|
The Indian Drug Manufacturers' Association (IDMA) has asked the Union health ministry to simplify the labeling to avoid confusion amongst the manufacturers, the public and the government authorities.
To clear all misconceptions and bring ease of use to industry, medical professionals, distributors, retailers, patients, and the regulatory officials, the association has suggested that all prescription medicines covered under schedule H, H1, G and X be clubbed together and categorised as Prescription Only Medicine and all others be considered as non prescription medicines. For easy and better distinction, the packs of these subcategories can be colour coded.
S V Veerramani, national president of IDMA, says, “Various schedules have been added over the years to the Drugs and Cosmetics Rules, such as Schedule H, H1, G and X for the prescription products with various labelling requirements applicable to each category. These multiple instructions, red lines, box warnings etc have added to the confusion and a times wrong interpretations.”
The association has proposed to insert a provision which says 'Provided that if the substance specified in schedule H1 comes within the purview of the narcotic drugs and psychotropic substances Act 1985 (61 of 1985), it shall be labeled with the symbol Nrx which shall be in red and conspicuously displayed on the left top corner of the label.' at the end of the clause 3, in sub rule 1, in sub rule 97 of Drugs and Cosmetics Rules 1945.'
The recent draft notification to amend labeling provisions under 96 and 97 says, 'In addition to the other particulars which are required to be printed or written under these rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical band on the left side running throughout the body of the label which should not be less than 5 mm in width, in which words “schedule drug” in black colour shall be overprinted and without disturbing other conditions printed on the label under these rules, namely:- Narcotic analgesics, hypnotics sedatives, tranquillers, corticoteroids, hormones, hypoglycemic, antimicrobials, antipileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under schedules G, H, H1 and schedule X whether covered or not in the above list:'
The association has explained in the recommendation to the health ministry that the proposed 5 mm width will give less space for printing the legal text matter. Hence there will be need to increase the dimension of the strips or packs of tablet or capsules which will increase the cost of packing material and labeling.
Whereas, affixing the symbol NRx in the schedule H and Schedule H1 is indicative of the substance being a Narcotic Drug. The schedule H and schedule H1 of the drugs and cosmetics rules 1945 contain narcotic drugs, psychotropic substances as well as controlled substances. Hence, to use a common symbol for all these categories of drugs or substance would mislead the patients to believe that such drugs being consumed is a Narcotic Drug.
It is a matter of common knowledge that narcotic drugs have a potential for abuse whereas psychotropic substances are more of a habit forming. Controlled substances are not abused directly but are precursors for manufacture of narcotic drugs and psychotropic substances. Hence, to place all such drugs or substances in the same category by using a common symbol thereon would not be appropriate. We suggest that products which are classified as psychotropic substances or controlled substances under the NDPS Act and rules may respectively be marked as PRx and CRx to distinguish them clearly as psychotropic or controlled substances, said IDMA.
|