The draft amendment to labelling rules for pharmaceuticals should be ready soon as the sub committee for reviewing labelling standards for drugs set up by the Union Health Ministry is expected to submit its report within a fortnight.

The sub committee is in the final stage of preparing draft report, on par with the global labelling standards of pharmaceutical products, which will be submitted to the health ministry now, official sources said. The report will deal with two critical areas such as labelling standards for exports of pharmaceutical products and the standards for drug packs in domestic market.

The report has to get approval from the concerned departments including Department of Law, before finalization of the draft. The draft amendment will be released after all these formalities are completed.

"The main agenda of the committee was to device methods to simplify the labelling, used even on the complicated, smallest packages and ampoules. The design should be in such a way that the primary and essential details about the product should be conveyable to the nurses and well educated persons who does not have much knowledge on the particular drug," a source from the sub-committee told Pharmabiz.

The report may also suggest inclusion of storage condition as mandatory in rules, to make the companies specify the storage conditions of the particular medicine on the label as compulsory. Though the manufacturing companies specifies the storage conditions in the label voluntarily even at present, there is no such rules to emphasis the inclusion as such, added the source. The move will bring in legibility in the label of drugs.

The sub committee would include provisions for flexible labelling for exports, to fix according to the registration dossier of each country. Following the issuance of product codes like PL number issued by MHRA, UK, the sub committee has also recommended for specific code numbers for the consignments to certain countries. Though this may not be added as mandatory with the amendment, there will be options for granting the code as on request from the relevant party.

The sub committee would also recommend provisions to ensure clarity of labels for easy readability of instructions to whom ever needs the details of the product. In case of instructions printed as box informations, at least one whole box should be in the middle of the label, with perfect clarity to convey the information.

The report may also include a suggestion to add an indication to differentiate vegetarian and non-vegetarian category in drugs. If this is approved, the label with a continuous red line may indicate non-vegetarian drugs including shells and gelatine, while a label with breaking red line would suggest vegetarian drugs. The committee has collected views from OPPI, IDMA and Pharmaceutical Exports Promotion Council.

As Pharmabiz reported earlier, the sub committee, which concluded the matter with two meetings within the last two months, is constituted to look into methods to improve the current labelling system considering the issues in overseas and domestic markets. The objective includes verifying whether the current labelling process is sufficient to meet the quality requirements of the destination region, how to make the labelling simple and effective and the major domestic issues including the introduction of bilingual labelling.