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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 7  |  Issue : 2  |  Page : 75-79

A study to evaluate ayurveda product labels for their compliance as per drug and cosmetic rules 1945, rule 161(B)


Central Ayurveda Research Institute, CCRAS, Bengaluru, Karnataka, India

Date of Submission15-Mar-2021
Date of Decision29-Jun-2021
Date of Acceptance01-Jul-2021
Date of Web Publication25-Aug-2021

Correspondence Address:
Dr. Raghavendra Naik
#12, Manavarthekaval, Kanakapura Main Road, Talaghattapura Post, Bengaluru - 560 109, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AYUHOM.AYUHOM_21_21

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  Abstract 


Background: Product labels are considered as clinical instruction manual which plays a vital role in providing information to the prescriber and end-user at a glance. As Ayurvedic drugs fall under the purview of the Drugs and Cosmetics Act, 1940, a set of quality criteria-based information is required to be displayed on the labels of Ayurvedic product containers marketed in India. Aim and Objective: In the present study, containers of different Ayurvedic products dispensed at Government hospitals and sold at private pharmacies in Bangalore were selected and checked for their compliance with labeling guidelines as mentioned in Drugs and Cosmetic Act 1940. Results: Among 150 selected products, 78 products were classical preparations and 72 were proprietary medicines. Among the fourteen criteria derived from labeling guidelines mentioned in drugs and cosmetic act, all the 150 products were following the standard guidelines with respect to the six basic criteria like name and address of the manufacture, net weight of the formulation, batch number, license number, date of manufacture and mentioning of the word Ayurvedic medicine. Conclusion: Even though majority of the labels of Ayurvedic drug containers fulfilled the requirements, a good number of Ayurvedic products are still not in accordance with the regulatory requirements in providing label information. Following a strict compliance in some labeling specifications like providing complete details of ingredient with their net weight in metric system, displaying the caution warning for formulations containing schedule E 1 drugs, providing the expiry date, and citing the reference from authentic texts in case of classical formulations is still lacking.

Keywords: Ayurvedic products, drug and cosmetic act, label information, quality criteria


How to cite this article:
Naik R, Shubhashree M N, Chandrasekharan C, Bhat S. A study to evaluate ayurveda product labels for their compliance as per drug and cosmetic rules 1945, rule 161(B). AYUHOM 2020;7:75-9

How to cite this URL:
Naik R, Shubhashree M N, Chandrasekharan C, Bhat S. A study to evaluate ayurveda product labels for their compliance as per drug and cosmetic rules 1945, rule 161(B). AYUHOM [serial online] 2020 [cited 2021 Oct 19];7:75-9. Available from: http://www.ayuhom.com/text.asp?2020/7/2/75/324633




  Introduction Top


Alternative systems of plant-based medicine form an important part of the health care systems in most of the developing countries. Ancient Indian literature comprises a remarkably broad definition of medicinal plants and considers all plant parts to be potential sources of medicinal substances.[1] However, a key obstacle which has hindered the acceptance of the alternative medicines in the developed countries is the lack of documentation and rigorous quality control. The process of standardization of Ayurvedic medicine impacts every process and component of pharmaceutical production, including machines, systems, equipment, documentation, etc. Among these components, labeling of the product is significant final component which is vital for documentation with complete clarity and traceability. Any negligence related to trivial issues in labeling guidelines may put patient safety at risk. A major report from the American College of Physicians' Foundation noted that problems with prescription drug labeling were cited as the cause of a large number of outpatient medication errors and adverse drug events.[1] Some of the more common sources of medication errors are confusion between sound-alike medication names or look-alike medication names and confusion due to similar appearances for medication packages or similar labels for different medications.[2]

A regulatory compliant drug label is mandatory for marketing of a drug, which should be in accordance with requirements given by regulators in respective country. Regulatory body of every country has a set of requirements for labeling of drugs. As per the Drug and Cosmetic Rules 1945, a set of quality criteria-based information is required to be displayed on the labels of Ayurvedic product containers marketed in India.[3] Keeping those requirements under consideration, labels are designed by the manufacturers.

