs from a place is not sufficient to prove a charge. For conviction, there should be stocking of the drugs for the purpose of sale and all its ingredients are to be satisfied. In this case, the appellant, a young man from a respectable family, made a very candid confession before the court in pleading guilty. In these circumstances any deterrent sentence was considered by the court to be uncalled for. The conviction of the appellant was, of course, upheld but he was given the sentence till the rising of the court which he had already undergone.
The release was ordered to be effected only after payment of a fine of Rs. 200/-.103
Where the Act has prescribed the specific term of imprisonment or quantum of fine, no fine more than the prescribed fine can be imposed.104
Contravention with respect to the provisions of section 18B, dealing with maintenance of records etc., is punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or with both.105 Manufactures, sales or distribution of any drug or cosmetic in contravention of the prohibitions in public interest issued under section 26A, are punishable with imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees.106
Use of any report of a test or analysis made by the Central Drugs Laboratory or by a government analyst, or any extract from such report, for the purpose of advertising any drug or cosmetic is punishable with fine which may extend to five thousand rupees.107 Subsequent conviction for an offence of this kind is punishable with imprisonment which may extend to ten years or with fine, or with both.108
Confiscation and cognizance of offences
Section 31 of the Act permits confiscation of stock of drugs or cosmetics in respect of which any contravention has taken place under the provisions of the Act. If such a contravention is in respect of manufacture of any misbranded, adulterated or spurious drug manufacture or sale without a valid licence, then beside the drug, any implements used for manufacture, any materials used for package and any carrier (animal, vehicle, vessel or
102. (1979) 1 SCC 568.
103. Ibid., see also Puran Hand v. State, 1986 EFR 405 at (Del.), Harichand Verma v. State of Punjab, 1992 (1) EFR 140 (P&H).
104. Rajastban Pharmaceutical Laboratory v. State ofKarnataka, AIR 1981 SC 809.
105. Supra note 3, sec. 28A.
106. M.sec. 28B.
107. Id., sec. 29.
108. Id., sec. 30(2).
other conveyance) used carrying such drugs can also be confiscated.109 Also, where the court is satisfied on the application of an inspector or otherwise and after it has been established through any enquiry that the drug or cosmetic is not of a standard quality or is a misbranded, adulterated or s p u r i o u s d r u g or c o s m e t i c , such a drug or cosmetic is liable t o confiscation.110
The provisions of the Act, except those relating to confiscation, apply in relation t o the manufacture, sale or distribution of drugs by any department of government, as they apply in relation to the manufacture, sale or distribution of drugs by any other person.111 The prosecution can be instituted only by an inspector or by the person aggrieved or by a recognized consumer association whether such person is a member of that association or not.1 1 2 N o court inferior to that of a metropolitan magistrate or of a judicial magistrate of first class can try the offence made punishable herein.113 Prosecution of any act punishable under any other law would not be affected by these provisions.114
The court can implead even the manufacturer of a drug or cosmetic or his agent, if it is satisfied on the evidence adduced before it that such manufacturer or agent is also involved in the offence and proceed against him as though a prosecution had been instituted against him.115 The above provisions do not apply to ayurvedic andsiddha.nb These are governed by a separate set of provisions under the Act.117
III. Regulations about Ayurvedic, Siddha and Unani Drugs A separate regulatory mechanism has been provided under the Act for controlling the manufacture and sale of ayurvedic, siddha and unani drugs. It provides for establishment of a separate board and committees for this purpose.
Regulating authorities
Ayurvedic, Siddha and Unani Drugs Technical Advisory Board
Section 33C of the Act authorizes the central government to constitute a
109. Id., sec. 31(1).
110. Id., sec. 31(2).
111. 7d.,sec. 31A.
