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Section 16 of Drugs and Cosmetics Act, 1940 – Standards of Quality

Section 16 of the Drugs and Cosmetics Act, 1940 deals with Standards of Quality.

Bare Text

16. Standards of quality. —4
[(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 5
[the Second
Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may
be prescribed.]
(2) The 6
[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 5
[the Second Schedule] for the purposes
of this Chapter, and thereupon 5
[the Second Schedule] shall be deemed to be amended
accordingly.
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Simple Meaning

Section 16 defines what “standard quality” means for the purposes of Chapter IV of the Drugs and Cosmetics Act, 1940. A drug is of standard quality when it complies with the standard set out in the Second Schedule. A cosmetic is of standard quality when it complies with the prescribed standard. This section is therefore the statutory foundation for deciding whether a drug or cosmetic passes the legal quality requirement.

Compliance Relevance

For manufacturers, distributors, pharmacists and lawyers, Section 16 is important because many enforcement actions begin with the allegation that a product is not of standard quality. It connects laboratory testing, official standards, Government Analyst reports and penalty provisions. In sample-failure matters, Section 16 should be read with Sections 18, 23, 25 and 27.

Related Provisions

Section 17, Section 17A, Section 17B, Section 18, Section 23, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 22 of Drugs and Cosmetics Act, 1940 – Powers of Inspectors

Section 22 of the Drugs and Cosmetics Act, 1940 deals with Powers of Inspectors.

Bare Text

[22. Powers of Inspectors.—(1) Subject to the provisions of section 23 and of any rules
made by the Central Government in this behalf, an Inspector may, within the local limits of
the area for which he is appointed,—
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[(a) inspect,—

(i) any premises wherein any drug or cosmetic is being manufactured and the
means employed for standardising and testing the drug or cosmetic;

(ii) any premises wherein any drug or cosmetic is being sold, or stocked or
exhibited or offered for sale, or distributed;

1. Subs by Act 35 of 1960, s. 4, for the original sections 20 and 21 (w.e.f. 16-3-1961).
2. Subs. by Act 21 of 1962, s. 16, for “class of drugs” (w.e.f. 27-7-1964).
3. Ins. by Act 68 of 1982, s. 17 (w.e.f. 1-2-1983).
4. Subs. by Act 21 of 1962, s. 17, for “class of drugs” (w.e.f. 27-7-1964).
5. Subs. by s. 17, ibid., for “in the manufacture, import or sale of drugs” (w.e.f. 27-7-1964).
6. Ins. by Act 68 of 1982, s. 18 (w.e.f. 1-2-1983).
7. Subs. by Act 11 of 1955, s. 11, for s. 22.
8. Subs. by Act 68 of 1982, s. 19, for cls. (a), (b) and (c) (w.e.f. 1-2-1983).

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(b) take samples of any drug or cosmetic, —
(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale,
or is being distributed;
(ii) 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;
(c) at all reasonable times, with such assistance, if any, as he considers
necessary,—

(i) search any person, who, he has reason to believe, has secreted about his person,
any drug or cosmetic in respect of which an offence under this Chapter has been, or is
being, committed; or

(ii) enter and search any place in which he has reason to believe that an offence
under this Chapter has been, or is being, committed; or

(iii) stop and search any vehicle, vessel or other conveyance which, he has reason
to believe, is being used for carrying any drug or cosmetic in respect of which an
offence under this Chapter has been, or is being, committed,

and order in writing the person in possession of the drug or cosmetic in respect of which the
offence has been, or is being, committed, not to dispose of any stock of such dru g or cosmetic
for a specified period not exceeding twenty days, or, unless the alleged offence is such that
the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such
drug or cosmetic and any substance or article by means o f which the offence has been, or is
being, committed or which may be employed for the commission of such offence;]

1
[(cc) examine any record, register, document or any other material object found 2[with
any person, or in any place, vehicle, vessel or othe r conveyance referred to in clause (c)],
and seize the same if he has reason to believe that it may furnish evidence of the
commission of an offence punishable under this Act or the rules made thereunder;]

3
[(cca) require any person to produce any record, register, or other document relating
to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale
or distribution of any drug or cosmetic in respect of which he has reason to believe that an
offence under this Chapter has been, or is being, committed;]

(d) exercise such other powers as may be necessary for carrying out the purposes of
this Chapter or any rules made thereunder.

