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In pharmaceutical industry, packaging is deemed vital due to the sensitive nature of the contents. Right packaging is required to ensure the quality of the drug product. Most drugs need protection from light and moisture. Medicine packaging has to meet the information dissemination standards. There must be enough space for clear labelling and correct information about the product. The colour of printing and font should support ease of reading to all including the elderly.
The present scenario in India, is far from the expectations of the patient. Reading the information on most of the small packs like blister packs, strip packs and small pouch packs is a superhuman task for the patients. The whole concept of product labelling in India needs to be transformed for the sake of patients both young adults, senior citizens. Lot needs to be done by the regulators, members of DTAB and the industry to ensure what is important for the patients is available and are legible and easy to read. Industry just follows what the regulators legislate and don’t question even when it is sometimes ludicrous. Why am I saying this? Many of you must have experienced, after using a few tablets from a blister pack or a strip pack, neither the product name nor the expiry date is visible. This obviously increases the risk of using expired product or discarding a good product. Patients ailing from chronic diseases who are taking multiple products and it becomes difficult to pick up the right product from a multiple product box or a pouch at home.
Indian labelling requirements are age old, with may requirements not relevant today and most of them not so much useful for the patients and meeting mostly regulators’ requirements. It is a wishful thinking of a few that some of the mandated label text benefits the patients. I have made an attempt to make labelling of medicines in India patient-friendly by proposing a major change to the manner of labelling of medicines in India.
From the point of view of its utility, the label text requirements as given in D&C Rules, may be divided into three categories.
Information for patients: Product name, composition, expiry date, MRP, directions for use, net contents and storage conditions.
Information for regulators: Composition, licence number and manufacturing date, expiry date, full address of the manufacturer, full address of marketing company (if any), symbol Rx for prescription drugs, red vertical line on certain categories of drugs, and generic name two font bigger than the brand name.
Information for retail chemists: Storage conditions, warnings and caution regarding categories of drugs like Schedule G & H, H1 drugs, MRP, name and address of the manufacturer.
Some of the requirements is given in the table below:
| Sr no | Labelling requirement introduced in 80’s and 90’s | Date of introduction of the provision | Present view for small packs - e.g., oral solid dosage forms packed in strips and blisters | | 1 | Schedule H drug warning: To be sold on the prescription of a registered medical practitioner | 22.6.1982 vide GSR462(E) | Need to appear only on outermost box or box that reaches retail outlets. Final strip/blister reaching patient should be spared of this. | | 2 | Schedule G drug caution: It is dangerous to take this preparation except under medical supervision. | 22.6.1982 vide GSR462(E) | How are drugs in Schedule G different from Schedule H drug? Do the regulators mean that it is fine to buy this without prescription, but after buying go to the doctor and tell you are taking the medicine? There should be only two categories of drugs viz., prescription & non-prescription drugs | |
3 | Schedule G drug Prescription drug-caution: it is dangerous to take this preparation except under medical supervision’
| GSR 408(E) dated 26.4.18
| It says schedule G drug is a prescription drug. However, can be sold without a prescription of registered medical practitioner. But patient should take it under medical supervision. Really ludicrous. | | 4 | Red line of 1 mm width on certain categories of drugs | 17.6.1992 vide GSR597(E) | Serves no purpose, patient does not look at it. It appears like a packaging design. Only regulators think red line means danger. | | 5 | Dosage: Take as directed by the physician. | 22.6.82 vide GSR462(E) | If the patient has purchased it after visiting a doctor, he/she will definitely take it as directed by the physician. So, either provide the dose details or omit this line. | | 6 | Generic name more conspicuous than the brand name. This was changed to generic name to be two fonts bigger than the brand name | 17.1.1981 vide GSR 27(E)
13.3.2018 vide GSR222(E)
| This is not going to help push prescribing in generic name and how is the patient benefiting from this archaic thinking? If regulators are so keen on generic name, let there be only generic drugs after patent expiry as in many countries. |
The labelling requirements for drug products generally apply to all container sizes and also requires that innermost container in which the drug is packed and every other covering in which that container is packed should include the label text. Some containers are too small to show all the information required by the rules in a manner they are readable with a normal eye. One may need a magnifying glass to read it. One way to address the problem and make our labelling more patient friendly, is to provide only patient related information for innermost pack of all small packs. That is, introduce abbreviated labelling for inner labels of small containers, special containers and blisters and strip packs and full labelling for outer cartons.
The outer carton should include the entire text as given in Rule 96 and 97.
However, some containers are too small to show all the information required by the Rules.
Rule 96 and 97 of D&C Rules should be revised to include the following:
Generic name and brand of same font size but repeated several times; Provide adequate directions for use of the drug product; Manufacturer should consider the colour, contrast, position, and spacing of the information when complying with the requirement; The format of the label including the manner in which all of its text and any graphics are displayed on it, shall not impede comprehension of the information;
It is to be recognized that under some conditions such as font type, colour, contrast, spacing and other factors, smaller font size may be legible, but it is the manufacturer's responsibility to ensure that this is readable to most people with normal vision; It is important that the particulars remain available to the user up to the point at which the last dose is removed from the blister pack; Requirement that the inner and outer labels show "adequate directions for use of the drug product;
The name and strength of the product expiry date should appear over each blister pocket or be oriented centrally across the pack; Colour for the text and the font style, should be chosen carefully as the legibility of the text on the foil is already impaired due to the nature of the material. Where possible, non-reflective material or coloured foils should be considered to enhance the readability of the information presented and the correct identification of the medicine. blister foils should be printed to ensure maximum legibility of the statutory information using a sufficiently large font.
Regarding category of drugs, there should be only two categories i.e., prescription drugs and non-prescription drugs and do away with Schedule G and its warning.
Pack insert and patient information leaflet
Package insert which provides details about the drug for the reference of the prescribing doctor is usually given along with only new drugs. The drug and cosmetic rule is silent on the need of package insert for Schedule H and H1 drugs.
Today it is left to the companies to provide pack insert with a prescription drug.
It should be made mandatory to include patient information leaflet for those drugs, for which more detailed information that may be necessary for the proper use of the drug product by the consumer. For example, drugs to be taken before food, food to be avoided and drugs to be avoided while taking certain drugs. For example, Azithromycin was administered by large number of patients, during Covid-19 pandemic period, how many have taken it before food to ensure adequate absorption is anybody’s guess. So, such directions need to be provided using patient information leaflet because there is huge self-medication that happens in India due to lax regulatory oversight.
Patient information leaflet is a regulatory requirement in many countries. For a prescription drug product, this consumer information may be a package insert.
The drugs should be categorised into two namely, prescription and non-prescription drugs and Schedule H, H1 and G should be omitted to make labelling easy and simple.
It should be responsibility of the companies launching new drugs to educate the retail outlets about nature of the drug in terms of prescription drug or any additional regulatory requirement on the label. State Pharmacy Councils also have the responsibility to educate registered pharmacists about the new drugs being launched in the country.
Conclusion
To ensure patient-friendly labelling, suggest the following: Text on the pack reaching the patient should include the following; Brand name as many times as possible on a pack if it is strip or blister; proper name, repeat it if there is no brand name; composition, colour used if any; lot number; expiry date - repeat as many times as possible; storage condition; direction for use; manufacturers’ names and addresses. The outer pack such as carton should include the following: Brand name; Proper name or generic name; composition, colour used if any; lot number; manufacturing date; expiry date; storage condition; direction for use; manufacturers’ names and addresses; Schedule H drug for all prescription drugs; licence number; marketed by, in case the product is marketed by a company other than the manufacturer.
(Author is pharmaceutical quality and compliance professional)
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