Original Article

Drug labeling: The study of compliance of regulatory

requirements for prescription drugs in India
Suchi Shah, Anil Singh1
Department of Pharmacology, B.J. Medical College, Ahmedabad, 1Department of Pharmacology, PDU Government Medical College,
Rajkot, Gujarat, India

Abstract Objectives: The objective was to check the compliance of regulatory requirements of drug labeling in India
according to guidelines given under the Drug and Cosmetic Rules (D & CRs) 1945, Section 96, 97; drug
samples were collected from government drug supply and private practitioners (PPs).
Materials and Methods: A total of 100 drugs were selected randomly from schedule H. They were
divided into two groups, each containing 50 drugs: (1) drug samples from drug store of a government
hospital, manufactured for Gujarat government and (2) drug samples from PPs which are given to them by
pharmaceutical companies. Each drug label was checked according to the criteria given under the D & CRs
1945, Section 96, 97. Data entry was done in Microsoft Excel 2013 and analysis was done.
Results: Major deficiencies were seen in criteria of pharmacopeia (absent in 8% samples from government
supply [GS] and 64% in samples from PPs), schedule (absent in 18% GS samples and 32% in PP samples),
warning of schedule (absent in 6% GS samples and 4% in PP samples), Rx (absent in 22% GS samples and
28% in PP samples), red line (absent in 14% GS samples), and drug warning (absent in 84% GS samples and
72% in PP samples).
Conclusion: As the study results show lacunae in the contents of the labeling of prescribed drugs in samples
from both the groups, there should be strict enforcement of D & CR 1945 and monitoring of drug labels
for better and safer use of medicines.

Keywords: Compliance, Drug and Cosmetic Rules 1945, drug labeling, regulatory requirements

Address for correspondence: Dr. Suchi Shah, Department of Pharmacology, B.J. Medical College, Asarwa, Ahmedabad ‑ 380 016, Gujarat, India.
E‑mail: suchi.shah1990@gmail.com
Received: 17-12-18, Revised: 23-03-19, Accepted: 03-04-19, Published: 05-09-19.

INTRODUCTION stakeholders such as health‑care professionals, patients and

pharmacists. A drug label is required for marketing of any
Labeling, in general, is defined as written, printed or drug and it is a useful tool for pharmacoeconomic studies.[2]
graphical matter on any article or container which provides
adequate and necessary information about the product. The safe use of all medicines depends on accurate
The primary purpose of labeling of medicines is the information on the label and users reading the label
clear unambiguous identification of the medicine and the carefully and being able to assimilate and act on the
conditions for its safe use.[1] It is also an informative tool for information presented. A compliant label can minimize

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DOI: How to cite this article: Shah S, Singh A. Drug labeling: The study of
10.4103/picr.PICR_195_18 compliance of regulatory requirements for prescription drugs in India.
Perspect Clin Res 2020;11:164-7.

164 © 2019 Perspectives in Clinical Research | Published by Wolters Kluwer - Medknow

 Shah and Singh: Compliance for regulatory requirements of drug labeling in India

the risk of prescribing and dispensing medication errors, study from the drugs listed in schedule H. They were divided
enhance consumer safety, avoid consumer confusion and into two groups, each containing 50 drugs [Figure 1].
the inappropriate use of medicines (including misuse,
overuse and underuse), assist in the safe and effective use There are 16 criteria which are essential to make a drug
of medicines and optimize identification and usability of label compliant in India (as mentioned below) mentioned
necessary information.[3] under the D & CRs 1945, Sections 96 and 97.[4]
1. Generic name
A regulatory compliant drug label is mandatory for 2. Brand name
marketing of a drug, which should be in accordance 3. Pharmacopeia
with requirements given by regulators in respective 4. Schedule
country. Regulatory body of every country has a set of 5. Warning of schedule
requirements for labeling of drugs. The criteria for drug 6. Net contents
labeling in India are listed in Drug and Cosmetic Rules 7. Active ingredients
(D and CRs) 1945 under Sections 96 and 97.[4] Keeping 8. Manufacturer name and address
those requirements under consideration, labels are designed 9. Batch number
by the manufacturers. 10. Manufacturing license number
11. Date of manufacturing
Hence, in this study, compliance of requirements of 12. Date of expiry
labeling of prescription drugs is checked in accordance 13. Presence of RX symbol
with the laws given by the Government of India in 14. Red line
drug samples collected from the government hospital 15. Warning about drug
supply as well as drug samples from the private 16. Storage instructions.
practitioners (PPs) (which are provided to them by
pharmaceutical companies). Each drug label was checked for each criterion, data entry
was done in Microsoft Excel 2013, and the percentage for
MATERIALS AND METHODS each criterion was calculated using Excel.
A total of 100 drug samples were selected randomly for the Red line represents drugs included in schedules G, H, H1,
and X, narcotic analgesic, sedative‑hypnotics, tranquilizers,
Total number of drugs (n=100)
corticosteroids, hormones, hypoglycemic, antimicrobial,
antiepileptic, anticancer, and anticoagulant drugs.[4]
Drug samples collected from the drug store
of government hospital, which are packed for
Drug samples collected from Private
practitioners which are given to them
RESULTS
Gujarat government (n=50) by pharmaceutical companies (n=50)

Figure 1: Drugs sample distribution for the study in 2 groups-

Table 1 shows drug‑labeling criteria: their compliance in
government drug store and samples from private practitioners the samples from government supply (GS) and PPs.