The patient's ability to understand the label instructions can be critical for safe use of medications since other sources of information on medicines for patients may not be adequate and physicians/pharmacists may not always have the opportunity to provide counseling to patients on prescribed medications.[4] Therefore, it is very important to follow stringent and noncompromising regulatory components such as labeling guidelines for Ayurveda formulations/products across the country. In this context, the present study was conducted with an intension to evaluate the labeling information provided on the containers of Ayurvedic drugs marketed in India for their compliance with the Drugs and Cosmetics Act, 1940.


  Materials and Methods Top


Identification and product acquisition

Containers of Ayurvedic medicines dispensed at government hospitals, sold at different private pharmacies in Bangalore and physician samples were selected based on convenience sampling depending on the availability, with the only selection criteria being that the formulation should be an Ayurvedic classical or proprietary medicine marketed for sale only in India. The data was collected by program assistant involved in pharmacovigilance program in a fixed duration of 3 months from August 2020 to October 2020. Formulations prescribed or marketed by traditional healers and available for direct purchase over the internet were excluded from the study.

Developing checklist

Based on the theoretical information accumulated from Drugs and Cosmetic Act 1940 and Rules 1945, a checklist was prepared and the labels were checked against the following points:

  • Name and address of the manufacturer
  • Net weight of the formulation (weight/volume expressed in metric system)
  • Name of the drug/ingredients
  • Net weight of the each ingredient in metric system
  • License number
  • Batch number
  • Date of manufacture
  • ”Caution” warning (for poisonous drugs [Schedule E (1) containing products] both in English and Hindi languages)
  • Mentioning the word “Ayurvedic Medicine” (classical/proprietary)
  • The label of the container or package of Ayurvedic, Siddha, or Unani (ASU) drug for external application shall conspicuously display the words “for external use only”
  • Every drug intended for distribution to the medical profession, as a free sample shall further bear on the label of the container the words “Physicians sample. Not to be sold” which shall be over-printed
  • Reference from authentic texts in case of classical formulations (as mentioned in the schedule 1)
  • Expiry date
  • Inclusion of package inserts.



  Observations and Results Top


Good manufacturing practice validation is an essential element of quality assurance underpinning the safety of Ayurvedic medicines. Among different components of validation, product labels can be viewed as a “clinical instruction manual,” providing a concise description of the benefits and risks for a consumer and relevant information to dispensers, patients, and their caregivers. The format and content of medicinal product labeling are defined by regulations which differ between jurisdictions. Regardless of the specific presentation, the purpose of labeling is to provide accurate, clear, and actionable information to all users of the product, with a primary focus on the prescriber, whose relevant clinical knowledge and ability to understand the content is presumed. Following proper labeling guidelines can assist health professionals and patients/caretakers to select the correct medicine and use it safely, thereby helping to minimize medication errors.

In the present study, containers of a total of 150 GMP-certified Ayurvedic medicines dispensed at Government hospitals and sold at different private pharmacies in Bangalore were assessed for their label information. The collected containers are checked for the compliance of labeling guidelines mentioned in Drugs and Cosmetic Rules 1945 and the result is presented in [Table 1]. Among these 78 products were classical preparations and 72 were proprietary medicines sold by different pharmacies. Total 11 different dosage forms were obtained and analyzed in the study. Among them, maximum classical products were Taila, tablets/Vati and Churna. Majority of the proprietary medicines were tablets and capsules [Table 2].
Table 1: Compliance to labeling guidelines by Ayurvedic medicines

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Table 2: Dosage forms of selected Products

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Among the fourteen criteria derived from labeling guidelines mentioned in Drugs and Cosmetic Rules 1945, all the 150 products were following the standard guidelines with respect to the six basic criteria such as name and address of the manufacture, net weight of the formulation, batch number, license number, date of manufacture and mentioning of the word Ayurvedic medicine (classical/proprietary). As per the rule, it is mandatory to specify “for external use only” if the medicine is intended for external application. In the present analysis, 24 formulations were meant for external application and all of them fulfilled the respective requirements without fail which shows that enough care has been taken to avoid the use of these preparations by wrong route. As per the drugs and cosmetic act, every drug intended for distribution to the medical profession, as a free sample shall further bear on the label of the container the words “Physicians sample. Not to be sold” which shall be over-printed. In the present study, 65 formulations were free samples and all of them were in accordance with the rules.

