In every drug prosecution case, section 16 is invariably invoked to bring the manufacturer to the statute book and to prosecute him. What is the real provision as to the standard quality? When can it be said that the drugs are not of standard quality? It is a matter of fact that unless the drug is declared not of standard quality, the prosecution can never go against the manufacturer. So, in every case, it is the endeavor of the prosecution i.e. Drug Control Department to declare the drug not of the standard quality on the basis of the Government Analyst report. It is the prerogative of the State Drug Analyst to report and declare the drug not of the standard quality and on the report of such Analyst only the Drug Inspector can declare the sample of not of standard quality.
The provision of Section 16 can be imported here to understand the meaning more clearly.Section 16 – Standards of quality-
(1) For the purposes of this Chapter, the expression “standard quality” means–
(a) in relation to a drug, that the drug complies with the standard set out in the Second Schedule, and(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.
(2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months’ notice of its intention so to do, may by a like notification add to or otherwise amend [the Second Schedule] for the purposes of this Chapter, and thereupon [the Second Schedule] shall be deemed to be amended accordingly.
From the reading of the section it is clear that the heading of the section says “STANDARD OF QUALITY”. It simply lays down that what should be the standard of quality. For that purpose, it clearly relates to the Second Schedule and says that the drug shall be of standard quality if it confirms to the standard laid down in the second schedule.
In Ishwar Singh Bindra and Ors. Vs. State of U.P. AIR1968SC1450, Supreme Court observed that –
- Chapter IV contains provisions relating to manufacture, sale and distribution of drugs. Section 16 says, the expression “standard quality” when applied to a drug means that the drug complies with the standard set out in the Schedule. Section 17 relates to misbranded drugs. Section 18 prohibits manufacture and sale of sub-standard drugs including misbranded drugs. Sections 20 and 21 provide for the appointment of Government Analysts and Inspectors, the procedure to be followed by them and the reports of Government Analysts. Section 27 contains the penalty for manufacture, sale etc. of drugs in contravention of Chapter IV; the punishments provided being quite severe
In Rashtra Deep Laboratory Vs. Commissioner of Sales Tax 53STC419(All), Allahabad High Court, while dealing the provisions of section 16 in sales tax related case, held that –
- Section 16 of the Drugs and Cosmetics Act provides that the expression “standards of quality” for the purposes of the chapter dealing with the manufacture, sale and distribution of drugs shall, in relation to a drug, mean that the drug complies with the standard set out in the Second Schedule of the Act. The Second Schedule, in turn, after mentioning some drugs specifically, provides at item No. 5 for drugs included in the Indian Pharmacopoeia and lays down, for standards of identity, purity and strength specified in the edition in the Indian Pharmacopoeia for the time being and such other standards as may be prescribed. In regard to drugs not included in the English Pharmacopoeia, it lays down standards which are provided for them in any pharmacopoeia of any other country.
From above it is clear that the operative part, which is most important for classification of the goods as of standard quality, takes its root from second schedule.
The second schedule has five entries out of which entry no.3 has been deleted by notification of 1984. Entry 1 provides for Patent or Proprietary Medicines (PPM) [other than Homoeopathic medicines]. The standard prescribed is “The formula of list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed. This mean the drug under the category of Patent and Proprietary medicines shall confirm to the formula mentioned on the label. The rule for display of label is provided under rule 96 of The Drugs and Cosmetics Rules, 1944. Other standard prescribed may includes the pharmacopeias as well as the government notification. The inclusive reading all the provision provides that the PPM shall first confirm to the formula it has been granted and to display the same. Further it shall confirm to the rule 96 of the Act and also other provision of the Act. It shall also confirm to the other requirement of the Act and other pharmacopeias standards where applicable.
The second entry relates to Substances known as vaccines, sera toxins, toxoids, antitoxins and antigens and biological products of such nature for human use or for veterinary use. The standard prescribed are – The standards maintained at the International Laboratory for Biological Standards (IILB), Stantans Serum Institute (SSI), Copenhagen and at the Central Veterinary Laboratory (CCVL), Weybridge Surrey, U.K.,(W.S.UK) and such other laboratories recognized by the World Health Organization (WHO) from time to time, and such further standards of strength, quality and purity, as may be prescribed. These requirements again have two components. First, the standards prescribed by the specialized laboratories, and second part requires such further standards as may be prescribed. These requirements may be laid down in statue, pharmacopeias, license, approval or order as the case may be.
Third entry (4 as classified) – Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction or vermin or insect which cause disease in human beings or animals. The standards are not defined but simply stated to be as such standards as may be prescribed. The standards again in respect of such drugs depend upon the license conditions and all such conditions such as pharmacopeias etc.
Next entry in the schedule is No.5 classified as Other Drugs. Drugs included in the Indian
Pharmacopoeia are classified separately under entry (a). The standard prescribed is Standards of identity, purity and strength specified in the edition of the Indian Pharmacopoeia for the time being in force and such other standards as may be prescribed.
In case the standards of identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian pharmacopoeia immediately preceding, the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia and such other standards as may be prescribed. In short the standards are those as prescribed in Indian pharmacopoeia existing or previous edition.
So far the drugs not included in Indian pharmacopoeia, the standards provided in the edition of such official Pharmacopoeia of any other country for the time being in force and such other standards as may be prescribed shall be the standard. If such things are not in current edition then the standards prescribed in earlier edition shall be taken into account.
Section 12 provides for the Power of Central Government to make rules. Such rule making power of the government is also extended to the rule prescribing for the methods of test or analysis to be employed in determining whether a drug [or cosmetic] is of standard quality. The standard of drug is also been dealt under section 18 of the Act relevant portion which is reproduced below:
Prohibition of manufacture and sale of certain drugs and cosmetics. —From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf ,no person shall himself or by any other person on his behalf—
(a) manufacture for sale 2[or for distribution] ,or sell, or stock or exhibit or offer for sale –
(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
(ii) any cosmetic which is not of a standard quality or is misbranded or spurious
The central government however is vested with the power of permitting the sale of the drug not of standard quality. Under the proviso to section 18, the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale, or for distribution, sale, stocking or exhibiting or offering for sale or distribution of any drug or class of drugs not being of standard quality.
Another exception to the standard drug is section 19 subsection 2 read as follows:
(2)For the purposes of section 18 a drug shall not be deemed to be misbranded or adulterated or spurious or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality only by reason of the fact that—
there has been added thereto some innocuous substance or ingredient because the same is required for 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 3[or cosmetic]or to conceal its inferior quality or other defects;
So, the drug shall not be taken as “not of standard quality” only because some other substance or ingredient is present in the drug if such ingredient is required to prepare the drug.
WITH DISCLAIMER: PL REFER TO FULL TEXT OF JUDGEMENT BEFORE ACTING ON IT.
Article by: SUSHANT MAHAPATRA, ADVOCATE AND IPR ATTORNEY, DELHI HIGH COURT AND SUPREME COURT. Email: firstname.lastname@example.org., Web: www.macecorpn.com © reserved with author