(2) The provisions of 4[the Code of Criminal Procedure, 1973 (2 of 1974)] shall, so far as
may be, apply to any search or seizure under this Chapter as they apply to any search or
seizure made under the authority of a warrant issued under 5[section 94] of the said Code.

3
[(2A) Every record, register or other document seized under clause (cc) or produced under
clause (cca) shall be returned to the person, from whom they were seized or who produce the

1. Ins. by Act 35 of 1960, s. 5 (w.e.f. 16-3-1961).
2. Subs. by Act 68 of 1982, s. 19, for certain words (w.e.f. 1-2-1983).
3. Ins. by s. 19, ibid. (w.e.f. 1-2-1983).
4. Subs. by s. 19, ibid., for “the Code of Criminal Procedure, 1898” (w.e.f. 1-2-1983).
5. Subs. by s. 19, ibid., for “section 98” (w.e.f. 1-2-1983).

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same, within a period of twenty days of the date of such seizure or produ ction, as the case may
be, after copies thereof or extracts therefrom certified by that person, in such manner as may be
prescribed, have been taken.]
(3) If any person wilfully obstructs an Inspector in the exercise of the powers conferred
upon him by or under this Chapter 1[or refuses to produce any record, register or other
document when so required under clause (cca) of sub-section (1),] he shall be punishable
with imprisonment which may extend to three years, or with fine, or with both.]

Simple Meaning

Section 22 sets out the statutory powers of Inspectors under the Drugs and Cosmetics Act, 1940. Subject to Section 23 and applicable rules, an Inspector may inspect premises where drugs or cosmetics are manufactured, sold, stocked, exhibited, offered for sale or distributed, and may exercise other enforcement powers provided by the section.

Compliance Relevance

This provision is important during inspections, sample collection, record verification, search and seizure and enforcement proceedings. Pharmacies, manufacturers and distributors should understand the scope of Inspector powers and maintain proper records, purchase invoices, sale documents and compliance documentation.

Related Provisions

Section 18, Section 23, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 23 of Drugs and Cosmetics Act, 1940 – Procedure of Inspectors

Section 23 of the Drugs and Cosmetics Act, 1940 deals with Procedure of Inspectors.

Bare Text

23. Procedure of Inspectors.—(1) Where an Inspector takes any sample of a drug 2[or
cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written
acknowledgment therefor.

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes
the stock of any drug 2 [or cosmetic] under clause (c) of section 22, he shall tender a receipt
therefor in the prescribed form.
(3) Where an Inspector takes a sample of a drug 2 [or cosmetic] for the purpose of test or
analysis, he shall intimate such purpose in writing in the prescribed form to the person from
whom he takes it and, in the presence of such person unless he wilfully absents himself, shall
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 the portions so sealed and marked:
Provided that where the sample is taken from premises whereon the drug 2 [or cosmetic]
is being manufactured, it shall be necessary to divide the sample into three portions only:

Provided further that where the drug 2 [or cosmetic] is made up in containers of small
volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 2 [or
cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall,
take three or four, as the case may be, of the said containers after suitably ma rking the same
and, where necessary, sealing them.

(4) The Inspector shall restore one portion of a sample so divided or one container, as the
case may be, to the person from whom he takes it, and shall retain the remainder and dispose of
the same as follows:—
(i) one portion or container he shall forthwith send to the Government Analyst for test
or analysis;

(ii) the second, he shall produce to the Court before which proceedings, if any, are
instituted in respect of the drug 2 [or cosmetic]; and
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[(iii) the third, where taken, he shall send to the person, if any, whose name, address
and other particulars have been disclosed under section 18A. ]

(5) Where an Inspector takes any action under clause (c) of section 22,—

(a) he shall use all despatch in ascertaining whether or not the drug 2 [or cosmetic];
contravenes any of the provisions of section 18 and, if it is ascertained that the drug 2 [or
cosmetic]; does not so contravene, forthwith revoke the order passed under the sa id
clause or, as the case may be, take such action as may be necessary for the return of the
stock seized;
(b) if he seizes the stock of the drug 2[or cosmetic]; he shall as soon as may be inform 4[a Judicial
Magistrate] and take his orders as to the custody thereof;

1. Ins. by Act 68 of 1982, s. 19 (w.e.f. 1-2-1983).
2. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
3. Subs. by Act 13 of 1964, s. 16, for cl. (iii) (w.e.f. 15-9-1964).
4. Subs. by Act 68 of 1982, s. 20, for “a Magistrate” (w.e.f. 1-2-1983).