Ingredients of the products and their drug quantity are the two major components of the labels which help the physicians to decide specific medication and dose accordingly. Apart from that, patients also need to know the contents of the medicines along with their quantity that are advised to them. The label of the container or package of drug shall conspicuously display the true list of all the ingredients used in the manufacture of the preparation together with their quantity. In the present study, it is observed that, though all the proprietary medicines fulfilled these criteria, about 24.35% (n = 78) classical formulations were not according to this specific rule.

Schedule E (1), Rule 161 (2) of the Drugs and Cosmetic Rules, 1945 is the list of poisonous substances under the ASU systems of medicine. If any of these substances are the ingredient of ASU medicine and that medicine is for internal use for the treatment of human ailments then its label shall be labeled conspicuously with the words “Caution: To be taken under medical supervision” both in English and Hindi language. Out of 150 products, 25 were containing poisonous substances specified in Schedule E (1) as an ingredient. Among those 80% (n = 20/25) of the products mentioned “Caution” warning and 20% (n = 5/25) of the products not mentioned the caution warning on their labels. It is observed that out of 20 products mentioned caution warning, 6 were classical and 14 were proprietary medicines. Among the 80% of the products which mentioned caution warning, only 10% (n = 2/20) of the labels provided warning in both Hindi and English languages and 90% (n = 18/20) of the product labels provided warning only in English. As the improperly processed raw drug or any error in preparation of medicines containing poisonous drugs may cause any unintended action, it is necessary to print caution warning in pharmacovigilance point of view. Making available this warning on the label in local language is also of utmost important to prevent the complications due to self-use of such products by the patients.

Among 78 classical formulations, 99% (n = 77/78) of the container labels mentioned the reference from the authoritative textbooks of Ayurveda mentioned in Schedule I of Drugs and Cosmetics Act 1940. In case of classical formulations, it is very important to provide the reference to the authentic Ayurvedic books which is also mandatory as per the act. It shows that even though majority of the classical products followed the rule a small percentage still need to comply with this rule.

Drugs and Cosmetics (5th Amendment) Rules, 2016 states that the date of expiry of ASU medicines shall be conspicuously displayed on the label of container or package of ASU medicine, as the case may be and after the said date of expiry, no medicine shall be marketed, sold, distributed or consumable. The shelf-life of a drug product is defined as the time at which the average drug characteristic or potency remains within an approved specification after manufacture.[5] Shelf life depends on the degradation mechanism of a specific product. It can be influenced by factors such as exposure to light, heat, moisture, transmission of gases, mechanical stresses, and contamination by micro-organisms.[6] In the present study, it is observed that 99% (n = 148/150) of the labels in the present study provided the information regarding the expiry date as per the rule. As there is a general belief that, Ayurvedic medicines can be taken for a long time without any issues, it is very important to provide information regarding the expiry date on their labels. References regarding the Saviryata Avadhi (shelf life) of the different dosage forms are also available in classical texts.[7]

Package insert is defined as a document accompanying a prescribed medication to provide information at a glance about the contents, dosing instructions, indications, adverse effects, contraindications, and precautions to be followed with the use of the drug.[8] In India, requirements for a package insert for Allopathic drugs are clearly defined in the Drugs and Cosmetics Rule 1945 Section 6 of Schedule D (II).[9] However, there is no regulatory requirement for providing package inserts for Ayurvedic drugs. In the present analysis, only 1% (n = 2/150) were accompanied with package inserts. The details provided in the package insets include composition of the product, indications, directions for use, route of administration, side effects, adverse effects, drug interaction, special warning, precautions, and contraindications. Since there is no separate rules available in India for Ayurvedic medicines, package inserts of Ayurvedic drug formulations cannot be expected to be compliant to Schedule D (II) which have been laid for pharmaceutical preparations. There is a need for guidelines to be formulated for package inserts of Ayurvedic medicines to provide all essential information regarding the drug use in a comprehensive manner. Majority of the products used plastic as packaging material in the form of container, strips, and bottles.

Limitations of the study

The objective of this study was to assess the extent of compliance to labeling guidelines specified by the regulatory authorities which may indirectly convey information on safety concerns. Generalizing the findings of the present study needs to be done with a degree of caution as relatively small sample size in this study may not be wholly representative of all Ayurvedic products available in the country. However, our findings corroborate previously published works,[10],[11],[12] and further studies are needed to identify trends in labeling and packaging. Since the Asavas specified in the Section 168 of Drug and Cosmetic Rules, 1945 were not included in the study, the limit of alcohol including maximum content and maximum size of packing could not be assessed which is also a limitation of this study.


