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The Central drug authority will soon constitute a sub-committee to look into the issues faced by the consumers in connection to the packaging and labelling of drugs, and propose if an amendment is needed to the Drugs Rules, 1945 in order to address the issue.
A Drugs Consultative Committee (DCC) meeting held in June, has recommended to the Drugs Controller General (India) to constitute a sub-committee to look into the issues and evaluate whether an amendment is required to the Drugs Rules, 1945 in this connection.
The DCC, the advisory committee that advises the Central and state governments on matters that require uniform implementation across the country, recommended to include one packaging expert in the sub-committee, and that it should also evaluate the feasibility of incorporating suitable regulation for suppliers of packaging materials and printed foils etc, under Drugs Rules.
The Committee was apprised of various concerns received by the authorities from the consumers in their public grievances platforms, from time to time with regard to labelling.
The concerns include that the paper where expiry date is mentioned is torn while taking out the medicine, and the surface of the medicine strip is too shiny to read the details.
Besides, the letters of expiry date are too small and the name of the medicine should be printed on a continuous basis instead of at one place only. The consumers also suggested that there should be a universally recognised symbol on the generic medicines that will distinguish it from the branded medicines.
The DCC, during the meeting, also directed the Central Drugs Standard Control Organisation (CDSCO) to share the recommendations of another sub-committee regarding problems faced by the blind and visually impaired people to read medicine strips, with the stakeholders for public comments.
The Committee recommended that the secondary packaging containing more than 10 units of medicines may have some braille cards for giving to such a population as and when required. Besides, the medicines can have QR code linked with voice assistance.
The DCC, after considering the recommendations of the sub-committee, opined that the recommendations of the sub-committee may be placed on the CDSCO website for public comments.
The sub-committee was formed after a proposal on the issues faced by the blind or visually impaired people to read medicine strips was raised in the 58th DCC meeting in July, 2020.
Strips of the tablets or capsules are not available with information in Braille and hence difficult to identify by the visually impaired people. The printed matter on such drugs has very small font and has poor legibility which even poses difficulty to the persons having normal vision.
The Committee in 2020 observed that at present, there is no labelling provision in the Drugs and Cosmetics Act and Rules, which take into consideration the needs of the blind or visually impaired people. As a result these special categories of people face difficulty to know the name and expiry date of the medicines. Hence, requested that a provision shall be made to label the drugs with Braille inscriptions.
The matter was also deliberated with the industry stakeholders in a virtual meeting held on June 23, 2020 to devise a mechanism in this regard. Industry, according to the DCC, informed that it is difficult to provide necessary information on the label of medicines in Braille due to space constraints. Further, the industry submitted that it is not aware whether internationally such practices are adopted and at this stage such a proposal is difficult to accept.
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