AI Structured Summary
Not yet generated for this judgment
Judgment
D.N. Patel, CJ
W.P.(C) 12254/2018
This Public Interest Litigation has been preferred with the following prayers :
“i. Issue a writ in the nature of Mandamus or any other Writ of like nature thereby passing order or directions to thereby directing
Respondents for issuing appropriate and mandatory direction(s) to the respondents, to act upon the representation dated 21-07-2018 made
by the Petitioner.
ii. Issue a writ in the nature of Mandamus or any other Writ of like nature thereby passing order or directions to thereby directing
Respondents for taking appropriate measures for replacing the existing mechanism of stamping the strip of medicine with other method viz
printing etc, so as to avoid or minimize the re-use of expired medicine by stamping afresh with new expiry date after erasing existing
manufacturing date/expiry date/price etc.
iii. Pass any other appropriate order or direction as this Hon'ble Court may deem fit and proper in the facts and circumstances of the
case.â€
Having heard learned counsel for both the sides and looking to the facts and circumstances of the case, it appears that as per Rule 96 of Drugs and
Cosmetics Rules, 1945 enacted under the Drugs and Cosmetics Act, 1940, there is already a provision for manner of labeling of medicines/drugs.
For the ready reference, Rule 96 of the Drugs and Cosmetics Rules, 1945 to be read with Section 33(2)(h) of the Drugs and Cosmetics Act, 1940
read as under :
“33 Power of Central Government to make rules. â€
(2) Without prejudice to the generality of the foregoing power, such rules mayâ€
(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any
specified drug or class of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs
after the expiry of a specified period from the date of manufacture or after the expiry of the date of potency;â€
“96. Manner of Labelling.â€
(1) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall
appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is
packed, namely:â€
(i) The name of the drug: 2[(A) For this purpose], 3[the proper name of the drug shall be printed or written in a more conspicuous manner
than the trade name, if any which shall be shown immediately after or under the proper name and shall be]â€
(a) for drugs included in Schedule F or Schedule F(1), the name given therein;
(b) for drugs included in the Indian Pharmacopoeia or the official Pharmacopoeias and official compendia of drug standards prescribed in
rule 124, the name or synonym specified in the respective official pharmacopoeias and official compendia of drug standards followed by
the letters “L.P.†or, as the case may be, by the recognised abbreviations of the respective official pharmacopoeia and official
compendia of drug standards;
(c) for drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters “N.F.I.â€;
(d) for other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international
non-proprietary name is not published, the name descriptive of the true nature or origin of the substance. 4[***]
(ii) A correct statement of the net contents in terms of weight, measure, volume, number of units of contents, number of units of activity, as
the case may be, and the weight, measure and volume shall be expressed in Metric system.
(iii) The content of active ingredientsâ€" This shall be expressedâ€
(a) for oral liquid preparations in terms of the content per single dose, the dose being indicated in 5 millilitres 5[***]: Provided that where
the dose is below 5 millilitres the contents of active ingredients may be expressed in terms of one millilitre 6[or fraction thereof]; 7[Provided
further that where the single dose is more than 5 millilitre, the content of active ingredients shall be expressed in terms of minimum single
dose as approved by the licensing authority,]
(b) for liquid parenteral preparations ready for administration, in terms of 1 millilitre or percentage by volume or per dose in the case of a
single dose container: Provided that if the preparation is contained in an ampoule it will be enough if the composition is shown on the label
or wrapper affixed to any package in which such ampoule is issued for sale;
(c) for drugs in solid form intended for parenteral administration in terms of units or weight per milligramme or gramme;
(d) for tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be;
(e) for other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or millilitre as the case may be:
Provided that clause (ii) shall not apply to a pharmacopoeial preparation where the composition of such preparation is specified in the
respective pharmacopoeia and to a preparation included in the National Formulary of India; (iv) 8[The name of the manufacturer and the
address of the premises of the manufacturer where the drug has been manufactured:] Provided that if the drug is contained in an ampoule
or a similar small container, it shall be enough if only the name of the manufacturer and his principal place of 9[manufacture] is shown.
(v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the
substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded
by the words “Batch No.†or “B No.†or “Batch†or “Lot No.†or “Lotâ€. Notes.â€"(1) In the case of drugs
manufactured by a continuous process, like manufacture of magnesium sulphate, pharmaceutical chemicals, etc., the production resulting in
one homogeneous mix of the finished products shall be considered as one “Batchâ€:
(2) In the case of powers, liquid orals, ointments, etc., one “Batch Number†shall be assigned to all the containers filed from one
homogeneous bulk.
(3) In the case of tablets, capsules, lozenges, torches, etc. one “Batch Number†shall be assigned to the products manufactured from
one homogeneous mix ready for compression or filing.
(4) In case of parental preparations sterilized by steam under pressure, one “Batch Number†shall be assigned to all containers filed
from one homogeneous bulk solution and sterilized load.
(5) In the case of containers of parental preparations filed from one homogeneous bulk solution and sterilized in more than one sterilizer
load, the “Batch Number†as signed to the containers in the different sterilizer loads shall be same “Batch Number†as is assigned
to the homogeneous bulk solution, provided the samples taken from all the sterilizer loads pass the sterlity test, and kept separate from one
another until the report of the sterility test is available. Explanation.â€"For the purpose of chemical and other tests, representative samples
from all containers filled from the homogeneous bulk solution should be taken.
