The present survey was conducted to assess whether the labels on Ayurvedic drug containers were in compliance with the Drugs and Cosmetics Act, 1940 with respect to their contents.
We observed thatmajority of the labels did not fulfill all the requirements that were mandatory as per the Act and there was not a single label, which fulfilled all 10 requirements as specified by the Drugs and Cosmetics Act, 1940. The results of the survey showed that nearly 45% of the classical formulations and 12% of proprietary formulations did not provide an Ingredient list.
As per the Act, a reference to the Ayurvedic texts is essential in case of classical formulations to rationalize the preparation of the same. However, this is not required for proprietary formulations. However, we observed that 9% of the proprietary formulations provided textual references for the individual ingredients, which is suggestive of the attempts made by manufacturers to rationalize the use of a particular ingredient in the formulation.
Regarding the issue of Expiry date, the Drugs and Cosmetics Act, 1940 states that the expiry date is mandatory only in case of Ayurvedic drugs that are exported outside the country,[1
] thus implying that it is not compulsory for the expiry date to be printed in case of products marketed in India. Unfortunately, this can be interpreted that Ayurvedic products can be used for years without any issues. However, Sharangadhar Samhita
has clearly specified that all Ayurvedic drugs should have an expiry date.[3
] According to this Samhita
every Ayurvedic formulation has a specific saviryataavadhi
(shelf life), which means that the active ingredients in the formulation are active only up to a given period of time and further use of such formulations can result into no or poor efficacy, e.g., a churna
has a saviryatavadhi
of only four months. If used after this period, the formulation may be ineffective. Hence, through this study we strongly propose that printing of the Expiry date be made compulsory even on those Ayurvedic drugs marketed in India.
The absence of caution warning on the labels is a serious matter as drug container labels remain a source for important information regarding the medications, viz., indications, ingredients, dosage, storage conditions and precautions to consumers and patients, and lack of availability of this information can result in irrational use of these drugs by patients.
None of the labels specified potential drug–drug or drug–food interactions and adverse effects since providing these details for Ayurvedic drugs is not mandatory by the Drugs and Cosmetics Act, 1940. However, considering the wide spread belief that Ayurvedic medicines are “natural” and, therefore, safe can thus lead to life threatening situations in case of misuse or interactions with other medications. Hence, we suggest that the manufacturers should also provide some information about the safety of the formulations (including dosage schedule and drug storage conditions) on the drug labels.
The Drugs and Cosmetics Act, 1940 does not insist on the processing details in case of Bhasmas
, with the result that none of the labels had any of these details. One can find several methods for preparation of one bhasma
in Ayurvedic texts.[4
] Hence, it is necessary to specify which method has been used to manufacture a particular formulation. As there have been serious concerns regarding the presence of heavy metals and their related toxicity in Bhasmas
in the recent past,[5
] a mention of elemental ion content of the heavy metals on the drug container labels will prove advantageous to tackle this problem.
The main limitation of the study is that we could analyze the labels of only 190 of about 630 classical formulations described in the Ayurvedic formulary[4
] and over 1000 Patent and Proprietary formulations available in the market.[7
The present survey highlights that stricter enforcement of law on the marketing of Ayurvedic formulation is necessary.