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( c ) without prejudice to the institution of any prosecution, if the alleged contravention be such
that the defect may be remedied by the possessor of the drug 1[or cosmetic]; he shall, on being
satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.
2
[(6) Where an Inspector seizes any record, register, document or any other material object under
clause (cc) of sub-section (1) of section 22, he shall, as soon as may be, inform 3[a Judicial Magistrate]
and take his orders as to the custody thereof.

Simple Meaning

Section 23 prescribes the procedure to be followed by Inspectors when taking samples of drugs or cosmetics. It deals with tendering fair price, written acknowledgment, receipt for seized stock, written intimation, division of samples, sealing, marking and forwarding of samples.

Compliance Relevance

This section is important because sample procedure often becomes central in drug prosecutions and regulatory disputes. Any person facing a sample-failure case should examine whether the statutory procedure under Section 23 was properly followed, especially regarding intimation, sample division, sealing and forwarding for analysis.

Related Provisions

Section 22, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 25 of Drugs and Cosmetics Act, 1940 – Reports of Government Analysts

Section 25 of the Drugs and Cosmetics Act, 1940 deals with Reports of Government Analysts.

Bare Text

25. Reports of Government Analysts. —(1) The Government Analyst to whom a
sample of any drug 1 [or cosmetic] has been submitted for test or analysis under
sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in
triplicate in the prescribed form.
(2) The Inspector on receipt thereof shall deliver one copy of the report to the person
from whom the sample was taken 4[and another copy to the person, if any, whose name,
address and other particulars have been disclosed under section 18A], and shall retain the
third copy for use in any prosecution in respect of the sample.
(3) Any document purporting to be a report signed by a Government Analyst under this
Chapter shall be evidence of the facts stated therein , and such evidence shall be conclusive
unless the person from whom the sample was taken 5[or the person whose name, address and
other particulars have been disclosed under section 18A] has, within twenty -eight days of the
receipt of a copy of the report, notified in writing the Inspector or the Court before which any
proceedings in respect of the sample are pending that he intends to adduce evidence in
controversion of the report.
(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory,
where a person has under sub-section (3) notified his intention of adducing evidence in
controversion of a Government Analyst’s report, the Court may, of its own motion or in its
discretion at the request either of the complainant or the accused cause the sample of the drug
1
[or cosmetic] produced before the Magistrate under sub -section (4) of section 23 to be sent for
test or analysis to the said Laboratory, which shall make the test or analysis and report in
writing signed by or under the authority of, the Director of the Ce ntral Drugs Laboratory the
result thereof, and such report shall be conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis made by the Central Drugs Laboratory under
sub-section (4) shall be paid by the complainant or accused as the Court shall direct .

Simple Meaning

Section 25 deals with reports of Government Analysts. It requires the Government Analyst to deliver a signed report in the prescribed form, provides for delivery of copies, and gives legal evidentiary value to the report, subject to the statutory right to challenge within the prescribed time.

Compliance Relevance

This section is extremely important in sample-failure cases. The Government Analyst report is often the foundation for prosecution or regulatory action. Manufacturers and other concerned persons must carefully track receipt of the report and the statutory time limit for contesting it and seeking further analysis.

Related Provisions

Section 16, Section 18, Section 22, Section 23, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 18 of Drugs and Cosmetics Act, 1940 – Prohibition of Manufacture and Sale of Certain Drugs and Cosmetics

Section 18 of the Drugs and Cosmetics Act, 1940 deals with Prohibition of Manufacture and Sale of Certain Drugs and Cosmetics.