  Conclusion Top


A label of the prescribed Ayurvedic medicine must follow the regulatory guidelines given in drugs and cosmetic act. Even though majority of the labels of Ayurvedic drug containers fulfilled the requirements, a good number of Ayurvedic products are still not in accordance with regulatory requirements. This study includes only few products which are collected from the ample of marketed drugs. But the results show many deficiencies in labeling of prescribed medicines which is a real area of concern. Based on the findings of the present analysis, further studies involving Ayurvedic medicines available all over India can be planned to get an exact estimate.

Recommendations

Looking at the current scenario, there is a need of strict enforcement of rules related to labeling content and format of prescribed drugs for better and safer use of medicines. The required labeling guidelines must be followed to ensure complete traceability. A variety of available labeling material options are used by the manufactures to provide the drug-related information. Special consideration is also needed to ensure such data is durable and cannot be rubbed off, even if products are packed tightly together when shipped. Optimum use of digital technology like 2D barcodes and variable print codes can also be considered to ensure traceability and to allow for late-stage customization of product labeling.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Shankar D, Ved DK. A Balanced Perspective for Management of Indian Medicinal Plants. In: The Indian Forester. Vol. 129. Dehradun: Nabu Press; 2003. p. 275-88.  Back to cited text no. 1
    
2.
Veronin M. Packaging and labeling of pharmaceutical products obtained from the internet. J Med Internet Res 2011;13:e22.  Back to cited text no. 2
    
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Malik V. Drug and Cosmetic Act 1940 and Drug and Cosmetic Rules, 1945 with Allied Acts and Rules. 17th ed. Lucknow: Estern Book Company; 2004. p. 141.  Back to cited text no. 3
    
4.
Schommer JC, Pedersen CA, Doucette WR, Gaither CA, Mott DA. Community pharmacists' work activities in the United States during 2000. J Am Pharm Assoc (Wash) 2002;42:399-406.  Back to cited text no. 4
    
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Jun Shao, Shein-Chung Chow. Drug Shelf-Life Estimation. Inc Statistica Sinica 2001;11:737-45.  Back to cited text no. 5
    
6.
Azanha AB, Faria JA. Use of mathematical models for estimating the shelf-life of cornflakes in flexible packaging. Packag Technol Sci 2005;18:161-222.  Back to cited text no. 6
    
7.
Brmhanand T. In: Manaparibhasha, Purvakhanda, Samhita S, editors. Revised edition. Varanasi: Choukhambha Surbharati Prakashan; 2004. p. 18.  Back to cited text no. 7
    
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US Department of Health and Human Services. United States: Food and Drug Administration. Prescription Drug Advertising. Available from: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm072025.htm. [Last accessed on 2016 Feb 19; Last updated on 2016 Feb 19].  Back to cited text no. 8
    
9.
CDSCO. India: Ministry of Health and Family Welfare the Drugs and Cosmetic Act, 1940 (as Amended Upto 30th June, 2005). Schedule D (II) 2005. Available from: http://www.cdsco.nic.in/writereaddata/Drugs and CosmeticAct.pdf. [Last acessed on 2016 Feb 19; Last updated on 2015 May 08].  Back to cited text no. 9
    
10.
Bhalerao S, Munshi R, Tilve P, Kumbhar D. A survey of the labeling information provided for ayurvedic drugs marketed in India. Int J Ayurveda Res 2010;1:220-2.  Back to cited text no. 10
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11.
Lamare R, Kumar B, Singh SK, Singh S. A survey on labeling challenges related to Ayurvedic and proprietary medicines. J Pharm Res 2017;11:823-9.  Back to cited text no. 11
    
12.
Mallick A, Roy A, Krishanu De AB. Assessment on the label of ayurvedic classical and proprietary medicines in accordance with the drug and cosmetic act 1940. Int J Pharma Sci Bio Sci 2012;1:67-74.  Back to cited text no. 12
    



 
 
    Tables

  [Table 1], [Table 2]



 

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