Table 1: Drug‑labeling criteria: Their compliance in the samples from government supply as well as private practitioners
n Criteria Drug samples from government supply (n=50), n (%) Drug samples from private practitioners (n=50), n (%)
1 Generic name 50 (100) 49 (98)
2 Brand name 17 (34) 48 (96)
3 Net contents 50 (100) 48 (96)
4 Pharmacopeia/formulary 46 (92) 18 (36)
5 Schedule 41 (82) 34 (68)
6 Warning of schedule 47 (94) 48 (96)
7 Name and address of 50 (100) 50 (100)
manufacturer
8 Date of manufacturing 50 (100) 50 (100)
9 Date of expiry 50 (100) 50 (100)
10 Active ingredients 50 (100) 50 (100)
11 Batch number 50 (100) 50 (100)
12 Manufacturing license 50 (100) 50 (100)
number
13 Rx symbol 39 (78) 36 (72)
14 Red line 43 (86) 50 (100)
15 Warning about drug 8 (16) 14 (28)
16 Storage 50 (100) 50 (100)

Perspectives in Clinical Research | Volume 11 | Issue 4 | October-December 2020 165

 Shah and Singh: Compliance for regulatory requirements of drug labeling in India

medicines categorized under schedules H, H1 and X. The

study sample also has lacunae in the criteria of “warning
of drug use” which is an area of concern with regard to
safe drug use.

The criteria for drug labeling described in Drugs and

Cosmetic Rules 1945 for India are in accordance with
the basic criteria for labeling recommended by the
WHO.[5] When we compare Indian guidelines to the
USFDA guidelines for drug labeling, the points such as
initial USFDA approval, recent major changes, adverse
reactions (proven as well as new and the contact details of
Figure 2: Comparison of drug‑labeling criteria in samples from
government supply and private practitioners the manufacturer for its notification), drug interactions, use
in specific population, and date of last revision of the label
Brand name was written in 17 of 50 drugs (34%) from GS are additional which can be added to the Indian label for
from which 7 (14%) were written more conspicuously than more complete and updated information which can lead
generic name. In drugs from PPs, brand name was written to effective and safe use of the medicines.[6]
in 48 of 50 drugs (96%) from which 30 (60%) were written
more conspicuously than generic name. On each sample In India, if the drugs do not comply with regulatory
from GS, “Gujarat Government Supply not for sale” was requirements of labeling, they are considered as
written in English and Gujarati, and on each sample collected “misbranded” drugs (defined under Section 17 – the
from PP, “Physician’s sample not to be sold” was written. Drugs and Cosmetics Act 1940 and rules 1945),[4] and
The total number of fixed‑dose combinations (FDCs) was there is a provision of prohibition of manufacture and
2/50 in GS and 18/50 in samples from PPs. sale of misbranded drugs under Section 18[4] of D and
CRs 1945. The monitoring of the drug label falls under the
Figure 2 shows the comparison of drug‑labeling criteria duties of the drug inspector along with notification to the
in samples from GS and PPs. government if the label does not comply with regulatory
requirements (Section 22).[7] Any person interfering with
DISCUSSION drug inspector on his duty is punishable for imprisonment
up to 3 years or fine or both (Section 22 (3)). There is also
Drug label consists of essential components which carry provision of “confiscation” meaning seizing someone’s
significant importance. Generic name and brand name are property with authority, for the production or distribution
required for the identification of the drugs. Schedule and of misbranded drugs under Section 31.
its warning are for drugs belonging to specific schedule
and the precautions required for its use. Pharmacopeia, In Australia, violation of the standards of drug labeling
net contents, active ingredients, manufacturer’s name is grounds for the secretary to suspend or cancel the
and address, batch number, manufacturing license registration of the drug along with public notification
number, date of manufacturing and expiry and storage and recovery of the medicine from the market.[3] In the
information are required not only for regulatory USA, the Federal Food, Drug, and Cosmetic Act (FDCA)
requirements but also for the quality control and safety prescribes criminal penalties for misbranded drugs. The
of the prescribed drug. potential consequences of an FDCA violation range from
a warning to a hefty fine and/or imprisonment, carrying
According to the criteria given in D and CRs 1945, brand a maximum sentence of 1 year in federal prison and/or
name should not be written more conspicuously than generic a $1,000 fine (21 U. S. C. § 333 (a)) which may extend
name.[4] In this study, 14% of samples from GS and 60% up to 3 years in prison and/or a maximum $10,000 fine
from PPs have a brand name written more conspicuously depending on severity.[8]
which is not recommended. It is recommended that the
drug label should mention pharmacopeia, which gives a The review process of a drug label is not specifically
standard reference for manufacturing of any drug, which defined in India which leads to lacunae in the final label
was deficient from the drug samples from PPs compared that is out for public use. This study is just the tip of
to GS. The deficit is also observed in criteria of schedule iceberg, as only a few drug samples are collected from
and its warning, which carries more importance for the ample of marketed drugs; still, the results show many
166 Perspectives in Clinical Research | Volume 11 | Issue 4 | October-December 2020
 Shah and Singh: Compliance for regulatory requirements of drug labeling in India

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