In a significant move to regulate the mostly unregulated medical devices industry in the country, the Union health ministry has amended Rule 109A of the Drugs and Cosmetics Rules (D&C Rules) to make labelling of medical devices mandatory in the country.
In a Gazette notification GSR 690 (E) dated 25th September, 2014, the ministry said, “Subject to the other provisions of these rules, the following particulars shall be printed in indelible ink on the label or sticker on the shelf pack of the medical device or on the outer cover of such medical device and on every outer covering in which the medical device is packed.
As per the notification, the label should carry proper name of the medical device; the details necessary for the user to identify the device and its use; the name of the manufacturer and address of the manufacturing premises where the device has been manufactured; the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package shall be expressed in metric system; and the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product: Provided that in the case of sterile devices the date of sterilisation may be given as date of the manufacture of the device: Provided further that the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary.
Besides, the label of a medical device should provide, wherever required, an indication that the device contains medicinal or biological substance; a distinctive batch number or lot number preceded by the word "Lot No." or "Lot" or "Batch No." or "B. No."; it should indicate, wherever required, any special storage or handling conditions applicable to the device; if the device is supplied as a sterile product, its sterile state and the sterilisation method; and the label should give, if considered relevant, warnings or precautions for the attention of the user of the medical device.
It should label the device, if the device is intended for single use; to overprint on the label of the container, the words "FOR CLINICAL INVESTIGATION ONLY", if the device is intended for clinical investigation; and to overprint on the label of the device, the words "Physician's Sample--Not to be sold", if a medical device is intended for distribution to the medical professional as a free sample.
According to the notification, the label of a medical device should provide, except for imported devices, the manufacturing licence number by preceding the words “manufacturing license number' or 'Mfg Lic No' 'ML'; devices or in-vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs shall provide the information affixing additional label or sticker on outer shelf pack; provide on the label, in case of imported devices, with the approval of the licensing authority mentioned in rule 21, the import licence number, name and address of the importer and address of the actual manufacturing premises, date of manufacture, (if not already printed at the time of import): Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardisation (ISO) in lieu of text and the device safety is not compromised by a lack of understanding on the part of the user in case the meaning of the symbol is not obvious to the device user'.