Bare Text

18. Prohibition of manufacture and sale of certain drugs and cosmetics.—From such 2date 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) 3[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or
distribute—
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[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
5
[(ii) any cosmetic which is not of a standard quality or is misbranded, adulterated or
spurious;]]
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[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof 3 [the true formula or list of active ingredients
contained in it together with the quantities thereof];]
(iv) any drug which by means of any statement design or device accompanying it or
by any other means, purports or claims 7[to prevent, cure or mitigate] any such disease or
ailment, or to have any such other effect as may be prescribed;
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[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use
under the directions indicated or recommended;
(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any
rule made thereunder;]
(b) 3[sell or stock or exhibit or offer for sale,] or distribute any drug 9[or cosmetic] which has been
been imported or manufacutred in contravention of any of the provisions of this Act or any rule made
thereunder;
(c) 3 [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,]
or distribute any drug 9[or cosmetic], except under, and in accordance with the conditions
of, a licence issued for such purpose under this Chapter:
Provided that nothing in this section shall apply to the manufacture, subject to prescribed
conditions, of small quantities of any drug for the purpose of examination, test or analysis :
Provided further that the 10[Central Government] may, after consultation with the Board, by
notification in the Official Gazette, permit, subject to any conditions specified in the notifica tion,
the 11[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.

1. Ins. by Act 26 of 2008, s. 2 (w.e.f. 10-8-2009).
2. 1st April, 1947 for sub-clauses (i), (ii), (iv) and (v) of cl. (a) and cls. (b) and (c); 1st April, 1949 for sub-clause (iii) of
cl. (a) in so far as it takes effect in Delhi, Ajmer and Coorg, see Notifn. No. 18-12-46-D, II, dated 11th February, 1947, Gazette of
India, 1947, Pt. I, p. 189, as amended by notifn. No. F. 1-2/48-D (ii), dated 29th September, 1948; 1st April, 1953 for the States of
H. P., Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide notifn. No. S.R.O. 664, dated the 30th March, 1953,
Gazette of India, 1953, Pt. II, Sec. 3, p. 451
3. Subs. by Act 68 of 1982. s. 14, for certain words (w.e.f. 1-2-1983).
4. Subs. by s. 14, ibid, for cls. (i), (ii) and (iia) (w.e.f. 1-2-1983).
5. Subs. by Act 26 of 2008, s. 3, for sub-clause (ii) (w.e.f.10-8-2009).
6. Subs. by Act 11 of 1955, s. 9, for sub-clause (iii).
7. Subs by s. 9, ibid., for “to cure or mitigate”.
8. Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964).
9. Ins. by s. 14, ibid. (w.e.f. 27-7-1964).
10. Subs. by Act 11 of 1955, s. 9, for “State Government”.
11. Subs. by Act 68 of 1982, s. 14, for “manufacture for sale, sale” (w.e.f. 1-2-1983).

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Simple Meaning

Section 18 is the central prohibition provision in Chapter IV. It prohibits manufacture for sale or distribution, sale, stocking, exhibition or offer for sale, and distribution of certain non-compliant drugs and cosmetics. It covers drugs that are not of standard quality, misbranded, adulterated or spurious, and also deals with licensing and other statutory restrictions.

Compliance Relevance

This section is one of the most important provisions for pharmacies, wholesalers, manufacturers and distributors. Many prosecutions and regulatory actions under drug law ultimately connect back to Section 18. It should be read with the definitions of misbranded, adulterated and spurious drugs, the powers of inspectors, the procedure for sampling and Government Analyst reports.

Related Provisions

Section 16, Section 17, Section 17A, Section 17B, Section 22, Section 23, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 17B of Drugs and Cosmetics Act, 1940 – Spurious Drugs

Section 17B of the Drugs and Cosmetics Act, 1940 deals with Spurious Drugs.

Bare Text

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be
spurious,—
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug
in a manner likely to deceive or bears upon it or upon its label or container the name of
another drug unless it is plainly and conspicuously marked so as to reveal its true character
and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the
manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

Simple Meaning

Section 17B states when a drug is deemed to be spurious. It includes drugs manufactured under the name of another drug, imitations or substitutes likely to deceive, drugs bearing a fictitious manufacturer’s name, substituted products, and products falsely purporting to be made by a manufacturer.

Compliance Relevance

Section 17B is central to anti-counterfeit and supply-chain compliance. Pharmacies, wholesalers and manufacturers must purchase and supply medicines only through reliable and authorised channels, maintain invoices and verify product identity. This provision is closely connected with Section 18 prohibitions and Section 27 penalties.

