The Union health ministry is planning to insert new provision under the labelling rules of the Drugs and Cosmetic (D&C) Rules to make sure that unnecessary information, other than the required, are not included on the labels.

This is being planned against instances that drug products are marketed by displaying additional information like the name of the firm as ‘marketed by’ or ‘in associations with’ in addition to the name of the manufacturer, thus creating confusion among the consumers with regard to the original manufacturer.

The names of the firm marketing a product sometime gives the impression that the product has been manufactured by the firm whose name appear in bold letters on the label, while it is not actually manufactured by the such firm, it was pointed out.

According to the existing rules, the labelling provisions laid down under Rule 96 and Rule 97 of D&C Rules does not expressly prohibit the labelling of drugs with the name of marketer along with the original manufacturer.

The Ministry is planning to have an amendment to the Rule 96 to prohibit the labelling of drugs with the name of any manufacturer/ marketer/promoter other than the original manufacturer of the product.

The recent meeting of the Drugs Consultative Committee (DCC) has also made a recommendation in this regard. “The DCC agreed in principle and recommended that a provision may be made in the rules that the label of the drug formulation should not contain any other information except what is required under the D&C Act and Rules or is required to be given in compliance to any other Act in force,” the meeting said.

Another amendment being planned is about the mentioning the batch number, expiry date and the name of the manufacturer on the cash / credit memo for all drugs. The mention of batch number, expiry date and name of the manufacturer is not mandatory for other than Schedule C, C1 and H drugs in the cash or credit memos issued for the sale of such drugs. Whereas the same details are to be mentioned in cash or credit memos issued for the sale of Schedule C and H drugs as per Rule 65(3)(1) & 65(4)(1) of D&C Rules. Such discrimination is causing difficulty during the investigation of cases related to serious adverse reactions caused by the consumption of other than Schedule C and H drugs.

The Rules 65(3)(1) and 65(4)(1) under the D&C Rules 1945 will be suitably amended for mentioning the details of the name of manufacturer of the drugs, Batch No. and date of expiry of potency in a cash or credit memo issued against the sale of any type of drug whether it is on prescription or without prescription, sources said.