112. Id., sec. 32(1).
113. Id., sec. 32(2).
114. Id., sec. 32(3).
115. Id., sec. 32 A.
116. Id.,sec. 33A.
117. Id., chapter IVA, sec. 33B.
board to be called the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board to advise the central and the state governments on technical matters relating to regulation oi ayurvedic, siddha and unani drugs, and to carry out any other functions required for this purpose.118 The Board comprises the following ex-offico and other members. The ex-officio m e m b e r s include:119
(i) the Director General of Health Services;
(ii) the Drugs Controller, India;
(iii) the Principal Officer dealing with Indian systems of medicine in the Ministry of Health;
(iv) the Director of the Central Drugs Laboratory, Calcutta;
The other members include:120
(i) one person holding the appointment as government analyst for analysis of ayrvedic drugs etc., to be n o m i n a t e d by the central government;
(ii) one pharmacognocist to be nominated by the central government;
(iii) one phyto-chemist to be nominated by the central government;
(iv) four persons to be nominated by the central government, two from amongst the members of the unani pharmacopoeia committee and one from amongst the members of the siddha p h a r m a c o p o e i a committee;
(v) one teacher in darvyaguna and bhaishajya kalpana, to be nominated by the central government;
(vi) one teacher in ilm-ul-advia and taklis-wa-dawa-sazi, to be nominated by the central government.
(vii) one teacher in gunapadam to be nominated by the central government.
(viii) three persons, one each to represent the ayurvedic, siddha and unani drug industry, to be nominated by the central government;
(ix) three persons, one each from among the practioners of ayurvedic, siddha and unani (tibb) systems of medicine to be nominated by the central government.
O n e m e m b e r of the Board w o u l d be a p p o i n t e d by the c e n t r a l government as its chairman. The nominated members of the Board would hold office for three years but are eligible for re-nomination. The Board may, subject to the previous approval of the central government, make bye- laws fixing a quorum and regulating its own procedure to conduct all
118. Id., sec. 33C(1).
119. Id., sec. 33C(2)(i) to (iv).
120. Id., sec. 33C (2)(v) to (xiii).
business to be transacted by it. The functions of the Board may be exercised notwithstanding any vacancy therein.1 2 1 The central government also appoints the secretary of the Board and provides the Board with necessary clerical and other staff.122
The Ayurvedic, Siddha and Unani Drugs Consultative Committee Section 33D of the Act empowers the central government to constitute an advisory committee, to be called the Ayurvedic, Siddha and Unani Drugs Consultative C o m m i t t e e , t o advise the central government, the state governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter related to ayurvedic, siddha or unani drugs. The c o m m i t t e e is t o consist of t w o persons n o m i n a t e d by the c e n t r a l government as its representatives, and one representative of each state to be nominated by the state government concerned. The committee is supposed to meet whenever required by the central government. It can regulate its own procedure.123
F o r the purpose of ayurvedic, siddha and unani drugs, the terms misbranded,124 adulterated125 and spurious126 have the same meaning as they have for the purpose of import of other drugs under sections 9A to 9C.127 However, a drug shall not be deemed to consist, in whole or in pan, of any decomposed substance if such decomposition is the result of any natural decomposition of the drug. Such a decomposition should not be due to any negligence on the part of the manufacturer of the drug or the dealer thereof. Further it should not render the drug injurious to health.128
Prohibitions on manufacture and sale
Section 33EEB of the Act allows manufacture of any ayurvedic, siddha or unani drug o n l y if it is in accordance with the prescribed standards.
Accordingly, n o person can manufacture for sale or distribution any misbranded, adulterated or spurious ayurvedic, siddha or unani drug or any patent; or proprietary medicine; or any other ayurvedic, siddha and unani drug in contravention of any of the provisions of this Act.129 Manufacture and sale of a patent or proprietary medicine can be allowed if a true list of all the ingredients contained in it is displayed on its label or container in the
121. 33C(2)to(6).
122. Id., sec. 33C(7).
123. Id., sec. 33D.
124. Id., sec. 33E.
125. Id, sec. 33 EE.
126. Id, sec. 33EEA.
127. See above in this chapter "Regulation about import of drugs and cosmetics".
128. Id., Explanation to sec. 33 EE.
129. Id., sec. 33 EEC (a).