Related Provisions

Section 16, Section 17, Section 17A, Section 18, Section 22, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 17A of Drugs and Cosmetics Act, 1940 – Adulterated Drugs

Section 17A of the Drugs and Cosmetics Act, 1940 deals with Adulterated Drugs.

Bare Text

17A. Adulterated drugs.— For the purposes of this Chapter, a drug shall be deemed to be
adulterated,—
(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or
(b) if it 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
(c) if its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is
prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to
health; or
(f) if any substance has been mixed therewith so as to reduce its quality or strength.

Simple Meaning

Section 17A states when a drug is deemed to be adulterated. It covers filthy, putrid or decomposed substances, insanitary preparation, packing or storage, injurious containers, prohibited colouring, harmful or toxic substances and mixing of any substance that reduces quality or strength.

Compliance Relevance

This provision is important for manufacturing hygiene, storage conditions, container safety, quality assurance and supply-chain control. It is relevant where a sample failure involves contamination, harmful substances, insanitary conditions or reduced quality or strength. It should be read with Sections 16, 18, 25 and 27.

Related Provisions

Section 16, Section 17, Section 17B, Section 18, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 17 of Drugs and Cosmetics Act, 1940 – Misbranded Drugs

Section 17 of the Drugs and Cosmetics Act, 1940 deals with Misbranded Drugs.

Bare Text

[17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be
misbranded,—

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it
is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if 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.

1. Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964).
2. Subs. by Act 68 of 1982, s. 11, for certain words (w.e.f. 1-2-1983).
3. Subs. by s. 12, ibid., for “DRUGS” (w.e.f. 1-2-1983).
4. Subs. by Act 21 of 1962, s. 12, for sub-section (1) (w.e.f. 27-7-1964).
5. Subs. by Act 13 of 1964, s. 11, for “the Schedule” (w.e.f. 15-9-1964).
6. Subs. by Act 11 of 1955, s. 8, for “State Government”.
7. Subs. by Act 68 of 1982, s. 13, for sections 17, 17A and 17B (w.e.f. 1-2-1983).

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Simple Meaning

Section 17 states when a drug is deemed to be misbranded. It covers situations where damage is concealed, where the drug is made to appear to have better or greater therapeutic value than it really has, where it is not labelled in the prescribed manner, or where the label, container or accompanying material contains a false or misleading claim.

Compliance Relevance

This section is crucial for labelling, packaging, product presentation and promotional claims. Manufacturers, marketers, distributors and pharmacies must ensure that the label and accompanying material do not create a false or misleading impression. Section 17 is directly connected with the prohibition in Section 18 and the penalty consequences under Section 27.

Related Provisions

Section 16, Section 17A, Section 17B, Section 18, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Cosmetics Rules, 2020 – Overview

The Cosmetics Rules, 2020 provide a separate regulatory framework for cosmetics in India.

These Rules are important for cosmetic manufacturers, importers, brand owners, pharmacists, lawyers, regulatory consultants and businesses dealing with skincare, beauty and personal care products.

Key Areas Covered

  • Import registration of cosmetics
  • Manufacture of cosmetics
  • Labelling requirements
  • Testing and standards
  • Prohibited cosmetics
  • Regulatory action and penalties

Last verified: June 2026

Drugs and Cosmetics Rules, 1945 – Overview

The Drugs and Cosmetics Rules, 1945 contain the detailed regulatory framework for implementing the Drugs and Cosmetics Act, 1940.

These Rules are extremely important for retail pharmacies, wholesale drug dealers, manufacturers, hospitals, pharmacists, regulatory professionals and lawyers dealing with drug law compliance.

Why These Rules Matter

  • Retail and wholesale drug licences
  • Conditions of sale licence
  • Schedule H, Schedule H1 and Schedule X drugs
  • Prescription and record requirements
  • Labelling and packaging requirements
  • Manufacturing and distribution compliance

Important Rules and Schedules

  • Rule 61 – Forms of sale licences
  • Rule 64 – Conditions before grant of licence
  • Rule 65 – Conditions of licences
  • Rule 65A – Additional conditions for Schedule X drugs
  • Schedule H – Prescription drugs
  • Schedule H1 – Special prescription and record requirements
  • Schedule X – Special control drugs

Last verified: June 2026