(6) In the case of parental and other sterile products filled aseptically a “Batch Number shall be assigned to all containers filled from
one homogeneous mix during one filling operation, the filling operation being completed in a period of not more than a day during which
no schedule change in the filling assembly is made. When containers are filled from one homogeneous mix, in a number of filling
operations, the “Batch Number†assigned to the containers filled in individual filling operations shall be the same “Batch Numberâ€
as is assigned to the homogeneous mix, provided the samples taken from all the direction filling operations pass the sterility tests, and are
kept separate from one another until the report of the sterility test is available. Explanation.â€"For the purpose of chemical and other tests,
representative samples from all containers filled from the homogeneous mix should be taken.
(7) In the case of medicinal gases produced by a continuous process of operation a weekâ€s production from one tank load shall be
considered as a Batch.
(vi) Every drug manufactured in India shall bear on its label the number of the licence under which the drug is manufactured, the figure
representing the manufacturing licence number being preceded by the words “Manufacturing Licence Number†or “Mfg. Lic. No.â€
or “M.L.â€.
(vii) Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of
manufacture and the date of expiry of potency, and the period between the date of manufacture and the date of expiry shall not exceed that
laid down in the said Schedule 10[under the conditions of storages specified therein. 11[Drugs and their] preparations not included in
Schedule P, shall bear on their labels the date of their manufacture and also the date of their expiry which shall not exceed sixty months
from the date of manufacture]: Provided that this period may be extended by the licensing authority specified in clause (b) of Rule 21 in
respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension.
(viii) Drugs specified in Schedule C(1) and their preparations including combinations with other drugs shall bear on the labels (a) the date
of manufacture, (b) date of expiry of potency fixed by the manufacturer, and (c) where such drugs are imported, also the number of licence
under which the drug is imported, preceded by the words “Import Licenceâ€: 12[Provided that drugs in bulk form included in Schedule
C(1) which are not ready for use and not included in Schedule P need not bear on the label the date of expiry of potency:] Provided further
that no reference shall be made to any other licence number granted by any authority outside India on any label or container or in any
covering in which the container is packed or in any other matter or advertisement enclosed therewith.
(ix) Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions
under clauses (i) to (viii), further bear on the label of the container the words “Physicianâ€s sampleâ€" Not to be sold†which shall be
overprinted. 13[(x) If any preparation contains not less than 3 per cent. by volume of alcohol the quantity of alcohol shall be stated in terms
of the average percentage by volume of absolute alcohol in the finished products.] 14[(xi) In addition to the other particulars which are
required to be printed or written under these rules, the label of innermost container of the following categories of drugs and every other
covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the
label which should not be less than 1 mm in width and without disturbing the other conditions printed on the label under these rules,
namely:â€" Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteriods, hormones, hypoglycemics, antimicrobials,
antiepileptics, antidepressants, anticoagulants, anti-Cancer drugs and all other drugs falling under Schedules G, H and X whether covered
or not in the above list: Provided that the provisions of this clause shall not apply toâ€
(a) preparations intended for animal treatment;
(b) preparations intended for external use;
(c) ophthalmic preparations and ear drops; and
(d) sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use.]
(2) (i) The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R.
(ii) The following particulars, in addition to those specified under sub-rule (1) shall be either printed or written in indelible ink and shall
appear in a conspicuous manner on the label of the innermost container and on every other covering in which the container of a
contraceptive, other than a mechanical contraceptive, is packed, namely:â€
(a) the date of manufacture;
(b) the date up to which the contraceptive is expected to retain its properties;
(c) the storage conditions necessary for preserving the properties of the contraceptive up to the date indicated in sub-clause (b): Provided
that for oral contraceptives it shall be sufficient to display on the label of the container the date of manufacture only.
(3) (i) The particulars prescribed in sub-rule (1) shall be printed or written in indelible ink either on the label borne by a container or
vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be
indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein.
(ii) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper, case or other covering used
solely for the purpose of packing, transport or delivery.
(4) Where by any provision of these rules any particulars are required to be displayed on a label on the container such particulars may,
instead of being displayed on a label, be etched, painted or otherwise indelibly marked on the container: Provided that, except where
otherwise provided in these rules, the name of the drug or any distinctive letters intended to refer to the drug shall not be etched, painted or
otherwise indelibly marked on any glass container other than ampoules. Explanation.â€"For the purpose of this rule, the date of expiry
shall be in terms of month and year and it shall mean that the drug is recommended till the last day of the month. The date of expiry shall be
preceded by the words “Expiry dateâ€.]â€
In view of the aforesaid provisions, it appears that there are sufficient provisions for manner of labeling of the medicines/drugs. Learned counsel for
the petitioner submits that there are several persons who are changing the manufacturing and expiry dates on the medicines/drugs, hence direction
may be issued to the respondents that the law may be complied with by them.
We are not in agreement with the learned counsel for the petitioner for giving such type of lump sum general directions to the respondents.
However, as and when any breach is pointed out to this court with a specific name of the person or of the manufacturer, the action can be initiated.
The breach of law has to be pointed out by the petitioner in an individual writ petition by joining the concerned person as a party/respondent.
Hence, we see no reason to entertain this writ petition. However, liberty is reserved with this petitioner to move appropriate proceedings before the
appropriate forum for the alleged breach of Rule 96 of Drugs and Cosmetics Rules, 1945 with proper averments, allegations and annexures.
With these observations, this writ petition is hereby disposed of.
CM No. 38337/2019
In view of the disposal of the writ petition, this application also stands disposed of.